FORMULASI DAN EVALUASI TABLET NIFEDIPIN

• Main Author: Aliyah
• Format: Theses
• Language: Indonesia
• Subjects: Farmakologi dan terapeutik
• Online Access: https://digilib.itb.ac.id/gdl/view/1090
• Institution: Institut Teknologi Bandung

Several techniques had been studied in order to find out an appropriate and affective method to increase the dissoluti-on rate of nifedipine from its tablet dosage form. The techniques were (a) the utilization of two tablet manufacturing methods (direct compression and wet granulation methods); (b) preparation of nifedipine solid solution in polyvinylpyrrolidone K-30 and polyethylene glycol 6000; (c) preparation of nifedipine deposit on Starch 1500 and Avicel PH 301; (d) the addition of several tablet excipients known to. have the capability of improving the dissolution rate of some active substances from their tablet dosage form, i.e. : disintegrants Primojel and: Ac-Di-Sol and binder polyvinylpyrrolidone K-30. The dissolution test was performed in simulated gastric fluid with out enzyme according to the paddle method of USP XXII at 50 rpm. It was found that (a) the preparation of nifedipine solid solution significantly increased the dissolution rate of nifedipine; (b) particle size of pure nifedipine as well as its solid solution strongly influenced the dissolution rate of nifedipine; (c) tabletting process significantlydecreased the dissolution rate of nifedipine but this effect. could be reduced by the addition of sufficient amount of fillers/disintegrants. Tablets made by direct compression using solid solution of nifedipine in polyvinylpyrrolidone K-30 in the ratio of 1:5 (100 mesh) containing about. 75% of filler/disintegrant conformed to the dissolution requirements of USP XXII. Stability study of nifedipine in aqueous solution, simulated gastric and intestinal fluids without enzyme, towards light at 3-7t 0.5° showed that nifedipine was very sensitive to light, especially in simulated gastric fluid.