Description

The stability of active pharmaceutical ingredient (API)-cyclodextrin complexes is a critical aspect in pharmaceutical formulation development. Cyclodextrins, particularly β-cyclodextrin and its derivatives, are commonly used to enhance the solubility, stability, and bioavailability of poorly soluble drugs. However, the understanding of the factors influencing the stability of these complexes is of paramount importance to ensure their effectiveness and shelf-life. This review aims to provide physicochemical insights into the stability of API-cyclodextrin complexes, highlighting the key factors that affect their stability and offering a comprehensive understanding of the underlying mechanisms.

Introduction: Cyclodextrins are cyclic oligosaccharides composed of glucopyranose units and possess a hydrophobic cavity that can encapsulate drug molecules. The formation of inclusion complexes between APIs and cyclodextrins has been extensively investigated as a means to improve the solubility, dissolution rate, and stability of drugs. However, the stability of these complexes is influenced by various physicochemical factors such as pH, temperature, humidity, and the presence of other excipients. Understanding these factors is crucial for designing and formulating stable API-cyclodextrin complexes.Understanding the physicochemical factors influencing the stability of API-cyclodextrin complexes is crucial for their successful formulation and utilization in pharmaceutical products. This review provides insights into the impact of pH, temperature, humidity, and excipients on complex stability, while highlighting the key mechanisms underlying their stability. A comprehensive understanding of these factors and mechanisms will aid in the design of robust and stable API-cyclodextrin complexes, ultimately enhancing the efficacy and quality of pharmaceutical formulations.