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Excipients
HPC-SSL-SFP: Super Fine Powder, Super Low
Viscosity For High Performance Dry Binding
ApplicAtion note
Hpc-SSl-SFp For Dry Binding: Summary
Hpc-SSl-SFp (Super Fine powder), a highly compressible grade of HPC, is introduced for dry binding applications. With a very fine particle size and low molecular weight, HPC-SSL-SFP imparts the expected HPC advantages in tablet hardness and friability at lower usage amounts and with faster dissolution when compared to regular HPC and other commonly used excipients.
Application of HPC-SSL-SFP include direct compression of poorly compressible drugs, formulas with high drug content, orally disintegrating tablets, and extra granule addition.
contentS Section
Tablet properties with Acetaminophen 1
ODT formulation using HPC-SSL-SFP + 2 superdisintegrant
Tablet properties for Glucosamine HCL 3
Extra-granule dry binder addition 4 using HPC-SSL-SFP
Powder properties of HPC-SSL-SFP 5
note #:ApplicAtion:
DC-ODT-02Direct Compression/ODT Formulation
Nisso HPC 2
1. tablet properties using Hpc-SSl-SFp with Acetaminophen
a) Formula:
b) Results:
Compression pressure 10kN, Tablet weight 200mg
other binders: HPC-SL (FP), MCC PH-101, PVP-PVA (PLASDONE S630),L-HPC (LH-21),Partially Pregelatinized Maize Starch
Hpc-SSl-SFp other binders
Acetaminophen (%) 60 60
lactose (%) 22.8 24.2 25.6 16.8
corn Starch (%) 9.7 10.3 10.9 7.2
Hpc-SSl-SFp (%) 7 5 3 -
other binders (%) - 15
Magnesium Stearate (%) 0.5 0.5
Silica (%) 0.5 0.5
0
10 20 30 40 50
20
40
60
Dru
g R
elea
sed
(%
)
Time (min)
120
100
80
0 7060
HPC-SSL-SFP 3%
HPC-SSL-SFP 5%
HPC-SSL-SFP 7%
HPC-SL-FP 15%
MCC-PH-101 15%
PVP-PVA 15%
L-HPC 15%
Partially PregelatinizedMaize Starch 15%
Chart 4: Dissolution Profile
Chart 1: Chart 2: Chart 3:
2 4 6 8 100 12 2 4 6 80 10 0.2 0.4 0.6 0.80.0 1.21.0
HPC-SSL-SFP 7%
HPC-SSL-SFP 5%
HPC-SSL-SFP 3%
HPC-SL-FP 15%
MCC-PH-101 15%
PVP-PVA 15%
L-HPC 15%
Partially PregelatinizedMaize Starch 15%
Tablet Hardness (kgf) Friability (%)Disintegration time (min)
16.22
Nisso HPC 3
3. tablet properties for Glucosamine Hcl (powdered form)
a) Formula:
Glucosamine HCL, powdered form 76%, Binder 20%, Lubricant 4% Compression pressure: 8kN, Tablet weight 200mg
b) Results:
Chart 5: Tablet hardness using HPC-SSL-SFP compared to other binders
0
2
4
6
8
Har
dn
ess
(Kg
f)
10
HPC-SSL-SFP HPC-L (FP) PLASDONE S630 MCC KG-802
conventional tabletFormulation
oD tablet Formulation
Acetaminophen (%) 60
lactose/cornstarch (7/3) (%) 34 -
Mcc-pH-102 (%) - 34
Hpc-SSl-SFp (%) 5 3
crospovidone (%) - 2
Silica (%) 0.5
Magnesium Stearate (%) 0.5
Hardness kgf 7.17 7.13
Friability (%) 0.49 0.29
Disintegration time seconds 83 23
2. oDt formulation using Hpc-SSl-SFp + superdisintegrant
Compression pressure 10kN, Tablet weight 200mg
√ High drug load
√ Downsizing of tablet
√ Anti-capping
Hpc-SSl-SFp is a high performance dry binder with applications for:
√ Direct compression
√ ODT
√ Dry granulation/roller compaction
© Copyright 2012 Nisso HPC
U.S./Canada
Nisso America Inc.
Wall Street Plaza
88 Pine Street, 14th Floor
New York, NY 10005
(T) 212-490-0350
Europe
Nisso Chemical Europe, GmbH
Berliner Allee 42, 40212
Duesseldorf, Germany
(T) +49-(0)-211-1306686-0
(F) +49-(0)-211-328231
www.nisso-chem.de
Head Office
Nippon Soda Co., Ltd
2-1 2-Chome, Ohtemachi
Chiyoda-ku, Tokyo 100-8165 Japan
(T) 81-3-3245-6159
(F) 81-3-3245-6059
4. extra-granule dry binder addition using Hpc-SSl-SFp
5. powder properties of Hpc-SSl-SFp
a) Formula:
Granulation: Erythritol 80% + Corn Starch 20% Extra-granule HPC addition: 0-5%
b) Results:
www.nissoexcipients.com
0.0
1.0 2.0 3.0 4.0
2.0
4.0
6.0
11.0
8.0
9.0
3.0
1.0
5.0
7.0
10.0
0.0 5.0
Friability (%)
SSL-SFP (5kN)
SSL-SFP (10kN)
SL-FP (5kN)
SL-FP (10kN)
0.0
1.0 2.0 3.0 4.0
1.0
2.0
3.0
HPC addition (%)
HPC addition (%)
HPC addition (%)
3.5
1.5
0.5
2.5
0.0 5.0
0.0
1.0 2.0 3.0 4.0
1.5
2.5
3.0
1.0
0.5
2.0
0.0 5.0
SSL-SFP (5kN)
SSL-SFP (10kN)
SL-FP (5kN)
SL-FP (10kN)
SSL-SFP (5kN)
SSL-SFP (10kN)
SL-FP (5kN)
SL-FP (10kN)
Ch
art
6:
Tab
let
Har
dn
ess
(Kg
f)C
har
t 7:
Fria
bili
ty (
%)
Ch
art
8:
Dis
inte
gra
tio
n T
ime
(min
)
DC-ODT-02Version 1.0
Hpc-SSl-SFp Hpc-Sl-Fp
Particle size* (D50/D90) 20µm/50µm 80µm/160µm
Angle of repose (degree) 53 47
Bulk density (loose/tapped) 0.18/0.33 0.32/0.48
Compressibility (%) 45.5 33.3
*for reference purposes only
