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The information in this guide is to our best knowledge true and accurate but, all instructions, recommendations or suggestions

are made without guarantee. Since the conditions of use are beyond their control, Signet Chemical Corporation Pvt. Ltd. disclaims any liability for loss or damage suffered for use of this data or suggestions. Furthermore, no liability is accepted if use of any product in accordance with this data or suggestions infringes any patent. Copyright 2011 Signet Chemical Corporation Pvt. Ltd. All rights reserved. The content in this publication is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher.

Signet Chemical Corporation Pvt. Ltd.

For over twenty five years, Signet has aligned its key focus towards providing the worlds best pharmaceutical raw materials to Indian scientists and formulators. By steadily establishing brands, promoting advanced processes and encouraging a shift towards newer developments and innovative applications, today Signet occupies a stellar position as Indias largest excipients distributing company. Setting Benchmarks through Market Understanding: We at Signet believe in providing the highest level of customer service, catering high quality products and providing a strong support infrastructure to ensure smooth delivery of customer expectations. Global Connections for Global Giants: Staying informed about every international excipient producer in the market and bringing all new developments to our customers doorstep, is what we strive to achieve every day. Everything Excipients: Signet, with its widely suitable, quality centred, robust and evolving range of excipients, today serves as a One-Stop-Shop for formulators, with products manufactured in locations approved by international drug regulatory bodies. The Entire Spectrum of Applications: Binders, fillers and disintegrants, sweeteners and coating agents - the company attempts at addressing every application need. From oral and dermal administration to intravenous delivery, our portfolio covers it all. Evolved Systems and Processes: The pharmaceutical industry operates in a stringent regulatory environment and to comply with this need, we at Signet provide all requisite documents and support regarding the use and safety of products. Our customers can be assured of quality, transparency and reliability, at all times. Team Signet. Our Power, Our Pride: At Signet, a fine blend of commercial and technical members have set a culture of proactivity, approachability and responsibility. The companys greatest asset - its people - come together to give Signet a distinctive edge in the market today.

towards success & growth

Product List

Application Guide

FMC BioPolymer

Roquette Frres

DFE Pharma

BASF

Shin-Etsu CP Kelco

Innophos Pharm-A-Spheres Ferro Corporation

Asahi Kasei Dead Sea Periclase

Scora

Imerys (Luzenac)

Kronos

Lakeshore Biomaterials

NovaMatrix

Ferro Pfanstiehl

FreislandCampina Domo

Eastman

Cytec

Tereos Excipients

Rockwood Pigments

AMCOL HBS

Specialty Minerals

GumBase

Glossary

Contact

Product List
Company Products
AVICEL PH - Microcrystalline Cellulose AVICEL DG - Microcrystalline Cellulose And Dibasic Calcium Phosphate AVICEL HFE-102 - Microcrystalline Cellulose And Mannitol AVICEL CE-15 - Microcrystalline Cellulose And Guar Gum AVICEL RC / CL - Microcrystalline Cellulose And Carboxymethylcellulose Sodium AC-DI-SOL - Croscarmellose Sodium ALUBRA PG 100 - Sodium Stearyl Fumarate AQUACOAT ECD-30 - Ethylcellulose Aqueous Dispersion LUSTRECLEAR LC-103 - Microcrystalline Cellulose And Carrageenan Based Coating System PROTANAL / MANUGEL / KELTONE / MANUCOL / KELCOSOL / KELSET / KELCOLOID - Alginates PROTACID / KELACID - Alginic Acid GELCARIN / VISCARIN / SEASPEN - Carrageenan PEARLITOL - Mannitol PEARLITOL FLASH - Compound Of Mannitol And Maize Starch XYLISORB - Xylitol NEOSORB - Sorbitol SWEETPEARL - Maltitol LYCASIN - Maltitol Solution POLYSORB - Anhydrized Liquid Sorbitol KLEPTOSE - Betadex KLEPTOSE HPB - Hydroxypropyl Betadex LYCADEX PF - Dextrose Monohydrate, Pyrogen-Free DEXTROSE MONOHYDRATE GC - Dextrose Monohydrate, Agglomerated DEXTROSE ANHYDROUS C - Dextrose Anhydrous, Crystalline MAIZE / WHEAT / POTATO STARCH - Native Starch LYCATAB PGS - Fully Pregelatinized Starch LYCATAB C - Partially Pregelatinized Starch LYCATAB DSH - Partially Hydrolyzed Starch GLYCOLYS - Sodium Starch Glycolate LYCOAT RS - Starch Based Coating System READILYCOAT - Ready-To-Use Starch Based Coating Sytem GLUCIDEX - Maltodextrin / Corn Syrup Solids TACKIDEX - Dextrin STARLAC - Compound Of Maize Starch And Lactose Monohydrate NUTRIOSE - Soluble Fibre HI-SWEET - High Fructose Corn Syrup PHARMATOSE / LACTOCHEM / HMS LACTOSE - Lactose Monohydrate, Sieved, Milled, Impalpable 33 21

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SUPERTAB SD / LACTOPRESS SD - Spray-Dried, Directly Compressible Lactose SUPERTAB AN / LACTOPRESS AN - Anhydrous, Directly Compressible Lactose SUPERTAB GR / LACTOPRESS GR - Granulated, Directly Compressible Lactose
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01

Product List
Company Products
KOLLIDON - Povidone (PVP K) KOLLIDON CL - Crospovidone KOLLIDON VA 64 - Copovidone KOLLIDON SR - Blend Of Polyvinyl Acetate And Povidone KOLLICOAT SR 30 D - Polyvinyl Acetate Dispersion KOLLICOAT IR - Macrogol Poly (Vinyl Alcohol) Grafted Copolymer KOLLICOAT IR COATING SYSTEMS - Ready-To-Use Coating Systems KOLLICOAT PROTECT - Macrogol Poly (Vinyl Alcohol) Grafted Copolymer And PVA KOLLICOAT MAE - Methacrylic Acid Copolymer KOLLICOAT SMARTSEAL 30 D - Methyl Methacrylate And Diethylaminoethyl Methacrylate Copolymer Dispersion KOLLIPHOR (CREMOPHOR) - Polyoxyl-Hydrogenated Castor Oil KOLLIPHOR CS (LANETTE PH) - Cetostearyl Alcohol, Emulsifying / Sodium Cetostearyl Sulfate KOLLIPHOR HS 15 (SOLUTOL HS 15) - Polyoxyl-15-Hydroxystearate KOLLIPHOR MCE (EUMULGIN B PH) - Polyoxyl Cetostearyl Ether KOLLIPHOR P / KOLLISOLV P (LUTROL F / LUTROL L) - Poloxamer KOLLIPHOR PS (POLYSORBATE PH) - Polysorbates KOLLIPHOR SLS (TEXAPON) - Sodium Lauryl Sulfate KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) - Vitamin E Polyethylene Glycol Succinate KOLLISOLV G (SPEZIOL G PF) - Glycerin / Glycerol KOLLISOLV PG - Propylene Glycol KOLLISOLV GTA (SPEZIOL GTA) - Triacetin KOLLISOLV PEG (LUTROL E) - Polyethylene Glycol (Macrogol) KOLLISOLV MCT (MYRITOL PH) - Medium Chain Triglycerides KOLLIWAX (SPEZIOL C PHARMA) - Myristyl / Cetyl / Stearyl / Cetostearyl Alcohol KOLLIWAX GDB (SPEZIOL GDB PHARMA) - Glyceryl Behenate KOLLIWAX GMS II (CUTINA GMS VPH) - Glyceryl Monostearate 40-55 (Type II) KOLLIWAX HCO (CUTINA HR PH) - Hydrogenated Castor Oil KOLLIWAX S (SPEZIOL L2SM) - Stearic Acid KOLLICREAM CP 15 (CUTINA CP PH) - Cetyl Palmitate 15 KOLLICREAM DO (CETIOL V PH) - Decyl Oleate KOLLICREAM IPM (ISOPROPYL MYRISTATE PH) - Isopropyl Myristate KOLLICREAM OA (HD EUTANOL V PH) - Oleyl Alcohol KOLLICREAM ODD (EUTANOL G PH) - Octyldodecanol LUDIFLASH - Compound Of Mannitol, Crospovidone And Polyvinyl Acetate LUDIPRESS - Compound Of Lactose Monohydrate And Povidone SOLUPLUS - Polyvinyl Caprolactam-Polyvinyl Acetate-Polyethylene Glycol Graft Copolymer NOVATA - Hard Fat PHARMACOAT - Hypromellose (HPMC), Low Viscosity METOLOSE SH - Hypromellose (HPMC), High Viscosity METOLOSE SR - Hypromellose (HPMC), For Sustained-Release METOLOSE SM - Methylcellulose HPMCP - Hypromellose Phthalate L-HPC - Low-Substituted Hydroxypropyl Cellulose SHIN-ETSU AQOAT - Hypromellose Acetate Succinate
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Product List
Company Products
A-TAB - Dicalcium Phosphate Anhydrous, Granular CALIPHARM A - Dicalcium Phosphate Anhydrous, Powder DI-TAB - Dicalcium Phosphate Dihydrate, Granular CALIPHARM D - Dicalcium Phosphate Dihydrate, Powder TRI-TAB - Tricalcium Phosphate Anhydrous, Granular TRI-CAL WG - Tricalcium Phosphate Anhydrous, Granular TCP-DC - Tricalcium Phospate, Granular CALIPHARM T - Tricalcium Phosphate Anhydrous, Powder VERSACAL MP - Tricalcium Phosphate Anhydrous, Micronized Powder CELPHERE - Microcrystalline Cellulose Spheres PC-10 - Partly Pregelatinised Starch SWELSTAR - Pregelatinised Starch TREHALOSE - Non-Reducing Di-Saccharide XANTURAL - Xanthan Gum KELCOGEL CG - Gellan Gum CEKOL - Carboxymethylcellulose Sodium
TM

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PHARM-A-SPHERES - Sugar Spheres MAGNESIUM OXIDE - Heavy / Directly Compressible MAGNESIUM CARBONATE - Heavy / Granulated MAGNESIUM HYDROXIDE - Directly Compressible SCORALITE - Calcium Carbonate SCORALITE DC - Directly Compressible Calcium Carbonate SCORABLEND - Compound Of Calcium Carbonate And Magnesium Oxide SCORAMAG DC - Directly Compressible Magnesium Carbonate LIGHT MAGNESIUM CARBONATE LIGHT MAGNESIUM OXIDE SYNPRO MAGNESIUM STEARATE VG SYNPRO ZINC STEARATE VG SYNPRO CALCIUM STEARATE VG SYNPRO ALUMINIUM STEARATE VG LUZENAC PHARMA - Talc LUZENAC PHARMA M - Talc, Micronized LUZENAC PHARMA UM - Talc, Ultra-Micronized KRONOS 1171 - Titanium Dioxide, Super-White, Anatase Grade POLYGLYCOLIDE POLY(DL-LACTIDE) POLY(DL-LACTIDE-CO-GLYCOLIDE) POLYCAPROLACTONE

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03

Product List
Company Products
PRONOVA - Sodium Alginate, Ultra-Pure PROTASAN - Chitosan, Ultra-Pure SODIUM HYALURONATE PHARMA GRADE SUCROSE, Low Endotoxin D-GALACTOSE, Low Endotoxin MALTOSE, Low Endotoxin PROYIELD / HYVITAL - Protein Hydrolysate HIPROTAL - Whey Protein Concentrate REFIT - Milk Protein VIVINAL GOS - Galacto-Oligosaccharide COLOSTRUM VIVINAL LACTOFERRIN CASEINATE CELLULOSE ACETATE (C-A) CELLULOSE ACETATE PHTHALATE (C-A-P) DSS - Docusate Sodium (100%) DSS GRANULAR - Docusate Sodium (85%) With Sodium Benzoate DSS 50% - Docusate Sodium (50%) In PEG 400 COMPRESSUC - Directly Compressible Sucrose ICING SUGAR - Milled Sucrose CASTER SUGAR / CRYSTAL SUGAR - Screened Sucrose SICOVIT - Ferric (Iron) Oxide MAGNABRITE HV - Magnesium Aluminium Silicate, High Viscosity MAGNABRITE K - Magnesium Aluminium Silicate, Acid Stable MAGNABRITE S - Magnesium Aluminium Silicate, Regular MAGNABRITE F - Magnesium Aluminium Silicate, Micro-Fine MAGNABRITE HS - Purified Bentonite, High Stability STURCAL - Precipitated Calcium Carbonate, Heavy CALOPAKE - Precipitated Calcium Carbonate, Extra-Light POWDER GUM - Directly Compressible Chewing Gum Base MEDGUM BASE - Medicated Chewing Gum Base 115 113 109 111 105 103 101 97 95

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04

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05

Application Guide
Products by Category
A-TAB AVICEL DG AVICEL HFE-102 AVICEL PH CALIPHARM CALOPAKE EXTRA LIGHT CASTER SUGAR / CRYSTAL SUGAR COMPRESSUC DEXTROSE ANHYDROUS C DEXTROSE MONOHYDRATE GC DI-TAB GLUCIDEX HMS LACTOSE ICING SUGAR KOLLIDON KOLLIDON VA 64 LACTOCHEM LACTOPRESS LUDIFLASH LUDIPRESS LYCATAB DSH LYCATAB PGS MAGNESIUM CARBONATE MAGNESIUM HYDROXIDE MAGNESIUM OXIDE MAIZE / WHEAT / POTATO STARCH METOLOSE SH / SM NEOSORB P PEARLITOL PHARMACOAT PHARMATOSE SCORALITE SCORALITE DC STARLAC STURCAL SUPERTAB SWEETPEARL SWELSTAR WB-1 TACKIDEX TCP-DC TREHALOSE TRI-CAL WG TRI-TAB VERSACAL MP XYLISORB

Description
Dicalcium Phosphate Anhydrous, Granular Microcrystalline Cellulose And Dibasic Calcium Phosphate Microcrystalline Cellulose And Mannitol Microcrystalline Cellulose Dicalcium Phosphate, Powder Precipitated Calcium Carbonate, Extra-Light Screened Sucrose Directly Compressible Sucrose Dextrose Anhydrous, Crystalline Dextrose Monohydrate, Agglomerated Dicalcium Phosphate Dihydrate, Granular Maltodextrin / Corn Syrup Solids Lactose Monohydrate, Impalpable Milled Sucrose Povidone (PVP K) Copovidone Lactose Monohydrate, Sieved / Milled Directly Compressible Lactose Compound Of Mannitol, Crospovidone And Polyvinyl Acetate Compound Of Lactose Monohydrate And Povidone Partially Hydrolyzed Starch Fully Pregelatinized Starch Magnesium Carbonate (Light / Heavy) Magnesium Hydroxide Magnesium Oxide (Light / Heavy) Native Starch Hypromellose (HPMC) / Methylcellulose Sorbitol Mannitol Hypromellose (HPMC), Low Viscosity Lactose Monohydrate, Sieved / Milled Calcium Carbonate Directly Compressible Calcium Carbonate Compound Of Maize Starch And Lactose Monohydrate Precipitated Calcium Carbonate, Heavy Directly Compressible Lactose Maltitol Pregelatinized Starch Dextrin Tricalcium Phospate, Granular Non-Reducing Di-Saccharide Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Micronized Powder Xylitol

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FILLERS / DILUENTS AND BINDERS

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06

Application Guide
Products by Category BINDER-DISINTEGRANT
L-HPC LYCATAB C PC-10

Description
Low-Substituted Hydroxypropyl Cellulose Partially Pregelatinized Starch Partly Pregelatinised Starch Croscarmellose Sodium Sodium Starch Glycolate Alginic Acid Crospovidone Low-Substituted Hydroxypropyl Cellulose Alginic Acid Pregelatinized Starch Carboxymethylcellulose Sodium Cellulose Acetate Carrageenan Propylene Glycol Alginate Sodium-Calcium Alginate Sodium Alginate Blend Of Polyvinyl Acetate And Povidone Vitamin E Polyethylene Glycol Succinate Glyceryl Behenate Glyceryl Monostearate 40-55 (Type II) Hydrogenated Castor Oil Stearic Acid Hypromellose (HPMC) Pregelatinized Starch Xanthan Gum Ethylcellulose Aqueous Dispersion Screened Sucrose Cellulose Acetate Cellulose Acetate Phthalate Hypromellose Phthalate Sodium Alginate Macrogol Poly (Vinyl Alcohol) Grafted Copolymer Ready-To-Use Coating Systems Methacrylic Acid Copolymer Macrogol Poly (Vinyl Alcohol) Grafted Copolymer And PVA Polyvinyl Acetate Dispersion Microcrystalline Cellulose And Carrageenan Based Coating System Starch Based Coating System Hypromellose (HPMC), Low Viscosity Ready-To-Use Starch Based Coating System Hypromellose Acetate Succinate Maltitol Xylitol

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59 28 66 17 29 19 39 59 19 67 72 102 20 19 19 19 40 46 49 49 50 50 58 67 70 18 108 102 102 57 19 41 41 42 41 40 18 29 56 29 60 25 23

AC-DI-SOL GLYCOLYS KELACID KOLLIDON CL L-HPC PROTACID F120NM SWELSTAR PD-1

DISINTEGRANTS

CEKOL CELLULOSE ACETATE GELCARIN / VISCARIN KELCOLOID / PROTANAL KELSET KELTONE / MANUCOL / KELCOSOL KOLLIDON SR KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) KOLLIWAX GDB (SPEZIOL GDB PHARMA) KOLLIWAX GMS II (CUTINA GMS VPH) KOLLIWAX HCO (CUTINA HR PH) KOLLIWAX S (SPEZIOL L2SM) METOLOSE SH / SR SWELSTAR MX-1 XANTURAL AQUACOAT ECD-30 CASTER SUGAR / CRYSTAL SUGAR CELLULOSE ACETATE CELLULOSE ACETATE PHTHALATE (C-A-P) HPMCP KELTONE / MANUCOL KOLLICOAT IR KOLLICOAT IR COATING SYSTEMS KOLLICOAT MAE KOLLICOAT PROTECT KOLLICOAT SR 30 D LUSTRECLEAR LC-103 LYCOAT RS PHARMACOAT READILYCOAT SHIN-ETSU AQOAT SWEETPEARL XYLISORB

MODIFIED RELEASE AGENTS

COATING AGENTS (FUNCTIONAL AND NON-FUNCTIONAL)

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07

Application Guide
Products by Category
AVICEL CE-15 AVICEL HFE-102 CASTER SUGAR / CRYSTAL SUGAR COMPRESSUC ICING SUGAR LUDIFLASH LUDIPRESS LYCOAT RS NEOSORB P PEARLITOL PEARLITOL FLASH STARLAC SWEETPEARL XYLISORB

Description
Microcrystalline Cellulose And Guar Gum Microcrystalline Cellulose And Mannitol Screened Sucrose Directly Compressible Sucrose Milled Sucrose Compound Of Mannitol, Crospovidone And Polyvinyl Acetate Compound Of Lactose Monohydrate And Povidone Starch Based Coating System Sorbitol Mannitol Compound Of Mannitol And Maize Starch Compound Of Maize Starch And Lactose Monohydrate Maltitol Xylitol Screened Sucrose Directly Compressible Sucrose Dextrose Anhydrous, Crystalline Dextrose Monohydrate, Agglomerated High Fructose Corn Syrup Milled Sucrose Maltitol Solution Sorbitol Mannitol Maltitol Non-Reducing Di-Saccharide Xylitol Sodium Alginate Betadex Hydroxypropyl Betadex Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Sodium Alginate, Ultra-Pure Chitosan, Ultra-Pure Ethylcellulose Aqueous Dispersion Betadex Hydroxypropyl Betadex Macrogol Poly (Vinyl Alcohol) Grafted Copolymer Methacrylic Acid Copolymer Methyl Methacrylate And Diethylaminoethyl Methacrylate Copolymer Dispersion Polyvinyl Acetate Dispersion Non-Reducing Di-Saccharide

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CHEWABLE AND ORODISPERSIBLE AIDS

CASTER SUGAR / CRYSTAL SUGAR COMPRESSUC DEXTROSE ANHYDROUS C DEXTROSE MONOHYDRATE GC HI-SWEET ICING SUGAR LYCASIN NEOSORB P PEARLITOL SWEETPEARL TREHALOSE XYLISORB KELTONE / MANUCOL KLEPTOSE KLEPTOSE HPB POLY(DL-LACTIDE) POLY(DL-LACTIDE-CO-GLYCOLIDE) POLYCAPROLACTONE POLYGLYCOLIDE PRONOVA UP / SL PROTASAN UP

BULK SWEETENERS

ENCAPSULATING AGENTS

TASTE MASKING AGENTS


AQUACOAT ECD-30 KLEPTOSE KLEPTOSE HPB KOLLICOAT IR KOLLICOAT MAE KOLLICOAT SMARTSEAL 30 D KOLLICOAT SR 30 D TREHALOSE

08

Application Guide
Products by Category SOLUBILIZERS
DOCUSATE SODIUM KLEPTOSE KLEPTOSE HPB KOLLICREAM DO (CETIOL V PH) KOLLICREAM IPM (ISOPROPYLMYRISTATE PH) KOLLICREAM OA (HD EUTANOL V PH) KOLLICREAM ODD (EUTANOL G PH) KOLLIPHOR (CREMOPHOR) KOLLIPHOR HS 15 (SOLUTOL HS 15) KOLLIPHOR P (LUTROL F) KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) KOLLISOLV GTA (SPEZIOL GTA) KOLLISOLV MCT (MYRITOL PH) KOLLISOLV P (LUTROL L) SOLUPLUS

