Solid Self Emulsifying Drug Delivery System Based on a Homolipid and Vegetable Oil: A Potential Vehicle for the Delivery of Indomethacin a Disadvantaged Drug

Abstract

Background: The successful utility of some biocompatible natural excipients may be more advantageous over their synthetic counterparts in drug formulations. Indomethacin is a potent non steroidal anti inflammatory drug disadvantaged by adverse effects. Aim: Hence, the aim of this study was to formulate indomethacin based solid self emulsifying drug delivery system (SSEDDS) for possible improvement on aqueous solubility and anti inflammatory property of indomethacin using two biocompatible lipid excipients. Materials and Methods: Indomethacin loaded SSEDDS were formulated with Bos indicus (BI) fat or its blend with Pentaclethra macrophylla oil. The surfactant component constituted of Tween 65 and Tween 80 blend while Span 85 served as the co surfactant. CarbosilR was incorporated in some of the formulations as a viscosity enhancer and stabilizer. The following in vitro properties of the formulations were studied: visual isotropicity test, droplet size, emulsification time, aqueous dilution and drug precipitation, drug content, and drug release studies respectively. The anti inflammatory properties were also studied in Wistar rats. Statistical Analysis: Results were presented as the mean ± standard deviation. One way analysis of variance was used to determine statistical significance using the Statistical Package for the Social Sciences (SPSS), version 13.0 (SPSS Inc. U.S.A). P < 0.05 was considered statistically significant. Results: All batches were isotropic before and after drug loading. Batches containing BI fat and PM oil blend exhibited faster emulsification time (P < 0.05) than those formulated with only BI fat. CarbosilR significantly (P < 0.05) increased the emulsification time. Faster drug release occurred in batches with oil blends. Higher significant (P < 0.05) anti inflammatory effect was demonstrated by indomethacin self emulsifying drug delivery system compared to the reference indomethacin powder. Therefore, BI fat and PM oil have proved useful lipid excipients in achieving improved solubility and increased anti inflammatory activity of indomethacin.