European Journal of Molecular & Clinical Medicine

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.

This research work deals with the design, fabrication and evaluation study of floating tablets using hydrophilic and hydrophobic based polymers, Hydroxy Propyl Methyl Cellulose (HPMC K4M), a hydrophilic polymer and ethyl cellulose a hydrophobic polymer. Xanthane gum was used as a swelling agent and sodium bicarbonate & citric acid at various compositions were used as a gas forming agent by wet granulation techniques. Metronidazole (MZ) was used as an antibiotic, amebicide, and antiprotozoal as a standard drug. The invitro dissolution study of Metronidazole floating tablets was carried out by USP Type- II dissolution test apparatus in 0.1N HCl at 37°C±0.5°C at 50 rpm for 12 hours. All prepared tablets were undergone compatibility study using Fourier transform infrared spectroscopy (FTIR) and Differential scanning calorimetric (DSC). No significant change in MZ drug and combination of drug and other excipients were detected. The percentage of drug dissolved in floating tablet was found to be 98.67 % at the end of 12 hrs. The kinetic release data were analyzed which showed zero order kinetic and is best fit with Higuchi model. The optimized formulation of tablet was formulated by combination of HPMC K4 M and Ethyl Cellulose gives floating lag time and sustained drug release characteristics. The novelty behind the hydrophilic-hydrophobic polymers combined formulations resulted controlled drug release duration reduced the dose frequency and prolonged the retention time of stomach.