Kollicoat MAE grades

Kollicoat

®

MAE grades

® = Registered trademark o BASF Aktiengesellschat

Methacrylic acid/ethyl acrylate copolymers or enteric coatings

Technical Inormation

April 2006Spersedes issue dated May 2005MEMP 030725e-02/Page 1 o 12

Excipients ActiesContract Manuacturing Value Added

Contents

Page

1. Introduction

31.1 General 31.2 Structural ormula 31.3 Trivial names 31.4 Commercial orm 3

2. Specifcations and properties

32.1 Description 32.2 Physicochemical properties 32.3Pharmacopoeia 4

3. Application and examples o ormulations

43.1 Processing instructions 43.2 Coloured enteric lm coatings or tablets 63.3 Coloured enteric lm coatings or pellets and crystals 83.4 White enteric lm coatings or pellets 93.5 Colourless enteric coatings or sot gelatin capsules 103.6 Subcoating o cores prior to sugar-coating 113.7 Further applications 113.8 Patents 11

4. Storage

11

5. Shel lie

11

6. PBG Number

11

7. Packaging

11

MEMP 030725e-02 April 2006Page 2 o 12Kollicoat

®

MAE grades

1. Introduction

1.1 General

Kollicoat

®

MAE 30 DP and Kollicoat

®

MAE 100P are copolymers derived rommethacrylic acid/ethyl acrylate and are used as lm-ormers in the pharmaceuticalindustry or the production o enteric coatings or solid dosage orms.

1.2 Structural ormula

The ratio o the components in the copolymer is roughly 1 : 1. The Kollicoat

®

MAE grades have an anionic character. The average molecular weight M

w

is o the order o 250,000.Kollicoat

®

MAE 100P has been treated with sodium hydroxide to neutralizeabout 6 mol-% o the carboxyl groups.

1.3 Triial names

Methacrylic Acid Copolymer Type C (USP), Methacrylic Acid Copolymer LD (JPE)

and Methacrylic Acid-Ethyl Acrylate Copolymer (Ph. Eur.), Methacrylsäure Copolymer.

1.4 Product orm

Kollicoat

®

MAE 30 DP is an aqueous dispersion with a solids content o 30%. The milky white, low-viscosity product has a aint, characteristic odour.Kollicoat

®

MAE 100P is a white redispersible powder with a aint characteristicodour. The neutralized carboxyl groups in the powder make it easy to redispersein water without urther auxiliaries. The properties and processing requirementso latices produced with it are the same as those o Kollicoat

®

MAE 30 DP, romwhich it is manuactured.

2. Specifcations and properties

2.1 Description

The Kollicoat

®

MAE grades contain 0.7% sodium lauryl sulate (USP) and 2.3%Polysorbate 80 (Ph. Eur.) as emulsiying agents. (The percentages reer to thesolid substances.) The atty acids used in the manuacture o Polysorbate 80 areo vegetable origin. The Kollicoat

®

MAE grades are weakly acidic copolymersthat dissolve at a pH above 5.5.

2.2 Physicochemical propertiesKollicoat

®

MAE 30 DP Kollicoat

®

MAE 100P

Identity conorms conorms Apearance o the Film conorms conorms Viscosity <15 mPas <100 mPasCoagulate content <1.0% – Acid value DIN 53402 300 – 330 mg KOHper g o dry substance280 – 310 mg KOHper g o dry substanceMethacrylic acid, % 46.0 – 50.6 43.2 – 47.6pH 2.0 – 3.0–Specic gravity (DIN 53217)1.062 –1.072 –Microbiological status conorms conormsSolids content 28.5 – 31.5%



95% Total monomer content <100 ppm <100 ppm Arsenic



1 ppm



2 ppmHeavy metals max. 20 ppm max. 20 ppmSulphated ash max. 0.1%

