Formulation and In-Vitro Evaluation of Mucoadhesive Diltiazem Hydrochloride Buccal Tablets

Abstract

Mucoadhesive tablets for buccal administration of diltiazem hydrochloride were prepared as an alternative to available diltiazem HCl dosage forms. Two types of tablets were developed each containing two mucoadhesive components (hydroxypropylmethyl cellulose HPMC and sodium alginate) and (HPMC and carbopol) for each types, batches were produced by changing quantity of polymer. The formulations were tested for mucoadhesive performance and release pattern. In vitro bioadhesive strength studies showed that the HPMC/carbopol formulations were more bioadhesive and less drug release rate compared with HPMC/alginate formulations. Increasing the content of HPMC in HPMC/alginate tablets resulted in increase in detachment forces and swelling index but lower release rates were observed. The release behavior of all formulations was non-Fickian mechanism controlled by a combination of diffusion and chain relaxation mechanisms and best fitted zero-order kinetics.The buccoadhesive diltiazem HCl tablets containing 18.75% sodium alginate and 37.5% HPMC showed suitable release kinetics (n = 0.86, K0 zero order release = 10.29 mg/h, MDT = 4.8 h) , good adhesive properties and did not show any interaction between polymers and drug based on FT-IR study.