Avicel DG Binder - FMC BioPolymer

FMC BioPolymer
Avicel ®
DG Binder
A Superior Excipient for
Roller Compaction and Dry Granulation

Introduction: Dry Granulation Binder
The use of dry granulation production techniques, like roller
compaction, continue to develop in the pharmaceutical
industry. It is an economical way to achieve good flow and
content uniformity. It has significant advantages over wet
granulation, primarily due to the elimination of the drying
step.
Advantages of this type of dry granulation process include:
• High-volume production of granules
• Uniform particle size
• Suitability for moisture and heat sensitive active
pharmaceutical ingredients (API)
• Good control of bulk density and flow
• Consistency of the final dosage form
• Consistent blend of excipients and API
Product Description: Avicel ® DG
Avicel DG is a high functionality excipient optimized for use in dry granulation processes. Avicel DG is the
result of a synergistic combination of two pharmaceutical excipients produced using FMC’s expertise in
spray dried, co-processing technology.
Avicel DG occurs as a white, odorless powder containing 75% of microcrystalline
cellulose* and 25% anhydrous dibasic calcium phosphate*. The wet
dispersion and spray drying of microcrystalline cellulose and anhydrous dibasic
calcium phosphate results in an intimate physical combination, which cannot
be achieved by traditional dry blending.
The unique characteristics of Avicel DG facilitate solid dosage form
manufacturing utilizing roller compaction by improving process
robustness, tablet hardness, and yields.
As an example, a model formulation containing Vitamin C (Ascorbic Acid),
lubricant and Avicel DG, compacted at 30 bars, produced tablet tensile
strengths 100-175% better than formulations containing physical blends
of common excipients.
* Both microcrystalline cellulose and anhydrous dibasic calcium phosphate are listed as
separate monographs in the JP, Ph Eur, and USP-NF, but the combination is not listed.
Scanning Electron Micrographs
(1000 x)
Microcrystalline cellulose
Avicel ® DG

Advantages of Avicel DG Binder
The use of Avicel DG improves yields by dramatically enhancing recompactability. It reduces costs
by minimizing steps in the production process.
Avicel DG offers good flow characteristics, a high quality initial compactability, required for the
production of robust ribbons, and excellent recompactability, resulting in enhanced tabletting
performance and fewer rejected tablets.
These features will result in better yields and savings:
• Increase of tablet hardness
• Reduction of equipment wear enabled by lower tabletting forces
• Elimination of time consuming weighing and blending steps
• Reduction of rejects due to improved tablet quality
Avicel DG doubles tablet strength as compared to physical blends
Tablet tensile strength at 120 MPa tabletting pressure, after compaction at 30 bars.Model formulation: 69.5% excipient, 30% Vitamin C
(ascorbic acid), 0.5% magnesium stearate.

Avicel DG binder extracts the full value from your roller compaction process
Cost savings are driven by the reduction of labor-associated steps within the process and improved
tablet quality.
• Raw materials - reduced number of excipients, inventory, QC and handling
• Blending - reduced dispensing, weighing and handling
• Roller compaction - improved ribbon robustness
• Extragranular binder - can be eliminated
• Tabletting - reduction of required tabletting forces and resulting equipment wear
• Tablet control - improved yields due to enhanced recompactability
• Coating and packaging - reduced rejects due to lower tablet friability
Poorly flowing blends are compacted and milled into uniform granules with good flow
If the elimination of the post granulation blending steps can be validated, resulting in the absence
of extragranular disintegrant and lubricant, roller compaction may evolve into a truly continuous
production process with consistent performance and stability.

