Sustained release of diltiazem hydrochloride using thermosoftening bases as semisolid matrix filled in hard capsule

Abstract

Sustained release diltiazem hydrochloride capsules using thermosoftening vehicle as semisolid matrix with 90 mg dosing level which had a dissolution properties following tolerance according to USP 23 supplement 5, test 1, for product labeled for every 12 hours could be prepared. They were composed of diltazem hydrochloride 90 mg and thermosoftening bases for 180 mg per capsule. Final weight of capsule was equal to 270 mg and the suitable hard gelatin capsule size was #2 capsule. Both pure gelucire 50/02 and combination with other gelucires were sufficient enough for controlling drug release as following above criterion. Combination weight ratios among gelucire 50/02 and gelucire 46/07, gelucire 53/10 and gelucire 50/13 as 144:36, 169:11.2 and 172:8, respectively, were preferred for the preparation and desirable property. Linear relationship between means dissolution time (MDT) and calculated HLB of gelucire mixture could be explored from the combination of gelucire 50/02 with gelucire 46,07, gelucire 44/14 and gelucire 42/12. Meanwhile, the relationship as mentioned above were not founded with combination among gelucire 50/02 with gelucire 50/13 and gelucire 53/10.