Development and formulation for Dutasteride hard capsules dosage form
| Autor: | LIU,MING-SIAN, 劉明憲 |
|---|---|
| Rok vydání: | 2016 |
| Druh dokumentu: | 學位論文 ; thesis |
| Popis: | 104 Dutasteride is a poorly soluble drugs, control product soft capsule formulation, but soft capsule dosage form with a short shelf life, gelatin with its contents may have a crosslinking effect and other problems. The experiment using solid dispersion technique and with the cosolvent tween 80, capryol 90, cremophor EL, gelucire 44/14 and citric acid, to improve the solubility of dutasteride, prepared into a hard capsule formulation, with the control product soft capsule dosage form AVODART○R for comparison, in vitro dissolution test, stability test and human trials. In vitro dissolution test of this test, simulated gastric environment (pH 1.2), was dissolved prescription DF-18 and the control of goods from the curve similarity factor (f2 vlue) was 58.64, showing a similar dissolution curve, settled in the first month 40oC/75% relative humidity environment detected in the content of points respectively, control the content of drug testing 101.14, DF-18 prescription drug content measured 101.3. Further, DF-18 with the control prescription merchandise pharmacokinetic study of six healthy male subjects, the DF-18 prescription pharmacokinetic parameters: maximum plasma concentration, respectively (Cmax) was 2326 ± 881 pg/mL, the highest the time required for plasma concentration (Tmax) was 1.33 ± 0.300 hours and the area under the curve (AUC0-t) 27119 ± 12067 hr×pg/mL; control commodity AVODART○R pharmacokinetic parameters: maximum plasma concentration (Cmax) was 2323±622 pg/mL, the maximum time required for plasma concentration (Tmax) 2.72±1.97 hours and the area under the curve (AUC0-t) 39306 ± 15397 hr×pg/mL, the experimental results show that this experiment selected in the prescription DF-18 maximum plasma concentration (Cmax), time to maximum plasma concentration required (Tmax) than the control product is excellent, but the area under the curve (AUC0-t) differ statistically. This experiment will be successful commercially available AVODART○R dutasteride soft capsule formulation, developed into a hard capsule form, though there is significant difference with the human trials in the area of the curve (AUC0-t), and therefore there is a space for improvement of the prescription DF-18. |
| Databáze: | Networked Digital Library of Theses & Dissertations |
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