PREPARATION AND EVALUATION OF SELF MICROEMULSIFYING DRUG DELIVERY SYSTEM FOR FEXOFENADINE HYDROCHLORIDE

Abstract

Developinga drug product with desirable bioavailability is a challenge for sparinglywater soluble drugs such as Fexofinadine hydrochloride. Objective: In the present investigation self microemulsifying drugdelivery system (SMEDDS) of Fexofenadine hydrochloride was developed forimproving solubility and dissolution rate of drug. Material Method: Solubility of Fexofenadine hydrochloride wasdetermined in various non-aqueous vehicles such as oils, surfactants, andco-surfactants. Psuedoternary phase diagrams were constructed to identify theself-micro emulsification region. Four formulations of SMEDDS were selected fromthe optimum concentration of oils, surfactant, and co-surfactants from psuedoternary diagrams. Resultsand Discussion: Selected formulations were evaluated for droplet size,in-vitro drug dissolution, drug content and solubility of drug. The optimumformulation was 20% oleic acid, 26.3% ACONON MC8 and 53.3% PEG 400. Self-microemulsification with the combination of oleic acid and ACONON MC8 was foundhigher. Conclusion: The resultsobtained from in vitro dissolutionindicated Fexofenadine hydrochloride in SMEDDS dissolved rapidly and completelyin phosphate buffer pH 6.8 which was used as dissolution medium.