Abstract

FORMULATION, CHARACTERIZATION, AND EVALUATION OF NANO-EMULSION CONTAINING CLOTRIMAZOLE FOR TOPICAL DRUG DELIVERY

Ritu Verma*, Ramnivas and Mohd Lateef

ABSTRACT

The objective of the present study was to formulate and evaluate nano-emulsion systems for topical delivery of clotrimazole (CTM). The solubility of CTM in various oils was determined to select the oil phase of the nano-emulsion systems. Pseudoternary phase diagrams were constructed to identify the area of nano-emulsion existence. Five CTM nano-emulsion formulations (M1–M5) were prepared and evaluated for their thermodynamic stability, pH, refractive index, droplet size, viscosity, and in vitro release across cellulose membrane. Among the prepared microemulsion formulations, M3 (lemon oil/ Tween 80/n-butanol/water) and M4 (isopropyl myristate/Tween 80/n-butanol/water) nano-emulsion systems were found to be promising according to their physical properties and CTM cumulative percentage release. Gel form of M3 and M4 were prepared using 1% Carbopol 940 as the hydrogel matrix. Both formulations were evaluated in the liquid and gel forms for drug retention in the skin in comparison to the marketed CTM topical cream and their stability examined after storage at 40°C for 6 months. Nanoemulsion formulations achieved significantly higher skin retention for CTM over the CTM cream. Stability studies showed that M4 preparations were more stable than M3. The in vitro anti- fungal activity of M4 against Candida albicans was higher than that of the conventional cream. Moreover, clinical evaluation proved the efficacy and tolerability of this preparation in the treatment of various topical fungal infections.

Keywords: Clotrimazole; Nano-emulsion; Skin retention; Topical cream; Topical gel.