Design and Evaluation of Self Emulsifying Drug Delivery System of Some Poorly Water Soluble Drugs

Abstract

The aim of present study was to design and evaluate self-emulsifying drug delivery system (SEDDS) of some poorly water soluble drugs. The drugs selected for this study were Sertraline Hydrochloride, Vardenafil Hydrochloride trihydrate and Nebivolol hydrochloride. A thorough survey of literature focused on drug delivery systems and drug profiles led to hypothesis that self micro-emulsifying drug delivery system (SMEDDS) could be used to improve the solubility of selected drugs. This would be accompanied by increased dissolution, permeation, absorption and overall bioavailability of these drugs leading to a possibility of decreased doses and cost of therapy. In order to test this hypothesis systematically designed experiments were performed with the compilation of ensuing results. Initially, physico-chemical properties of procured drugs were investigated and found to comply with standard specifications indicating authenticity. Next, preliminary studies were performed for each of the three drugs in order to arrive at optimal formulation variables viz. the oil phase, surfactant and cosurfactant. Drug solubility in various oil phases was studied by modifying routine shake flask method to identify self emulsifying components offering better drug solubility. CONCLUSION AND IMPACT OF STUDY: The successful development of Self emulsifying drug delivery systems of three poorly water soluble drugs namely Sertraline hydrochloride, Vardenafil Hydrochloride and Nebivolol hydrochloride could be accomplished through the present work. From the compiled results it can be concluded that i) Liquid, Powder and Tablet dosage form of Sertraline HCL and Vardenafil HCl, while self solidifying capsule dosage form of Nebivolol HCl were developed with scalable techniques. ii) Using nontoxic and cheap excipients. iii) With significant improvement in solubility and rate and extent of dissolution in media simulating gastrointestinal fluids. iv) Enhanced intestinal permeability would result in improved therapeutic performance, decreased doses and lesser cost of treatment.