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REPRESENTANTE

wltLtAMS & CtA. PRODUCTOS QUIIilCOS 5.A.

MAGARTñoS cERVANTES 1944' r16oo N¡oNTEVtDEo- uRUcuAy
TEL, 47 05 ]2 - TELEX 26941 WILIAMS UY
FAX (005982) 47 06 10
 fMC
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TheA/icef
Diffierence.
Eu", since FMC introduced the first
microcrystalline cellulose (MCC) product
Lror use in pharmaceuticals, we have been
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the innovator and world leader in setting .,,.9*r .

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and maintaining MCC quality and perfor- *&.
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mance standards.
This has resulted in a product with
well-defined characteristics and excep-
tional uniformity, produced in a wide
selection of grades that optimize
pharmaceutical performance. This
product quality, combined with
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global availability and accepta-
^
boility, and technical support,
is what we call "The Avicel
Difference." The difference that
can, and has, turned formulation
problems into profitable solutions.
We are an MCC supplier worlds
apart from other producers, A
partner to help you keep up with
an ever-changing, mq[
demanding world. l.:

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 'W.
ur" the world's leading MCC supplier
not only because we produce a full line of
Avicel@ PH grades, but also because we pro-
vide sales support and technical assistance in
North America, Europe, South America, the
M¡ddle East and Asia/Pacific. Our joint part-
nership with Asahi Chemical lndustry Co. Ltd.
enables us to further service our customers..
FMC provides state-of-the-art, fully-
equipped laboratories - complete with R&D
staff - on two continents, in addition to dedi-
cated technical resources everywhere we do
busi ness,
Further, with our integrated business
information system and inventory management
capabilities, our ability to service your needs
is unparalleled on a local level or on a global
basis. But, this is only part of the story.
Over the years, Avicel@ PH MCC has
earned its place in countless solid dosage for-
mulations, thanks to its proven abllity to pertorO
many different functions. lt is used in direct com-
pression, wet granulation, and slugging or roller
compaction tableting; as a binder, flow aid and
filler; and in encapsulation and spheronization.
As the originator and leading producer of
MCC for the pharmaceutical industry, FMC has
attained incomparable control over production
factors that affect quality and performance. For
this reason, even our standard MCC grades are
superior. But, since the beginning, we recog
a
form of MCC was noF
nized that offering a single
good enough.
You work with different active ingredients,
different delivery systems, different formulations,
and you need to consider impact on production
processes as well as on the nature of the final
pharmaceutical product. lt makes sense to adjust
the physical attributes of MCC if doing so can
result in greater process efficiencies and superior
functionality and efficacy of the delivered dose.
o
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 #MC
t
Therc Is Nothing In The World
LikeA/icel.
A number of the grades we offer today
were originally developed as custom grades,
AUes¡gned to solve specific problems or capi-
lalize on unique opportunities for customers.
Having a supplier customize your MCC
may not always be practical, but FMC has
developed so many different and clearly
differentiated grades of Avicel@ PH
MCC, you can often get custom
grade performance from one
of our existing grades. lf
customization proves to be
best solution, you will
-the
Cl.,no no better source ot this
type of support than FMC.

The added value of FMC.

As different from other MCC producers
as apples and oranges

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FVIC...One Global MCC
Supplier That Is Differen[ Fhom
AllTheOthers.
Or, ,unrfacturing plants - in Newark,
Delaware, in the U.S. and in Cork, lreland -
are ISO 9002 Certified and manufacture
products to current Good Manufacturing
Practices. FMC has recognized the pharma-
ceutical industry's increasing requirements
around validation and is actively undertaking
efforts to address this issue. So, wherever.
in the world you need high quality MCC, you
can depend on FMC to meet your needs
with batch-to-batch consistency.
What's more, our global production http : //www. av i c e l. co m
control allows for harmonization with all the
world's major pharmacopoeias: the United Ü.
States Pharmacopeia/National Formulary, the
European Pharmacopoeia, the Japanese Phar-
macopoeia, and the British Pharmacopoeia.
Whether you are working on a new
product or grappling with old production
problems, looking for unique functionality or
seeking greater efficiencies, FMC stands
ready to help. FMC can make a real difference
for you, your products and your company.
Put us to the test.
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Avicef PH-101 MCC

The original innovator product, and the best MCC for
/ess specralized applications, especially in wet granulation and
roller compaction.

