QUALITY RISK ASSESSMENT OF A NEWLY DEVELOPED ORAL SUSPENSION CONTAINING DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND CHLORPHENIRAMINE MALEATE AND TASTE-MASKED WITH AN ION EXCHANGE RESIN.

Quality Risk Assessment plays a pivotal role in pharmaceutical formulation, ensuring the development of safe, effective, and high-quality products. In line with International Council for Harmonisation Q9 guidelines, this study applied a structured QRA approach to the development of an oral suspension containing multiple active pharmaceutical ingredients (Dextromethorphan HBr, Phenylephrine HCl, and Chlorpheniramine Maleate), which were taste-masked using Indion 234 resin. Failure Mode and Effects Analysis was used to identify, score, and prioritize formulation and process-related risks. Key risks such as drugresin interaction, resin loading efficiency, pH influence, and suspension uniformity were carefully analyzed. Mitigation strategies included resin selection optimization, pH control, and adjustment of mixing parameters. These interventions resulted in a stable, homogeneous, and palatable oral suspension with improved patient compliance. The outcome of this work demonstrates that a proactive risk-based approach not only supports regulatory compliance but also strengthens formulation robustness and ensures consistent product performance throughout the product lifecycle.