Chemical Stability of Drug Substances: Strategies in Formulation Development

Abstract

Drug stability is a fundamental aspect of pharmaceutical chemistry, directly affecting the efficacy, safety, and shelf life of pharmaceutical products. This paper investigates the chemical degradation pathways of active pharmaceutical ingredients (APIs) and highlights formulation strategies to enhance stability. The study focuses on the hydrolysis and oxidation sensitivity of model drugs such as aspirin and ascorbic acid. Accelerated stability testing was conducted under various environmental conditions, followed by analysis using HPLC and UV spectroscopy. The incorporation of antioxidants, pH modifiers, and protective coatings were found to significantly mitigate degradation. These findings offer formulation scientists a guide to anticipating and resolving stability issues early in the development process, ensuring product integrity throughout its lifecycle.

Keywords: Drug Stability, Formulation Development, Degradation Pathways, Antioxidants, HPLC Analysis