Design, Formulation and In Vitro Evaluation of Oxybutynin HCl Floating Matrix Tablets

Abstract

The goal of this study was to prepare and test a hydrodynamically balanced floating matrix controlled Oxybutynin HCl drug delivery system. The muscarinic acetylcholine receptor subtypes M1, M2, and M3 are competitively antagonized by oxybutynin HCl. It is used to treat urinary and bladder problems. It has a 10-12 h elimination half-life. The effervescence produced by the combination of sodium bicarbonate with hydrochloric acid in the stomach causes the Oxybutynin HCl tablets to float in the stomach. Twelve alternative floating tablet formulations were made utilizing direct compression using hydrophilic polymers like HPMC K4M, K15M, and K100M and hydrophobic polymers such ethyl cellulose in various ratios. The produced formulation was characterized using FTIR and DSC analysis. In terms of general appearance, content consistency, hardness, friability, and buoyancy, the examination found that all formulations meet the specifications of official pharmacopoeias and/or standard reference. Formulation F11, which contained 25% HPMC K100M and 12.5% ethyl cellulose, had the best in vitro drug release up to 99% after 12 hours. The formulations with more than 12.5% NaHCO3 had a floating time of more than 12 hours. In vitro drug release kinetics of improved formulation F11 were discovered to be zero order, with anomalous diffusion coupled with erosion being the drug release mechanism. At the conclusion of 90 days, accelerated stability studies revealed negligible change in physicochemical attributes and drug release profiles, indicating that all the formulations were stable.