Novel fenofibrate-loaded gelatin microcapsules with enhanced solubility and excellent flowability: Preparation and physicochemical characterization

Abstract

A novel free-flowing fenofibrate-loaded gelatin microcapsule formulation was prepared using ethanol via the solvent-evaporation method by the spray-drying technique. The evaluation of solubility, dissolution and physicochemical characteristics was accomplished compared to the drug powder. For selecting an appropriate composition, several formulations were spray-dried using various amounts of fenofibrate and gelatin, and their effect on the aqueous solubility and dissolution of the microencapsulated drug was determined. All the formulations presented optimized aqueous solubility and dissolution of fenofibrate as compared to hydrophobic drug powder. The microcapsules containing less than 8-fold gelatin improved more drug solubility compared to those prepared with >= 10-fold gelatin. Moreover, the formulations with >= 1:8 ratio provided good free-flowing property. Amongst the formulations tested in this study, the smooth-surfaced spherical microcapsules containing fenofibrate/gelatin at a ratio of 1:8 (w/w) exhibited the most improved drug solubility (about 15 mu g/ml) and dissolution (approximately 80% at 30 min). The microencapsulated drug was in the crystalline state, the drug molecule did not modify during microencapsulation process, and the drug had no interaction with gelatin. Thus, this fenofibrate-loaded gelatin microcapsule would be a potential oral drug delivery system with enhanced drug solubility and excellent flowability. (C) 2015 Elsevier B.V. All rights reserved.