FORMULATION DEVELOPMENT OF ROSUVASTATIN CALCIUM DRUG IN ADHESIVE TRANSDERMAL SYSTEM

Current investigation was aimed at designing a Rosuvastatin calcium loaded drug- in- adhesive patch (DIAP) to overcome the problems associated with the daily oral administration of the drug. The patches were prepared by solvent casting method using acrylate emulsion polymers like Covinax 525-78, Mowinyl 461 and Novacryl PSR 3^2, which served as sustained release matrix polymer and adhesive. Methocel K100M was added as a solubilizer whereas propylene glycol (PG), labrasol, transcutol, and polyethylene glycol 400 (PEG400) were tried as permeation enhancers for the drug- in- adhesive film. The combination of Novacryl –PEG 400 and Novacryl-Transcutol was further optimized by 3² factorial design to study the effect of two independent variables i.e. concentration of solubilizer and permeation enhancer on responses i.e. % drug release, tensile strength and peel adhesion strength. The effect of the solubilizer and permeation enhancer on the final formulation was studied. The % cumulative release of drug at the end of 24 h was found to be between 90-93%. The formulations also show tensile strength in the range of 6-11 kg/cm² and peel adhesion strength of 14-16 N/25 mm. Hence the developed transdermal patch could be acceptable for transdermal use.