Avicel DG significantly improves tablet robustness at all tabletting pressure
Tablet tensile strength at increasing tabletting pressures, after a compaction at 30 bars. Model formulation: 69.5% excipient, 30% Vitamin C
(ascorbic acid), 0.5% magnesium stearate.
Avicel DG demonstrates a clear improvement over physical blends of excipients
Avicel DG Binder exhibits enhanced recompactability and higher tensile strength compared to either
MCC or the physical blends of MCC and lactose, or MCC and dicalcium phosphate.
In this model formulation, physical blends, without the addition of an extragranular excipient, offered
a maximum tensile strength of about 1.0 MPa. This is typical of weak and friable tablets. Avicel DG,
without any additional excipients, enabled the production of robust tablets, characterized with tensile
strengths exceeding 2.0 MPa.
The use of Avicel DG may enable the use of roller compaction for formulations which previously could
not achive adequate tablet strength from a dry granulation process.

Compendial Status
Avicel DG is co-processed in a cGMP production facility from two compendial excipients at a
constant ratio to provide a quality high functionality excipient compatible with the majority of active
pharmaceutical ingredients. It is processed and tested under tight controls to meet our high quality
standards.
Product Specifications
Avicel DG (Dry Granulation Binder)
[75% Microcrystalline Cellulose NF, Ph. Eur., JP]
[25% Anhydrous Dibasic Calcium Phosphate USP, FCC, Ph. Eur., JP]
Test Specfication
Loss on drying, % NMT 5.0
pH 5.5 - 7.5
Sieve fraction, %, 2 - 35
Alpine +200 mesh
PS Malvern d50, m 35 - 55
LBD, g/cc 0.25 - 0.40
Assay DCP, % 21 - 29
ID test A, Ca 2+
Pass
ID test B, PO4 3-
Pass
ID test C, cellulose Pass
ID test D, degree of polymerization Pass
Heavy metals, % NMT 0.001
Water soluble substances, mg/5g NMT 20.0
Ether soluble substances, mg/10g NMT 5.0
Ether soluble substances, % NMT 0.050
Microbial Limits
Total aerobic microbial, count/g NMT 1000
Total yeast and mold, count/g NMT 100
Pseudomonas aeruginosa None present in a 10g sample
Escherichia coli None present in a 10g sample
Staphylococcus aureus None present in a 10g sample
Salmonella species None present in a 10g sample
NMT = Not More Than

Contact FMC for assistance.
FMC is the world leader in quality
excipients for pharmaceuticals and
supplements.
As the world’s foremost manufacturer
of high quality pharmaceutical excipients,
FMC has vast experience in the areas
of formulating and processing. When
customers use Avicel they get the
benefit of this unparalleled technical
support.
For further information on FMC’s
outstanding products and services,
contact us at 1800-526-3649, or visit
us at our website at
www.fmcbiopolymer.com

United States
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Sales/Technical
Assistance:
Tel: 1 215 299 6534
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Fax: +353 21 4517 201
Patents
FMC Corporation is owner and/or licensee of
several patents related to its products. The
products, processes and uses of such products
referred to in this document may be covered by
one or more patents or pending applications in
the United States and/or other countries. FMC
does not warrant against any infringement claim
arising from the sale and/or use of any FMC
product in combination with other materials;
the use of any FMC product in the operation of
any process; any FMC product manufactured to
a customer's designs or specifications; or any
FMC product manufactured by any process
requested by a purchaser.
www.fmcbiopolymer.com/pharmaceutical
pharm_info@fmc.com
The roller compaction equipment photos were provided
by The Fitzpatrick Company, Elmhurst, Illinois
FMC logo and Avicel are trademarks of FMC.
© 2009 FMC Corporation.
All rights reserved. 10/29/09.RS
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Product Suitability
The information contained in this document
(as well as any advice or assistance) is provided
by FMC only as a courtesy and is intended to
be general in nature. Any uses suggested by
FMC are presented only to assist our customers
in exploring possible applications. FMC makes
no warranty, express or implied, as to its
accuracy or completeness, or the results to
be obtained from such information, advice or
assistance. Each customer is solely responsible
for determining whether the FMC products are
suitable for such customer's intended use, and
for obtaining any necessary governmental
registrations and approvals for such customer's
production, marketing, sale, use and/or
transportation of finished goods using or
incorporating the FMC products.
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