Pharmaceutical Regulatory Affairs: Open Access

Advancing Drug Chemical Stability: Unravelling Recent Developments and Regulatory Considerations

Abstract

Shrikant Mahesh Sharma*, Rupali Sharma, Pankaj Chandrateya and Satish Sardana

The present study explores the domain of chemical stability, with particular emphasis on semisolid pharmaceutical formulations. This paper presents a comprehensive analysis of the various factors that impact the stability of chemicals. These factors encompass environmental conditions, chemical interactions, pH levels and the materials used for packaging. The discourse also encompasses the utilization of analytical methodologies employed in stability testing, as well as the examination of case studies that shed light on the chemical stability of antifungal semisolid formulations.

This paper critically analyses the current regulatory guidelines pertaining to stability testing, explores the difficulties encountered in adhering to these standards and investigates the practical implications of these challenges. This study investigates various strategies aimed at improving the chemical stability of substances, including the utilization of stabilizing excipients, modified drug delivery systems, innovative packaging technologies and the potential impact of nanotechnology. The paper concludes by providing an overview of potential areas for future research and discussing emerging technologies within the field of antifungal semisolid stability. The significance of chemical stability in maintaining the effectiveness and safety of pharmaceutical products is emphasized, especially in light of changing regulatory environments.