Drugs' stability in tropical climates: Formulation challenges, degradation pathways, and mitigation strategies

Throughout a product's shelf life, the stability of pharmaceuticals (drugs) is a crucial factor in determining drug safety, efficacy, and quality. In tropical areas, where high relative humidity and high temperatures speed up chemical, physical, and microbiological degradation processes, the problem is more prevalent. Several countries in Asia, Africa, and Latin America are located in climatic zones III and IV of the International Council for Harmonization, where traditional packaging systems and formulations designed for temperate climates frequently fall short of stability standards. This review offers a comprehensive discussion of how tropical weather affects pharmaceutical dosage forms, with a focus on formulation-related issues, drug degradation pathways, and workable mitigation techniques. This article will serve as a practical reference for formulation scientists, and quality professionals working in tropical markets.