The present investigation relates to the development of extended release matrix tablets containing Oxybutynin Hydrochloride for the treatment of over reactive urinary bladder. Oxybutynin Hydrochloride is an anticholinergic agent, having short half life of (2-3hours) the development of extended release formulations of Oxybutynin Hydrochloride is therefore therapeutic relevance and can be used to provide a consistent dosage through extending an appropriate level of drug over time. To achieve this goal various prototype formulation trials are taken and evaluated with respect to the various quality control such as dissolution. The formula will be finalized by comparing the in vitro dissolution profile with that of the Ditropan tablets.
Reason for selection of delayed release dosage form:
Due to instability in acidic environment, a trail was made to by-pass the stomach by using enteric coating which thereby improves bioavailability and therapeutic efficacy with no degradation of drug. Objective of the study: To formulate and evaluate Extended release tablets of Oxybutynin Hydrochloride. To determine the best fit dissolution profile for dosage form. To study the release profile of the dosage form and to compare their drug-release profiles with the Ditropan(innovator). To study the stability of the optimized formulation. The oral extended release matrix tablet containing 15mg of Oxubutynin Hydrochloride provided extended release for 24 hours. The hydrophilic polymer HPMC K100M alone gave a satisfied release profile compared in combination with Kollidon K90 F. The optimized formulation followed first order kinetics while the drug release mechanism was non-Fickan (Anomalous type) controlled by diffusion through swollen matrix.
The optimized formulation F8 and the marketed formulation (Ditropan) were found to have a similar in vitro release profile, which is confirmed by f1 and f2 values.
A month of stability study data revealed no marked changes in the physical parameters and drug release profile
