Online ISSN: 2515-8260

EVALUATION OF AN ANTIFUNGAL LULICONAZOLE GEL FORMULATION USING SEMI-AUTOMATIC DIFFUSION CELL APPARATUS AND APPLICATION OF MATHEMATICAL MODELS IN DRUG RELEASE KINETICS

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Saba Maanvizhi1 , V.Iyyappan2 , P.G.Bhavishi3

Abstract

Luliconazole, an FDA sanctioned novel azole antifungal drug that combats fungal contagions caused by Trichophyton rubrum and Epidermophyton floccosum, specifically tinea pedis, cruris and corporis. It is existing in the souk as topical cream 1%. Topical formulations possess diversified benefits for instance escaping of first pass metabolism, easiness of application, evades oscillation in drug planes, tranquil cessation when desirable, and amplified bioavailability. FDA advocates characterization parameters of luliconazole cream should include assessment of appearance, particle/globule size distribution, polymorphic forms, rheological behaviour, In-Vitro Release Test (IVRT), InVitro Permeation Test (IVPT) and In-vivo bioequivalence study for a generic product. FDA endorses usage of appropriate apparatus for IVRT technique as pronounced in USP General Chapter <1724>. These comprise diverse models of a vertical diffusion cell (VDC), an immersion cell, and a flow through cell used with USP Apparatus 4. The current research work addresses the evaluation of IVRT of two luliconazole cream formulation (Brands A and B) with that of lab made reference luliconazole gel using semi-automatic VDC apparatus through synthetic membrane. The study was done for 4 hours and analysed by UV-spectroscopy. The release kinetics was construed with various mathematical prototypes like zero order, first order, higuchi model and korsmeyer-peppas model. The outcomes showed that brand B of commercial cream formulations was found to be analogous to that of the reference formulation. The release kinetics of the formulations were found to be zero order that fits into Korsemeyar-peppas model. The variance between the in-vitro release rate of the two brands may be ascribed to diverse bases incorporated into the product. Zero-order indicates that the drug release is constant, independent of concentration. Fitting into Korsemeyer-peppas plot indicates that the release mechanism is diffusion controlled and follows Super case II transport as R2 value is more than 0.89.

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