Main Article Content
Abstract
Sorafenib is a multikinase inhibitor widely used in the treatment of hepatocellular carcinoma and renal cell carcinoma; however, its clinical effectiveness is limited by poor aqueous solubility, low oral bioavailability, and variable gastrointestinal absorption. The present study was aimed at developing and evaluating a bilosome-based nano-vesicular drug delivery system to enhance the physicochemical properties and in-vitro performance of Sorafenib. Sorafenib was initially authenticated and characterized using Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), and Powder X-ray Diffraction (PXRD), which confirmed its purity, chemical integrity, and crystalline nature. Preformulation studies revealed poor aqueous solubility and high lipophilicity, justifying the need for a lipid-based delivery system. Sorafenib-loaded bilosomes were prepared using a modified thin-film hydration technique employing bile salts, surfactants, and cholesterol in varying concentrations. The formulated bilosomes were evaluated for drug content, entrapment efficiency, vesicle size, polydispersity index, and zeta potential. The results demonstrated successful encapsulation of Sorafenib within nano-sized bilosomes with narrow size distribution and adequate surface charge, indicating good colloidal stability. In-vitro drug release studies showed a biphasic release pattern characterized by an initial burst followed by sustained drug release. Release kinetic analysis revealed that drug release from bilosomes was predominantly diffusion-controlled with a non-Fickian transport mechanism. Overall, the study confirms that bilosomes are a promising nano-vesicular carrier system for improving the solubility and sustained release of Sorafenib. The developed bilosomal formulation has the potential to enhance oral drug delivery and therapeutic performance, warranting further ex-vivo and in-vivo investigations.