DEVELOPMENT AND EVALUATION OF ORAL ELEMENTARY OSMOTIC PUMP TABLETSFOR ROPINIROLE HYDROCHLORIDE

The objective of the present study was to develop a sustained release once a day oral elementaryosmotic tablet for ropinirole hydrochloride and evaluate its in vivo performance. The core of elementaryosmotic tablet of ropinirole hydrochloride was prepared by compression of mixture consisting of drug,different concentrations of osmogens, and other tablet material. Core tablets were then coated withdifferent concentrations of cellulose acetate and PEG-400. FTIR was used to identify if the excipients arecompatible with the drug. All the tablets that were prepared were evaluated for drug release and basedon the results an optimum and ideal osmotic pump composition with a zero-order drug release extendedfor 24 h was proposed and this was considered the optimized formulation. Surface morphology of coatedformulation was studied by scanning electron microscopy. The drug release was determined in differentpH media and different agitation speeds. The pharmacokinetics of the drug after oral administrationof optimized osmotic pump was investigated in rabbits and the data were compared with that of aconventional tablet. In vitro in vivo correlation was determined for the optimized formulation. A suitableand simple sustained release elementary osmotic pump for ropinirole hydrochloride was developed. Therelease rate was independent of the pH of the dissolution medium and the agitation speeds. In vivo studieswith optimized osmotic tablet formulation demonstrated that drug concentration in plasma was maintainedfor prolonged period and minimized fluctuation. A better in vitro in vivo correlation was achieved with theosmotic tablet. A simple once a day elementary osmotic tablet is feasible for ropinirole hydrochloride.