FORMULATION AND EVALUATION OF GASTRO RETENTIVE FLOATING TABLET OF AMLODIPINE BESYLATE USING NATURAL ORGANIC POLYMERS

Abstract

Objective: This study was designed to formulate and evaluate the gastro retentive floating tablets of Amlodipine besylate by using different proportions of four polymers, namely xanthan gum, gum acacia, carbopol 940, and HPMC K 100 M. Methods: Nine different batches of the floating tablets were formulated by direct compression technique. The constant amount of gas generating agents, namely, sodium bicarbonate and citric acid, were used for the floating character. The powder blend was subjected to pre-compression parameters analysis and the prepared tablets were evaluated for post-compression parameters such as hardness, friability, drug content, weight variation, floating lag time, total floating time, and swelling index. In vitro dissolution study was carried out for 12 h as per the specification of Indian Pharmacopeia 2018. Results: For the optimized batch (4th batch), all the physicochemical parameters like angle of repose (33.47), Carr’s index (17.46%), Hausner’s ratio (1.21), weight variation (221 mg), hardness (5.2 Kg/cm2), friability (0.1%), thickness (3.92 mm), dissolution (94.65% at 12 h), and drug content (92.5%) were within the acceptable limit. Furthermore, swelling index, floating lag time, and total floating time was reported to be 203.0%, 7.5 seconds,>12 h, respectively. Fourier Transform Infrared Spectroscopy analysis suggested that there is no drug excipients interaction. Conclusion: Hence, this study suggested that gastro retentive floating tablets of Amlodipine besylate can be formulated to enhance gastric residence time and thereby improve its drug release characteristics.