Description
Dioctyl Ester Of Sodium Sulfosuccinate Betadex Hydroxypropyl Betadex Decyl Oleate Isopropyl Myristate Oleyl Alcohol Octyldodecanol Polyoxyl-Hydrogenated Castor Oil Polyoxyl-15-Hydroxystearate Poloxamer Vitamin E Polyethylene Glycol Succinate Triacetin Medium Chain Triglycerides Poloxamer Polyvinyl Caprolactam-Polyvinyl Acetate-Polyethylene Glycol Graft Copolymer Dioctyl Ester Of Sodium Sulfosuccinate Propylene Glycol Alginate Cetyl Palmitate 15 Cetostearyl Alcohol, Emulsifying / Sodium Cetostearyl Sulfate Polyoxyl Cetostearyl Ether Poloxamer Polysorbates Sodium Lauryl Sulfate Vitamin E Polyethylene Glycol Succinate Poloxamer Glyceryl Monostearate 40-55 (Type II) Stearic Acid Magnesium Aluminium Silicate Gellan Gum Propylene Glycol Alginate Crospovidone Propylene Glycol Aluminium Stearate Microcrystalline Cellulose And Carboxymethylcellulose Sodium Carboxymethylcellulose Sodium Carrageenan Gellan Gum Magnesium Aluminium Silicate Hypromellose (HPMC) / Methylcellulose Xanthan Gum

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DOCUSATE SODIUM KELCOLOID / PROTANAL KOLLICREAM CP 15 (CUTINA CP PH) KOLLIPHOR CS (LANETTE PH) KOLLIPHOR MCE (EUMULGIN B PH) KOLLIPHOR P (LUTROL F) KOLLIPHOR PS (POLYSORBATE) KOLLIPHOR SLS (TEXAPON) KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) KOLLISOLV P (LUTROL L) KOLLIWAX GMS II (CUTINA GMS VPH) KOLLIWAX S (SPEZIOL L2SM) MAGNABRITE

EMULSIFIERS

STABILIZERS

KELCOGEL CG KELCOLOID / PROTANAL KOLLIDON CL-M KOLLISOLV PG SYNPRO STEARATE (Al)

AVICEL RC / CL CEKOL GELCARIN / VISCARIN / SEASPEN KELCOGEL CG MAGNABRITE METOLOSE SH / SM XANTURAL

SUSPENDING AGENTS

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09

Application Guide
Products by Category THICKENERS
CEKOL GELCARIN / VISCARIN / SEASPEN KELCOGEL CG KOLLIDON KOLLIPHOR P (LUTROL F) KOLLISOLV P (LUTROL L) MAGNABRITE METOLOSE SH / SM SYNPRO STEARATE (Al) XANTURAL

Description
Carboxymethylcellulose Sodium Carrageenan Gellan Gum Povidone (PVP K) Poloxamer Poloxamer Magnesium Aluminium Silicate Hypromellose (HPMC) / Methylcellulose Aluminium Stearate Xanthan Gum Myristyl / Cetyl / Stearyl / Cetostearyl Alcohol Glyceryl Behenate Glyceryl Monostearate 40-55 (Type II) Stearic Acid Glycerin / Glycerol Sorbitol Solution Decyl Oleate Isopropyl Myristate Oleyl Alcohol Octyldodecanol Glycerin / Glycerol Polyoxyl-Hydrogenated Castor Oil Glycerin / Glycerol Triacetin Polyethylene Glycol (Macrogol) Propylene Glycol Glyceryl Monostearate 40-55 (Type II) Anhydrized Liquid Sorbitol Carboxymethylcellulose Sodium Carrageenan Gellan Gum Sodium Alginate Poloxamer Xanthan Gum Talc Titanium Dioxide, Super-White, Anatase Grade Ferric (Iron) Oxide

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CONSISTENCY REGULATORS

KOLLIWAX (SPEZIOL C PHARMA) KOLLIWAX GDB (SPEZIOL GDB PHARMA) KOLLIWAX GMS II (CUTINA GMS VPH) KOLLIWAX S (SPEZIOL L2SM) KOLLISOLV G (SPEZIOL G) NEOSORB LIQUID

HUMECTANTS EMOLLIENTS

KOLLICREAM DO (CETIOL V PH) KOLLICREAM IPM (ISOPROPYLMYRISTATE PH) KOLLICREAM OA (HD EUTANOL V PH) KOLLICREAM ODD (EUTANOL G PH) KOLLISOLV G (SPEZIOL G)

KOLLIPHOR (CREMOPHOR) KOLLISOLV G (SPEZIOL G) KOLLISOLV GTA (SPEZIOL GTA) KOLLISOLV PEG (LUTROL E) KOLLISOLV PG KOLLIWAX GMS II (CUTINA GMS VPH) POLYSORB 85/70/00 CEKOL GELCARIN KELCOGEL CG KELTONE / MANUGEL KOLLIPHOR P (LUTROL F) XANTURAL

PLASTICIZERS

GELLING AGENTS

GLIDANTS

LUZENAC PHARMA KRONOS 1171 SICOVIT

COLOURANTS

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Application Guide
Products by Category
ALUBRA PG 100 KOLLIPHOR SLS (TEXAPON K) KOLLIWAX GDB (SPEZIOL GDB PHARMA) KOLLIWAX GMS II (CUTINA GMS VPH) KOLLIWAX HCO (CUTINA HR PH) KOLLIWAX S (SPEZIOL L2SM) LUZENAC PHARMA SYNPRO STEARATES (Mg, Zn, Ca) A-TAB CALIPHARM CALOPAKE CASEINATE COLOSTRUM DI-TAB HIPROTAL HYVITAL KOLLISOLV MCT (MYRITOL PH) MAGNESIUM CARBONATE MAGNESIUM HYDROXIDE MAGNESIUM OXIDE NUTRIOSE REFIT SCORALITE SCORALITE DC STURCAL TCP-DC TRI-CAL WG TRI-TAB VERSACAL MP VIVINAL GOS VIVINAL LACTOFERRIN

Description
Sodium Stearyl Fumarate Sodium Lauryl Sulfate Glyceryl Behenate Glyceryl Monostearate 40-55 (Type II) Hydrogenated Castor Oil Stearic Acid Talc Magnesium / Zinc / Calcium Stearate Dicalcium Phosphate Anhydrous, Granular Dicalcium Phosphate, Powder Precipitated Calcium Carbonate, Extra-Light Spray-Dried Milk Protein Colostral Whey Protein Dicalcium Phosphate Dihydrate, Granular Whey Protein Concentrate Protein Hydrolysate Medium Chain Triglycerides Magnesium Carbonate (Light / Heavy) Magnesium Hydroxide Magnesium Oxide (Light / Heavy) Soluble Fibre Milk Protein Calcium Carbonate Directly Compressible Calcium Carbonate Precipitated Calcium Carbonate, Heavy Tricalcium Phospate, Granular Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Micronized Powder Galacto-Oligosaccharides Lactoferrin Microcrystalline Cellulose Spheres Mannitol Sugar Spheres Galactose, Low Endotoxin Hydroxypropyl Betadex Povidone (PVP K) Polyoxyl-15-Hydroxystearate Poloxamer Polyoxyl-35-Hydrogenated Castor Oil Polyethylene Glycol (Macrogol) Dextrose Monohydrate, Pyrogen-Free Maltose, Low Endotoxin Hypromellose (HPMC), High Viscosity Sorbitol, Pyrogen-Free

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LUBRICANTS

MINERAL AND NUTRITIONAL SUPPLEMENTS

NEUTRAL CORES
CELPHERE PEARLITOL PHARM-A-SPHERES

D-GALACTOSE KLEPTOSE HPB KOLLIDON KOLLIPHOR HS 15 (SOLUTOL HS 15 ) KOLLIPHOR P (LUTROL F ) KOLLIPHOR ELP (CREMOPHOR ELP) KOLLISOLV PEG (LUTROL E) LYCADEX PF MALTOSE METOLOSE SH NEOSORB PF

PARENTERAL AND OPHTHALMIC AIDS

11

Application Guide
Products by Category
PEARLITOL PF POLY(DL-LACTIDE) POLY(DL-LACTIDE-CO-GLYCOLIDE) POLYCAPTROLACTONE POLYGLYCOLIDE PRONOVA UP / SL PROTASAN UP SUCROSE TREHALOSE

Description
Mannitol, Pyrogen-Free Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Sodium Alginate, Ultra-Pure Chitosan, Ultra-Pure Sucrose, Low Endotoxin Non-Reducing Di-Saccharide Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Sodium Alginate, Ultra-Pure Chitosan, Ultra-Pure Ultra-Pure Sodium Hyaluronate Galactose, Low Endotoxin Maltose, Low Endotoxin Plant Protein Hydrolysates Sucrose, Low Endotoxin Chewing Gum Base Hard Fat Sodium Alginate

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BIOMATERIALS

POLY(DL-LACTIDE) POLY(DL-LACTIDE-CO-GLYCOLIDE) POLYCAPTROLACTONE POLYGLYCOLIDE PRONOVA UP / SL PROTASAN UP SODIUM HYALURONATE

D-GALACTOSE MALTOSE PROYIELD SUCROSE

FERMENTATION AIDS

CHEWING GUM BASE SUPPOSITORY BASE


NOVATA PH PROTANAL / MANUCOL

POWDER GUM / MEDGUM BASE

WOUND CARE AGENTS

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12

FMC BioPolymer, with a legacy of over 60 years of innovation, is the market leader in cellulose based excipients. FMCs Avicel, is the worlds largest selling brand of microcrystalline cellulose. The companys other products ranging from alginates, carrageenans and gels to coating systems have been strategically harnessed from natural resources. They serve as raw materials to the worlds pharmaceutical, food and personal care industry. FMCs commitment to high standards of quality and care is reflected in their motto quality begins with me and in their consistent efforts at protecting the environment, health and safety of its employees. Along with providing focused support to core markets, they also draw upon the expertise of a network of professionals involved in developing new technologies and applications. This enables them to have a wide partnering reach with their customers, including companies looking to increase efficiency and speed of their own research and development efforts. FMC BioPolymer, a signatory to the responsible care initiative of the International Coalition of Chemical Associations, is trusted to deliver the most consistent products, to the right place, at the right time and to assist customers in catering to the fast paced, challenging markets of today.

FMC BioPolymer

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13

AVICEL PH
Microcrystalline Cellulose USP/NF, EP, JP
Avicel PH, FMCs innovator brand of microcrystalline cellulose, is a purified, partially depolymerized alpha-cellulose made by acid hydrolysis of specialty wood pulp. The process of polymerization involves high levels of quality and stringency. Avicel PHs unique properties - superior compactibility, drug carrying capacity and rapid disintegration - make it the excipient of choice in direct compression applications. When used in the wet granulation process, the risk of over-granulation is reduced, screen blockage is avoided and uniform, rapid drying is promoted. The distinct properties of this excipient also benefit the dry granulation processes of roller compaction and slugging. Avicel PH is an excellent extrusion-spheronization binder and its inclusion in capsule formulations improves flow, facilitates plug formation and aids capsule disintegration. With the development of differentiated grades, Avicel PH remains an indispensible formulation tool, boosting productivity and meeting tough formulation challenges.

Grade Avicel PH-101 Avicel PH-102 Avicel PH-103 Avicel PH-105 Avicel PH-112 Avicel PH-113

Particle Size (m) 50 100 50 20

Moisture Content (%) 3.0 - 5.0 3.0 - 5.0 NMT 3.0 NMT 5.0

Applications Conventional grade for wet and dry granulation Improves flow in direct compression, dry phase of wet granulation and dry granulation Well suited for moisture sensitive actives Extra-fine particle size, used for direct compression of materials which are coarse or hard to compress Lowest moisture content and is best suited for direct compression of moisture sensitive actives Improves product stability, particularly of formulations using moisture sensitive actives Largest particle size, enhances flow in direct compression and dry granulation whilst maintaining high levels of compressibility with minimum weight variation and content uniformity Largest particle size with lowest moisture content, allowing for better flow rate than Avicel PH-112. Improvised grade for direct compression of moisture sensitive actives High bulk density grade, for manufacturing of small tablets. Reduces powder stratification and tablet weight variation by allowing efficient mixing High bulk density grade with larger particle size, used for production of thin tablets especially in high dose drug formulations. Avoids powder segregation and achieves good flow rates
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100

NMT 1.5

50

NMT 2.0

Avicel PH-200

180

2.0 - 5.0

Avicel PH-200 LM

180

NMT 1.5

Avicel PH-301

50

3.0 - 5.0

Avicel PH-302

100

3.0 - 5.0

FMC BioPolymer

14

AVICEL DG
Microcrystalline Cellulose USP/NF, EP, JP and Dibasic Calcium Phosphate USP/NF, EP, JP
Avicel DG is a synergistic combination of 75 percent microcrystalline cellulose and 25 percent anhydrous dibasic calcium phosphate, produced using spray-dried, co-processing technology. This product is a novel, high functionality excipient and is optimized for use in dry granulation. It has improved flow characteristics, high quality initial compactibility and excellent recompactability, which in turn minimizes the granulation process steps.

Grade

Advantages Produces robust ribbons, lowers tablet rejection rates and improves overall tableting performance

Applications Dry granulation processes like roller compaction or slugging

Avicel DG

AVICEL HFE-102
Microcrystalline Cellulose USP/NF, EP, JP and Mannitol USP/NF, EP, JP
Avicel HFE-102, a high functionality excipient, is a spray dried blend of 90 percent microcrystalline cellulose and 10 percent mannitol. This novel, proprietary product exhibits synergistic functionality thereby providing superior benefits compared to individual or dry blended components.

Grade

Advantages Compared with traditional microcrystalline cellulose grades it has improved flow, superior compactibility, low sensitivity to lubrication and better disintegration properties

Applications

Avicel HFE-102

Direct compression of chewable, fast dissolving, M-U-P-S technology tablets and similar applications

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FMC BioPolymer

15

AVICEL CE-15
Microcrystalline Cellulose and Guar Gum
Avicel CE-15 is a patented combination of microcrystalline cellulose and guar gum, specially engineered to improve the organoleptic properties of chewable tablets. This free flowing, co-processed blend results in dramatic differences for end users, primarily in the areas of overall sensory experience and perceived taste when compared to other existing products.

Grade

Advantages Provides smoother and creamier mouth feel, less grittiness, minimum chalkiness, low friability and reduced tooth packing

Applications Designed for direct compression formulations to produce softer chewable tablets with low friability and rapid disintegration

Avicel CE-15

AVICEL RC / CL
Microcrystalline Cellulose and Carboxymethylcellulose Sodium USP/NF, EP
Avicel RC / CL is a colloidal, water dispersible, spray-dried blend of microcrystalline cellulose and carboxymethylcellulose sodium. Formulations which include this excipient have high thixotropy, low viscosity and display reduced settling or sedimentation effects. The range of thixotropies, viscosities, gel strengths and dispersion characteristics offered by this product line provide unparalleled suspension stability and functional versatility.

Grade

Viscosity (cps) 39 - 91 (1.2% solids)

Advantages

Applications

Avicel RC-591

Avicel CL-611

50 - 118 (2.6% solids)

Oral suspensions, Viscosity regulator and modifier, nasal / topical sprays, eliminates lengthy hydration lotions, liquids, semi-solid times, displays stability to heat dosage forms and freeze / thaw over a wide pH range and has excellent emulsifying properties for Reconstitutables / dry oil-in-water systems and oral suspensions

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FMC BioPolymer

16

AC-DI-SOL
Croscarmellose Sodium USP/NF, EP, JP
Ac-Di-Sol, the best known superdisintegrant, is crosslinked sodium carboxymethylcellulose or modified cellulose gum. This insoluble, hydrophilic polymer has dual-functionality of water wicking and rapid swelling, which results in its superior disintegration characteristics.

Grade

Advantages Effective at low use levels, has enhanced long term stability and facilitates quick disintegration and dissolution in tablets, capsules, granules and other dosage forms

Applications Highly effective in direct compression, dry granulation and wet granulation independent of tablet hardness. Is used intra as well as extra-granularly

Ac-Di-Sol SD-711

ALUBRA PG 100
Sodium Stearyl Fumarate USP/NF, EP, JPE
Alubra PG 100 is a fine, white to off-white powder used as a water soluble lubricant in capsule and tablet formulations. The fumarate moiety of Alubra increases its melting temperature, which allows for greater functionality at high press speeds while the stearate chain maintains the lubricity of the compound, supporting low ejection forces.

Grade

Advantages Enhanced dissolution, compatible with a wide range of APIs, flexibility in blending and improved compactibility

Applications Water soluble lubricant for orodispersible tablets, capsules, effervescent dosage forms and for formulations of poorly soluble drugs

Alubra PG 100

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FMC BioPolymer

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AQUACOAT ECD-30
Ethylcellulose Aqueous Dispersion USP/NF, JPE
This excipient is a 30 percent by weight aqueous dispersion of ethylcellulose polymer. It is a water based, pseudo latex system free of ammonia and used for solvent-free coating.

Grade

Advantages Low viscosity, non-tacky and allows for various kinds of drug release patterns with the use of suitable plasticizers and pore formers

Applications Variety of functional coating applications such as sustained-release, taste masking and providing a moisture-barrier

Aquacoat ECD-30

LUSTRECLEAR LC-103
Microcrystalline Cellulose USP/NF, EP, JP and Carrageenan USP/NF Based Coating System
This product offers a unique, aqueous film coating technology that combines microcrystalline cellulose and carrageenan. It is an all-in-one, solvent-free, conventional, aesthetic coating system providing greater flexibility for processing a wide variety of products.

Grade

Advantages

Applications

Provides a distinctive, clear, smooth, satin finish on solid dosage forms and makes their processing easier. The LustreClear LC-103 consequent advantages of taste masking and ease of swallowing of the coated dosage form enhances patient compliance

Aqueous film coating system used for a variety of tablets and other solid dosage forms

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FMC BioPolymer

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ALGINATES and ALGINIC ACID USP/NF, EP


Alginates are natural hydrocolloids of vegetable origin that occur as a structural component in marine brown algae and give strength and flexibility to the plant. In contrast to most other polysaccharide gels, alginate gels can develop instantaneously into acid gels in the presence of divalent cations, low pH and constant temperature. The gelling gives rise to a three dimensional network which determines the gel strength. Alginates with a high content of G-blocks give stronger gels while M-rich alginates give softer and more fragile gels. The molecular weight determines the viscosity of alginate solutions while the ratio of mannuronic acid to guluronic acid (M / G) determines the relative strength of the gel. FMCs range of alginates and alginic acids, offer unique gel forming, film forming, thickening and stabilizing properties.

Grade

Description Type Viscosity, mPa.s (% concentration)


-

Applications

Protacid F120NM Kelacid NF Protanal LFR 5/60 Manugel LBA Keltone LVCR Keltone HVCR Manucol LKX Kelcosol NF Kelset NF Protanal Ester SD-LB Kelcoloid K3B426 Protanal LF 10/60FT Manucol DH Protanal KF 200FTS Protanal LF 200FTS Protanal HF 120RBS Protanal KF 200RBS

Alginic acid

Disintegrant in direct compression and wet granulation. Used in anti-reflux and effervescent tablets Anti-reflux suspensions, effervescent tablets and used as a gelling agent

Sodium alginate

300 - 700 (10%) 100 - 300 (2%)

Sodium alginate

600 - 900 (1.25%) 60 - 170 (1%) 1000 - 1500 (1%)

Controlled-release formulations

Sodium-calcium alginate

500-1000 (0.5%) 700 - 1800 (2%) 1000 - 1500 (2%) 30 - 60 (1%) 40 - 90 (1%) 200 - 400 (1%)

Propylene glycol alginate

Stabilizer, emulsifier and matrix former

Sodium alginate

Wound care

Potassium alginate Sodium alginate

600 - 800 (1%) 200 - 400 (1%)

Dental impression material

Potassium alginate

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FMC BioPolymer

200 - 400 (1%)

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MARINE COLLOIDS
Carrageenan USP/NF, EP
Carrageenan is a family of naturally occurring, high molecular weight polysaccharides extracted from red seaweed which yield kappa, iota and lambda types. They differ in properties mainly due to the number and position of ester sulfate groups on the galactose units. While kappa forms a brittle gel, iota forms an elastic gel and lambda does not form a gel. All carrageenans display protein and polyol reactivity. Based on their properties, they are used as stabilizers, thickeners, suspending agents, gelling agents and flow regulators in pharmaceutical dosage forms.

Grade Type Gelcarin PH-379 Gelcarin PH-812 Gelcarin PH-911 Viscarin PH-109 Viscarin PH-209 SeaSpen PF Kappa lota

Description Gel Type, Strength Elastic, medium Brittle, strong Brittle, firm

Applications

Creams and suspensions. Promotes freeze thaw Gives stronger gels than PH-911 with higher syneresis Encapsulation / delivery systems Creams and lotions. Also used for controlled-release formulations Suspensions, reconstitutables, topical lotions and creams

Lambda

Non-gelling

lota

Elastic, weak

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FMC BioPolymer

20

Founded in 1933, Roquette is today one of the worlds most advanced producers of starch and its derivatives. Along with this, it is an expert in the field of polyols and a leading producer of maltodextrins, pyrogen-free raw materials and cationic starches. Roquettes extensive line of products which cater to the pharma, food and cosmetics industries of the world are derived from renewable resources such as corn, wheat, potatoes and peas. Their commitment towards deliverance of high quality and environment friendly results can be seen in their superior production techniques. With a sophisticated research centre, several production sites, a strong customer service base and a wide network of subsidiaries and agents, Roquette is looked upon as a reliable, responsible and innovative partner in the pharmaceutical industry.

