DEVELOPMENT AND EVALUATION OF BILAYER MUCOAHESIVE GASTRORETENTIVE TABLET OF DILTIAZEM HYDROCHLORIDE

摘要

Objective: The objective of present study was to formulate an oral mcoadhesive tablet of diltiazem hydrochloride. Methods: Investigate?the?effect?of?amount?of?HPMC?K4M and sodium alginate?on the sustained release and gastric residence time of dosage form. The mucoadhesive tablet prepared by direct compression method was used varying concentrations of HPMC K4M and Sodium alginate and (1:1, 1:1.5, 1:2) Drug and Polymer ratio. Results: The formulations were evaluated and results revealed that FTIR studies showed no evidence of interactions between drug and excipients used. The mucoadhesive strength, residence time and drug content of formulation F3 was found to be 26.35 ± 1.15 mg, >7.5hrs, and 98.75 ± 0.05 % respectively. The formulation F3 exhibited sustained drug release i.e. 75.71% in 12 h. The In Vitro release kinetics studies reveal that formulations fit well with zero order kinetics and mechanism of drug release is Super case II transport. Conclusion: The study was concluded that formulation of mucoadhesive tablets from the cumulative % drug release study reveals that increase in the concentration of adhesive polymers cause slow the drug release. Sustained release tablet of DTZ can be beneficial in treatment of hypertension.