Drug Dissolution and Colour Cheque Monitoring in Acidic Dissolution of Domperidone Pellets Ip (Enteric Coated)

Domperidone, a peripherally selective dopamine D2 receptor antagonist, is frequently prescribed for the treatment of gastrointestinal motility disorders, including nausea, vomiting, and delayed gastric emptying. Despite its therapeutic potential, its oral bioavailability remains a significant challenge due to its poor solubility and instability in acidic environments, such as the stomach. To overcome these limitations, pharmaceutical scientists have developed enteric-coated pellet formulations designed to bypass the gastric region and enable targeted release in the alkaline milieu of the small intestine, where domperidone exhibits improved solubility and absorption. This review provides an in-depth evaluation of the formulation, optimization, and evaluation of enteric-coated domperidone pellets, with a particular focus on advanced techniques such as powder layering technology and the incorporation of pH-sensitive polymers like Eudragit L100-55. The use of these polymers ensures that the pellets remain intact in the stomach but promptly release the drug upon reaching the intestinal pH, thus enhancing therapeutic efficacy and patient compliance. Moreover, the review explores the critical role of dissolution testing in acidic and buffer media to characterize the pH-dependent release kinetics of the enteric-coated formulations. Emphasis is placed on the behavior of domperidone in simulated gastric fluid (0.1N HCl) and its release profile in phosphate buffer at pH 6.8, illustrating how the structural integrity of the coating governs the temporal and spatial release of the drug.In addition to in vitro drug release evaluation, the article highlights the importance of stability assessment, particularly through physical indicators such as color changes in the pellet formulation. These visual cues, which can signify oxidative degradation or interactions with excipients, are increasingly being recognized as valuable, low-cost markers of product integrity during shelf life and accelerated stability testing.To ensure comprehensive characterization and quality assurance, several analytical methodologies are discussed, including High-Performance Liquid Chromatography (HPLC) for quantification, UV-Visible spectroscopy for monitoring drug content and degradation, Differential Scanning