TITLE:
Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways
AUTHORS:
Kishore Kumar Hotha, Swapan Roychowdhury, Veerappan Subramanian
KEYWORDS:
Drug, Excipients, Forced Degradation, Impurities, Adducts, Degradation Pathways, HPLC, LC-MS/MS, Synthesis, Chemistry, Characterization
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.7 No.1,
January
28,
2016
ABSTRACT: The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The formation of the impurities was not limited to drug related impurities but there were several possibilities of the drug-excipient adduct formations as well as excipient impurities reaction with Active Pharmaceutical Ingredients. Identification of drug degradation in presence of excipients/excipient impurities requires extensive knowledge and adequate analytical characterization data. Systematic literature review and understanding about the drug formulation process, give you a smooth platform in establishing the finished product in the drug market. This paper discusses mechanistic basis of known drug-excipient interactions with case studies and provides an overview of common underlying themes in solid, semisolid and parenteral dosage forms.