¹Department of Pharmaceutics, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pune, India
²Department of Pharmaceutics Dr. L. H.Hiranandani College of Pharmacy, Ulhasnagar, Mumbai, India DOI : 10.35333/jrp.2020.204 Current investigation is aimed at designing a fluvastatin sodium loaded drug-in-adhesive patch (DIA Patch ) 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 PSR32 which served as sustained release matrix polymer and adhesive. Methocel K-15M was added as a solubilizer whereas transcutol, oleic acid and isopropyl myristate were tried as permeation enhancers for the drug-in-adhesive patch. The combination of mowinyl-isopropyl myristate patch 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 formulation was further evaluated for its lipid lowering activity and skin irritation index. The % cumulative release of drug at the end of 24 h was found to be 87.74%. The formulation shows tensile strength of 12.75 kg/cm2 and peel adhesion strength of 32.44 N/25 mm. The Primary irritation index (PII) for DIA patch was found to be 0.22. The fluvastatin sodium loaded DIA patch significantly inhibits serum cholesterol and triglyceride levels as compared to oral control (p<0.01) in triton WR 1339 induced hyperlipidemic rat. Hence the developed transdermal patch could be acceptable for transdermal use. Keywords : Pressure-sensitive–adhesive; fluvastatin sodium; drug-in-adhesive patch; % cumulative release; peel adhesion strength; total cholesterol