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klucel exf ultra hpc ™

ultra fine particle size, premier tablet binder

description
Klucel™ hydroxypropylcellulose (HPC) has long been the
tablet binder of choice for oral solid dosage forms in
pharmaceutical applications.

Klucel™ EXF Ultra HPC, ultra fine particle size,


takes tablet binding effectiveness to the next level.
Need premium performance that assures formulation
predictability, reliability and robustness? Klucel™ EXF Ultra
HPC is your solution.

key features and benefits


¢ ultra fine particle size

¢ exceptional plasticity

¢ outstanding compressibility

¢ enhanced tablet strength

¢ low friability even at low usage levels outstanding compressibility


¢ low impact on disintegration time The outstanding compressibility of pure polymer
tablets demonstrates the plasticity and toughness of
Klucel™ EXF Ultra HPC. Unlike other binders, pure polymer
ultra fine particle size tablets of Klucel™ EXF Ultra HPC never actually break,
they just deform.
Klucel™ EXF Ultra HPC has significantly lower typical
particle size ranges, to enhance performance. Pure polymer tablets of 400 mg each were made on the
STYLCAM compaction simulator using standard 11.28
average
mm flat-faced punches, then subjected to diametral
binder D10 (µm) D50 (µm) D90 (µm) compression testing using Instron. Polymers used
Klucel™ EXF Ultra HPC 4–12 4–12 15–30 were microcrystalline cellulose (MCC), two grades of
Klucel™ EXF HPC 10–35 10–35 45–90 competitive HPC, Klucel™ EXF HPC and Klucel™ EXF Ultra
HPC. We were unable to cause the tablets made of
exceptional plasticity Klucel™ EXF Ultra HPC to break.
Klucel™ EXF Ultra HPC exhibits exceptional plasticity, to
enable higher binder efficiency—leading to enhanced
tablet strength and low friability at lower usage levels.

Need even smaller, stronger tablets with good


disintegration time? Adding just small amounts of
highly plastic Klucel™ EXF Ultra HPC (1 to 2%) improves
compaction behavior and friability of poorly compressible
blends with low impact on disintegration time.

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1200 Klucel™ EXF Ultra HPC exhibits exceptional tablet
microcrystalline cellulose
strength, even with poorly compressible metformin.
competitive HPC 1
1000 competitive HPC 2
80
Klucel™ EXF HPC

800 Klucel™ EXF Ultra HPC 70


load (N)

60
600

breaking force (N)


50
400
40

200 30 Klucel™ EXF HPC

competitive HPC

20 Klucel™ EXF Ultra HPC


0
0 1 2 3 4 5 6 7 MCC
displacement (mm) 10

0
5 10 15 20 25
Klucel™ EXF Ultra competitive HPC MCC compaction force (kN)

Klucel™ EXF Ultra HPC provides low friability even at low


compaction force.

Klucel™ EXF Ultra HPC


2.5 Klucel™ EXF HPC
competitive HPC
MCC
2
case study
percent friability

acetaminophen formulation 1.5

Klucel EXF Ultra HPC exhibits exceptional binder


1
efficiency with enhanced tablet strength and low
friability at lower usage levels. Tablets were made
0.5
on a STYLCAM compaction simulator using direct
compression and 11.28 mm flat faced punch and die,
0
according to the formulation listed in the table. Binders 10 kN 15 kN 20 kN
used were Klucel™ EXF HPC, Klucel™ EXF Ultra HPC,
and a competitive HPC.
Klucel™ EXF Ultra HPC provides higher binder
efficiency for enhanced tablet strength and low
ingredients wt% mg/tablet
friability, with even the most difficult to compress
acetaminophen DC 80 320
active pharmaceutical ingredients.
MCC 18 72

binder 1.5 6
Klucel™ EXF Ultra HPC takes binder efficiency to the
next level.
magnesium stearate 0.5 2

total 100 400

regional centers Middle East, Africa The information contained in this brochure and the
Istanbul, Turkey various products described are intended for use only by
North America Tel: +00 90 216 538 08 00 persons having technical skill and at their own discretion
Wilmington, DE USA and risk after they have performed necessary technical
Tel: +1 877 546 2782 Latin America investigations, tests and evaluations of the products and their
Mexico uses. Certain end uses of these products may be regulated
Europe Tel: +52 55 52 76 6121 pursuant to rules or regulations governing medical devices,
Switzerland drug uses, or pesticidal or antimicrobial uses. It is the end
Tel: +41 52 560 55 00 ashland.com/contact user’s responsibility to determine the applicability of such
India ® Registered trademark, Ashland regulations to its products.
Maharashtra or its subsidiaries, registered in All statements, information, and data presented herein
various countries
Tel: +91 22 61489696 are believed to be accurate and reliable, but are not to be
™ Trademark, Ashland or its
taken as a guarantee of fitness for a particular purpose, or
Asia Pacific subsidiaries, registered in
representation, express or implied, for which seller assumes
Singapore various countries
legal responsibility. No freedom to use any patent owned
Tel: +65 6775 5366 © 2019, Ashland / PHA19-028
by Ashland, its subsidiaries, or its suppliers is to be inferred.

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