AverageParticleSize(¡Lm) ....00
Loose Density(g/cc). ....,.0.29
TapDensity(g/cc) . ..0.45
Compressibility(Slopex10') ....... 34
Mass Flow (Kg/nin) . . 0.56
VolumetricFlow(L/min) ......2.07
MoistureContent(%) .....NMTS b

Avicef PH-102MCC
Developed in response to customer requests. Like pH_lOl,
and equally compressible, but with a larger particte size to
improve flow in direct compression, the dry phase of wet gran-
ulation and dry granulation.

Avicef PH-103MCC
This specialty grade offers low moisture content in combi-
nation with medium particle size. tt is especially well-suited to
m o i stu re- sen s itive d ru g s.

$t,r = ,io! More Than

&
 Avicef PH-105MCC
With its very fine particle size and resultant increase in
surface area, this grade is often specified for use in direct com-
pression of coarse, granular, crystalline or otherwise hard-to-
compress materials. lt is often admixed with PH-l01 or PH-102
to achieve flow and/or compression properties.

Aücef PH-112 MCC

By combining low moisture with large particle size, this
grade sfands out in applications that call for increased flow for
uniform direct compression with moisture-sensitive ingredients.

AverageParticleSize(¡Lm) ....90
Loose Density(g/cc). ....,.0.30
TapDensity(g/cc) . ..0.48
Compressibility(Slopex10') .......29
Mass Flow (Kg/min) ...1.0
Volumetric Flow (L/min) . . S.0S
MoistureContentf/,) .. ... NMT l.s

Avicef PH-113 MCC

Another of the low-moisture grades of MCC, this product
can help extend shelf life and improve final product stability, espe-
cially with moisture-sensitive drugs.

AverageParticleSize(¡tm) ,...50
Loose Density(g/cc). ..,...0.30
TapDensity(g/cc) . ..0.44
Compressibility(Slopex10') ....... 32
Mass Flow (Kg/min) . . 0.46
Volumetric Flow (L/min) ....1.59
Moisture Content (%) . . .NMT 2

¡,
Avicef PH-200MCC
Our largest particle size MCC produces the greatest f,c,,,
rate in direct compression and dry granulation, yet matnia rs
high levels of compressibility. Consider PH-200 first to avoid
problems with weight variation and content uniformity.
Average Particle Size (pm)
Loose Density (g/cc).
Tap Density (g/cc) .
Compressibility (Slope x 10')
Mass Flow (Kg/min)
Volumetric Flow (L/min) . . 4.80
MoistureContent(%), .,.. NMTs

Aücef PH-301 MCC

To reduce powder stratification and tablet weight variation,
this grade has been given a high bulk density. This property facili-
tates mixing of fine actives and increases fhe potential for making
smaller tablets.
AverageParticleSize(¡Lm) .... OO
Loose Density(g/cc), ......0.42
TapDensity(g/cc) . ..0.59
Compressibility(Slopex10') .......23
Mass Flow (Kg/min) . . 0.BB
VolumetricFlow(L/min) ....2.10
Moisture Content (%) , NMT 5

