Abstract

FORMULATION, DEVELOPMENT AND EVALUATION OF NOVEL BUCCOADHESIVE BILAYER TABLET OF DILTIAZEM HYDROCHLORIDE BY DIRECT COMPRESSION METHOD

Akshay M. Kasambe*, P. P. Chirde, A. S. Jiddewar and A. M. Bhatkar

ABSTRACT

Diltiazem hydrochloride is the most widely used calcium channel blocker, which inhibits the entry of C++ from extracellular to intracellular passage. Diltiazem hydrochloride is the salt form of diltiazem, which is used to prevent heart disease, heart attack, stroke. It is also used to prevent chest pain caused by angina as well as Reynaulds phenomenon. It can also be used in anal fissure suppression. The bilayer tablets were prepared by direct compression method using HPMC K100, Xanthan gum, Carbopol 940, lactose, ethyl cellulose, mg. Sterate. The bilayer tablets were evaluated for performulation studies, UV spectroscopy, FTIR study, invitro drug release study. The drug release date fitted in the standard kinetic data. The optimised F2 batch formulation shows first order kinetic and accelerated studies were performed for bilayer tablets. The buccoadhesive bilayer tablet was prepared to modulate the rate of drug distribution and increase bioavailability and stability. All the invitro studies were carried out in phosphate buffer (6.8pH) + -37.05°C. In-vitro dissolution was carried out using USP type - 2 at 50 rpm. The IR spectrum of diltiazem was obtained in KBr pellet using shemadzu 206-7350038 FTIR Spectrophotometer. The FTIR spectra was recorded in the region of 400 - 4000 cm-1. Stability studies of optimzed to ICH, changes in physical characteristics drug dissolution and drug content. The drug was found at maximum wavelength of 235 nm. The results obtained were found to be in limits.

Keywords: Diltiazem HCl, FTIR, UV spectroscopy, Buccoadhesive Bilayer tablet.