Pharmaceutical characterization and dissolution behavior of ibuprofen/Soluplus solvent cast films

Abstract

Purpose: To characterize the physicochemical and dissolution properties of Soluplus®/ibupofen solid dispersions prepared by solvent casting technique. Methods: Soluplus® was used as a film-forming agent whereas ibuprofen served as a poorly soluble biopharmaceutics classification system (BCS) class II active pharmaceutical ingredient (API). The solution casting of ethanolic Soluplus®/ibuprofen was carried out on a release liner and dried under a vacuum. The crystallinity of crushed films was examined using powder x-ray diffraction (PXRD), while a USP Type II apparatus was used to determine their dissolution behaviour. Results: Ibuprofen was uniformly distributed in an amorphous form into the cast films. The PXRD-based confirmation of crystalline peaks' absence revealed a significantly higher dissolution rate in alkaline and acid media when compared to the pure drug. Conclusion: Soluplus® (polymeric dispersant)-based solvent casting is a simple and efficient technique to prepare highly water-soluble solid dispersions of ibuprofen. This film cast technique may be suitable for various applications where a film or powder form of a drug with enhanced solubility in different aqueous media is desired.