Avicef PH-302 MCC

With high bulk density and large particle size. thts QGce tS
a good choice for avoiding powder segregatron whiie acbte,.,.c
greater flow rates, and it can be used for high dose fcrn-:t,i-s
to produce thinner tablets.
Average Particle Size (¡tm)
Loose Density (g/cc).
Tap Density (g/cc) .
Compressibility (Slope x 10').
Mass Flow (Kg/nin)
Volumetric Flow (L/min) .
Moisture Content (%) .
m/ICMakes
The Grades.
l{o is as qualified as FMC at
"ornpany
defining, producing and supporting unique MCC
grades. By controlling the raw materials used and
employing proprietary process technology and tech-
niques, the innovators at FMC maintain control of
three distinct physical properties of Avicel@ PH MCC
grades. They are particle size, moisture content and
bulk density.
Particle size is an especially important factor
in the direct compression of solid dosage
forms. lf the particle sizes of active
ingredients and excipients are not
properly matched, the powder
mix may segregate at various
stages of manufactur
During processi
large particle ,;:
size grade ".'i
like Avicel PH-200
can enhance: flow rate and uniformity, tablet content
and weight uniformity; compressibility; lubrication
sensitivity. In the finished product, particle size can
affect: crushing strength and friability; disintegration
time; dissolution time; surface properties.
Moisture can have a significant impact on drug
stability, manufacturing efficiency and finished
product shelf life. For this reason, FMC has devel-
oped three Avicel grades specifically as low-mois-
ture options for formulators: Avicel PH-103, PH-112
and PH-l'13. These special grades yield several
benefits: they are more compatible with moisture-
sensitive active ingredients and other excipients; they
extend shelf life and improve product stability; tne¡r il
desiccating effect eliminates the need for pre-drying,
thereby speeding throughput and reducing costs.
FMC also produces two high-density grades
for your formulation challenges: Avicel PH-301
and PH-302. While maintaining the com-
pressibility ffir{;# of standard Avicel grades,
the high-density grades offer
these advantages: greater compati-
bility with certain active ingredients,
eliminating stratification and drrg*
content variations; greater uniformity in
tablet weight; reduced tablet size; faster
tablet production; better flow in filling capsules
As shown to the left, we offer nine distinct
grades with variations in particle size, density, and
moisture content. This means there is a superior
Avicel match for most of your active and process-
ing preferences. lf we do not already have an
Avicel grade that is perfect for your formulation
challenge, FMC can custom design and produce
an MCC for you. .lt
+MC
FMC Corporation
Pharmaceutical Division
t
USA:
'1735 Market Street
Philadelphia, PA 19103
Phone Numbers:
Technical Assistance: 21 5-299-6534
Fax: 215-299-6821
Customer Service: 800-362-3773
Fax: 302-453-6518
Europe:
Avenue Louise 480-Bg
1050 Brussels, Belgium
Phone: 32-2-645-9578
Fax: 32-2-640-056
Asia:
12/F Caroline Centre
28 Yun Ping Road
Causeway Bay, Hong Kong
Phone: 852-2839-6600
Fax: 852-2839-2918

Patents
FMC Corporation does not wanant against infringements of patents of thid pahies by reason
of any uses made of the product in combination with other material or in the operation of any
process, and purchasers assume all risks of patent infringement by reason of any such use,
combinat¡on, or operation.
The products ment¡oned herein may be protected by one or more of the following U.S.
patents or corresponding patents in other countries, or may be described in pending patenl
appl¡cations flicensed to FMC): 4,1 59,345; 4,1 59,346; 4,1 69,01 4; 4,1 96,21 9-; 4,1 99,368;
4,231,802; 4,234,316; 4,275,196-; 4,290,911;4,330,338.; 4,381 ,082; 4,387 ,164i 4,415,428i
4,462,839; 4,484,141', 4,504,641; 4,518,433; 4,542,200-,4,588,555; 4,659,672; 4,689,302;
4,693,896; 4,695,548-; 4,701,754; 4,717,667; 4,744,987; 4,749,620; 4,774,093i 4,861,44Ü;
4.966.71 3: 4,983,268; 4,990,61 1; 5,051 ,261; 5,053,332; 5,075,1 1 5; 5,1 43,646; 5,1 55,1 ¿14;
5,206,030; 5,212,299;5,248,516; 5,258,436; 5,277,915;5,326,572. Forfurther
¡nformation, call (800) 362-3773.

Warranty
Because of the numerous factors affecting results, FMC
ingred¡ents are sold on the understanding that purchasers will
make their own test to determine the suitabil¡ty of these products
for their particular purpose. The several uses suggested by FMC
Corporation are presented only to assist our customers in exploring
possible applications. All information and data presented are
believed to be accurate and reliable, but are presented without the
assumption of any liability by FMC Corporation.

Technical Service ,,,

The information contained in this bulletin is intended to be '.:
general in nature. Techniques and data pertaining to specific uses
for FMC ingredients and new developments will be published
periodically in the form of supplemental application bulletins. Our
technical staff is ready to offer assistance ¡n the use of Avicelo
microcrystall¡ne cellulose products.

Regulatory Status
Avicel@ microcrystall¡ne cellulose meets the standads set forth in the United States
Pharmacopeia/National Formulary the European Pharmacopoeia, the Japanese
Pharmacopoeia and the British Pharmacopoeia.
Microcrystalline cellulose is generally recognized as safe (GRAS) by qual¡fied experts.
FMC ma¡ntains a Drug lvlaster File at the U.S. Food and Drug Administration to support the
use of Avicel in drug products. Avicel products are manufactured in accordance with current
Good Manufacturing Practice and are in compliance with the U.S. Federal Food, Drug and
Cosmetic act, as amended, and applicable regulations.

#MC, Avicel and Not Just Products. Partners. - FMC trademarks.

01998 FMC Corporat¡on. All.rights reserved. Visit our website at www.avi*|$

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