Roquette Frres

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PEARLITOL
Mannitol USP/NF, EP, JP
Mannitol is a polyol manufactured by catalytic hydrogenation of starch, a natural raw material of vegetable origin. It occurs as a slightly sweet, white crystalline powder that gives a cooling sensation on dissolution in the mouth. It has excellent stability, low hygroscopicity and good solubility in different solvents. It forms an ideal excipient for solid orals as well as injectable dosage forms and can be used for wet or dry granulation and direct compression. It also serves as a cryoprotective agent in freeze drying applications. Mannitol has low calorific values, is non-cariogenic and ideal for sugar-free formulations. Crystalline Mannitol Grade Mean Diameter (m) 25 50 160 Type Applications

Pearlitol 25 C (Mannitol 25) Pearlitol 50 C (Mannitol 35) Pearlitol 160 C (Mannitol 60) Pearlitol PF (Mannitol PFG)

Extra-fine Fine Standard Pyrogen-free

Diluent for tablets, capsules and sachets, excipient for chemically unstable or moisture sensitive actives and flash release forms, freeze-drying carrier and sweetener for pharmaceutical chewing gums Diuretic-osmotic for injectable solutions and also for freeze dried injectables

Granular Mannitol Grade Mean Diameter (m) 100 Spray-dried 180 250 360 Granulated 520 Type Applications

Pearlitol 100 SD Pearlitol 200 SD Pearlitol 300 DC Pearlitol 400 DC Pearlitol 500 DC

Diluent for direct compression especially for chewable, effervescent and orodispersible tablets, ideal excipient for chemically unstable or moisture sensitive actives and also diluent for capsules and sachets DC types are also used as a neutral carrier base onto which actives are loaded

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PEARLITOL FLASH
Compound of Mannitol USP/NF, EP, JP and Maize Starch USP/NF, EP, JP
Pearlitol Flash is a novel excipient specifically designed for orodispersible tablets using the process of direct compression. This spray-dried compound of 80 percent mannitol and 20 percent maize starch allies robustness with rapid disintegration. It offers chemical inertness, requires a low level of lubricant usage and makes tablet formulation surprisingly simple. Pearlitol Flash results in end products with a very creamy mouth feel, smooth texture and a pleasant, sweet taste.

Grade

Advantages Excellent compressibility, high dilution potential, self-disintegrating properties, superior flowability and melt-in-mouth taste experience

Applications

Pearlitol Flash

Ideal excipient for direct compression of orodispersible / fast-melt tablets

XYLISORB
Xylitol USP/NF, EP, JP
Xylisorb is a five-carbon polyol with a characteristic crystalline shape. Of all polyols, it has the sweetest taste equaling that of sucrose. It induces a very pleasant sensation of cooling and freshness in the mouth resulting from its negative heat of solution. These qualities, coupled with its non-cariogenic nature and low calorific value, makes it an important alternative for use in a variety of pharmaceutical dosage forms.

Grade

Mean Diameter (m) 90 300 700 300

Applications

Xylisorb 90 Xylisorb 300 Xylisorb 700 Xylisorb P 300 DC

Diluent for sachets, chewable and suckable tablets, excipient for coating as well as candying of lozenges, sweetener for pharmaceutical chewing gums, mouth rinses and tooth-pastes Direct compression of smooth chewable tablets for nutraceuticals

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NEOSORB POWDER
Sorbitol USP/NF, EP, JP
Neosorb P grades are a range of crystalline sorbitol powders in the gamma stable form. These polyols have excellent tableting properties which readily form hard tablets. Neosorb powders have high chemical stability and do not undergo reducing or discolouration reactions with amino groups. They have a cool taste with a pleasant mouth feel and are used for non-cariogenic, non-acidogenic and sugar-free formulations in different types of tablets, as well as in sachets and dry syrups.

Grade

Mean Diameter (m) 110 180 480 650 300 -

Type

Applications

Neosorb P 100 T Neosorb P 60 W Neosorb P 30/60 Neosorb P 20/60 Neosorb P 300 DC Neosorb PF

Fine Excellent excipient for direct compression of suckable, effervescent and chewable tablets, diluent for sachets, sweetener Coarse in pharmaceutical chewing gums and in Highly coarse reconstitutable syrups Standard Spray-dried Pyrogen-free Parenteral nutrition - used in combination with amino acids

NEOSORB LIQUID
Sorbitol Solution USP/NF, EP, JP
Neosorb liquid is a solution of sorbitol along with other hydrogenated long chain oligomers and polymers. It finds use as a substitute for sucrose and meets organoleptic (sweetening power) and dietetic requirements (sugar-free, low-calorie, non-cariogenic) and may be advised for diabetics.

Grade

Type Non-crystallizing sorbitol solution Crystallizing sorbitol solution

Sorbitol (dry basis) 74% min. 93% min.

Applications Bulk sweetener and humectant in syrups, suspensions, oral ampoules, lozenges, pastilles, paste and topical preparations. Also used as an excipient for pan-coating

Neosorb 70/70 B Neosorb 70/20

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SWEETPEARL
Maltitol USP/NF, EP
SweetPearl is maltitol powder of high purity obtained by catalytic hydrogenation of D-maltose using a process which is patented by Roquette. It is a dimeric polyol providing a cool mouth feel and sweetness close to that of sucrose. SweetPearl is a stable, polyhydric, non-cariogenic sugar alcohol with low glycemic index and calorific value. It is a robust and stable excipient with optimum flow, particle size and density, making it an ideal excipient for oral dosage forms.

Grade

Mean Diameter (m) 90 200 300

Powder Type

Applications

SweetPearl P 90 SweetPearl P 200 SweetPearl P 300 DC

Fine, crystalline Coarse, crystalline Granulated

Diluent for tablets and sachets, excipient for hard coating as well as for candying of lozenges and sweetener for pharmaceutical chewing gums Diluent for direct compression of crunchy chewable tablets

LYCASIN
Maltitol Solution USP/NF, EP
Lycasin is obtained by the hydrogenation of maltose syrup and constitutes D-sorbitol, hydrogenated disaccharides and polysaccharides. It is supplied as a pure, odourless liquid and has a pleasant sweet taste. It is non-cariogenic, has low calorific value, is easily miscible with water and is chemically stable (absence of Maillard reaction). Lycasin has high sweetening power (70 - 80 percent of sucrose) with good solubility and is used as a replacement for sugar in syrups, lozenges and jellies for specific patient groups.

Grade Lycasin 75/75 Lycasin 80/55 Lycasin HBC

Maltitol (dry basis) 72 - 76% 50 - 55% 50 - 55%

Mean Viscosity (mPa.s) at 20oC 2400 3000 13000

Applications Non-crystallizing bulk sweetener for sugarless syrups, suspensions, lozenges, oral ampoules and pharmaceutical chewing gums A unique dry matter composition for hard boiled candies, pastilles and lozenges

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POLYSORB
Anhydrized Liquid Sorbitol USP/NF, EP
Polysorb 85/70/00 is a water solution containing a defined mixture of D-sorbitol and 1,4-sorbitan. This clear, colourless, syrupy liquid is perfectly miscible with water but practically insoluble in oils and has been developed particularly as an additive for the soft gelatin capsule application. The advantage of this product in soft gels relates to its remarkable, balanced plasticizer properties without surface crystallization i.e. graining, as is the case with standard crystallizing plasticizers and without the leaching phenomena in the filler media of the soft gels.

Grade Polysorb 85/70/00

Composition High dry solid content of 83% constituting: 1,4-sorbitan: 24 - 28% (on a dry basis) D-sorbitol: 35 - 45% (on a dry basis)

Applications Optimal plasticizer for gelatin shell of soft capsules. Also enables good stability with the fillers used in the soft gels

KLEPTOSE
Betadex USP/NF, EP
Betacylcodextrins are cyclic oligosaccharides obtained from starch by enzymatic cyclization using enzymes called cycloglycosyl transferases. Their hydrophobic cavity of the truncated cone formed by the betacyclodextrin ring can accomodate suitable guest molecules and complexes or inclusion compounds. An inclusion complex is a form of supramolecular complex in which one or part of a molecule, the guest or substrate is enclosed, entrapped, encapsulated or embedded with another molecular structure. Kleptose allows the formation of complexes with actives in the solvent or dry phase.

Grade Kleptose STD Kleptose DC Kleptose 10

Type Standard Granular for direct compression Micronized, suitable for aerosols Low water content for moisture sensitive actives

Properties Improves solubility thereby facilitating higher bioavailability, enhances flowability and compressibility, improves organoleptic properties, increases stability, reduces side effects and transforms liquid actives into easily manipulated solid complexes

Applications

Encapsulating agent for tablets, capsules, sachets, syrups, solutions and oral suspensions

Kleptose 7 PC

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KLEPTOSE HPB
Hydroxypropyl Betadex USP/NF, EP
Kleptose HPB is a purified, polydisperse product resulting from controlled reaction of propylene oxide and native betadex under base catalysis. This product overcomes the low solubility and inadequate biological tolerance of the native betacyclodextrin molecule. Kleptose HPB is produced in a purpose built, state-of-the-art manufacturing plant following USFDA type GMP quality guidelines and is well supported by toxicology data.

Grade

Description

Applications Suitable for parenteral use, syrups, solutions and oral suspensions as well as for dry formulations (with possibility of in-situ encapsulation). Increases water solubility of poorly soluble drugs thereby improving bioavailability and enhances organoleptic properties of bitter or unpleasant actives

Kleptose HPB

Parenteral grade, medium molecular substitution, endotoxin controlled

DEXTROSE USP/NF, EP, JP


Glucose or dextrose is a monomer of natural starch polymer. In its crystalline form, this natural sugar has long been used both as a sweetener and as a filler for oral dosage forms.

Grade

Description Pyrogen-free dextrose monohydrate

Applications Osmotic agent in injectables and dialysis solutions, energy source for parenteral nutrition and treatment of hypoglycemia Direct compression diluent with excellent compressibility and flowability for tablets, sachets and capsule formulations Diluent for tablets, capsules and sachets

Lycadex PF

Dextrose Monohydrate GC

Agglomerated dextrose monohydrate Crystalline dextrose anhydrous

Dextrose Anhydrous C

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STARCH USP/NF, EP, JP


Native Starches
Starch is one of the most reliable excipients produced from different sources such as maize (corn), wheat, potato and peas. All grades are GMO free and microbiologically compliant.

Grade Maize Starch B Maize Starch Extra White Maize Starch 5% Wheat Starch TB Potato Starch B

Description Conventional Super-white Low water content Standard

Applications Diluent for tablets and capsules, powder for sachets and a disintegrant in solid orals Low water content grade is for moisture sensitive actives

MODIFIED STARCHES
Pregelatinized Starch USP/NF, EP
To overcome the drawbacks of native starch viz. cooking step, high viscosity, poor flow, agglomeration etc, the modified range of maize (corn) starch products were introduced. The Lycatab range consists of pre-cooked, partially cooked and partially hydrolyzed starches made using special production processes. These products bring in reliability, flexibility and several advantages in wet granulation as well as direct compression tableting.

Grade Lycatab PGS

Type Fully pregelatinized starch

Applications Robust wet granulation binder Highly effective binder-disintegrant in direct compression and wet granulation, filler-disintegrant for hard gelatin capsules. Also used as a flow aid in powder blends High wettability, low viscosity binder for wet granulation without impeding disintegration or dissolution. Ready-to-use, easily dispersible and quickly soluble with no maturation time. Also used as a diluent for direct compression of smooth tablets

Lycatab C

Partially pregelatinized starch

Lycatab DSH

Partially hydrolyzed, spray-dried starch

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GLYCOLYS
Sodium Starch Glycolate USP/NF, EP, JP
Glycolys or sodium carboxymethyl starch, is a very well known and widely used superdisintegrant for all solid oral dosage forms. It has a potato starch base and the capacity to swell upto 280 - 320 times its original granule volume. Glycolys is sparingly soluble in ethanol and practically insoluble in water. It is a versatile excipient suitable for wet / dry granulation as well as direct compression and can be incorporated in intra and / or extra-granular modes.

Grade Glycolys Glycolys LV Glycolys Low pH

Description Standard, SSG - Type A Low viscosity, SSG - Type A

Applications Conventional disintegrant for solid oral dosage forms Optimized to withstand high shear, wet granulation processes Designed to resist acidic pH and maintain stability in strongly acidic drug formulations

Acid stable, SSG - Type B

LYCOAT
Pregelatinized Hydroxypropyl Starch
Lycoat is a modified, pea starch based polymer specifically designed for aqueous film coatings of immediate release, solid oral dosage forms. This breakthrough polymer has low viscosity, allowing preparation of coating suspensions with high solid content. Coating time is thus drastically reduced when compared to traditional HPMC film coating systems. It is a new alternative for the formulator with benefits such as instant dispersion at room temperature, no foam formation, excellent mechanical properties, high gloss and smoothness with no logo bridging and a neutral taste. Ready-mix products based on Lycoat are also available under the brand name of ReadiLycoat.

Grade Lycoat RS 780 ReadiLycoat Lycoat RS 720

Description Low viscosity grade Ready-to-use film coating system based on Lycoat High viscosity grade

Applications Aqueous, aesthetic film coating system for solid oral dosage forms Novel excipient for orodispersible films

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GLUCIDEX
Maltodextrin USP/NF, EP Corn Syrup Solids USP/NF, EP
Glucidex is a family of maltodextrins and dried glucose syrups obtained from starch by hydrolysis, followed by purification and spray-drying. These products exhibit good stability and display a varying range of sweetness depending on the degree of hydrolysis. Glucidex can help adjust and control the properties of viscosity and texture, anti-crystallizing power, browning reactions, fermentability and freezing point depression. These products are soluble in water and have a high standard of organic, mineral and bacteriological purity. Glucidex is also available in an IT range which has a particular physical structure and provides superior free flowing properties with better solubilization effects.

Maltodextrin
These are starch hydrolysis products with a dextrose equivalent (D.E.) of 20 and below. Grade Glucidex 2 Glucidex 6 Glucidex 9 Glucidex 12 Glucidex 17 Glucidex 19 Dextrose Equivalent (D.E.) 5 max. 5-8 8 - 10 11 - 14 15 - 18 18 - 20 Diluent for tablets, capsules, sachets, carrier for spray-drying and as a carbohydrate source in infant and enteral foods. Can also be used for direct compression formulations Applications

Corn Syrup Solids (Dried Glucose Syrup)


These are starch hydrolysis products with a dextrose equivalent (D.E.) greater than 20.

Grade Glucidex 21 Glucidex 33 Glucidex 47

Dextrose Equivalent (D.E.) 20 - 23 31 - 34 43 - 47

Applications

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Diluent for tablets, capsules, sachets, carrier for spray-drying and as a carbohydrate source in infant and enteral foods. Can also be used for direct compression formulations

30

TACKIDEX
Dextrin USP/NF, EP
Tackidex is a starch polymer derived through solid-state heating from partially hydrolyzed starch. It is partially or completely soluble in cold water and has low viscosity.

Grade Tackidex B 167

Description

Applications Tablet and capsule filler, medium viscosity thickener in liquid formulations, fibre source and emulsion stabilizer

Potato starch based

STARLAC
Compound of Maize Starch USP/NF, EP and Lactose Monohydrate USP/NF, EP
StarLac is an innovative, spray-dried compound of 15 percent native maize starch and 85 percent alpha-lactose monohydrate available in a free flowing powder form designed for direct compression. This product shows technical improvements and adds value to the formulations due to its easier tableting development process and a combination of good binding performance with outstanding disintegration power.

Grade

Advantages High compactibility, superior flowability, optimized disintegration, excellent tablet hardness, high shear force resistancy and good storage stability

Applications Filler-binder for direct compression and dry granulation processes. Also used for fast-dissolving tablets, capsule filling, cores for coating and low dosage formulations

StarLac

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NUTRIOSE
Soluble Fibre
Nutriose is an agglomerated soluble dextrin with high dietary fibre and very low sugar content. It is made by dextrinization of wheat or corn starch followed by refining, purification and drying. This free flowing powder has high digestive tolerance and exhibits good stability to pH and heat.

Grade Nutriose FB

Type

Advantages High fibre content (85%), low glycaemic and insulinaemic response, low calorific value, quick dissolution and dispersion, high stability, low osmolality, non-cariogenic and a neutral taste

Applications For enteral nutrition, gut regulation and moderation of glucidic and lipid metabolism. Also used for low calorie formulations as well as for clinical nutrition and nutraceutical forms

Wheat fibre

Nutriose FM

Maize fibre

HI-SWEET
High Fructose Corn Syrup (HFCS)
HFCS is a sweet, clear and odourless liquid manufactured by controlled hydrolysis of starch polymers, resulting in high fructose compositions with valuable bulk sweetening profiles. It exhibits less tendency to crystallize at low temperatures due to its lower dextrose and higher fructose level.

Grade

Description

Applications Used as a bulk sweetener and viscosity enhancer in syrups and suspensions. Provides high sweetness and a clean mouth feel, making it an ideal replacement for sucrose and invert sugar in various applications

Hi-Sweet 55

Solid content of minimum 55% fructose on dry basis

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DFE Pharma, a global leader in excipient solutions, develops, produces and markets products for oral solid dosage and dry powder inhalation formulations. The companys new brand name, DFE Pharma, combines the former names DOMO-pharma and DMV-Fonterra Excipients into one new name, enabling them to further strengthen their knowledge base, sales network, sourcing and R&D capability. The company continuously invests in cGMP standards and advanced excipient technologies teamed with high quality personnel, resulting in customers having great confidence in their overall capabilities. DFE Pharma, in its pursuit of achieving excipient excellence, offers strong co-operation, complete reliability and the shortest possible time-to-market during new product launches and is looked upon as a trustworthy partner in the pharmaceutical world.

DFE Pharma

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33

PHARMATOSE
Lactose Monohydrate USP/NF, EP, JP
Pharmatose is crystalline alpha-cellulose monohydrate available in sieved and milled forms. The sieved type consists of regular shaped particles with good flowability while the milled type consists of small particles with a high surface area. Pharmatose displays extremely low moisture absorption even at high relative humidity. Grade Type Mean Particle Size m (d50)* 350 290 210 Sieved 230 170 155 145 70 90 45 Milled 35 25 20 Good flowability and As a filler in wet or mixing characteristics dry granulation, in extrusion spheronization, in capsules and as a diluent in sachets. Also used in direct compression formulations Small particles and high surface area for excellent wettability and compressibility Advantages Applications

Pharmatose 50M Pharmatose 60M Pharmatose 70M Pharmatose 80M Pharmatose 90M Pharmatose 100M Pharmatose 110M Pharmatose 125M Pharmatose 130M Pharmatose 150M Pharmatose 200M Pharmatose 350M Pharmatose 450M * As determined by laser diffraction

SUPERTAB SD
Lactose Monohydrate (Spray-Dried) USP/NF, EP, JP
SuperTab SD is spray-dried lactose with spherically shaped porous particles having a narrow size distribution. Particles consist of small alpha-lactose monohydrate crystals and some amorphous lactose to enhance compactibility. Grade Mean Particle Size m (d50)* Advantages Excellent flow properties, enhances compactibility, affords good blend and tablet content uniformity and has low lubricant sensitivity Tablets made with SuperTab 14SD disintegrate more readily than those with SuperTab 11SD Applications Used in direct compression formulations of drugs with poor flow properties. Has excellent mixing characteristics and prevents drug segregation in very low dose formulations. Also used in capsules and sachets
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SuperTab 11SD

125

SuperTab 14SD

130

* As determined by laser diffraction

DFE Pharma

34

SUPERTAB AN
Anhydrous Lactose USP/NF, EP, JP
SuperTab AN is an anhydrous grade of directly compressible lactose with a very low moisture content obtained by physical modification. Particles are a build up of microcrystals, mainly consisting of betalactose and possess a high fragmentation propensity and high compactibility.

Grade

Mean Particle Size m (d50)*

Advantages

Applications

SuperTab 21AN

150

SuperTab 22AN

210

Has low moisture content and absorbs very little moisture even at higher Used in direct compression relative humidities, has excellent compactibility and formulations of moisture sensitive actives. Used also low lubricant sensitivity in dry granulation processes, chewable tablets and for high SuperTab 22AN is dose drug formulations especially suitable for improvement of flow properties

* As determined by laser diffraction

SUPERTAB GR
Lactose Monohydrate (Granulated) USP/NF, EP, JP
SuperTab GR is a standard grade of directly compressible lactose characterized by good flowability and good compactibility due to its special particle structure.

