FORMULATION AND EVALUATION OF HEPARIN MICRONEEDLE TRANSDERMAL PATCH

There is an urgent need to replace the injection currently used for low molecular weight heparin (LMWH) multi-dose therapy with a non-invasive delivery device. In this study, unsaturated polyester resin and peroxide were used to fabricate microneedle mould by using 3M microneedle. Dissolving microneedle arrays transdermal patch was prepared by using 20 % w/v polymers of PVA and PVP (polyvinyl alcohol and polyvinyl pyrrolidone) and active drug 20 mg (IU) low molecular weight heparin (LMWH). The physicochemical compatibility of the drug and the polymers was studied by infrared spectroscopy suggested the absence of any incompatibility. Formulated transdermal films were physically evaluated with regard to weight variation, drug content, folding endurance, percentage of moisture content and water uptake.  All prepared formulations indicated good physical stability. In-vitro permeation studies of formulations were performed by using Franz diffusion cells. The formulation prepared with PVP: PVA 1:2 showed best ex-vivo skin permeation through rat skin (Wistar rat) as compared to all other formulations. The release profile of the optimized formulation F2 (R² = 0.9933 for Higuchi) indicated that a diffusion mechanism governed the permeation of the drug from the patches.  Microneedle transdermal patches were successfully prepared for LMWH, and their evaluation suggested it can have potential applications in the therapeutic arena, offering advantages in terms of effective non-invasive delivery with improved patient compliance and bioavailability.