technical Data sheet - Nisso HPC

1 Excipientstechnical data sheetDatasheet #:tds-01hPc Grades & availability Nisso hPcsslsllmhViscosity mPa s @20 C/2% ~ ~ ~ ~ 4001,000 ~ 4,000 Molecular Weight/GPC method~40,000~~100,000~~140,000~~620,000 ~~910,000~AvailabilityRegular Powder (40mesh) *d50: 70-150 mFine Powder (100mesh) *d50: 50-80 mSuper Fine Powder *d50 < 20 mApplicationFilm coatingBindingModified release*Particle size is for reference purposes Powder type FormatsRegular 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 Powder. Fine Powder type HPC has better formability than Regular Powder type and is mainly used in dry powder form.

2 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 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 3: viscosity change vs. Temperature, Aqueous solutionFig 4: viscosity change vs. Temperature, Ethanol solution11020304010100 viscosity (mPa s)Temperature ( C)100016050 HPC-MHPC-LHPC-SL11020304010100 viscosity (mPa s)Temperature ( C)100016050 HPC-HHPC-MHPC-L & SL123456101001000 viscosity (mPa s)Concentration (%)100,00010,000110897 HMLSLSSL123456101001000 viscosity (mPa s)Concentration (%)100,00010,000110897 HMLSLSSLFig 1: viscosity change vs.

3 Concentration, Aqueous solutionFig 2: viscosity change vs. Concentration, Ethanol solutionViscosity changeViscosity 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 SolutionDispersionHEATING >> << COOLINGLCST = Lower Critical Solution TemperatureLCST44~46 CHPC-L at 20 CHPC-L at 50 CFig 6: viscosity change vs. pHFig 7: viscosity change vs. Days lapsed under UV radiationFig 5: Phase transition effect is completely reversible upon cooling1510152025100101000 viscosity (mPa s)Days lapsed10,000030 HPC-HHPC-MHPC-L 014711201030 viscosity (mPa s)pH value40014 HPC-HHPC-MHPC-L HPC-SLNisso HPC2 Nisso HPC2additivesNisso HPC contains no silica or other statusUSP/NF, EP, JP compliant; Food use approved 21 CFR , E463expirationExpiration date is (3) years from date of HPC is available in a 10kg of manufactureNippon Soda Co.

4 , Ltd. Nihongi Plant 350 Fujjisawa, Joetsu city Niigata prefecture, JapanPhysical and chemical Propertiessoftening temperatureSpecific gravity (particles) temperature195-210 CCharring temperature260-275 CSoftening temperature ( C)1st transition2nd transitionHPC-H73164 HPC-M68178 HPC-L60185 HPC-SL68192 HPC-SSL75183moisture UptakeFig 8: Moisture uptake at 50% and 80% relative humidity01234628410121416 Moisture content (%)Days elapsed (days)18065 HPC-L, SLHPC-M80% RH50% RHhPc-sslhPc-slhPc-lhPc-mhPc-hBulk density loose (g/cc) density tapped(g/cc) (%) of repose(Degree)4946454240 Particle size (D50)( m)50-7070-90100-120130-150130hPc-ssl (sFP)hPc-sl (FP)hPc-l (FP)hPc-m (FP)hPc-h (FP)Bulk density loose (g/cc) density tapped(g/cc) (%) of repose(Degree)5047474644 Particle size (D50)( m)< 2060-8060-8060-8050-70 Powder characteristicssolubilityHPC is soluble in water, water-free lower alcohols and polar solvents. Solutions are transparent and have a smooth feel.

5 Solubility in organic solvents is limited only by the viscosity increase. solubleWater, Methyl alcohol, Ethyl alcohol, Isopropyl alcohol, Pyridine, Cyclohexanone, Cellosolve, Acetic acidHazyAcetone, Tertiary butanol , Dioxane, Cyclohexanol, Cyclohexanol, Lactic acid, Methyl ethyl ketoneInsolubleAliphatic hydrocarbons, Benzene, Xylene, Glycerin, Toluene, GasolineORHydroxypropyl Cellulose(cellulose, 2-hydroxypropyl ether)HORCH2 ORCH2 OROOOOHHORORHHHHHH R : -HCH3 HmCH2CH0orCAS No. 9004-64-2chemical structureNisso America Broadway, Suite 2120 New York, New York 10006(T) 212-490-3050(F) Chemical Europe, GmbHBerliner Allee 42, 40212 Duesseldorf, Germany(T) +49-(0)-211-1306686-0(F) OfficeNippon Soda Co., Ltd2-1 2-Chome, OhtemachiChiyoda-ku, Tokyo 100-8165 Japan(T) 81-3-3245-6159(F) Copyright 2011 Nisso HPCnoticeThe 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.

6 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