Compatibility Studies

The goal of drug-excipient Compatibility studies is to detect, measure, and forecast possible interactions (physical or chemical), as well as the influence of these interactions on the manufacturability, quality, ad performance of the final therapeutic product. Excipients are chemicals that are included in dosage forms together with the active pharmaceutical ingredient (API). The majority of excipients have no direct pharmacological effect; however, they are useful for simplifying administration, regulating active component release, and stabilising API against degradation. However, improper excipients might cause accidental and/or unanticipated impacts on the chemical composition, stability, and bioavailability of the API, and hence their medicinal effectiveness and safety. In the development stage of all dosage forms, drug-excipient compatibility studies are a crucial step in finding interactions between prospective formulation excipients and the API.