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), In-
Vitro 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.