(Chemical name :Hydroxypropyl Cellulose) Manufacturing started in 1967,and the product was mentioned in the pharmacopeia of Janpan in 1967.

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2 Preface CELNY consist of hydroxypropyl ethers obtained by the reaction of cellulose with propylene oxcide. (Chemical name :Hydroxypropyl Cellulose) Manufacturing started in 1967,and the product was mentioned in the pharmacopeia of Janpan in Mnufacturing Process Characteristics 1. Celny dissolves in water and organic polar solcents at room temperature. 2. Products of various degrees of polymerization are available, and you can choose one having a suitable visicosity depending on your uses. 3. Being chemically inert,celny reacts with other reagents. Main uses Hydroxypropyl Cellulose is widely used as binder, corting agent for pharmaceutical tablets. Also n food field, it can be used as thickner, stabilizer, emulsify agent,binder, coating agent, because of its characteristics Grades of Celny We have 5 grades of Celny depending on the viscosity, please refer to the data below. Grades SSL SL L M H Viscosity (mpa s) Coating Binder Thickner Measured the values of an aqueous solution containing 2% by weight of dry Celny at 20 (60 )

3 Particle Size Distribution We have two different size of Celny. Basicly normal type is used wet formulation, fine powder type is used as it is. Physical and Chemical Properties 1.Apparent density of the powder : 0.5~0.6g/ml 2.Thermal stability Specific gravity of particles : Coloring temperature 195~210 Charring temperature 260~275 Powder Characterization Soften Point Solubility of Celny in water and in typical organic solvents Valus are the amont of Celny(g) Which dissolves in 100g of solvents

4 Dessolve method Prepareing 2% CELNY aqueous solution 1.Stiring method (CELNY-L) 1 Put water into a container temperature at Weight CELNY and put it into water *Put water first. When you dessolve large quantity of CELNY,put CELNY into water grandually, while stiring. 3 About 2 hours later, CELNY dissolves completely. 1Put CELNY into water 230min stiring past 360min stiring past 4120min stiring past : dissolved

5 2. Stiring and kneading method (CELNY-L) 1 Put CELNY into a container. 2 Put small amount of water into above container. 3 Knead well using grass stick about 15min. (make paste) 4 Put rest water into container and stir about 60min. 1Put CELNY and small amount of water 2Knead about 15min 3Add rest of water 4Stir about 60min

6 3.Heat method (CELNY-M ) 1Heat water about 1/2~1/3 of prepared temperature at 60~65 2Put CELNY into water while stiring. *CELNY does not dessolve at this temperature but decentralize.(refer P6 Fig2) 3When CELNY decentralize equally, put rest of water into the container. 4Keep the water temperature below 40,and stir well. 1Put CELNY into 60~65 water. 2Stir10min:decentralize equally(temperature60~65 ) 3Put rest of water (temperature 50 ) 4Stir 60 min: dissolved(temperature 37 )

7 6 Viscosity vs.concentration Viscosity of aqueous solution The relationship between the concentration of Celny and viscosity of solution,and the relationship between temperature and viscosity of the solution are shown respectively in Figure.1 and Figure.2. Aqueous solutions are transparent and feel smooth.as shown in Figure.1,xiscosity is grandually lowered with elevation of the temperature,and suddenly drops at a temperature above 45.Such process is due to limited solubility.the process is reversible. Figure.1 Viscosity vs.concentration of water at 2 Figure.2 viscosity vs.temperature of 2% water Viscosity of ethanol solution Figure.3 shows the viscosity change in concentrated ethanol solutions with concentration. Figure.4 shows the viscosity in ethanol solutions at certain tempratures. Relationship between the concentration of absolute ethanol solution and its viscosity is similar to that of aqueous solution.viscosity of absolute ethanol solution dereases with elevation of the temperature,but unlike aquelous solution,rapid decrease in viscosity due to gelation was not observed. Figure.3 Viscosity vs.concentration of Ethanol solution at 20 Figure.4 Viscosity vs.temperature of 2% Ethanol solution