Grade

Mean Particle Size m (d50)*

Advantages Good flow properties, superior compactibility and shows consistent compaction over a wide range of humidities Tablets produced with this grade disintegrate quickly compared to other directly compressible lactose grades

Applications

SuperTab 30GR

140

Used in direct compression formulations and for low dose actives. Also used in capsules and sachets

* As determined by laser diffraction

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DFE Pharma

35

LACTOCHEM and LACTOPRESS


Grade Lactochem Fine Powder Description Lactose monohydrate USP/NF, EP, JP (Milled type) Applications Filler in wet granulation, capsules and powder mixtures Ideal for direct compression tableting with excellent flow, high compressibility and enables good content uniformity In direct compression tableting of moisture sensitive actives. Is characterized by superior dissolution and binding properties In direct compression tableting with an improved disintegration profile

Lactose monohydrate USP/NF, EP, JP Lactopress Spray-Dried 250 (Spray-dried, directly compressible) Anhydrous lactose USP/NF, EP, JP (Low-moisture, directly compressible) Lactose monohydrate USP/NF, EP, JP (Granulated, directly compressible)

Lactopress Anhydrous 250

Lactopress Granulated

HMS LACTOSE
Lactose Monohydrate USP/NF, EP

Grade HMS Lactose

Description Impalpable grade

Applications Filler in wet granulation, capsules and powder mixtures

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DFE Pharma

36

BASF SE, headquartered in Ludwigshafen, Germany is the largest chemical company in the world. In 2008, this German company was converted into a European company (Societas Europaea SE) and was renamed BASF SE from BASF Aktiengesellschaft. They have now also acquired Cognis, a German based leading supplier of innovative specialty chemicals. BASF has been an expert partner to the pharmaceutical industry for decades, with its active ingredients, excipients and custom synthesis services manufactured by highly trained and experienced staff meeting the highest standards. They have been pioneers in the production of polyvinyl pyrrolidone range of products and their brands today are considered as quality benchmarks in the pharmaceutical industry. With their in-depth knowledge of science, research and technology, they have converted market trends and scientific ideas quickly into successful innovations. Through new technologies, they have launched several innovative, high functional excipients for various pharmaceutical applications, thus creating added value and opportunities for customers to achieve even greater business success. Quality is BASFs overriding priority and not just because pharmaceuticals are subject to strict legalization. All their production facilities are approved by international regulatory bodies and function within the strict framework of quality and safety. Decades of experience, knowledge, innovation, product consistency and unmatched quality has made BASF the partner of choice for manufacturers of pharmaceutical products in all four corners of the globe.

BASF SE

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37

KOLLIDON
Povidone USP/NF, EP, JP
The soluble grades of Kollidon are polyvinylpyrrolidone (PVP K) obtained by free-radical polymerization of N-vinylpyrrolidone. By virtue of its solubility in water and many organic solvents as well as its high binding power and ability to form complexes, soluble PVP occupies a special position among the synthetic colloids. Soluble Kollidon is available in a variety of grades based on their K-value and weight average molecular weight.

Grade K-value

Description Weight Average Molecular Weight (Mw)

Applications

Kollidon 12 PF

10.2 - 13.8

2000 - 3000

Low molecular weight povidone of pyrogen-free quality for use as a solubilizer, crystallization inhibitor and suspension stabilizer in injections Same as Kollidon 12 PF. Additionally used as a lyophilization agent in injections and ophthalmic preparations Medium molecular weight povidone used as binders in tablets, capsules and granules, stabilizers in oral suspensions, as film formers, oral solubilizers, dispersants for pigments, enzyme stabilizers and as bioavailability enhancers Special low-peroxide and low-formaldehyde grade to prevent degradation of actives sensitive to oxidation. Other applications similar to Kollidon 30 High molecular weight povidone serving as a highly effective binder, stabilizer for oral and topical solutions, thickener, hydrophilizer and pore-former in surgical plastics

Kollidon 17 PF

15.3 - 18.0

7000 - 11000

Kollidon 25

22.5 - 27.0

28000 - 34000

Kollidon 30

27.0 - 32.4

44000 - 54000

Kollidon 30 LP

27.0 - 32.4

44000 - 54000

Kollidon 90 F

81.0 - 96.3

1000000 - 1500000

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BASF

38

KOLLIDON CL
Crospovidone USP/NF, EP, JPE
The insoluble grades of Kollidon are crosslinked polyvinylpyrrolidone manufactured by a polymerization process using an aqueous system, yielding crosslinked insoluble PVP in the form of a popcorn polymer. Kollidon CL grades are used as superdisintegrants due to their property to swell very fast and predictably without forming a gel. These grades accelerate the dissolution and the bioavailability due to its power to form complexes with many insoluble actives.

Grade

Average Particle Size Range (m) 110 - 130

Applications

Kollidon CL

Standard grade, for use as a tablet disintegrant and for improving the release of active substances from tablets, capsules and granules Fine particle size grade, for use as a disintegrant in tablets, especially in formulations for small tablets and in wet granulation Super-fine particle size grade for use as a disintegrant in fast dispersible tablets due to its smooth mouth feel Micronized particle size grade used as a stabilizer for oral and topical suspensions and for improving the release of active substances from tablets, capsules and granules

Kollidon CL-F

20 - 40

Kollidon CL-SF

10 - 30

Kollidon CL-M

3 - 10

KOLLIDON VA 64
Copovidone USP/NF, EP, JPE
Kollidon VA 64 is a vinylpyrrolidone-vinyl acetate copolymer in a ratio of 6:4 (by mass) that is soluble in water and alcohol. This product strongly improves dry binding capacity. Due to its high plasticity, distinguishing it from povidone (Kollidon 30), it produces granules and mixtures that are less susceptible to capping and tablets that are less brittle.

Grade

Average Particle Size (m)

K-value

Applications

Kollidon VA 64

55

25.2 - 30.8 Kollidon VA 64 Fine 17

Fine particle size grade resulting in higher binding efficiency. Displays increased tablet hardness, less friability and higher mechanical stability. Applications similar to Kollidon VA 64
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BASF

Standard grade for use as a dry binder for direct compression and roller compaction, as a binder for wet granulation in tablets, capsules and granules, as a film forming agent in tablet coating / sub-coating as well as in topical sprays

39

KOLLIDON SR
Blend of Polyvinyl Acetate and Povidone USP/NF, EP, JP
Kollidon SR is a blend of 80 percent polyvinyl acetate and 19 percent povidone along with small quantities of sodium lauryl sulfate and silica, used as stabilizers. Due to its combination of the very plastic polyvinyl acetate and strongly binding povidone, Kollidon SR has excellent compressibility and endows tablets with enormous hardness and low friability. When tablets formulated with this product are introduced into gastric or intestinal fluid, the water soluble povidone is leached out to form pores through which the active ingredient slowly diffuses out resulting in sustained action.

Grade

K-value

Advantages

Applications Matrix-forming agent in directly compressible sustained-release tablets. Can also be applied to roller compaction, wet granulation and extrusion

Kollidon SR

60.0 - 65.0

Non-ionic, pH-independent, allows drug release independent of compression force and tablet hardness

KOLLICOAT SR 30 D
Polyvinyl Acetate Dispersion 30 Percent EP
Kollicoat SR 30 D is an aqueous dispersion consisting of 27 percent polyvinyl acetate stabilized with 2.7 percent povidone and 0.3 percent sodium lauryl sulfate. This product is miscible with water in any ratio whilst retaining its milky white appearance. It is however insoluble in dilute alkaline or acidic solutions.

Grade

Advantages Low viscosity, pH-independent drug release, high binding capacity and excellent, flexible, film-forming properties

Applications Used as a sustained-release coating on pellets, microspheres, granules and crystals, as a controlled-release matrix in tablets following wet granulation of the active substance. Also used for taste and odour masking and as a sub-coat for isolating active ingredients in order to prevent interactions

Kollicoat SR 30 D

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BASF

40

KOLLICOAT IR
Macrogol Poly (Vinyl Alcohol) Grafted Copolymer, EP
Kollicoat IR is a polyvinyl alcohol-polyethylene glycol graft copolymer with the addition of colloidal silica. It is a water soluble, film forming agent, ideal for manufacturing instant release coatings for solid dosage forms. The key features of this innovative excipient are low viscosity of the polymer solution, outstanding flexibility of the film coating without the addition of plasticizers and extremely rapid dissolution in the body. In terms of viscosity alone, this new technology offers significant advantages over cellulose derivatives.

Grade

Composition

Applications For instant release coatings of tablets, pellets and particulate matter, pore former in sustained-release coatings, as a binder for wet granulation and also film former in sprays and transdermal therapeutic systems Ready-to-use moisture barrier system for use in combination with pigments. Also acts as a pore former in sustained-release coatings and a taste masking agent

Kollicoat IR

Graft copolymer of PVA - PVP (75:25)

Kollicoat Protect

Co-processed product of Kollicoat IR (55-65%) and polyvinyl alcohol (35-45%)

KOLLICOAT IR COATING SYSTEMS


Ready-To-Use Coating Systems
Kollicoat IR Coating Systems are unique, innovative, ready-to-use coloured coating materials based on Kollicoat IR (polyvinyl alcohol-polyethylene glycol graft copolymer). This novel system consists of seven globally approved base colour components which makes it possible to obtain a wide variety of shades simply by combining different numbers and concentrations of these individual components. The innovative, spray-agglomeration manufacturing process used, results in a raspberry-like structure, granular polymer with high surface area, enabling extremely rapid re-dispersibility in water. The coating suspensions can be easily prepared by weighing and dispersing the required individual components in water without additives.

Grade Kollicoat IR White II Kollicoat IR Black Kollicoat IR Red Kollicoat IR Yellow Kollicoat IR Brilliant Blue Kollicoat IR Sunset Yellow Kollicoat IR Carmine

Advantages

Applications

Easy re-dispersion, excellent flow properties without dust formation, low viscosity of coating suspension, high solid concentration, no lump formation and short process time

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BASF

Ready-to-use colour film coating system for all solid oral dosage forms. Can even be applied at temperatures below 25C, making it ideal for coating formulations with thermo-sensitive ingredients

41

KOLLICOAT MAE
Methacrylic Acid Copolymer USP/NF, EP, JPE
Kollicoat MAE is an anionic polymer derived from methacrylic acid-ethyl acrylate in the molar ratio of 1:1. This product is a state-of-the-art, film-forming agent used for reliable and convenient enteric coating of solid oral dosage forms. Film coatings formed using Kollicoat MAE are insoluble below pH 5 and thus resistant to gastric fluid. Due to salt formation in the neutral to weakly alkaline medium of intestinal fluid, the films dissolve step-wise at pH values above 5.5.

Grade

Description

Applications Enteric film coating of tablets, pellets, capsules and other solid dosage forms. Also used as a moisture barrier, for taste / odour masking and as a protective barrier between incompatible actives For production of an aqueous dispersion for coatings or a solution in organic solvents for enteric coatings of solid dosage forms. Other applications similar to Kollicoat MAE 30 DP

Kollicoat MAE 30 DP

30% aqueous dispersion of low viscosity

Kollicoat MAE 100 P

Partially neutralized, re-dispersible powder

KOLLICOAT SMARTSEAL 30 D
Methyl Methacrylate and Diethylaminoethyl Methacrylate Copolymer Dispersion
Kollicoat Smartseal 30 D is the first water based dispersion for taste masking and moisture barrier applications. It is a 30 percent aqueous polymer dispersion of methyl methacrylate and diethylaminoethyl methacrylate stabilized with approx. 0.6 percent macrogol cetostearyl ether and 0.8 percent sodium lauryl sulfate. Kollicoat Smartseal 30 D is stable in saliva (pH 6.8 - 7.2) and specifically soluble in gastric juices which insures effective protection from unpleasant taste and rapid release with onset of drug action, in the stomach. It is highly impermeable to water vapour, helping preserve the potency of sensitive actives.

Grade

Advantages Hides bitter taste with significantly reduced coating thickness. Has low viscosity and can be used at high spray rates

Applications

Kollicoat Smartseal 30 D

Innovative taste masking agent and an effective sealant against moisture

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BASF

42

KOLLIPHOR (CREMOPHOR)
Solubilizers / Emulsifiers
Kolliphor (earlier known as Cremophor) is a family of non-ionic solubilizers and emulsifiers. Kolliphor RH 40 is obtained by reacting one mole of hydrogenated castor oil with 45 moles of ethylene oxide, while Kolliphor EL and ELP are made by reacting castor oil with ethylene oxide in a molar ratio of 1:35.

Grade

Pharmacopeial Name

Appearance

Applications To solubilize vitamins, hydrophobic actives and essential oil-in-water or hydroalcoholic mixtures, to improve bioavailability in solid dosage forms and as a solubilizer in oral / topical liquid and semi-liquid dosage forms Extra-pure grade for special injection solutions. Also used as a solubilizer and emulsifier in liquid form for oral and topical preparations

Kolliphor RH 40 (Cremophor RH 40)

Polyoxyl 40 hydrogenated castor oil USP/NF, EP

White to yellowish paste

Kolliphor EL (Cremophor EL)

Polyoxyl 35 Polyoxyl 35 castor oil Pale yellow, oily Pale USP/NF, EPcastor oil USP/ liquid yellow, oily liquid NF, EP Polyoxyl 35 castor oil USP/NF, EP (Purified grade of Cremophor EL)

Kolliphor ELP (Cremophor ELP)

White to yellowish paste or cloudy liquid

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BASF

43

KOLLIPHOR CS (LANETTE PH)


Kolliphor CS (earlier known as Lanette PH) is a family of self emulsifying cetostearyl alcohol and sodium cetostearyl sulfate. Kolliphor CS A and Kolliphor CS B are anionic emulsifying waxes prepared by melting cetostearyl alcohol and heating to about 950C. Purified water and suitable anionic surfactants are added and this mixture is further heated upto 1150C with vigorous stirring until frothing ceases. The resulting wax is then rapidly cooled. Kolliphor CS A contains cetostearyl alcohol and sodium cetostearyl sulfate while Kolliphor CS B contains cetostearyl alcohol and sodium lauryl sulfate. Kolliphor CS S on the other hand is an anionic emulsifier which is a mixture of fatty alcohol sulfates, especially sodium cetostearyl sulfate.

Grade Kolliphor CS A (Lanette N PH) Kolliphor CS B (Lanette 20 PH) Kolliphor CS S (Lanette E PH)

Pharmacopeial Name Cetostearyl alcohol (Type A), emulsifying EP Cetostearyl alcohol (Type B), emulsifying EP Sodium cetostearyl sulfate EP

Applications

Anionic self-emulsifying base for topical emulsions Anionic emulsifier used for topical emulsions

KOLLIPHOR HS 15 (SOLUTOL HS 15)


Polyoxyl-15-Hydroxystearate USP/NF, EP
Kolliphor HS 15 (earlier known as Solutol HS 15) is a non-ionic solubilizer and emulsifying agent obtained by reacting 15 moles of ethylene oxide with 1 mole of 12-hydroxy stearic acid. It is soluble in water, ethanol and 2-propanol to form clear solutions. Its solubility in water decreases with increasing temperature and it is insoluble in liquid paraffin. This product has high chemical stability and toxicology tests have shown that it is extremely well tolerated. Kolliphor HS 15 meets the requirements of a potent, modern, low toxicity solubilizer.

Grade Kolliphor HS 15 (Solutol HS 15)

Description Yellowish white paste at room temperature which transforms into a liquid at approx. 30C

Applications Non-ionic solubilizer for manufacturing aqueous parenteral preparations with vitamins and other lipophilic actives

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BASF

44

KOLLIPHOR MCE (EUMULGIN PH)


Polyoxyl Cetostearyl Ether USP/NF, EP
The Kolliphor MCE (earlier known as Eumulgin PH) range of products is polyoxyethylene alkyl ethers prepared by the condensation of linear fatty alcohols derived from vegetable sources with ethylene oxide. The reaction is a controlled one, so that the required ether is formed with the polyethylene glycol of desired molecular weight.

Grade Kolliphor MCE 12 (Eumulgin B1 PH) Kolliphor MCE 20 (Eumulgin B2 PH)

Pharmacopeial Name Macrogol cetostearyl ether 12 EP Polyoxyl 20 cetostearyl ether USP/NF, EP

Applications Non-ionic surfactant for topical emulsions. Also used as a solubilizer and wetting agent

KOLLIPHOR P (LUTROL F / LUTROL L)


Poloxamer USP/NF, EP, JPE
Poloxamers are synthetic block copolymer of ethylene oxide and propylene oxide. They are available in F types (Kolliphor P) which are white, coarse grained powders with a waxy consistency containing an appropriate quantity of the antioxidant BHT; while the L type (Kollisolv P) is a milky white paste or liquid containing DL-alpha tocopherol as an antioxidant.

Grade Kolliphor P 188 (Lutrol F 68) Kolliphor P 237 (Lutrol F 87) Kolliphor P 338 (Lutrol F 108) Kolliphor P 407 (Lutrol F 127) Kolliphor P 188 Micro (Ltrol Micro 68) Kolliphor P 407 Micro (Ltrol Micro 127) Kollisolv P 124 (Lutrol L 44)

Type Poloxamer 188 Poloxamer 237 Poloxamer 338 Poloxamer 407 Microprilled poloxamer 188 Microprilled poloxamer 407

Applications Emulsifier, solubilizer and suspension stabilizer in liquid, oral, topical and parenteral dosage forms and as a plasticizer and bioavailability enhancer in solid formulations Gel former, thickening agent and solubilizer in oral and topical solutions and as a stabilizer in topical suspensions Solubilizing agent and dissolution enhancer for actives in solid oral dosage forms and a water soluble lubricant for actives incompatible with stearates As a dispersion medium for APIs in liquid filled soft gel capsules. It is the only monographed poloxamer in liquid form at room temperature

Poloxamer 124

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BASF

45

KOLLIPHOR PS
Polysorbate USP/NF, EP, JP
Kolliphor PS is a range of polysorbate grades produced by partial esterification of sorbitan (a cyclic sorbitol anhydride) with a fatty acid derived from vegetable sources, to yield a hexitan ester. Finally, ethylene oxide is chemically added in the presence of a catalyst to yield the polysorbate. These products exist in liquid form and contain 20 units of oxyethylene.

Grade Kolliphor PS 20 (Polysorbate 20 PH) Kolliphor PS 60 (Polysorbate 60 PH) Kolliphor PS 80 (Polysorbate 80 PH)

Chemical Description Polyoxyethylene 20 sorbitan monolaurate Polyoxyethylene 20 sorbitan monostearate Polyoxyethylene 20 sorbitan monooleate

Applications This hydrophilic, non-ionic surfactant is widely used as an emulsifier for topical dosage forms. Also used as a wetting, dispersing and solubilizing agent

KOLLIPHOR SLS (TEXAPON)


Sodium Lauryl Sulfate USP/NF, EP, JP
Kolliphor SLS, (earlier known as Texapon) is manufactured by sulfation of the corresponding fatty alcohol of natural origin and subsequent neutralization with sodium hydroxide. The product is characterized by a very high active substance matter and a very low content of inorganic salts and unsulfated fatty alcohol. Kolliphor SLS is extremely efficient throughout the tableting process by assisting in drug dissolution and aiding water uptake during disintegration of the end formulation.

Grade Kolliphor SLS Fine (Texapon K 12 P PH) Kolliphor SLS (Texapon K 12 G PH)

Type
Low and defined particle size, free flowing powder

Applications Wetting agent in tableting, glidant, lubricant, anti-adherent, anionic surfactant, emulsifying agent and skin penetrant

Granular powder

KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA)


Vitamin E Polyethylene Glycol Succinate USP/NF
Kolliphor TPGS (earlier known as Speziol TPGS Pharma) is a mixture formed by the esterification of d-alpha tocopheryl acid succinate and polyethylene glycol for use in oral and topical dosage forms. It is a water soluble derivative of naturally sourced vitamin E that can directly enhance the bioavailability of poorly soluble drugs and also offers high solubilization effectiveness.

Grade

Properties

Applications Emulsifier and drug solubilizer for lipophilic actives, absorption enhancer, antioxidant, vehicle for lipid based drug delivery and a source of natural vitamin E
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Kolliphor TPGS (Speziol TPGS Pharma)

Waxy solid of white to light brown appearance with a melting range of 37 - 41C

BASF

46

KOLLISOLV G (SPEZIOL G PF)


Glycerin USP/NF, EP
Kollisolv G (earlier known as Speziol G PF) is a clear and colourless viscous liquid at temperatures of 20C. This product, derived from vegetable sources, is hygroscopic and has a sweet taste approximately 0.6 times that of sucrose. It is used in a wide variety of preparations such as oral, otic, ophthalmic, topical, rectal and parenteral. Depending on the glycerin content, it is available in two grades.

Grade Kollisolv G 99 (Speziol G 99.8% PF) Kollisolv G 85 (Speziol G 86% PF)

Pharmacopeial Name
Glycerin USP/NF, EP, JP

Applications Moisturizer, humectant, tonicity agent, solvent, co-solvent, sweetening agent and viscosifier. Also used as a plasticizer of gelatin in the production of soft gelatin capsules and gelatin suppositories

Glycerol EP

KOLLISOLV PG
Propylene Glycol USP/NF, EP
Kollisolv PG is produced by converting propylene to chlorohydrin by chlorine water and hydrolyzing it to 1,2-propylene oxide. With further hydrolysis 1,2-propylene oxide is converted to propylene glycol.

