DefinePK

Abstract

One of the biggest and most significant challenges in the development of pharmaceutical is poor water solubility or bioavailability. Solid dispersions were introduced as a means of enhanced dissolution rates and consequent therapeutic effectiveness of poorly water-soluble biopharmaceutical classification system (BCS) Class II drugs by incorporating the drugs into hydrophilic carriers. In this review, we cover the core principles, benefits and recent developments in solid dispersion technology. It discusses different preparation approaches, like fusion, solvent evaporation, spray drying, hot-melt extrusion, and newer routines like supercritical fluid processing and electrospinning. Different strategies have their unique advantages including molecular-level distribution, enhanced solubility rate, and larger-scale production capabilities. The review also provides a historical perspective on Solid dispersion system development, from crystalline carriers to amorphous and controlled-release carriers and the four generations of solid dispersion systems. Here, we discuss challenges including recrystallization, thermodynamic instability, and phase separation and strategies to overcome these challenges. Additionally, enhanced characterization techniques like DSC, XRD, and SEM are explored for assessing the structural and dissolution characteristics of solid dispersions. Moreover, solid dispersion techniques are an essential method for increase the solubility of hydrophobic agents and improving the performance of newly developed or established pharmaceutical agents by advancing oral delivery systems. This review highlights their critical role in addressing solubility challenges and advancing the field of drug formulation.