FORMULATION AND EVALUATION OF EXTENDED RELEASE TABLET OF DILTIAZEM HYDROCHLORIDE USING “DRUG-RESIN COMPLEX”

Antihypertensive treatment should be maintained for life. A simple dosing scheme with a once- or twice-daily administration of the antihypertensive agent is known to increase patient compliance. The present research endeavour was directed towards the development of a Extended release tablet formulation containing diltiazem hydrochloride loaded resinates, with goal of delivering the same dose of the drug through a tablet taken once rather than two or three times a day. The selection of resin was done on the basis of drug loading. Effect of Swelling time, stirring time, pH, and drug to resin ratio was employed to optimize resinates. The Optimized diltiazem hydrochloride resinates with wet granulation technique were utilized for the formulation of extended release tablet. Polymer such as Eudragit RS100, Eudragit RL 100, Ethyl cellulose and PVP were utilized as granulating agent and optimized to obtain extended drug release. It was found that resinates based once daily extended release of diltiazem hydrochloride were successfully formulated using Eudragit RS100 as granulating agent showing the best physical tablet properties, and the best drug release characteristics, releasing the drug for the period of 24 hrs. The best formulation (ER1) has shown a drug release (R18h >85%) was in accordance with the USP dissolution criteria for extended release diltiazem hydrochloride formulation. In conclusion, in the present research, Extended release tablet formulations of diltiazem hydrochloride loaded resinates were successfully prepared with desirable drug release modulation for a once daily administration.