Formulation and Evaluation of the Fenofibrate Spray-dried Emulsion Tablets

Abstract

The present research work deals with the development of a self-micro emulsifying drug delivery system (SMEDDS) of Fenofibrate (FF) followed by spray drying to form solid SMEDDS and tablets with enhanced solubility and dissolution. FF is BCS class II drug with low bioavailability and low aqueous solubility. The solubility of the FF can be improved by formulating SMEDDS. Liquid SMEDDS were developed by adding the drug in oleic acid, Tween 80, and Transcutol HP to get a clear solution. In the spray drying method, dextran was used to form the granules. Further, direct compression method was used to manufacture the tablets. The spray-dried product containing solid SMEDDS of FF showed nearly 30-fold solubility enhancement in distilled water in comparison to pure FF. The optimized formulation containing solid SMEDDS of FF (F9) showed an increased dissolution rate (100% drug release at 60 minutes) in comparison to conventional tablets. The optimized batch showed excellent stability at the accelerated condition for the period of 3 months. The current research work demonstrates spray drying as a potential approach to transfer the liquid SMEDSS to a solid SMEDDS with an enhanced solubility and dissolution rate.