Development and Evaluation of Sorbitan Monostearate Organogels as a Topical Delivery System for Aceclofenac

Abstract:

The studies were conducted with an object to develop stable safe and efficient delivery system for aceclofenac. During the course of studies different organogel formulations of aceclofenac for topical application were prepared by using sorbitan monostearate (span 60), isopropyl myristate, purified water, sorbic acid, potassium sorbate, tween 20, vitamin E, methyl salicylate and menthol. The formulated organogels were evaluated for psychorheological characteristic, drug content, pH, spreadability. The viscosities of different formulations were determined by using Brookfield Viscometer at 25°C, the viscosity of formulations increases as the surfactant concentration increases. The developed 2 formulation then subjected to in vitro diffusion study. The two formulations showed best release having flux > 0.2 mg/cm /hr were selected and modified with incorporation of 10% methyl salicylate and 5% menthol. Further efficacy of these formulations was evaluated and compared with standard marketed formulation by anti-inflammatory activity on albino rats using carageenan-induced rat paw edema model, promissing edema inhibition withen three hr was observed. Safety was determine through skin irritancy testing on Guinea pigs for seven days showing no signs of skin irritation. Finally stability studies were carried out for three months showed no separation of gel indicating overall stability. The result indicates that Sorbitan Monostearate organogels serves as a better vehicle for topical delivery of aceclofenac.

KEYWORDS: Aceclofenac, Sorbiton monostearate, Organogel