ABSTRACT

The present review article investigates the crucial role of excipients during the manufacturing of pharmaceutical products, with a key focus on compatibility evaluations of active pharmaceutical ingredients and excipients. The compatibility of excipients and active pharmaceutical ingredients plays a significant role in ensuring the highest quality in drug product manufacturing. This is further explored through compatibility assessments, which contribute significantly to the overall comprehensive development of drug product quality. The detailed methodologies of compatibility studies for different active pharmaceutical ingredients and excipients are delved into in the article, utilizing diverse analytical tools including Differential Scanning Calorimetry, Fourier Transform Infrared spectroscopy, High- Performance Liquid Chromatography, Preformulation, Stability indicating methods, and Scanning Electron Microscopy. The results of various case studies on the compatibility between active pharmaceutical ingredients and excipients are compiled in this review article. A wide range of case studies is covered, addressing different aspects of drug stability and compatibility complexities, considering both the active pharmaceutical ingredient and excipients. Additionally, critical factors such as thermal stability, incompatibility reactions, and compatibility challenges associated with various active pharmaceutical ingredients used intreating central nervous system disorders, along with their respective excipients, were explored. The current review article highlights the challenges encountered in interpreting compatibility data obtained from various analytical instruments. It recognizes the significance of these challenges and provides a comprehensive exploration, making it a valuable reference for researchers in their future research endeavors. Keywords: Compatibility, Differential Scanning Calorimetry, Fourier Transform Infrared spectroscopy, High-Performance Liquid Chromatography, Preformulation, Stability indicating methods, Scanning Electron Microscopy
Publication date: 01/04/2025

https://ijbpas.com/pdf/2025/April/MS_IJBPAS_2025_8879.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.4.8879