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Excipients
technical Data sheet
Datasheet #: tds-01
hPc Grades & availability
nisso hPc ssl sl l m h
Viscosity mPa•s @20˚C/2%aq 2.0 ~ 2.9 3.0 ~ 5.9 6.0 ~ 10.0 150 ~ 400 1,000 ~ 4,000
Molecular Weight/GPC method ~40,000~ ~100,000~ ~140,000~ ~620,000~ ~910,000~
Ava
ilab
ility
Regular Powder (40mesh) *d50: 70-150µm
Fine Powder (100mesh) *d50: 50-80µm
Super Fine Powder *d50 < 20µm
Ap
plic
atio
n Film coating
Binding
Modified release
*Particle size is for reference purposes only.
hPc Powder type Formats
Regular Powder. Regular Powder type HPC is mainly used in solution form. As a binder for wet granulation applications, low viscosity grades of HPC give an excellent balance of properties to oral solid dosage tablets by imparting superior strength and elegance without compromise of the disintegration profile. As a film coating agent, HPC improves film flexibility, elongation, and adhesion to the tablet.
Fine Powder. Fine Powder type HPC has better formability than Regular Powder type and is mainly used in dry powder form. Having good wettability, lower viscosity grades are used as a dry-mix binder in high shear mixer formulations. Higher viscosity grades of HPC are applicable to controlled release matrix tablet formulations by direct compression application and give better release profiles compared to other common CR polymers.
Super Fine Powder. SFP grade offers the highest level of formability. Excellent tablet properties can be obtained at low use level in direct compression applications. SFP is applicable to poorly compressible drug and high drug load formulations. Additionally, excellent tablet properties can be achieved in orally disintegration tablet (ODT) formulations by direct compression method when SFP grade is used in combination with a super disintegrator.
Fig 3: Viscosity change vs. Temperature, Aqueous solution Fig 4: Viscosity change vs. Temperature, Ethanol solution
1
10 20 30 40
10
100
Vis
cosi
ty (
mP
a •s)
Temperature (˚C)
1000
1 6050
HPC-M
HPC-L
HPC-SL
1
10 20 30 40
10
100
Vis
cosi
ty (
mP
a •s)
Temperature (˚C)
1000
1 6050
HPC-H
HPC-M
HPC-L & SL
1
2 3 4 5 6
10
100
1000
Vis
cosi
ty (
mP
a •s)
Concentration (%)
100,000
10,000
1 108 97
H
M
L
SL
SSL
1
2 3 4 5 6
10
100
1000
Vis
cosi
ty (
mP
a •s)
Concentration (%)
100,000
10,000
1 108 97
H
M
L
SL
SSL
Fig 1: Viscosity change vs. Concentration, Aqueous solution Fig 2: Viscosity change vs. Concentration, Ethanol solution
Viscosity change
Viscosity of HPC in aqueous solution is virtually unchanged in pH range from 1-12. HPC viscosity is also unaffected by UV irradiation. Viscosity change caused by change in HPC concentration or change in temperature are shown in figures below.
Aqueous Solution Dispersion
HEATING >>
<< COOLING
LCST = Lower Critical Solution Temperature
LCST44~46° C
HPC-L at 20° C HPC-L at 50° C
Fig 6: Viscosity change vs. pH Fig 7: Viscosity change vs. Days lapsed under UV radiation
Fig 5: Phase transition effect is completely reversible upon cooling
1
5 10 15 20 25
100
10
1000
Vis
cosi
ty (
mP
a •s)
Days lapsed
10,000
0 30
HPC-H
HPC-M
HPC-L
0
1 4 7 11
20
10
30
Vis
cosi
ty (
mP
a •s)
pH value
40
0 14
HPC-H
HPC-M
HPC-L
HPC-SL
Nisso HPC 2Nisso HPC 2
additives
Nisso HPC contains no silica or other additives.
compendial status
USP/NF, EP, JP compliant; Food use approved 21 CFR 172.870, E463
expiration
Expiration date is (3) years from date of manufacture.
Packaging
Nisso HPC is available in a 10kg box.
site of manufacture
Nippon Soda Co., Ltd. Nihongi Plant 350 Fujjisawa, Joetsu city Niigata prefecture, Japan
Physical and chemical Properties softening temperature
Specific gravity (particles) 1.2224
Coloring temperature 195-210°C
Charring temperature 260-275°C
Softening temperature (°C)
1st transition 2nd transition
HPC-H 73 164
HPC-M 68 178
HPC-L 60 185
HPC-SL 68 192
HPC-SSL 75 183moisture Uptake
Fig 8: Moisture uptake at 50% and 80% relative humidity
0
1 2 3 4
6
2
8
4
10
12
14
16
Mo
istu
re c
on
ten
t (%
)
Days elapsed (days)
18
0 65
HPC-L, SL
HPC-M
80% RH
50% RH
hPc-ssl hPc-sl hPc-l hPc-m hPc-h
Bulk density loose (g/cc) 0.37 0.39 0.37 0.44 0.44
Bulk density tapped (g/cc) 0.55 0.51 0.48 0.54 0.53
Compressibility (%) 32.7 23.5 22.9 18.5 17.0
Angle of repose (Degree) 49 46 45 42 40
Particle size (D50) (µm) 50-70 70-90 100-120 130-150 130
hPc-ssl (sFP) hPc-sl (FP) hPc-l (FP) hPc-m (FP) hPc-h (FP)
Bulk density loose (g/cc) 0.24 0.32 0.33 0.37 0.33
Bulk density tapped (g/cc) 0.41 0.49 0.48 0.50 0.48
Compressibility (%) 41.5 34.7 31.3 26.0 22.3
Angle of repose (Degree) 50 47 47 46 44
Particle size (D50) (µm) < 20 60-80 60-80 60-80 50-70
Powder characteristics
solubility
HPC is soluble in water, water-free lower alcohols and polar solvents. Solutions are transparent and have a smooth feel. Solubility in organic solvents is limited only by the viscosity increase.
solubleWater, Methyl alcohol, Ethyl alcohol, Isopropyl alcohol, Pyridine, Cyclohexanone, Cellosolve, Acetic acid
HazyAcetone, Tertiary butanol , Dioxane, Cyclohexanol, Cyclohexanol, Lactic acid, Methyl ethyl ketone
InsolubleAliphatic hydrocarbons, Benzene, Xylene, Glycerin, Toluene, Gasoline
OR
Hydroxypropyl Cellulose(cellulose, 2-hydroxypropyl ether)
H
OR
CH2OR
CH2OR
O
O
O
O
HH
OR
ORH
H
HH
H H
•R : -H CH3 H
mCH2 CH 0
or
CAS No. 9004-64-2
chemical structure
Nisso HPC 3
U.S./Canada
Nisso America Inc.
45 Broadway, Suite 2120
New York, New York 10006
(T) 212-490-3050
(F) 212-972-9361
Europe
Nisso Chemical Europe, GmbH
Berliner Allee 42, 40212
Duesseldorf, Germany
(T) +49-(0)-211-1306686-0
(F) +49-(0)-211-328231
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
Version 1.1© Copyright 2011 Nisso HPC
noticeThe information described in this sheet is believed to be accurate and are presented in good faith with no guarantee or obligation as to accuracy and no assumption of liability. Users should make their own tests to determine the suitability of products for their own particular use. NISSO makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose other than the material conforms to its applicable current standard specifications.
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