Effects of Granulating Agents in the Solubility Enhancement of Low Water Soluble Drug

Abstract

It is widely recognized that, according to the Biopharmaceutics Classification System (BCS), Class II drugs are defined by low aqueous solubility and high permeability. As a result, developing formulations for these drugs is particularly complex and challenging. Incomplete or inconsistent drug release can lead to reduced absorption and poor bioavailability. Therefore, there is a strong need to develop innovative strategies for Class II drugs to enhance their bioavailability and improve drug release.

The limited aqueous solubility of an active pharmaceutical ingredient (API) directly impacts both drug release and its permeability across biological membranes, thereby affecting overall bioavailability. Consequently, improving the solubility of these drugs through the use of suitable excipients or solubility-enhancing agents is essential to increase their dissolution in biological media.

This study focused on solubility enhancement approaches for the active molecule Celecoxib. Various types of granulating agents were employed in tablet formulation, and their physicochemical properties were systematically evaluated.

Keywords: Granulating Agents, Solubility, Bioavailability, Drug Release