Drug Excipient Compatibility Testing Protocols and Charaterization: A Review

Abstract

Drug molecule contains various reactive functional groups which are susceptible to react with another reactive functional groups which might be excipients, excipient or drugs impurities formed during manufacturing or storage. The objective of the current review article is to provide a comprehensive review of excipients-drug compatibility study, their degradation product characterization with different analytical methods and further impact of methodologies in pharmaceutical industry for potential stability assessment. The incompatibility of drug excipient was very common due to the reactive functional groups in drugs and excipients. These leads to formation of drug related impurities as well as excipient impurities reaction with active Pharmaceutical Ingredients. Sometimes these impurities found to be mutagenic and genotaxic to human beings. Identification of drug degradation in presence of excipient impurities requires extensive knowledge and adequate analytical characterization data. Systematic literature review and understanding about the drug-excipient chemistry in formulation process is important criteria to select compatible excipient and formulate ideal formulation. The analytical characterization data gives idea about degradation pathway. This paper discusses drug-excipient interactions, compatibility and characterization by different analytical methods with case studies and provides an overview of different excipients compatibility in formulation.