Product Development and Experimental Design of Solid Dosage Forms

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1、Absorbance (1 cm) at 400 nm% Certified APHA Color Standard (500 units)1252503755000APHA Color NumberOH-H+246810121454321Indomethacin(weak acid)Chlorpromazine(weak base)Oxytetracycline(amphoteric)C, VcXcDXgkdkakeAbsorption site(gi-tract)Central compartment(blood circulation)DissolutionAbsorptionElimi

2、nationkd “dissolution rate-limited”RotatingPaddleTablet surfaceHarden waxor paraffinDissolutionmedium(Finholt)Petri dishClear glass ampulacyclovirEthylcellulose filmDiltiazem HCl50 % w/w diltiazem HCl in ethylcellulose 10 cps25 % w/w diltiazem HCl in ethylcellulose 10 cpsEthylcellulose 10 cps 2.78 p

3、pm (H-C21)Diltiazem HClEthylcellulose 10 cps25 % w/w diltiazem HCl in ethylcellulose 10 cpsA-A+B-B-B+B+C- C+ C- C+ C- C+ C- C+ D-D+E- E-E+E+1211111112222222A-A+B-B-B+B+C-C+D-D-D+D+2222222211111111A-A+B-B-B+B+C-C+VIII 301.0 4.0 6.2 0.6 1.14 8.00 3.00 Rx Weight (mg) Hardness (kg) % Friability Disinteg

4、ration (20 tablets)(10 tablets) (20 tablets) Time (min) XSD X SD X SDTime% Drug DissolvedRx Diluent Hardness (kg) % Friability Disintegration Ratio(10 tablets) (20 tablets) Time (sec) LactoseDCP X SD X SDTime (min)Cumulative % DissolvedLactose:DCPTime (min)Cumulative % DissolvedLactose:DCPRx Diluent

5、 Hardness (kg) % Friability Disintegration Ratio(10 tablets) (20 tablets) Time (sec) LactoseDCP X SD X SDRx Diluent Hardness (kg) % Friability Disintegration Ratio (10 tablets) (20 tablets) Time (sec) Lactose DCP X SD X SDTime (min)Cumulative % DissolvedLactose:DCPTime (min)Cumulative % DissolvedLactose:DCPTime (min)Cumulative % DissolvedTime (min)Cumulative % Dissolved. : . : , 2534: 1-103.n . : . : , 2534: 104-116.n . . : , . . : , 2534: 161-183.n . . : , . . : , 2534: 117-189.