Grade

Advantages

Applications Used as a solvent and a water-miscible co-solvent. Also used as a humectant, plasticizer, anti-microbial preservative and a stabilizing agent in a variety of solid, liquid and semi-solid dosage forms

Kollisolv PG

Clear, colourless viscous liquid with a sweet, slightly acrid taste

KOLLISOLV GTA (SPEZIOL GTA)


Triacetin USP/NF, EP
Kollisolv GTA (earlier known as Speziol GTA) is a triester of glycerol and acetic acid which is esterified at increased temperatures.

Grade

Description

Applications As a hydrophilic plasticizer in both, aqueous and solvent based polymeric coating of capsules, tablets, beads and granules. Also used as a solubilizer

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BASF

Kollisolv GTA (Speziol GTA)

Clear, colourless, slightly viscous liquid

47

KOLLISOLV PEG (LUTROL E)


Polyethylene Glycol (Macrogol) USP/NF, EP
These products (earlier known as Lutrol E) are liquid polyethylene glycols manufactured by alkali catalyzed polymerization of ethylene oxide with subsequent neutralization of the catalyst. They are readily soluble in water, ethanol, acetone, glycols and chloroform. Kollisolv PEG grades are available in different molecular weights. The higher the molecular weight of the product, the less hygroscopic it is and lower is its solubility in water.

Grade

Molecular Weight (Mw)

Viscosity (mPa.s)

Applications Solvents and solubilizing agents for actives in oral, parenteral, topical, ophthalmic and rectal preparations and carriers for dissolved or suspended actives in soft gelatin capsules. Also used widely as an ointment base

Kollisolv PEG 300 (Lutrol E 300)

285 - 315

80 - 105

Kollisolv PEG 400 (Lutrol E 400)

380 - 420

105 - 130

KOLLISOLV MCT (MYRITOL PH)


Medium Chain Triglyceride USP/NF, EP
Kollisolv MCT (earlier known as Myritol PH) is a triglyceride based on saturated fatty acids C8 and C10. It is produced by esterification of fatty acids or fatty acid methyl esters and glycerol at high temperatures.

Grade Kollisolv MCT 70 (Myritol 318 PH)

Description

Applications Solubilizer for oil soluble actives. Due to its polarity and spreadability, it is used for skin care preparations

Clear, slightly yellowish, odourless oil

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BASF

48

KOLLIWAX (SPEZIOL C PHARMA)


Kolliwax (earlier known as Speziol C Pharma) grades are derived from vegetable sources using the fatty alcohol production process. They are available in the form of wax pellets while the other types exist in free flowing micro pearls form.

Grade Kolliwax MA (Speziol C 14 Pharma) Kolliwax CA (Speziol C 16 Pharma) Kolliwax SA (Speziol C 18 Pharma) Kolliwax CSA 50 (Speziol C 16 18 Pharma)

Pharmacopeial Name Myristyl alcohol USP/NF Cetyl alcohol USP/NF, EP, JP Stearyl alcohol USP/NF, EP Cetostearyl alcohol USP/NF, EP, JPE

Applications

Viscosity regulator for oil-in-water emulsions. Also used as a pH-independent sustained-release agent

KOLLIWAX GDB (SPEZIOL GDB PHARMA)


Glycerin Behenate USP/NF, EP
Kolliwax GDB (earlier known as Speziol GDB Pharma) is a mixture of glycerol esters produced by esterification of fatty acids of vegetable origin with glycerol, at increased temperatures and with the use of a suitable catalyst.

Grade Kolliwax GDB (Speziol GDB Pharma)

Description Hydrophilic wax available in powder / pellets form

Applications Viscosity increasing agent in emulsions, thickening agent, lubricant and binder in solid orals and a lipophilic matrix or a coating agent for sustained-release tablets or capsules

KOLLIWAX GMS II (CUTINA GMS VPH)


Glyceryl Monostearate 40-55 (Type II) USP/NF, EP
This product (earlier known as Cutina GMS VPH) is manufactured by the reaction of glycerin with triglycerides derived from vegetable sources, resulting in a mixture of monoglycerides and diglycerides.

Grade Kolliwax GMS II (Cutina GMS VPH)

Description White to slightly yellowish, hydrophilic wax powder

Applications Viscosity regulatory in oil-in-water emulsions. Also used as a non-ionic emulsifier, solubilizer, plasticizer, lubricant and stabilizer and to form sustained-release matrices for solid dosage forms

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BASF

49

KOLLIWAX HCO (CUTINA HR PH)


Hydrogenated Castor Oil USP/NF, EP, JP
Kolliwax HCO (earlier known as Cutina HR PH) is manufactured by hydrogenation of castor oil derived from vegetable sources. It is a hard wax with a high melting point.

Grade Kolliwax HCO (Cutina HR PH)

Description White or pale yellow, free flowing powder

Applications Sustained-release agent, lubricant for solid orals and a consistency enhancer in topicals

KOLLIWAX S (SPEZIOL L2SM)


Stearic Acid USP/NF, EP, JP
This product (earlier known as Speziol L2SM) is a mixture of stearic acid and palmitic acid, in neutralized saponified form, derived from raw materials of vegetable origin. Kolliwax S grades are available in a free flowing powder form of different particle sizes and display low variances in tablet characteristics due to material uniformity.

Grade Kolliwax S Fine (Speziol L2SM GF) Kolliwax S (Speziol L2SM GS)

Particle Size Min. 40% <100 m Max. 10% <100 m

Applications Lubricant in oral dosage forms, matrix forming agent in sustained-release dosage forms, emulsifying and solubilizing agent in topical formulations and hardening agent in glycerin suppositories

KOLLICREAM CP 15 (CUTINA CP PH)


Cetyl Palmitate 15 EP
This product (earlier known as Cutina CP PH) is an ester which is manufactured by catalytic esterification of fatty acid and fatty alcohol.

Grade Kollicream CP 15 (Cutina CP PH)

Description White, coarse pellets

Applications For emulsions, on account of its body giving characteristics

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BASF

50

KOLLICREAM DO (CETIOL V PH)


Decyl Oleate EP
Kollicream DO (earlier known as Cetiol V PH) is a mixture of decyl esters of fatty acids, mainly oleic acid. Through the addition of mixed tocopherols, it is protected from autooxidation.

Grade Kollicream DO (Cetiol V PH)

Description Clear, slightly yellowish polar oil

Applications Emollient for topical delivery systems

KOLLICREAM IPM
Isopropyl Myristate USP/NF, EP, JP
This product (earlier known as Isopropylmyristat PH) is manufactured by transesterification of fatty acid methyl esters with isopropyl alcohol. It has low viscosity and congeals at about 5C.

Grade

Description

Applications Non-greasy emollient and skin penetrant in topical preparations Also used as a solubilizer for lipid soluble actives

Kollicream IPM (Isopropylmyristat PH)

Clear, colourless oil of medium polarity and high spreadability

KOLLICREAM OA (HD EUTANOL V PH)


Oleyl Alcohol USP/NF, EP
This product (earlier known as HD Eutanol V PH) is manufactured by the production process of fatty alcohols derived from vegetable sources. It is a mixture of unsaturated and saturated long chain fatty alcohols consisting mainly of oleyl alcohol and elaidyl alcohol. Mixed tocopherols are added to prevent autooxidation.

Grade Kollicream OA (HD Eutanol V PH)

Description Clear, slightly yellowish, weak polar oil

Applications Emollient and emulsifying agent for semi-solid dosage forms. Also as a solubilizer for oil soluble actives

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BASF

51

KOLLICREAM ODD (EUTANOL G PH)


Octyldodecanol USP/NF, EP
Kollicream ODD (earlier known as Eutanol G PH) is produced by the condensation of two molecules of decyl alcohol using the Guerbet reaction. It is stable to hydrolysis and can be used in both the alkaline and acidic pH range.

Grade Kollicream ODD (Eutanol G PH)

Description Clear, slightly yellowish oil of low polarity and good spreadability

Applications Emollient and emulsifying agent for semi-solid dosage forms. Also as a solubilizer for oil soluble actives

LUDIFLASH
Compound of Mannitol USP/NF, EP, Crospovidone USP/NF, EP and Polyvinyl Acetate EP
Ludiflash is an innovative, unique co-processed blend of 90 percent mannitol, 5 percent crospovidone and 5 percent polyvinyl acetate dispersion stabilized with povidone, specifically designed for orodispersible formulations. This sugar-free composition provides a pleasant, creamy mouth feel without a chalky or grainy sensation. Tablets made with Ludiflash are compact but highly porous with exceptional hardness and low friability. They rapidly disintegrate or disperse within a few seconds when placed on the tongue and do not require external liquids to facilitate swallowing.

Grade

Advantages Rapid disintegration, superior flow, low hygroscopicity and good compressibility

Applications Direct compression of fast disintegrating, solid oral dosage forms (mouth-melts). Can also be used for wet granulation and roller compaction processes

Ludiflash

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BASF

52

LUDIPRESS
Compound of Lactose Monohydrate USP/NF, EP, JP and Povidone USP/NF, EP, JP
Ludipress is an advanced, pre-granulated product based on lactose monohydrate (filler) and povidone (binder)-the functional components required for tablets in the necessary proportion. It is a ready-to-use, granular excipient for direct compression of solid oral dosage forms which reduces the tablet production process to a few steps. Excellent flowability, low water absorption, ideal particle size distribution, no segregation of active ingredients and binding capacity are the key features of this product.

Grade

Composition 93% lactose monohydrate, 3.5% povidone and 3.5% crospovidone 96.5% lactose monohydrate and 3.5% povidone

Applications Direct compression of solid orals (disintegrating tablets) and as a filler in hard gelatin capsules Direct compression of lozenges, sublingual, chewable and effervescent tablets. Also used as a bulking agent for modified-release formulations

Ludipress

Ludipress LCE

SOLUPLUS
Polyvinyl Caprolactam-Polyvinyl Acetate-Polyethylene Glycol Graft Copolymer
Soluplus is a polymeric solubilizer with an amphiphilic chemical structure which was particularly developed for solid solutions. Due to its bi-functional character, it acts as a matrix polymer for solid solutions on one hand and on the other hand, it is capable of solubilizing poorly soluble drugs in aqueous media. The safety of this product is documented by a comprehensive range of toxicological data.

Grade

Advantages Effectively solubilizes poorly soluble actives, significantly improves bioavailability, has excellent capability to form solid solutions and displays high extrudability

Applications Innovative excipient for hot-melt extrusion, solubility and bioavailability enhancer. Also used as a binder in wet and dry granulation

Soluplus

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BASF

53

NOVATA
Hard Fat EP
Novata is a range of hard fat suppository bases consisting mainly of mixtures of the triglyceride esters of higher saturated fatty acids along with varying proportions of mono and diglycerides. This product is manufactured by the esterification of fatty acid derived from vegetable sources with glycerin by using a suitable catalyst. Novata is available in pellet form and each type is characterized by its melting point, saponification value and hydroxyl value.

Grade Novata 299 PH Novata B PH Novata BC PH Novata BCF PH Novata BD PH

Melting Point Range (C) 33.3 - 34.5 33.5 - 35.5 33.0 - 34.5 35.0 - 37.0 33.5 - 35.5

Saponification Value Hydroxyl Value Applications 235 - 250 225 - 240 225 - 240 225 - 240 225 - 245 Max. 5 20 - 30 30 - 40 20 - 30 5 - 15 Suppository bases

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BASF

54

Shin-Etsu Chemical Co., Ltd.

Shin-Etsu, founded in Japan in 1926, has grown to become the worlds largest producer of methylcellulose and hypromellose. The companys specialty products include film coating materials, binders, water soluble cellulose ethers and their derivatives, sustained-release agents and enteric coating materials. As part of their expansion strategy, they acquired the cellulose business unit of the Swiss based company, Clariant. The companys Naoetsu plant fully implements the Shin-Etsu six sigma activities and pursues the principle of total quality control. Their speciality chemicals research centre proactively works on new applications for existing products and on development of innovative products to meet the customers ever growing needs. Shin-Etsus corporate symbol, memorable glow is representative of their abidance to advanced technology, top quality, dynamism, high spirits and flexibility, all of which are activated by the light source at the centre, and today, this company has made themselves indispensible in the development of successful and new generation formulations.

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55

PHARMACOAT
Hypromellose USP/NF, EP, JP
Pharmacoat is a low viscosity hydroxypropyl methylcellulose polymer which is easy to use as a film coating material and gives an excellent finish to the final product. It is versatile and suitable for many applications in the design of film coated tablet formulations. This product is also effective as a binder since it does not interact with drugs, has superior stability and is non-ionic in character.

Grade Viscosity (mPa.s) Pharmacoat 603 Pharmacoat 645 Pharmacoat 606 Pharmacoat 615 3.0 4.5 6.0 15.0

Description USP Substitution Type

Applications

Binder in wet granulation 2910 Regular film coating Film coating of greater strength

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Shin-Etsu

56

HPMCP
Hypromellose Phthalate USP/NF, EP, JP
This product is a monophthalic acid ester of hypromellose, widely used as a solvent based enteric coating agent to protect drugs from gastric degradation or to protect the gastric mucosa from irritant drugs. Its threshold pH value for rapid disintegration can be controlled by varying the phthalyl content.

Grade

Description Dissolving pH Viscosity (cst) 40 5.5

Applications

HPMCP HP-55

Regular grade for enteric coating Due to its high molecular weight, this enteric film coat has greater strength and higher acid resistance Enteric coat soluble at lower pH

HPMCP HP-55S

170

HPMCP HP-50

5.0

55

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Shin-Etsu

57

METOLOSE
Hypromellose USP/NF, EP, JP and Methylcellulose USP/NF, EP, JP
Metolose is a non-ionic, water soluble cellulose ether derived from highly purified natural pulp by initial treatment with caustic soda to obtain alkali-cellulose, followed by etherification with methyl chloride or with the combination of methyl chloride and propylene oxide. It can be used as a binder for solid dosage forms and enjoys a variety of properties such as water retention, thickening, sustained-release and protective colloid. Metolose consists of methylcellulose and three substitution types of hypromellose each available in several grades of differing viscosity. Shin-Etsu also manufactures Metolose SR grades specifically for use in hydrophilic sustained-release matrix systems.

Grade Viscosity (cps) Metolose 60SH-50 Metolose 60SH-4000 Metolose 60SH-10000 Metolose 65SH-50 Metolose 65SH-4000 Metolose 90SH-4000 Metolose 90SH-15000 Metolose 90SH-100000 Metolose 90SH-100SR Metolose 90SH-4000SR Metolose 90SH-15000SR Metolose 90SH-100000SR Metolose SM-4 Metolose SM-15 Metolose SM-400 Metolose SM-4000 50 4000 10000 50 4000 4000 15000 100000 100 4000 15000 100000 4 15 400 4000

Description USP Substitution Type

Applications

2910 HPMC polymer, used as a sustained-release agent, thickener, suspending agent and binder for tablets and granules. Also used for ophthalmic formulations

2906

2208

2208

Special HPMC grade, used as hydrophilic matrix agents allowing for more controllable and reproducible drug release, along with good consistency in the final product Methylcellulose polymer for granule coating Methylcellulose polymer used as a granulating agent, emulsifying agent, thickener and bulk laxative

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Shin-Etsu

58

L-HPC
Low-Substituted Hydroxypropyl Cellulose USP/NF, JP
L-HPC is a low-substituted hydroxypropyl ether of cellulose. It is non-ionic, less reactive to active ingredients, insoluble in water and alcohol but swells in water by holding water molecules around hydroxypropyl groups that are distributed on the cellulose backbone. L-HPC is widely used as a dualfunctionality excipient (binder-disintegrant) for tablets, granules or other pharmaceutical solid dosage forms depending on its particle size and substituent content. Tablets containing L-HPC disintegrate into very fine individual particles, thus resulting in rapid drug dissolution. Shin-Etsu has also launched new L-HPC NBD grades with different particle morphology that are designed to significantly improve binding capability.

Grade

Mean Particle Size (m) 55

Hydroxypropoxy Content (%) 11 11

Description

Particle Appearance Highly fibrous

Applications

L-HPC LH-11 L-HPC LH-21

Direct compression, anticapping Dry mixing, wet granulation

45 L-HPC LH-22 L-HPC LH-31 L-HPC LH-32 L-HPC LH-B1 L-HPC NBD-020 L-HPC NBD-021 L-HPC NBD-022 45 8 11 8 11 14 11 8

Moderately fibrous

Allows for better disintegration due to lower hydroxypropoxy content

20

Micronized

Pellet extrusion, layering Fluidized-bed granulation, direct compression for high load formulations Higher binding capability in wet granulation

55

Non-fibrous

Non-fibrous and smaller primary Direct compression particles Quick swelling, especially for orodispersible tablets

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Shin-Etsu

59

SHIN-ETSU AQOAT
Hypromellose Acetate Succinate USP/NF, JPE
This excipient is a novel, enteric coating polymer manufactured from highly purified pulp involving introduction of acetyl and succinoyl groups into the hydroxyl backbone of hypromellose. The characteristics of Shin-Etsu AQOAT allow its use in different coating techniques such as aqueous, solvent based, ammonia neutralization and dry / deposition coating. It is also recommended in solid dispersions to enhance the bioavailability of poorly soluble drugs as well as in the design of controlled-release dosage forms for targeting drug release to specific gastrointestinal sites. Various grades of Shin-Etsu AQOAT are available which differ in chemical substitution levels and particle sizes.

Grade Mean Particle Size AQOAT AS-LF AQOAT AS-MF AQOAT AS-HF AQOAT AS-LG AQOAT AS-MG AQOAT AS-HG 1 mm 5 m

Description Dissolving pH 5.5 6.0 6.5 5.5 6.0 6.5 Acetyl (%) / Succinoyl (%) 8/15 9/11 12/7 8/15 9/11 12/7

Applications

Micronized grade for aqueous and dry coating

Granular grade for solvent based coating

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Shin-Etsu

60

Innophos, established in 1902, is the culmination of over a century of advancement in phosphate technology. It is the leading manufacturer of high quality calcium phosphates, catering to the worlds pharmaceutical and food markets. Innophos and its predecessor company Rhodia, had pioneered the process of manufacturing extremely low lead content, superior quality, calcium phosphate excipients in both anhydrous and dihydrate forms. The company also holds a number of key patents governing the manufacture and use of phosphates. Innophos quality management systems ensure a high level of performance in meeting customer needs and specifications. The company subscribes to the principals of sustainable development and continues to add to its product line, making constant improvements in products as well as enhancing capabilities at their manufacturing sites. Today, as a result of their consistent efforts, Innophos has set high industry standards in purity, uniformity and formulation versatility.

Innophos, Inc.

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61

CALCIUM PHOSPHATES
Calcium phosphates are manufactured by using a very pure grade of phosphoric acid which is reacted with calcium hydroxide derived from limestone. When calcium hydroxide is added to phosphoric acid in the appropriate ratio, dicalcium phosphate (DCP) is precipitated. On the other hand, when acid is added to calcium hydroxide, the precipitate is tricalcium phosphate (TCP) which contains the highest level of calcium content. After drying, the resulting granular grades can be further milled to obtain a powder grade. The milled or powder grade is typically used in wet granulation processes while the unmilled or granular grade is used for direct compression.

Dicalcium Phosphate USP/NF, EP, JP


Grade Type Calcium (%) / Phosphorus (%) Applications Tablet and capsule diluent for direct compression. Is non-hygroscopic and stable at room temperature resulting in better product stability Filler in wet granulation, vitamin premixes and nutritional drinks Tablet and capsule diluent for direct compression, flow agent, blend densifier, tablet punch polishing agent, time-release agent and a carrier of actives Filler in wet granulation, vitamin premixes and nutritional drinks

A-Tab

DCP, anhydrous granular

29.0 / 22.2

Calipharm A

DCP, anhydrous powder

29.0 / 22.2

Di-Tab

DCP, dihydrate granular

23.3 / 18.1

Calipharm D

DCP, dihydrate powder

23.3 / 18.1

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Innophos

62

CALCIUM PHOSPHATES
Tricalcium Phosphate USP/NF, EP

Grade

Description

Calcium (%) / Phosphorus (%)

Applications Tablet and capsule diluent for direct compression, glidant due to its high surface area and carrier of actives. Ideal for formulations requiring high calcium content Special high density grade for use in wet granulation. Benefits similar to Tri-Tab Spray-dried blend for improved compressibility relative to Tri-Tab. Exhibits enhanced taste profile and mouth feel in chewable tablets with the virtual elimination of grittiness and chalkiness Filler in wet granulation - particularly antacid formulations for its buffer action. Used in nutritional drinks and for formulations requiring calcium / phosphorous fortification Provides fortification without grittiness due to its controlled particle size of less than 10 - 12 m, especially in soft chews

Tri-Tab

TCP, anhydrous granular

38.0 / 17.3

Tri-Cal WG

TCP, anhydrous granular

37.6 / 17.3

TCP-DC

TCP, granular

34.5 - 37.5 / 15.6 - 17.4

Calipharm T

TCP, anhydrous powder

38.0 / 17.3

Versacal MP

TCP, anhydrous micronized powder

38.0 / 17.3

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Innophos

63

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Innophos

64

Asahi Kasei Chemicals Corporation

Asahi Kasei Chemicals Corporation is a core operating company of Asahi Kasei Group established in Japan in 1931. Process and product innovation have driven the expansion and growth of the companys operations and they have a specialized line of excipients which include microcrystalline spheres and starch derivatives amongst their other products. With a keen focus on domestic, global and new businesses, they hold true to their groups vision of providing new value to society by enabling living in health, comfort and harmony with the natural environment. All their production facilities in Japan are compliant with various international, national and community standards. By creating new value through unity and synergy and with sincerity towards everyone, Asahi Kasei continuously seeks change and boldly takes on new challenges.

