FORMULATION, IN-VITRO AND EX-VIVO CHARACTERIZATION OF ROPINIROLE HYDROCHLORIDE BUCCAL MUCOADHESIVE FILMS

Abstract

Ropinirole Hydrochloride (RHCl) is one of the most important highly selective Dopamine agonist drugs for the treatment of Parkinson’s disease (PD). The aim of the present study is to develop buccoadhesive films of RHCl to overcome the first pass hepatic metabolism of the drug which is the cause for its low bioavailability (50-55%) and to achieve the greater therapeutic efficacy. Buccal films of RHCl were prepared by the solvent casting method using the hydrophilic mucoadhesive polymer chitosan as the base matrix at different concentrations (1& 1.5 %w/v). Polyvinyl pyrrolidone (PVP) K25 & K30 at different concentrations ( 0.035& 0.07gm) were incorporated into the films to modify RHCl release rate from formulation. Compatibility studies of drug and polymers were performed by DSC and FTIR spectroscopy. In-vitro and ex-vivo characterization was done as well as stability study. A 24 full factorial design was employed to study the effect of independent variables on ex-vivo mucoadhesive strength, ex-vivo residence time and in-vitro drug release. Results showed the absence of incompatability between the drug and chosen polymers. Prepared Mucoadhesive films were clear, flexible, with good folding endurance, uniform in weight, thickness, drug content and stable either in human saliva for 6 hours or at ambient temperature for 1 year. Formula F4 (1 % w/v chitosan, PVP K25, PEG 400) was the optimal bucoadhesive film having the highest percentage drug release (95.25% ) with high stability.