ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF POORLY WATER-SOLUBLE DRUG BY HYDROTROPIC SOLID DISPERSION

Abstract

A major obstacle in the development of effective oral drug formulations is the poor aqueous solubility of many active pharmaceutical ingredients (APIs), which directly affects their dissolution rate and bioavailability. This limitation often results in inconsistent therapeutic effects and challenges in achieving optimal clinical outcomes. In recent years, the integration of hydrotropic solubilization with solid dispersion technology has emerged as a promising strategy to address this issue. Hydrotropy involves the use of hydrotropic agents highly water-soluble, non-toxic compounds such as sodium benzoate, urea, or citric acid that significantly enhance the solubility of poorly water-soluble drugs by altering the solvent environment without forming micelles. When these agents are combined with solid dispersion techniques, where the drug is molecularly dispersed in a hydrophilic carrier such as PEG or PVP, the resultant system exhibits improved wettability, reduced particle size, and transformation to an amorphous state each contributing to increased dissolution rates. This study explores the formulation of hydrotropic solid dispersions of a model poorly water-soluble drug, focusing on optimizing the ratio of drug to hydrotrope and polymer, evaluating physicochemical properties, and assessing the improvement in solubility and dissolution behavior through in vitro analysis. The findings suggest a marked enhancement in both solubility and dissolution rate compared to pure drug and conventional solid dispersions, indicating the potential of this novel approach in overcoming solubility-related challenges in drug delivery. This technique offers a scalable, cost-effective, and efficient pathway to improve the bioavailability of poorly soluble drugs, ultimately enhancing therapeutic efficacy and patient compliance.[7][8][9]