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65

CELPHERE
Microcrystalline Cellulose Spheres USP/NF, EP, JPE
Celphere is a 100 percent pure microcrystalline cellulose sphere which is highly spherical and uniform in its particle size distribution, enabling greater accuracy and consistency in drug layering and coating. This product exhibits high mechanical strength and low friability, allowing it to withstand the rigors of fluidized-bed or wurster coating process. Celphere is insoluble, yet it absorbs water during processing, thereby reducing particle agglomeration even at high spray rates. During dissolution it avoids film deformation or rupturing under stress. It has low chemical reactivity and hence can be freely used to layer high dose, moisture sensitive and potent actives.

Grade Celphere CP-102 Celphere CP-203 Celphere CP-305 Celphere CP-507 Celphere CP-708

Particle Size Range (m) 106 - 212 150 - 300 300 - 500 500 - 710 710 - 850

Applications

Used as a spherical seed core for drug layering, film coating and also for manufacturing sustained-release or taste masked granules

PC-10
Pregelatinized Starch USP/NF, EP, JPE
PC-10 is a partly pregelatinized starch manufactured by controlled thermal gelation of raw corn starch. It is inert, high in water absorption and has pH-independent disintegrating properties. With a far lower soluble content, its particles swell in contact with water rather than dissolve, thereby serving as an excellent disintegrant to effect active ingredient release. PC-10 has high whiteness, good texture and excellent flow properties.

Grade

Particle Size (m)

Applications Disintegrant and dissolution enhancer, granulation aid, stabilizer for moisture sensitive actives and a carrier for hygroscopic ingredients

PC-10

70

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Asahi Kasei

66

SWELSTAR

Pregelatinized Starch USP/NF, EP, JPE


Swelstar is a novel, pregelatinized starch produced by the modification of potato starch. This product is available in different grades which find broad application in the control of drug release, stability and disintegration.

Grade

Average Particle Diameter (m)

Advantages

Applications

Swelstar MX-1

20 - 40

Non-ionic, strong gel structure, low reactivity, high swelling ability by rapid hydration, alpha-amylase resistant Excellent stability, non-ionic and low hygroscopic characteristics Excellent binding and disintegration properties, low reactivity and allows for a fast drug dissolution profile

For gel-matrix tablets, achieves pH-independent sustained-release under high ionic strength conditions Superdisintegrant with high swelling properties. Reduces drug interaction and improves stability Binder for high-shear granulation and fluidized-bed granulation

Swelstar PD-1

40 - 60

Swelstar WB-1

70 - 90

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Asahi Kasei

67

TREHALOSE
Trehalose is a non-reducing di-saccharide. It has moderate sweetness and displays distinctive characteristics such as low reactivity to basic drugs, high stability to moisture, heat and pH, high compactibility, effective taste masking and faster disintegration than sugar alcohols. It is digestible, has low laxative effect and is similar to sucrose in viscosity, osmotic pressure and water reactivity.

Grade Trehalose P Trehalose G Trehalose SG

Description Powder Crystalline granule High purity, endotoxin-free powder

Applications As a compactible sugar-type filler and a taste masking agent in solid as well as liquid dosage forms Protein stabilizer and freeze-drying agent for parenteral dosage forms. Also used for ophthalmics

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Asahi Kasei

68

CP Kelco, a Huber company, is an innovation leader in the production of polysaccharides by microbial fermentation, extraction from land and sea plants and modification of cellulose based raw materials. With over 200 years of experience, they are experts in hydrocolloid manufacturing, modification and application. Through the use of nature based chemistry, CP Kelco strives to provide products such as xanthan gum, gellan gum and carboxymethylcellulose sodium with minimal modifications. These hydrocolloids in turn serve multiple functions such as viscosity modification, thickening, suspension stabilization and gelation.

CP Kelco U.S., Inc.

With operations in several diverse global markets and a focus on responsible business practices, environmental stewardship and ethical conduct, the company has reached great heights. Based on their steadfast commitment to core values, CP Kelco is on the path of achieving continual success.

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69

XANTURAL
Xanthan Gum USP/NF, EP, JP
Xantural is an exocellular heteropolysaccharide produced by the process of fermentation. It has a unique polymeric structure where chains tend to associate forming a complex network, gel-like structure. When shear is applied, these hydrogen bonds are disrupted producing a flowable liquid. The process instantly reverses when the shear is removed. Hence, Xantural solutions exhibit extremely high viscosity at rest or under low shear conditions and very low viscosity under high shear conditions, demonstrating high degree of pseudoplastic behaviour. Xantural gives clear and transparent gels / solutions and displays good stability and viscosity properties over a wide pH and temperature range. This enables it to function across a variety of applications as a suspending agent, stabilizer, viscosity enhancer, gelling and sustained-release agent.

Grade

Particle Size (m) 75 180 1100

Applications Fine particle size grade for reconstitutable / oral suspensions, syrups and gels. Also used as a hydrophilic matrix former in sustained-release tablets Standard grade for oral suspensions and syrups Agglomerated grade which disperses easily and hydrates effectively under all mixing conditions

Xantural 75 Xantural 180 Xantural 11K

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CP Kelco

70

KELCOGEL CG
Gellan Gum USP/NF
Kelcogel CG is a water soluble, exocellular heteropolysaccharide produced by the process of fermentation. This novel gelling agent is extremely effective at low use levels in forming gels with cations, displays thermal stability and reversibility, is compatible with anionic, amphoteric as well as non-ionic surfactants and is stable over a wide pH range. These properties make it a multi-functional product for a variety of applications such as oral, ophthalmic, mucosal and transdermal drug delivery systems. Ophthalmic solutions with gellan gum, on instillation, form in-situ gels in presence of ions of the lacrimal fluid. This gel may provide controlled or extended-release of actives. The pseudoplastic nature of the gel provides gelled solutions at rest but quickly flows under the shear of blinking, resulting in enhanced patient comfort.

Grade Kelcogel CG LA

Description Low acyl type, forms hard, non-elastic, brittle gels High acyl type, forms soft, very elastic, non-brittle gels

Applications

Kelcogel CG HA

Versatile polymer used as a gelling, texturizing, stabilizing, suspending and film forming agent for liquid, semi-solid and solid dosage forms

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CP Kelco

71

CEKOL
Carboxymethylcellulose Sodium USP/NF, EP, JP
CEKOL or sodium CMC, is a water soluble polymer derived from wood and cotton cellulose by introducing carboxymethyl groups on the cellulose backbone. The formed anionic cellulose molecule hydrates and dissolves readily in water. Cekol is one of the most versatile water soluble colloids and has the ability to form viscous solutions in both cold and warm water.

Grade

Viscosity Range, mPa.s (% concentration) 150 - 300 (2%) 350 - 700 (2%) 500 - 900 (2%) 1000 - 2000 (2%) 1500 - 2500 (2%) 300 - 700 (1%) 1000 - 1500 (1%) 1500 - 2500 (1%) 2500 - 3500 (1%) 3000 - 4500 (1%) 4500 - 7500 (1%)

Applications

Cekol 150 Cekol LVD Cekol 700 Cekol HVD Cekol 2000 Cekol 4000 Cekol 10000 Cekol 20000 Cekol 30000 Cekol 40000 Cekol 50000 Cekol 100000

Thickener, stabilizer, film former, suspending and gelling agent in liquid and semi-solid dosage forms. High strength tablet binder and matrix former in sustained-release tablet formulations. Also used as a bulk laxative

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CP Kelco

7500 - 10000 (1%)

72

TM

(Hanns G. Werner GmbH + Co. KG)

Founded in 1952, Hanns G. Werner is a leading manufacturer of exceptionally high quality neutral pellets (sugar spheres) and globuli sacchari (sugar globules) catering to the worlds pharmaceutical and food industries. Located in Germany, they are globally known for their in-house brand of sugar spheres called pharm-a-spheres. These products are of high sphericity and strength and find usage as drug-free cores for sustained-release formulations. They are also available in a wide range of particle sizes from 125 - 2000 m. Along with pharm-a-spheres, the company also produces little sugar spheres (globuli sacchari) which are used mainly by homeopathic manufacturers for loading actives in tincture form. Werners long term, focused and consistent innovation in the field of manufacturing sugar spheres has helped them to meet and exceed the customers requirements in all aspects of formulating successful products.

pharm-a-spheres

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73

TM

PHARM-A-SPHERES
Sugar Spheres USP/NF, EP
Pharm-a-spheres are non-pareil seeds / neutral pellets of spherical form, composed of sucrose and corn starch. They are primarily used as inert cores in capsule and tablet formulations, particularly multi-particulate, sustained-release formulations. They form the base upon which a drug is coated, usually followed by a release-modifying polymer coating. Pharm-a-spheres offer great mechanical strength, low friability and good flowability. Their high sphericity with a narrow particle size distribution allows for precise calculation of drug loading quantity. Pharm-a-spheres range covers the whole spectrum of diameters from 125 - 2000 m. Customized sizes of this product, to meet specific formulation needs, are also possible.

Particle Size Range (mesh ASTM) 100 - 120 80 - 100 70 - 80 60 - 70 50 - 60 45 - 50 45 - 60 40 - 60 40 - 50 40 - 45 35 - 50 35 - 45 35 - 40 30 - 35 25 - 30 20 - 25 18 - 20 16 - 20 16 - 18 14 - 16 12 - 16 12 - 14 10 - 12

Particle Size Range (m) 125 - 150 150 - 180 180 - 212 212 - 250 250 - 300 300 - 355 250 - 355 250 - 425 300 - 425 355 - 425 300 - 500 355 - 500 425 - 500 500 - 600 600 - 710 710 - 850 850 - 1000 850 - 1180 1000 - 1180 1180 - 1400 1180 - 1700 1700 - 2000 1400 - 1700

Applications

Used as drug-free cores for multi-particulate, sustained-release formulations

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pharm-a-spheres

74

Dead Sea Periclase, a division of the ICL Industrial Products, is a world leader in the production of high quality magnesium oxide, magnesium hydroxide and magnesium carbonate range of products. The waters of the Dead Sea, the most concentrated, naturally occurring solutions of dissolved salts in the world, are the brines which serve as raw materials to the companys products.

Dead Sea Periclase Ltd.

Headquartered in Israel, the company has production plants in Israel and France and successfully manages the worlds largest magnesia supply chain. Two different processes for the production of their complimentary range of magnesia products are used. In the Israel plant, production is carried out using the Aman Process while in France they follow the Pattinson Process. As leaders in their field, they have the technical competence to offer solutions in most areas of magnesia utilization and at the same time also welcome discussions with end users in designing tailor made magnesia products for specific applications. Stringent quality conditions ensure that the end products consistently meet purity standards and today, Dead Sea Periclases magnesium based products find usage across multiple pharmaceutical applications.

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75

MAGNESIUM OXIDE / HYDROXIDE / CARBONATE


This wide range of magnesium oxide, magnesium hydroxide and magnesium carbonate products are derived through a unique production process known as the Aman Process. These products are low in impurities such as lead and other metals present in magnesia derived from conventional precipitation processes. They also have exceptionally high purity and tightly controlled physical parameters.

Magnesium Oxide USP/NF, EP


Grade Description Typical Bulk Density (g/cc) 0.25 - 0.55 0.48 Used in antacid preparations and mineral supplements, as a pH modifier and in the production of magnesium derivatives Applications

PHRA 50 Magnesium Oxide HA Magnesium Oxide HA5 Magnesium Oxide HA4 Magnesium Oxide DC

Heavy grade, regular type Heavy grade, sieved type Heavy grade, micronized version of MgO HA Heavy grade, fine particle size Heavy grade, directly compressible, granular type

0.48

0.25 - 0.55 0.95

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Dead Sea Periclase

76

Magnesium Hydroxide USP/NF, EP

Grade

Tapped Bulk Density (g/cc) 0.40 - 0.60 0.61 - 0.80

Applications

Magnesium Hydroxide HD5 Magnesium Hydroxide HD7 Magnesium Hydroxide HD9 Magnesium Hydroxide HD12

0.81 - 1.00

Spray-dried, directly compressible powders for use in manufacture of antacid preparations and mineral supplements

1.01 - 1.25

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Dead Sea Periclase

77

Magnesium Carbonate USP/NF, EP

Grade

Description

Bulk Density (g/cc)

Applications Used in antacid preparations and mineral supplements. Also used as a pH modifier, tablet and capsule diluent, adsorbent, anti-caking agent and free flowing agent

BMC

Basic magnesium carbonate, heavy grade, free flowing powder

0.25 - 0.45

BMC - GR

Granulated basic magnesium carbonate, heavy grade

0.70 typical

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Dead Sea Periclase

78

Established in 1931, Scora is located in Caffiers, France and is the manufacturer of specialty performance products based on calcium & magnesium. In 1999, Scora was acquired by ICL Industrial Products, Israel and today it is an integral part of the ICL-IP Magnesia Division. Scoras expertise comes from a deep insight into the chemistry of calcium and magnesium, its proprietary processes and the use of specialized equipments. A unique process to manufacture synthetic calcium carbonates is used, while their magnesium carbonates and oxides are obtained through the Pattinson Process, ensuring results of highest purity and exceptional quality. Using advanced available technology and with the presence of expert application technicians in their laboratories, Scora is able to effectively and satisfactorily cater to growing customer needs.

Scora S.A.

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79

SCORALITE
Calcium Carbonate USP/NF, EP, JP
Scoralite is a highly pure, free flowing, synthetic calcium carbonate manufactured using a unique synthesis and purification process. This results in a cubic crystalline structure which is tasteless contrary to other products that have a strong chalky taste. Another important parameter of Scoralite is its higher density as compared to other natural calcium carbonate types.

Grade Scoralite Scoralite LL 250 Scoralite LA Scoralite LI Scoralite M

Description Standard grade Low lead content (less than 250 ppb) Low aluminium content (less than 2 ppm) Low iron content (less than 5 ppm) Micronized grade

Applications

Tablet and capsule diluent. Also used in antacid preparations, osteoporosis treatment, mineral supplements and production of calcium derivatives

SCORALITE DC
Directly Compressible Calcium Carbonate
Scoralite DC range is a compound of 90 - 95 percent precipitated calcium carbonate granulated with different binders using the continuous fluid bed granulation process. This provides tableting advantages like excellent flowability, reduced dust formation and homogenous particle size distribution. Due to its high bulk density, production of tablets with lower thickness is easily achievable. All these grades are also available with low lead (less than 250 ppb) or low aluminium (less than 2 ppm) contents.

Grade Scoralite DC 90ST Scoralite DC 95ST Scoralite DC 90MD Scoralite DC 95MD Scoralite DC 85SO Scoralite DC 97PVP Scoralite DC 95AC Scorablend DC MO 10ST

Composition 90% CaCO3 and 10% starch 95% CaCO3 and 5% starch 90% CaCO3 and 10% maltodextrin 95% CaCO3 and 5% maltodextrin 85% CaCO3 and 15% sorbitol 97% CaCO3 and 3% povidone 95% CaCO3 and 5% acacia gum Blend of CaCO3 and MgO (in 2:1 ratio) with 10% starch

Applications

Directly compressible diluent for solid oral dosage forms. Also used in antacid preparations, osteoporosis treatment and mineral supplements

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Scora

80

LIGHT MAGNESIUM OXIDE USP/NF, EP, JP


This free flowing product of low bulk density is produced through a distinctive process known as the Pattinson Process. Amongst several other applications, this high purity product is also used as a precursor in the manufacture of magnesium hydroxide.

Grade

Bulk Density

Applications Alkaline diluent in solid dosage forms, modifies pH, regulates viscosity and serves as a mineral supplement. Also used in antacid preparations

Light Magnesium Oxide

NMT 0.15 g/cc

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Scora

81

LIGHT MAGNESIUM CARBONATE USP/NF, EP, JP


This light magnesium carbonate is a free flowing, high purity product manufactured through the Pattinson Process. It is used as a base to treat dyspepsia, rheumatism and gout as well as in the production of magnesium derivatives and high purity magnesium compounds as an acid acceptor.

Grade Light Magnesium Carbonate

Description Bulk density: NMT 0.15 g/cc Granulated, directly compressible powder Granulated, directly compressible powder of 90% MgCO3 and 10% starch

Applications

ScoraMag DC 100

ScoraMag DC 90ST

Tablet and capsule diluent, used in antacid preparations and laxatives. Also used as an adsorbent, viscosity regulator, anti-caking agent, free flowing agent and in mineral supplements

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Scora

82

Ferro is a leading global producer of technology based performance materials used for a variety of applications across diversified markets. Established in 1919, the company supplies superior quality alkali stearates to the pharmaceutical industry. These special grades of metallic stearates (of magnesium, zinc, calcium and aluminium) are specifically manufactured from vegetable derived stearic acid. To match manufacturing and process requirements of clients, Ferro, backed by strong technical capabilities, develops these materials to deliver specific product performance characteristics. The companys objective is to increase the economic benefits for their customers through the use of advanced technology and service excellence.

Ferro Corporation

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83

SYNPRO STEARATES
Synpro stearates are a family of metallic stearates (of magnesium, zinc, calcium and aluminium) derived from non-genetically modified vegetable fatty acids. These hydrophobic products are offered in a fine, impalpable, white powder form with consistent particle size. The validated and special process of manufacturing, guarantees a high degree of batch-to-batch consistency and specific surface area of the produced stearates. This results in a good speed of release during compression and constant performance of the tablets across parameters such as hardness and dissolution.

Grade Synpro Magnesium Stearate VG Synpro Zinc Stearate VG Synpro Calcium Stearate VG

Pharmacopeial Name Magnesium stearate USP/NF, EP, JP Zinc stearate USP/NF, EP Calcium stearate USP/NF, EP Aluminium stearate USP/NF

Applications

Lubricant for solid oral dosage forms

Synpro Aluminium Stearate VG

Viscosity enhancer in non-aqueous formulations and also as an emulsion stabilizer

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Ferro Corporation

84

Imerys mines rare minerals and turns them into specialties that improve the products and processes of all its customers. Their recent acquisition of the Luzenac Group, a world leader in talc processing, strongly complements their current range of products, extending and reinforcing Imerys position in key markets. Active in 47 countries with more than 240 commercial and industrial sites, the company maintains high standards in areas such as innovation, technical assistance, product quality, health safety and the environment. Offering the widest talc product range an unsurpassed applications expertise, today Imerys is the only talc producer that can meet and exceed all end user requirements worldwide.

Imerys S.A.

(Luzenac)

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85

LUZENAC PHARMA
Talc USP/NF, EP, JP
Talc or hydrated magnesium silicate, is the softest mineral in the world. This water repellant, inert, impalpable, platy mineral shows an affinity for organic substances. The speciality of Luzenac Pharma is its lamellar structure, extra-fine particle size and super-white colour. During manufacturing, these grades undergo a heat treatment process resulting in bacteriologically controlled products of exceptionally high purity. Luzenac Pharma is an ideal excipient for use as a glidant, lubricant and diluent in various dosage forms. Imerys talc products are purified, bacteria controlled grades and are manufactured according to the IPEC GMP guide for bulk pharmaceutical excipients. They are heat-treated (sterilized) for decontamination before being packaged and form ideal excipients for use as glidants, lubricants and diluents.

Grade

Type

Average Diameter (m) 10.0

Applications

Luzenac Pharma

Standard grade

Highly effective flow agent, reduces fluctuations in tablet weight and enhances tablet homogeneity and quality Anti-tacking agent for tablet coating, prevents agglomerations in the coater, eliminates stickiness during drying and reduces coating time High surface area lubricant for tablet presses, reduces friction, prevents binding during compression as well as ejection and guarantees smooth crackfree results

Luzenac Pharma M

Micronized grade

4.7

Luzenac Pharma UM

Ultra-micronized grade

1.1

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Imerys (Luzenac)

86

Kronos is a leading, global manufacturer of Titanium Dioxide. With several years of experience combined with highly reliable products, technical experience and customer service, the company today, has established a strong market position. Kronos owns mines in different parts of the world and all their facilities use environment friendly processes and integrated management systems compliant with international quality standards. Kronos mines the titanium ore, refines it to produce pigments using either the sulfate process (with sulfuric acid) or the chloride process (with chlorine) and grinds it into a fine, uniform powder for optimum technical performance. Today, Kronos titanium dioxide is the worlds primary pigment for providing whiteness, brightness and opacity. Throughout the years the company has consistently delivered high product quality to all its customers and is in turn, poised on the path of continuous growth.

Kronos Worldwide, Inc

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87

KRONOS 1171
Titanium Dioxide USP/NF, EP, JP
KRONOS 1171 is a super-white, untreated, anatase powder manufactured by the sulfate process. Owing to its high refractive index, it has unique light scattering properties that may be exploited in its use as a white pigment and opacifier. Kronos 1171 is of exceptionally high purity, is chemically inert, insoluble in aqueous and organic solvents and yet disperses readily.

Grade Kronos 1171

Description Super-white, amorphous, extra-fine particle size and bacteriologically controlled

Applications Used as a white pigment and opacifier in film coating mixes for tablets, gelatin capsules and dermatological preparations

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88

Lakeshore Biomaterials, Inc.

