Abstract

DEVELOPMENT AND EVALUATION OF SELF EMULSIFYING DRUG DELIVERY OF A POORLY WATER SOLUBLE NSAID

S. V. Modi* and Dr. N. J. Patel

ABSTRACT

The present work was aimed at formulating a SMEDDS (self microemulsifying drug delivery system) of Mefenamic acid and evaluating its in-vitro and in-vivo potential. The solubility of Mefenamic acid was determined in various vehicles. Pseudoternary phase diagrams were used to evaluate the microemulsification existence area, and the release rate of Mefenamic acid was investigated using an in vitro dissolution test. The SMEDDS formulations were evaluated for parameters like macroscopic evaluation, visual assessment, self emulsification, transmittance test, droplet size, zeta potential and particle size distribution. Formulation development and screening was done based on results obtained from solubility data and phase diagrams. The optimized formulation for in vitro dissolution, Analgesic activity and Anti- inflammatory studies was composed of Sefsol 218 (oil), Labrasol (surfactant) and Cremophor EL (co-surfactant). Droplet size ranged between 17 and 26 nm. Formulations were clear and almost near to 100% transmittance after dilution with water. The SMEDDS formulation showed more than 80 % of the active was released in 20 min. as compared with the plain drug, which showed a limited dissolution rate. Thus, the study confirmed that the SMEDDS formulation can be used as a possible alternative to traditional oral formulations of Mefenamic acid to improve its bioavailability.

Keywords: Mefenamic acid; Ternary phase diagram; Self-emulsifying drug delivery system; Droplet size; Zeta potential