FORMULATION AND EVALUATION OF POLYMERBASED FILM FORMING GEL OF CLOTRIMAZOLE & BECLOMETHASONE DIPROPIONATE FOR TRANSDERMAL DELIVERY

Transdermal drug delivery systems (TDDS) have the potential to be a superior alternative toconventional drug delivery as they deliver the drug across the skin into the bloodstreambypassing gastrointestinal degradation and first-pass metabolism. The aim of the present workwas to formulate and evaluate a polymer-based film forming gel system containingclotrimazole and beclomethasone dipropionate to treat fungal skin infections associated withinflammation. Clotrimazole acts as a broad-spectrum antifungal agent by inhibiting fungal cellmembrane synthesis, while beclomethasone dipropionate provides anti-inflammatory action byregulating glucocorticoid receptor-mediated gene transcription. Preformulation studies,including organoleptic evaluation, melting point determination, solubility studies, calibrationcurve, and FTIR analysis, were performed to assess drug characteristics and compatibility withexcipients. Film-forming gels were prepared using HPMC E4M, Kollidon VA64, SepineoD.E.R.M, propylene glycol, methyl paraben, and ethanol through a solvent evaporationtechnique, producing nine formulations (F1–F9) with varying polymer concentrations. Allformulations were analyzed for physical characteristics, pH, viscosity, spreadability, dryingtime, drug content and in-vitro drug release studies by using a Franz diffusion cell withcellophane membrane in phosphate buffer pH 5.5. All formulations showed clear to slightlytranslucent appearance with homogeneous and smooth spread. The values of pH were inbetween 5.7-6.2 and suitable for topical application. With increased concentration of HPMC(4220±126 to 6550±131cP) viscosity was increased and spreadability was found to bedecreased. Drying time was found to be nearly within 4-7 min suitable for film formingformulation. Drug content was found between 85.49–97.65% for clotrimazole and 88.15–98.10% for beclomethasone dipropionate, demonstrating uniform drug distribution. In vitrodrug release studies showed sustained release profiles, with clotrimazole release ranging from78.87–96.50% and beclomethasone dipropionate from 75.22–93.25% over 10 hours, withformulation F6 showing the highest drug release.