Lakeshore Biomaterials, a product focused leader in the area of drug delivery, provides a broad range of bioabsorbable polymers to pharmaceutical, biotech and medical device companies across the world. Their core focus is the development of extended-release parenteral products that systemically or locally deliver active pharmaceutical ingredients for days to months. Lakeshores product range consists of customized polymers, developed to suit their clients exact needs and standard grade polymers for commercial products and feasibility studies. The company is a responsive supplier with built-in flexibility in product development, specifications and packaging and just as required in chemistry, Lakeshore Biomaterials aims at forging bonds in working relationships to create substantial results.

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89

LAKESHORE BIOMATERIALS
Bioabsorbable Polymers
Lakeshore biomaterials are biodegradable polymers such as polylactides (PLA), polyglycolides (PGA), polycaprolactone (PCL) and their combinations, which have the benefit of being reabsorbed / biodegraded naturally by the body after a period of time. These polymers control drug delivery rates by either the molecular diffusion process and / or the biodegradation of the matrix, to provide sustained delivery (typically from weeks to months) for a wide range of compounds from small molecules to proteins. They enable site-specific and systemic delivery of drugs, employing durable and biodegradable polymer technologies. This range of biodegradable polymers is available in different monomers along with differing monomer ratios (0:100 and 100:0), inherent viscosity (1.0 - 2.0 dL/g), end-group chemistry (acid or ester), molecular weight, solubility, degradation and PEG or mPEG chemistry, allowing for a broad range of polymer properties to suit the customers precise needs. Using this extensive technology base, one can develop extended-release, injectable microparticles for systemic, local and cellular delivery of active pharmaceutical ingredients and vaccines. Examples of actives microencapsulated include small molecules, peptides, proteins (including antibodies) and nucleic acids.

Grade 100 PGA 100 L 9010G/L 100 DL 8515 DL/G 7525 DL/G 6535 DL/G 5050 DL/G 8515 DL/PCL 8515 L/PCL 7525 L/PCL 100 PCL

Composition 100% polyglycolic acid 100% poly-l-lactide 90% glycolide / 10% l-lactide 100% d,l-lactide 85% d,l-lactide / 15% glycolide 75% d,l-lactide / 25% glycolide 65% d,l-lactide / 35% glycolide 50% d,l-lactide / 50% glycolide 85% d,l-lactide / 15% polycaprolactone 85% l-lactide / 15% polycaprolactone 75% l-lactide / 25% polycaprolactone 100% polycaprolactone

Tg (C) 35 - 40 56 - 60 35 - 45 50 - 55 50 - 55 48 - 53 45 - 50 43 - 48 20 - 25 20 - 25 13 - 20 (-60) - (-65)

Melting Point (C) 225 - 230 173 - 178 180 - 200 Amorphous* Amorphous* Amorphous* Amorphous* Amorphous* Amorphous* Amorphous* Amorphous* 60

Applications

Matrices for drug delivery systems such as microspheres, implants and in-situ gelling Medical devices such as sutures, pins, anchors, stents and stent coating Tissue engineering matrices

* Amorphous polymers process temperature range: 140 - 160 C

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Lakeshore Biomaterials

90

NovaMatrix is one of the worlds leading producers of highly purified and well characterized biopolymers and biomaterials for use in pharmaceutical, biotechnology and biomedical applications. It is a business unit of FMC Healthcare Ventures and is associated with FMC BioPolymer, a leading supplier of microcrystalline cellulose to the food, pharmaceutical and specialty products industries. The ultra pure range of sodium alginates, chitosan and sodium hyaluronate offered by NovaMatrix are used in the development of novel drug delivery systems, in the formation of biostructures for tissue engineering, wound healing, for implants and advanced biotechnology applications amongst several other specialized uses. The companys dedication and consistent focus in the sphere of innovation, allows them to meet the challenging application demands of all their customers.

NovaMatrix

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91

PRONOVA
Ultra Pure Sodium Alginate USP/NF, EP
The Pronova product range is a family of highly purified, well characterized, biocompatible and biodegradable alginates, developed for use in biomedical and pharmaceutical applications. These products are available in two variants, Pronova UP (ultra pure) and Pronova SL (sterile), both having extremely low levels of endotoxins and proteins. Alginates are linear copolymers with homopolymeric blocks of (1 >4)-linked beta-D-mannuronate (M) and its C-5 epimer alpha-L-guluronate (G) residues respectively, covalently linked together in different sequences or blocks. Alternating M and G blocks form the most flexible chains which exhibit excellent solubility at lower pH. The process of sterilizing alginate solutions may often be an obstacle due to polymer degradation during autoclaving or irradiation procedures. On the other hand, sterile filtration of highly viscous solutions may also be difficult. To overcome these problems, Pronova SL grades are introduced which are available in a sterilized and lyophilized form. Sterile aqueous solutions of sodium alginates can now be made by simply adding sterile water or buffers to Pronova SL and shaking the vial to facilitate its dissolution.

Grade

Type

Apparent Viscosity (mPa.s) < 20 20 - 200 > 200

Monomer Content

Applications

Pronova UP VLVG Pronova UP LVG Pronova UP MVG Ultra pure Pronova UP VLVM Pronova UP LVM Pronova UP MVM Pronova SLG20 Pronova SLG100 Pronova SLM20 Pronova SLM100

Guluronate: Min. 60% In the development of novel drug delivery systems in the form of alginate beads for immobilization / encapsulation of living cells or other biomaterials and in the form of alginate foams and gels in areas such as tissue engineering, wound management, anti-adhesion, in-vivo / in-vitro cell support, medical implants and in-situ controlled release applications

< 20 20 - 200 > 200 20 - 99 100 - 300 Sterile 20 - 99 100 - 300 Mannuronate: Min. 50% Mannuronate: Min. 50%

Guluronate: Min. 60%

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NovaMatrix

92

PROTASAN
Ultra Pure Chitosan
The Protasan product range is a series of ultra pure and well characterized chitosan bases and water soluble chloride and glutamate salts with low levels of endotoxins and proteins. Chitosan is a linear polysaccharide composed of randomly distributed beta-(1 >4)-linked D-glucosamine and N-acetylD-glucosamine. It is produced commercially by deacetylation of chitin, the structural element in the exoskeleton of crustaceans, with its viscosity primarily dependent on the average molecular weight of the polymer. Chitosan is a biocompatible, biodegradable, bioadhesive, cationic, polyamine with a high charged density and readily binds to negatively charged surfaces such as mucosal membranes. It also enhances the transport of polar drugs across epithelial surfaces.

Grade

Type

Degree Of Acetylation (%)

Apparent Viscosity (mPa.s) 20 - 199

Applications

Protasan UP B 80 20 Protasan UP B 80 200 Protasan UP B 80 500 Protasan UP B 90 20 Protasan UP B 90 500 Protasan UP B 90 1000 Protasan UP CL 113 Protasan UP CL 213 Protasan UP CL 214 Protasan UP G 113 Protasan UP G 213 Protasan UP G 214 Chitosan glutamate Chitosan chloride 75 - 90 90 75 - 90 > 90 Chitosan base 90 80 - 89

200 - 499 500 - 999 20 - 199 500 - 999 1000 - 2000 < 20 20 - 200 20 - 200 < 20 20 - 200 20 - 200 In biomedical applications such as wound healing, tissue re-engineering, tissue repair and local delivery of cells, drugs, proteins, genes and other therapeutics. Also used for nasal and mucoadhesive drug delivery systems

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NovaMatrix

93

SODIUM HYALURONATE PHARMA GRADE


Ultra Pure Sodium Hyaluronate EP
Sodium hyaluronate pharma grade consists of highly purified and well characterized sodium hyaluronate with controlled endotoxin content (max. 2.5 EU/g). It is a linear copolymer composed of (Beta-1,4)-linked D-glucuronate and (Beta-1,3)-N-acetyl-D-glucosamine. Sodium hyaluronate is a non-sulfated glycosaminoglycan found abundantly in the extracellular matrix of skin, joints, eyes and most tissues and organs of all higher animals. This product forms highly viscous aqueous solutions due to its random coil structure and can trap approx.1000 times its weight in water, resulting in the molecule's unique physiochemical properties as well as distinct biological functions.

Grade

Intrinsic Viscosity (m3/kg) 1.2 - 2.0

Endotoxin Limits (EU/g) 2.5

Applications

Sodium Hyaluronate Pharma Grade 80 Sodium Hyaluronate Pharma Grade 150

2.1 - 2.8

40

An attractive building block for new biocompatible and biointeractive materials in drug delivery, tissue engineering and viscosupplementation

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NovaMatrix

94

Ferro Pfanstiehl Laboratories, Inc.

Ferro Pfanstiehl Laboratories, based in Waukegan, USA, is a wholly owned subsidiary of Ferro Corporation and specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin injectable formulation ingredients, pharmaceutical intermediates and active pharmaceutical ingredients, in gram to multi-ton commercial quantities. With over four decades of experience, Ferro Pfanstiehl works closely with its clients in the pharmaceutical and biotechnology sectors and is conscious not only about product purity but also of the environment and their workers safety. Their production facilities are designed and equipped to comply with various international regulations and they successfully move new and innovative compounds from the laboratory to the commercial marketplace.

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95

ULTRA-PURE, LOW-ENDOTOXIN CARBOHYDRATES


The properties of high purity and low endotoxin limits are needed when even the lowest level of contaminants, especially endotoxins (cell wall fragments of gram negative bacteria) and other high molecular weight impurities can compromise the final products purity, biological activity, shelf-life or patient safety. This ultra-pure, low-endotoxin carbohydrate range of products from botanical sources is purified through a combination of various techniques including chromatography, de-ionization, ultrafiltration, nanofiltration, activated carbon treatment and dissolution re-crystallization. The key advantages of these products are its lot-to-lot and intra-lot consistency, low reducing sugar content, reduced sugar polymer content and its chemical and microbial purity, making it ideal for parenteral dosage forms and other specialized applications.

Grade S-124-2-MC S-124-1 G-106-1 M-131-2

Product Description Sucrose, low endotoxin (<0.6 EU/g), USP/NF, EP, JP, Beet-derived Sucrose, low endotoxin (<1.5 EU/g), USP/NF, EP, Cane-derived D-Galactose, low endotoxin USP/NF, EP, Plant-derived Maltose, hydrate, low endotoxin USP/NF, EP, Bioburden tested

Applications As excipients and carrying agents in parenteral drug formulations, particularly intravenous and intramuscular injectables For blood protein fractionation products As nutrients in cell culture or fermentation media

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Ferro Pfanstiehl

96

FreislandCampina Domo

Domo, an operating company of FrieslandCampina - the worlds largest dairy co-operative, discovers, develops and produces high quality ingredients and semi-finished products such as whey and milk products, hydrolysed proteins, galacto-oligosaccharides, bioactive products and various types of lactose. They cater to the medical nutrition, cell nutrition and sports nutrition industry on a global scale. Domo is flexible, knowledgeable and result oriented and aims to provide ingredients that add value to end products and enrich peoples lives. The company, through its unique partnership process, focuses on the customer and their performance, markets and business processes. Over the years, Domo has built success through mutual trust with clients and is today sought after in the pharmaceutical world for the valuable partnership it offers.

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97

PROTEIN HYDROLYSATES
Cell Culture and Fermentation
This range of ultrafiltered protein hydrolysates is obtained due to the hydrolysis of plant proteins by enzymes. They are mainly composed of peptides and may also contain amino acids, carbohydrates and (essential) minerals. Media formulated with protein hydrolysates typically give higher yields when compared with those using chemically defined media, due to their complex nature and high content of essential micronutrients These hydrolysates of non-animal origin display excellent growth promotion as well as titer levels and display increased productivity. Additionally, they have reduced endotoxins, are light in colour, have no detectable Mycoplasma and no residual protease activity. This range is also a good source of iron and trace minerals, contains growth promoting factors, provides amino acids and peptides that are readily absorbed by the cells and can be autoclaved.

Grade

Type

Endotoxin Limits (EU/ml) <5 <10 <10 <16 <10

Applications

Proyield Soy SE50MAF-UF Proyield Soy SE70M-UF Proyield Pea PCE80B Proyield Wheat WGE80M-UF Proyield Cotton CNE50M-UF

Soy protein Soy protein concentrate Pea protein concentrate Wheat gluten protein Cotton seed

For mammalian cell culture, bacterial cell culture, tissue culture media and sensitive cell culture applications where a reduced endotoxin level is required. Also used in fermentation nutrient systems

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FreislandCampina Domo

98

PROTEIN HYDROLYSATES
Infant Nutrition
This specialty range of hydrolysates, based on cows milk proteins, is ideal for use in formulae for infants with general, non-specific gastrointestinal problems due to their easy-to-digest property. Protein hydrolysates are also used to manage existing cows milk allergy and prevent its development, as well as the causes of and risk factors for developing the allergy. The CMA grades are used in formulae for infants with existing cows milk allergy while the HA grades prevent the development of cows milk allergy.

Grade Hyvital Casein Easy-To-Digest Hyvital Whey Easy-To-Digest

Description Slightly hydrolysed casein Slightly hydrolysed whey protein concentrate

Advantages Low lactose for use in (clinically) lactose-free products Delivers a source of readily absorbable peptides Reduced allergenic properties by 106 times (ELISA), high concentration of di and tripeptides, low lactose for use in (clinically) lactose-free products and low in bitterness and off-flavours Reduced allergenic properties by 105 times (ELISA), high concentration of di and tripeptides and low in bitterness and off-flavours Reduced allergenic properties by 103 times (ELISA) and low in bitterness and off-flavours

Hyvital Casein CMA

Extensively hydrolysed casein

Hyvital Whey CMA

Extensively hydrolysed whey protein concentrate

Hyvital Whey HA

Partially hydrolysed whey protein concentrate

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FreislandCampina Domo

99

PROTEIN CONCENTRATES
These products contain a varying range of protein concentrates and are used as a protein base for infant nutrition. They are derived from whey or casein by acid hydrolysis.

Grade Hiprotal Casein Whey 80 Food Hiprotal Casein Whey 80 Food Inst. Caseinate Refit MPC 80 Refit MPC 80 LR Refit MPI 85

Description Pure whey protein concentrate (80%) Instantized pure whey protein concentrate (80%) containing 1 ppm soy protein Spray-dried milk protein. Variants include Na, K, Ca and Mg caseinates Milk protein concentrate (80%) Milk protein concentrate (80%) with reduced lactose content Milk protein isolate (85%)

Applications A superior source of protein fortification for infant food Excellent emulsifying properties and has an extremely low lactose content Emulsifier / stabilizer in liquid nutritional formulae

BIO ACTIVES
Grade Description Glycoprotein derived from milk Description Colostral whey protein rich in immunoglobulin G (25%) Galacto-oligosaccharides (GOS) syrup GOS powder with whey protein as a carrier GOS powder with maltodextrin as a carrier Advantages Applications

Vivinal Lactoferrin FD Grade Colostrum 2570 Vivinal GOS Syrup Vivinal GOS Powder WPC Vivinal GOS Powder Maltodextrin

Anti-bacterial and anti-viral properties, iron building and immune stimulation Closer Applications to mothers milk. Used in Immune stimulation many standard and premium instant formulae, follow-on formulae and growing Pre-biotic, supports up milks growth of beneficial bacteria

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100

FreislandCampina Domo

Eastman Chemical Company

Eastman, founded in 1920, is a pioneer in the production of the cellulose acetate series of products. Technology, quality, manufacturing excellence and customer service have been the pillars of their success globally. Accountability, empowerment, high performance culture, whatever you may call it, the company holds itself to high standards. Today, their products are extensively used in a variety of pharmaceutical dosage forms. Eastman is a member of Responsible Care, a global voluntary initiative developed autonomously by the chemical industry to improve health, safety and environmental performance and has also been named one of the five best corporate citizens amongst chemical companies in the USA, by the Corporate Responsibility Officer magazine.

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101

EASTMAN CELLULOSE ACETATE


Cellulose Acetate USP/NF, EP
Cellulose acetate is cellulose in which a portion or all of the hydroxyl groups are acetylated. It is prepared from highly purified cellulose by treatment with acid catalysis and acetic anhydride and occurs as a white, odourless, tasteless, free flowing powder. Cellulose acetate is used as a semi-permeable coating on tablets, especially on osmotic pump-type tablets and implants allowing for controlled-release of the actives. Cellulose acetate films, in conjunction with other materials, also offer sustained-release without the necessity of drilling a hole in the coating as is typical with osmotic pump systems. Cellulose acetate and other cellulose esters have also been used to form drug loaded micro-particles with controlled-release characteristics.

Grade

Acetyl (%) 39.8 32.0

Hydroxyl (%) 3.5 8.7

Viscosity (P) 38.0 2.4

Applications Semi-permeable coating for osmotic drug delivery systems. Also used for taste masking and as a directly compressible matrix former in extended-release tablets

CA-398-10 CA-320S

EASTMAN C-A-P
Cellacefate USP/NF
C-A-P or cellulose acetate phthalate is a pH sensitive cellulose derivative designed for enteric coating of solid dosage forms. C-A-P enteric coating material withstands prolonged contact with acidic gastric fluids, but dissolves readily in the mildly acidic to neutral environment of the small intestine. C-A-P is compatible with many plasticizers and also used in combination with other coating agents for drug controlled-release preparations.

Grade

Types Pellets or powder

Phthalyl (%) 35.0

Acetyl (%) 24.0

Viscosity (cP) 68.0

Applications Enteric coating and matrix former in solid dosage forms

C-A-P

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102

Eastman

Cytec is a global, specialty chemicals company focused on developing, manufacturing and selling value-added products. They are a pioneer in the manufacture of Docusate Sodium (DSS), a versatile and highly effective anionic surfactant used across a variety of pharmaceutical applications. Cytec uses its technology and application development expertise to formulate solutions catering to specific and critical requirements of the pharma industry. They are dedicated towards helping customers achieve business objectives by developing high quality products and improving the performance of manufacturing processes. A similar focus is seen in their commitment towards the health and safety of their employees and the overall natural environment. Through innovation and operational excellence, Cytec adds and enhances product value and brings success to its employees, customers and shareholders.

Cytec Industries Inc.

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103

DOCUSATE SODIUM USP/NF, EP


Docusate sodium (DSS), a dioctyl ester of sodium sulfosuccinate, is a versatile and effective anionic surfactant. This product aids the granulation process, improves tablet disintegration and dissolution, facilitates tablet coating and emulsifies gels and suspensions. DSS has a low order of toxicity coupled with good stability and compatibility with a wide range of actives.

Grade DSS DSS Granular

Composition 100% DSS 85% DSS with sodium benzoate

Description Rolls of wax-like plastic sheets White, crystalline powder

Applications An excellent solubilizing, wetting, dispersing and emulsifying agent in oral dosage forms. Used in laxatives, stool softeners and enema / pre-operative colon cleansers. Also used as a tableting aid, in liquid or gel suspensions, topicals, iron preparations, effervescent tablets, ear wax removals, transdermal patches, transmucosal systems and sustained-release dosage forms

DSS 50%

50% DSS in PEG 400

White to yellow, clear viscous liquid

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104

Cytec

Tereos, one of the worlds leading producers of sugar, is a major player of pharmaceutical sucrose in global markets. With a solid understanding of technology and markets and its long term strategic vision, Tereos over the years has made continuous improvements in product quality, variety and the production process. Its expertise extends right through the production chain, starting from beet or cane to the finished product. Its sucrose based excipients are available in different galenic forms that enable many pharmaceutical applications for dry as well as liquid formulations. With several modern, large-scale and quality focused manufacturing plants in France, Tereos offers a wide range of dry crystal sugars, liquid sugars and sugar specialities.

Tereos Excipients

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105

COMPRESSUC
Sucrose (Directly Compressible)
Compressuc represents a new generation of sugars for direct compression, produced from an innovative and patented spray-drying process. It is made up of spherical, porous particles with a narrow particle size distribution which give remarkable free-flowing, mixing and compaction properties. Compressuc is anhydrous, fully soluble in water and has a sweet taste thereby masking the aftertaste of actives.

Grade

Pharmacopeial Name Compressible sugar USP/NF Sucrose USP/NF, EP

Composition Spray-dried compound of sucrose (95 - 98%) with maltodextrins / inverted sugar (2 - 5%) Spray-dried sucrose (100%) without additives

Applications Excellent diluent, binder for direct compression of chewable, effervescent and orodispersible tablets. Also used in sachet fillings and dry syrups

Compressuc MS

Compressuc PS

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106

Tereos Excipients

ICING SUGAR
Sucrose (Milled)
Icing Sugar is obtained by continuous milling of sugar crystals. This high purity sugar range is available in an impalpable, easily compressible and very fine powder form which dissolves quickly in water compared to regular sugars.

Grade

Pharmacopeial Name Confectioners sugar USP/NF, EP Sucrose USP/NF, EP

Composition Blend of milled sucrose and maize starch as an anti-caking agent Milled sucrose (100%) without additives

Applications

Icing Sugar with Starch Pure Icing Sugar

Used for granulation, coating and sachet fillings

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107

Tereos Excipients

CASTER SUGAR / CRYSTAL SUGAR


Sucrose (Screened) USP/NF, EP
This range of sucrose is obtained by purification and crystallization of juice extracted from sugar beet followed by its continuous screening. It is an extremely pure, free flowing and dust-free crystalline powder which ensures production of quick dissolution, homogeneous dry mixes.