8 7 Moisture content/change of viscosity with phvalue and under UV Moisture content The relationship between the lapse of days and moisture absorption,and the relationship between humidity of the atmosphere(rh)and moisture absorption are shown respectively in Figure.5 and Figure.6.A sample of Celny is dried at 100 to 105 to a constant weight.then the sample is taken in a weight bottle and accurately weighed.this is left standing in an atomosphere of constant relative humidty(50%rh and 80%RH)at 25,and the weight increase is demtermined after the lapse of days. Figure.5 moisture content vs.lapse of Figure.6 Moisture content vs.relative humidity Figure.7 Viscosity change of Celny aqueous Solutions vs.ph value Figure.8 Viscosity change of Celny aqueous solution Under irradiation of UV-rays after the lapse of days Figure.7 shows the viscosity change of the solutions obtained by dissolving respectively 2%,2%,1%and0.5% of HPC-SL,LM and H in aqueous solutions of various ph values between 1 and 12. Figure8.shows the viscosity change of HPC aquous solutions containing2% of HPC-L.M and H respectively after irradiating the solutions with UV rays of wavelength 2537A at 25 to 30 for 30 days. viscosity was measured at 20

9 Tabletting Test using CELNY By adding CELNY when you make tablets,you could have hard tablets and less friction loss. Here,we show some experiments using CELNY as a binder. 8 No.1<Wet Granulation Method(without main ingredients)> 1.Production process 1Put CELNY-L into certain amout of water or ethanor to make 8% CELNY solution. 2Mixing other excipients in powder form.(15min) 3Put the mixed powderinto granulator then spray CELNY solution on the above of powder form. 4Sieve the granules by 30 mesh and add sugar ester. 5Make tablets by the pressure rate kg. Granulator:SPIRA-A-FLOW(Freund) Tabletting machine:kikusui No6B-2 2.Formulation wt.% 錠劑组成 No. A B C D Lactose CELNY-L Sugar ester Evaluation of tablets 1Hardness:20 pieces,erweka TBH28 2Friction loss:20pieces,diameter 27cm,26rpm/10min 3Disintegration time:6pieces,toyamasangyo NT-2 4.Results No. A B C D CELNY-L content(wt.%) Hardness(kg) Friction loss(%) Disintegration time(min)

10 Tabbetting Test using CELNY Using Glucosamine as main ingredient.glucosamine is well known that it has difficulty in tabletting. In this Test,we try making Glucosamine high content tablert by adding CELNY. No2.<Wet Granulation method(glucosamine)> 1.Production Process 1Put CELNY-L into certain amout of water to make 8% CELNY solution. 2Mixing Glucosamine and other excipients in powder form.(15min) 3Put the mixed powder into granulator then spray CELNY solution on the above of powder form. 4Sieve the granules by 30 mesh and add sugar ester. 5Make tablets by the pressure rate kg. Granulator:SPIRA-A-FLOW(Freund) Tabletting machine:kikusui No6B Evaluation of tablets 1Hardness:20 pieces,erweka TBH28 2Friction loss:20pieces,diameter 27cm,26rpm/10min 3Disintegration time:6pieces,toyamasangyo NT-2 3.Results Formulation&Results Excipients No. Glucosamine Lactose Cornstarch Sugarester CELNY-L Results Hardness(kg) Friction loss(%) 1 38% 35% 23% 1% 3% % 23% 15% 1% 3% % 11% 8% 1% 3% Disintegration (min) We succeed to make Glucosamine high content tablets by adding CELNY. By reducing Cornstarch content,you could put even more Glucosamine in the tablets but inthat case you have to careful the disintegration time tends to be a longer.

11 CELNY VISCOSITY DATA(VS.Salt) 10 CELNY-L 5% 20 CELNY-M 2% 20 CELNY VISCOSITY DATA(VS.Saccharide) CELNY-L 5% 20 CELNY-M 2% 20 CELNY VISCOSITY DATA(VS.Protein) CELNY VISCOSITY DATA(VS.Acid) CELNY-L 5% 20 CELNY-L 5% 20 Vol.2