You are on page 1of 4

VIVAPUR MCC SPHERES

Microcrystalline Cellulose Pellets


Ph.Eur., NF, JP

Chemically Inert Carrier for


Multi-particulate Formulation Applications
Compatible with Soluble and Insoluble APIs
Permits Dissolution Profile Flexibility
Adaptable to High and Low Dose Loading

VIVAPUR
VIVA
PUR MCC SPHERES

Microcrystalline Cellulose Pellets

VIVAPUR MCC SPHERES

General Information
Spheres become more important in today s formulation
development strategy. When multiple API or controlled
release doses are preferred, VIVAPUR MCC SPHERES
provide benefit.

VIVAPUR MCC SPHERES are extremely robust. They consist


purely of Microcrystalline Cellulose (Ph.Eur., NF, JP) which
makes them the preferred, chemically inert carrier
Compatible with soluble and insoluble APIs
Permits dissolution profile flexibility
Adaptable to high and low dose loading
For formulation application, VIVAPUR MCC SPHERES can
be used as API carriers. The coated spheres can be filled
into capsules or compacted into tablets.

Excellent Content Uniformity


Consistent and Controlled API Release Profiles
Multiple Drugs Combined in One Unit Dose
High Drug Stability

Product Portfolio
VIVAPUR MCC SPHERES

mesh

Grade 100

100 - 200

70 - 140

Grade 200

200 - 350

45 - 60

Grade 350

350 - 500

35 - 45

Grade 500

500 - 710

25 - 35

Grade 710

710 - 1000

18 - 25

Tab. 1

A new technology allows the production of pellets in the


range of 100-200 m.
VIVAPUR MCC SPHERES shows a high degree of sphericity.

Characteristics
Appearance

nearly white round shaped spheres

Taste / Odor

tasteless, odorless

Solubility

insoluble in water and most organic solvents

Bulk Density

800 g/l

Sphericity

0.9 0.05

Friability

< 0,1 %

Loss on Drying < 7.0 %


Swelling Index < 2
Tab. 2

Why use VIVAPUR MCC SPHERES ?

Pic. 1:

Scanning electron micrograph picture VIVAPUR MCC SPHERES Grade 100


Specific Surface area: 0.11 m/g

The multiparticulate technology based on VIVAPUR MCC


SPHERES bears following advantages:
VIVAPUR MCC SPHERES can be coated in different
colours, making it easier to differentiate APIs.
The coating spheres can be filled into two-piece gelatin
or HPMC capsules, or compacted into tablets.
Dose dumping r isks are greatly reduced when the
API is applied in multi-particulate systems.

Excellent Content Uniformity


Pic. 2:

Scanning electron micrograph picture from competitor's MCC pellets (x400).

VIVAPUR MCC SPHERES prossess a tight particle


size distribution allowing for better control of API
release profiles.
2

VIVAPUR
VIVA
PUR MCC SPHERES

Microcrystalline Cellulose Pellets

VIVAPUR MCC SPHERES

Particle Size Distribution


Diff. Volume [%]

25
20
15

VIVAPUR MCC SPHERES


Competitors MCC pellets

VIVAPUR MCC SPHERES Advantages


VIVAPUR MCC SPHERES provide high mechanical
robustness. Friability is negligible. Therefore, VIVAPUR
MCC SPHERES are excellent in improving production yields
during dosage manufacture.

10
5

VIVAPUR MCC SPHERES can be used in aqueous and


0.375
0.496
0.656
0.868
1.149
1.520
2.011
2.660
3.519
4.655
6.158
8.147
10.780
14.260
18.860
24.950
33.010
43.670
57.770
76.420
101.100
133,700
176,900
234.000
309.600
409.600
541,900
716.800
948,300
1255.00
1660.00

solvent based systems depending on API requirements.

Particle Size [m]

Fig. 1

Sphere particle size uniformity minimizes segregation


risks during encapsulation or tableting, permitting greater
API content uniformity.

Multiple Drugs can be Combined


in One Unit Dose
It is possible to apply different APIs in various
concentrations and combine the coated spheres in a
single unit dose.

Consistent and Controlled


API Release Profiles
By coating each API separately on the VIVAPUR MCC
SPHERES, assay can be performend independently
without other API interference.
Different API release profiles are often required and can
be achieved using VIVAPUR MCC SPHERES. The spheres
can be coated to provide unique API release profiles.

High Drug Stability


It is also possible to enhance API stability by coating the
individual spheres with a protective coating after the API
has been coated onto the sphere.

Benefits of Cellulose Spheres vs.