Grade

Particle Size Range (m) 200 - 300 300 - 500 500 - 700 700 - 1000

Applications

Caster Sugar 250 Caster Sugar 400 Crystal Sugar N1 600 Crystal Sugar N1 800

Ideal for dry syrups / suspensions, powder sachets, granules and for sugar coatings

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108

Tereos Excipients

Rockwood Pigments NA, Inc.

Rockwood Pigments, a unit of Rockwood Holdings Inc., has a proud history of manufacturing and supplying the worlds finest pigments since 1889. The company is a primary manufacturer and processor of liquid, powder and granulated forms of iron oxide colour pigments and supplies a wide range of natural and synthetic inorganic pigments and automated pigment handling systems. Their manufacturing facilities and quality management systems comply with the highest regulatory requirements. Beyond the sale of their products, Rockwood is committed to solving its customers colour formulation and handling challenges. Their team of experienced chemists and technicians can help troubleshoot and modify existing formulations, develop new products, explore new applications, match colour shades or provide innovative product handling systems.

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109

SICOVIT
Ferric Oxide
The Sicovit product line comprises of highly pure, insoluble powders of iron oxide pigment which provide good opacity and protection to light sensitive actives. These inorganic compounds consist of any one or a combination of synthetically prepared iron oxides.

Grade Sicovit Red 30 E172 Sicovit Yellow 10 E172 Sicovit Black 80 E172 Sicovit Brown 70 E172

Description Red pigment USP/NF Yellow pigment USP/NF Black pigment Mixture of red, yellow and black pigments

Applications

As colourants and UV absorbers across a variety of dosage forms

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110

Rockwood Pigments

AMCOL Health & Beauty Solutions, Inc.

AMCOL Health & Beauty Solutions, Inc. is a wholly owned subsidiary of AMCOL International Corporation and caters to the fields of pharmaceutical, nutraceutical, cosmetics and personal care. AMCOLs micro-particle delivery systems along with their rheological products based on colloidal montmorillonite and saponite or smectite clays, provide solutions to improve the functional performance and aesthetic characteristics of final products. Their manufacturing facility in Los Angeles, USA manufactures a range of rheology modifiers under the brand name Magnabrite. These products, based on purified bentonite and / or magnesium aluminium silicate, are manufactured through a combination of advanced purification processes, mineral selection and surface modification. They are designed to enhance product stability, viscosity and efficacy. The breadth of AMCOLs offerings and their dedication to providing rapid technical and new product development assistance significantly enhances their value proposition to pharmaceutical firms.

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111

MAGNABRITE
Magnesium Aluminum Silicate USP/NF
Magnesium Aluminum Silicate products are natural smectite clays that are water washed to optimize purity and performance. Smectite clay, which is also known as bentonite, is valued for its ability to swell in water and to impart useful rheological properties to aqueous compositions. Due to its plate-like structure and colloidal nature, it functions as a unique thixotropic additive for emulsion stabilizing, suspending, binding, gelling, bodying and disintegrating activities. Magnabrite is the brightest magnesium aluminium silicate and is stable over a wide pH range. Additionally it is non-toxic, non-irritating and rapidly reaches maximum viscosity.

Grade

MAS Type

Key Viscosity Characteristics (cps, 5% solids) High viscosity grade 800 - 2200

Applications Excellent suspension and emulsification properties, delivers high viscosity with good rheology in low solids formulations Stabilizing and suspending agent in liquid and semi-solid dosage forms, especially useful for acidic preparations. Has low acid demand and high acid compatibility Excellent emulsification and thickening abilities, used in formulations requiring medium viscosity, high brightness and ease of dispersion Used as an inert, low-bulk disintegrant. Excellent for large tablets where actives are the major weight and bulk of the tablet. Also used as a suspending and binding agent

Magnabrite HV Type IC

Magnabrite K

Type IIA

Acid stable type

100 - 300

Magnabrite S

Type IA

Regular grade

225 - 600

Magnabrite F

Type IB

Microfine particle size

150 - 450

MAGNABRITE HS
Purified Bentonite USP/NF
Magnabrite HS is an absorbent aluminium phyllosilicate, highly refined, naturally occurring, complex colloidal white smectite clay. Chemically it is colloidal montmorillonite which has been processed to remove grit and non-swellable ores. The properties of Magnabrite HS are similar to that of the other Magnabrite grades.

Grade

Description

Viscosity (cps, 5% solids)

Applications Used as a suspending, thickening and binding agent. Easily hydrates in warm or cold water producing high electrolyte stability. Typically used in antacids, oral suspensions, hydrocortisone and analgesic creams

Magnabrite HS

High stability grade

40 - 200

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AMCoL HBS

Specialty Minerals, a U.K. based wholly owned subsidiary of Minerals Technologies Inc., is the worlds largest manufacturer of precipitated calcium carbonate and has a history dating back to 150 years of innovation in the manufacture and use of this widely used product.

Specialty Minerals Inc.

The company has achieved great success due to their commitment to staying at par with advances in technology. Their research and technology centers are consistently developing new products for the fast growing market. Specialty Minerals production facilities are fully compliant with international quality standards. Additionally, precipitated calcium carbonate for pharmaceutical applications is covered by a specific certificate of suitability from the European Directorate for the Quality of Medicines & Healthcare.

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STURCAL and CALOPAKE


Calcium Carbonate USP/NF, EP, JP
Sturcal and Calopake belong to the family of precipitated calcium carbonates (PCC) produced by the direct carbonation of hydrated lime, known as the milk of lime process. These precipitated calcium carbonate grades are microcrystalline, white powders characterized by their high chemical purity, controlled particle shape and narrow particle size distribution. Although a number of different calcite crystal forms are possible, these products consist of agglomerates of scalenohedral calcite crystals.

Grade

Type

Apparent Density (g/ml) 0.78 - 0.96

Applications Tablet and capsule diluent, pH modulator and used in dentifrice products due to its flow and polishing properties. Also used in antacid preparations, mineral supplements and as a source of calcium

Sturcal L

Heavy grade

Calopake Extra Light

Extra light grade

0.42 - 0.50

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Specialty Minerals

GumBase Co., founded in 1967 as a privately held subsidiary of the Perfetti van Melle Group, is a world leader in the manufacture of gum base and compressed powder gum for the pharmaceutical, nutraceutical and confectionery industry. Headquartered in Italy, the company delivers a range of more than 200 different gum base formulations in five different shapes i.e. slabs, sheets, pearls, pellets and drops. A founding member of the International Chewing Gum Association (ICGA), GumBase believes in constant research and innovation and their R&D personnel are trained to deliver the highest level of expertise in the manufacture of quality gum bases. Based on uncompromising and unconditional integrity coupled with strong focus on customers, employees and the environment, GumBase, in its pursuit of excellence, has successfully overcome many challenges posed by the different industries it caters to.

GumBase Co.

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GUM BASE
Chewing Gum Base
Gum base is a non-nutritive, non-digestible, water-insoluble masticatory delivery system designed to carry sweeteners, flavours, minerals, vitamins, active pharmaceutical ingredients and other desired substances in chewing gum. The composition of gum bases differ but generally consist of elastomers, resins, waxes, fats, emulsifiers, fillers and antioxidants in varying proportions. This new, alternative drug delivery system may contain one or more active substances, which are released on chewing, subsequent to which the gum base should be discarded and not swallowed. GumBase products provide fast onset of action with high bioavailability and pleasant taste. They can be taken anywhere, at any time, without the requirement of water, promoting high patient compliance.

Grade Powder Gum (PG) MedGum Base

Description Directly compressible chewing gum base powder Specific gum base developed for medicated chewing gums

Applications Chewing gum base in formulations for smoking cessation, weight management, xerostomia (dry mouth relief), stress reduction, motion sickness, pain relief and preventing dental caries amongst others

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GumBase

Glossary
Brand Name
AC-DI-SOL ALUBRA PG 100 AQUACOAT ECD-30 A-TAB AVICEL CE-15 AVICEL DG AVICEL HFE-102 AVICEL PH AVICEL RC / CL CALIPHARM A CALIPHARM D CALIPHARM T CALOPAKE CASEINATE CASTER SUGAR / CRYSTAL SUGAR CEKOL CELLULOSE ACETATE PHTHALATE (C-A-P) CELPHERE COLOSTRUM COMPRESSUC DEXTROSE ANHYDROUS C DEXTROSE MONOHYDRATE GC D-GALACTOSE DI-TAB DSS DSS 50% Dextrose Monohydrate, Agglomerated Galactose, Low Endotoxin Docusate Sodium (100%) Docusate Sodium (50%) In PEG 400 Roquette Frres Ferro Pfanstiehl Cytec Cytec 27 96 62 104 104 Cellulose Acetate Phthalate Microcrystalline Cellulose Spheres Colostral Whey Protein Directly Compressible Sucrose Dextrose Anhydrous, Crystalline Eastman Asahi Kasei Tereos Excipients Roquette Frres 102 66 106 27 Screened Sucrose Carboxymethylcellulose Sodium Tereos Excipients CP Kelco Eastman 108 72 102

Product Description
Croscarmellose Sodium Sodium Stearyl Fumarate Ethylcellulose Aqueous Dispersion Dicalcium Phosphate Anhydrous, Granular Microcrystalline Cellulose And Guar Gum Microcrystalline Cellulose And Dibasic Calcium Phosphate Microcrystalline Cellulose And Mannitol Microcrystalline Cellulose Microcrystalline Cellulose And Carboxymethylcellulose Sodium Dicalcium Phosphate Anhydrous, Powder Dicalcium Phosphate Dihydrate, Powder Tricalcium Phosphate Anhydrous, Powder Precipitated Calcium Carbonate, Extra-Light Spray-Dried Milk Protein

Company
FMC BioPolymer FMC BioPolymer FMC BioPolymer Innophos FMC BioPolymer FMC BioPolymer FMC BioPolymer FMC BioPolymer FMC BioPolymer Innophos Innophos Innophos Specialty Minerals

Page
17 17 18 62 16 15 15 14 16 62 62 63 114

FreislandCampina Domo 100

CELLULOSE ACETATE (C-A) Cellulose Acetate

FreislandCampina Domo 100

Dicalcium Phosphate Dihydrate, Granular Innophos

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Glossary
Brand Name
DSS GRANULAR GELCARIN / VISCARIN / SEASPEN GLUCIDEX GLYCOLYS HIPROTAL HI-SWEET HPMCP ICING SUGAR KELCOGEL CG KLEPTOSE KLEPTOSE HPB KOLLICOAT IR KOLLICOAT IR COATING SYSTEMS KOLLICOAT MAE Ready-To-Use Coating Systems Methacrylic Acid Copolymer Methacrylate Copolymer Dispersion KOLLICOAT SR 30 D KOLLICREAM CP 15 (CUTINA CP PH) KOLLICREAM DO (CETIOL V PH) KOLLICREAM IPM (ISOPROPYL MYRISTATE PH) Isopropyl Myristate KOLLICREAM OA (HD EUTANOL V PH) KOLLICREAM ODD (EUTANOL G PH) KOLLIDON KOLLIDON CL KOLLIDON SR KOLLIDON VA 64 KOLLIPHOR (CREMOPHOR) Octyldodecanol Povidone (PVP K) Crospovidone Copovidone Polyoxyl-Hydrogenated Castor Oil BASF BASF BASF BASF BASF 52 38 39 40 39 43 Oleyl Alcohol BASF 51 BASF 51 Decyl Oleate BASF 51 Cetyl Palmitate 15 BASF 50 Polyvinyl Acetate Dispersion BASF BASF BASF BASF 41 42 42 40 Carrageenan Maltodextrin / Corn Syrup Solids Sodium Starch Glycolate Whey Protein Concentrate High Fructose Corn Syrup Hypromellose Phthalate Milled Sucrose Gellan Gum Betadex Hydroxypropyl Betadex Macrogol Poly (Vinyl Alcohol) Grafted Copolymer BASF 41 FMC BioPolymer Roquette Frres Roquette Frres Roquette Frres Shin-Etsu Tereos Excipients CP Kelco Roquette Frres Roquette Frres 20 30 29 32 57 107 71 26 27

Product Description
Docusate Sodium (85%) With Sodium Benzoate

Company

Page

Cytec

104

FreislandCampina Domo 100

KOLLICOAT SMARTSEAL 30 D Methyl Methacrylate And Diethylaminoethyl

Blend Of Polyvinyl Acetate And Povidone BASF

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118

Glossary
Brand Name
KOLLIPHOR CS (LANETTE PH) KOLLIPHOR HS 15 (SOLUTOL HS 15) KOLLIPHOR MCE (EUMULGIN B PH) KOLLIPHOR P / KOLLISOLV P (LUTROL F / LUTROL L) KOLLIPHOR PS (POLYSORBATE PH) KOLLIPHOR TPGS (SPEZIOL TPGS PHARMA) Vitamin E Polyethylene Glycol Succinate BASF BASF BASF BASF BASF BASF BASF BASF BASF BASF BASF Kronos 46 47 47 48 48 47 49 49 49 49 50 88 59 82 81 52
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Product Description
Cetostearyl Alcohol, Emulsifying / Sodium Cetostearyl Sulfate Polyoxyl-15-Hydroxystearate Polyoxyl Cetostearyl Ether Poloxamer Polysorbates

Company

Page

BASF BASF BASF BASF BASF BASF

44 44 45 45 46 46

KOLLIPHOR SLS (TEXAPON) Sodium Lauryl Sulfate

KOLLISOLV G (SPEZIOL G PF) Glycerin / Glycerol KOLLISOLV GTA (SPEZIOL GTA) Triacetin KOLLISOLV MCT (MYRITOL PH) KOLLISOLV PG KOLLIWAX (SPEZIOL C PHARMA) KOLLIWAX GDB (SPEZIOL GDB PHARMA) KOLLIWAX GMS II (CUTINA GMS VPH) KOLLIWAX HCO (CUTINA HR PH) KOLLIWAX S (SPEZIOL L2SM) KRONOS 1171 L-HPC LIGHT MAGNESIUM CARBONATE LIGHT MAGNESIUM OXIDE LUDIFLASH Magnesium Carbonate, Light Grade Magnesium Oxide, Light Grade Compound Of Mannitol, Crospovidone And Polyvinyl Acetate Stearic Acid Titanium Dioxide, Super-White, Anatase Grade Hydrogenated Castor Oil Glyceryl Monostearate 40-55 (Type II) Glyceryl Behenate Medium Chain Triglycerides Propylene Glycol Myristyl / Cetyl / Stearyl / Cetostearyl Alcohol KOLLISOLV PEG (LUTROL E) Polyethylene Glycol (Macrogol)

Low-Substituted Hydroxypropyl Cellulose Shin-Etsu Scora Scora BASF

119

Glossary
Brand Name
LUDIPRESS LUSTRECLEAR LC-103 LUZENAC PHARMA LUZENAC PHARMA M LUZENAC PHARMA UM LYCADEX PF LYCASIN LYCATAB C LYCATAB DSH LYCATAB PGS LYCOAT RS MAGNABRITE F MAGNABRITE HS MAGNABRITE HV MAGNABRITE K MAGNABRITE S MAGNESIUM CARBONATE MAGNESIUM HYDROXIDE MAGNESIUM OXIDE MAIZE / WHEAT / POTATO STARCH MALTOSE MEDGUM BASE METOLOSE SH METOLOSE SM METOLOSE SR NEOSORB NOVATA NUTRIOSE PC-10 PEARLITOL Native Starch Maltose, Low Endotoxin Medicated Chewing Gum Base Hypromellose (HPMC), High Viscosity Methylcellulose Hypromellose (HPMC), For Sustained-Release Sorbitol Hard Fat Soluble Fibre Partly Pregelatinised Starch Mannitol Shin-Etsu Roquette Frres BASF Roquette Frres Asahi Kasei Roquette Frres 58 24 54 32 66 22
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Product Description
Compound Of Lactose Monohydrate And Povidone Microcrystalline Cellulose And Carrageenan Based Coating System Talc Talc, Micronized Talc, Ultra-Micronized Dextrose Monohydrate, Pyrogen-Free Maltitol Solution Partially Pregelatinized Starch Partially Hydrolyzed Starch Fully Pregelatinized Starch Starch Based Coating System Magnesium Aluminium Silicate, Micro-Fine Purified Bentonite, High Stability Magnesium Aluminium Silicate, High Viscosity Magnesium Aluminium Silicate, Acid Stable Magnesium Aluminium Silicate, Regular Magnesium Carbonate Magnesium Hydroxide Magnesium Oxide

Company

Page

BASF FMC BioPolymer Imerys (Luzenac) Imerys (Luzenac) Imerys (Luzenac) Roquette Frres Roquette Frres Roquette Frres Roquette Frres Roquette Frres Roquette Frres AMCOL HBS AMCOL HBS AMCOL HBS AMCOL HBS AMCOL HBS Dead Sea Periclase Dead Sea Periclase Dead Sea Periclase Roquette Frres Ferro Pfanstiehl GumBase Shin-Etsu Shin-Etsu

53 18 86 86 86 27 25 28 28 28 29 112 112 112 112 112 78 77 76 28 96 116 58 58

120

Glossary
Brand Name
PEARLITOL FLASH PHARMACOAT PHARM-A-SPHERES PHARMATOSE / POLY(DL-LACTIDE) POLY(DL-LACTIDECO-GLYCOLIDE) POLYCAPROLACTONE POLYGLYCOLIDE POLYSORB POWDER GUM PRONOVA PROTACID / KELACID PROTANAL / MANUGEL / KELTONE / MANUCOL / KELCOSOL / KELSET / KELCOLOID PROTASAN PROYIELD / HYVITAL READILYCOAT REFIT SCORABLEND SCORALITE SCORALITE DC SCORAMAG DC SHIN-ETSU AQOAT SICOVIT SODIUM HYALURONATE PHARMA GRADE SOLUPLUS STARLAC STURCAL Ultra-Pure Sodium Hyaluronate Polyvinyl Caprolactam-Polyvinyl AcetatePolyethylene Glycol Graft Copolymer Compound Of Maize Starch And Lactose Monohydrate Precipitated Calcium Carbonate, Heavy Roquette Frres Specialty Minerals 31 114
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Product Description
Compound Of Mannitol And Maize Starch Hypromellose (HPMC), Low Viscosity Sugar Spheres Lactose Monohydrate, Sieved, Milled,

Company
Roquette Frres Shin-Etsu Pharm-a-spheres DFE Pharma

Page
23 56 74 34 / 36 90 90 90 90 26 116 92 19

LACTOCHEM / HMS LACTOSE Impalpable Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Bioabsorbable Polymers Anhydrized Liquid Sorbitol Sodium Alginate, Ultra-Pure Alginic Acid

Lakeshore Biomaterials Lakeshore Biomaterials Lakeshore Biomaterials Lakeshore Biomaterials Roquette Frres NovaMatrix FMC BioPolymer

Directly Compressible Chewing Gum Base GumBase

Alginates Chitosan, Ultra-Pure Protein Hydrolysate Ready-To-Use Starch Based Coating System Milk Protein Compound Of Calcium Carbonate And Magnesium Oxide Calcium Carbonate Directly Compressible Magnesium Carbonate Hypromellose Acetate Succinate Ferric (Iron) Oxide

FMC BioPolymer NovaMatrix FreislandCampina Domo Roquette Frres

19 93 98 29

FreislandCampina Domo 100 Scora Scora 80 80 80 82 60 110 94 53

Directly Compressible Calcium Carbonate Scora Scora Shin-Etsu Rockwood NovaMatrix BASF

121

Glossary
Brand Name
SUCROSE SUPERTAB AN / LACTOPRESS AN SUPERTAB GR / LACTOPRESS GR SUPERTAB SD / LACTOPRESS SD SWEETPEARL SWELSTAR SYNPRO ALUMINIUM STEARATE VG SYNPRO CALCIUM STEARATE VG SYNPRO MAGNESIUM STEARATE VG TACKIDEX TCP-DC TREHALOSE TRI-CAL WG TRI-TAB VERSACAL MP VIVINAL GOS VIVINAL LACTOFERRIN XANTURAL XYLISORB Magnesium Stearate Dextrin Tricalcium Phospate, Granular Non-Reducing Di-Saccharide Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Granular Tricalcium Phosphate Anhydrous, Micronized Powder Galacto-Oligosaccharide Lactoferrin Xanthan Gum Xylitol Innophos 63 FreislandCampina Domo 100 FreislandCampina Domo 100 CP Kelco Roquette Frres 70 23 Innophos 63 Innophos 63 Ferro Corporation Ferro Corporation Roquette Frres Innophos Asahi Kasei 84 84 31 63 68 SYNPRO ZINC STEARATE VG Zinc Stearate Calcium Stearate Ferro Corporation 84 Aluminium Stearate Ferro Corporation 84

Product Description
Sucrose, Low Endotoxin Anhydrous, Directly Compressible Lactose Granulated, Directly Compressible Lactose Spray-Dried, Directly Compressible Lactose Maltitol Pregelatinised Starch

Company
Ferro Pfanstiehl DFE Pharma DFE Pharma DFE Pharma Roquette Frres Asahi Kasei

Page
96 35, 36 35, 36 34, 36 25 67

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Signet Chemical Corporation Pvt. Ltd.


Corporate Office: A-801, Crescenzo C/38-39, G-Block Bandra Kurla Complex Mumbai - 400 051 India Tel: +91 22 61462725 Fax: +91 22 61462726 Email: sales@signetchem.com

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