Sugar Based Pellets
Sugar Cores*
Biological constraints
Sugar-sensitive users
Energetic excipient
Cariogenic product
Technological constraints
Agglomeration (water)
Organic solvents
* Sugar pellets are available from JRS Pharma, too.
Outside of North America.

VIVAPUR MCC SPHERES


Biologically inert
Insoluble in water
Moisture and heat resistant
Adapted for coating and tableting
Rough surface (adheres small APIs)
Particle size < 200 m available

JRS PHARMA offers:

VIVAPUR
VIVA
PUR MCC SPHERES

Excipients

Microcrystalline Cellulose Pellets

Family of High Functionality Excipients


The Next Generation of Modern Excipients:

PROSOLV EASYtab

Microcrystalline Cellulose, Colloidal Silicon Dioxide,


Sodium Starch Glycolate, Sodium Stearyl Fumarate
All-in-One, Ready-to-Use Excipient Composite:
Binder/Filler, Glidant, Superdisintegrant, Lubricant

Regulatory and Logistics

PROSOLV ODT

Microcrystalline Cellulose, Colloidal Silicon Dioxide,


Mannitol, Fructose, Crospovidone
ODT Excipient Matrix - License and Royalty Free

VIVAPUR MCC SPHERES


meets the following
requirements:
CAS- No. 9004-34-6
Ph. Eur., NF, JP
Food Status: USA-GRAS / EU-E460

PROSOLV SMCC

Manufacturing

Silicified Microcrystalline Cellulose

High Functionality Excipient Line

Plant MCW, Weissenborn, Germany


ISO 9001
EIP available

Binders

VIVAPUR, EMCOCEL

Microcrystalline Cellulose

EMCOMPRESS

Calcium Hydrogen Phosphate Dihydrate and Anhydrous


Dibasic Calcium Phosphate Dihydrate and Anhydrous

Storage Stability

EMDEX

MCC Pellets are classified as stable .


1

Plant Origin

.according to the IPEC Excipient Stability


Program Guide 2010 .

Dextrates

COMPACTROL

BSE/ TSE Free


Allergen Free

Calcium Sulfate Dihydrate

Coating

Packaging:

VIVA PHARM

Gluten Free

Hypromellose

Sugar Free

Superdisintegrants

MCC is listed in the Inactive


Ingredients Database
published by the FDA.

VIVASTAR, EXPLOTAB
Sodium Starch Glycolate, Sodium Carboxymethyl Starch

VIVASOL

Residual Solvent Free

Would you like to receive


a sample? Please visit
http://orderforms.jrspharma.com

Croscarmellose Sodium

Polyethylene-lined carton
net weight 25 kg.
500 kg / container pallet
400 kg / euro pallet

EMCOSOY
Soy Polysaccharides

Lubricants+Modified Release

PRUV

Sodium Stearyl Fumarate

Sample Size:

LUBRITAB

Hydrogenated Vegetable Oil, Hydrogenated Oil

Disclaimer: The information provided in this brochure


is based on thorough research and is believed to be
completely reliable. Application suggestions are
given to assist our customers, but are for guidance only.
Circumstances in which our material is used vary and
are beyond our control. Therefore, we cannot
assume any responsibility for risks or liabilities,
which may result from the use of this technical
advice.

Functional Fillers

ARBOCEL

Powdered Cellulose

Thickener+Stabilizer

VIVAPUR MCG

Aluminum Bags 100g or 400g

Microcrystalline Cellulose and


Carboxymethylcellulose Sodium

Carriers

VIVAPUR MCC SPHERES

WORLDWIDE HEADQUARTERS

USA+Canada

JRS PHARMA GMBH&CO.KG

JRS PHARMA LP, USA

73494 Rosenberg
(Germany)
Phone: + 49 (0) 7967 / 152 0
Fax:
+ 49 (0) 7967 / 152 345
info@jrspharma.de
www.jrspharma.de
www.jrs.de

2981 Route 22, Suite 1


Patterson, NY 12563-2359
Toll-Free: (800) 431 2457
Phone: +1 (845) 878 3414
Fax:
+1 (845) 878 3484
info@jrspharma.com
www.jrspharma.com, www.jrs.de

Customer Service: +49 (0) 7967 / 152 312

Customer Service: +1 (845) 878 3414

4155GB_V1_3.01009KE

Microcrystalline Cellulose Pellets

NON-PAREIL SEEDS
Sugar Spheres

Technology

R&D Services

Co-Processing of
Actives

3rd party formulation development

PROSOLV

S.Zhaveri, India -

TECHNOLOGY

an associate
of JRS PHARMA