La stabilité in-use du diclofénac sodique 1%

Abstract

This thesis examines the stability in use of diclofenac sodium 1%, a topical formulation utilized for various inflammatory conditions. The study encompasses theoretical concepts, regulatory guidelines, and practical experiments to evaluate the product's stability under specific storage conditions. The theoretical section provides a comprehensive understanding of stability in use and explores key parameters affecting the stability of pharmaceutical formulations, specifically diclofenac sodium 1% gel. It also discusses the chemical properties, mechanism of action, and therapeutic recommendations for diclofenac sodium, along with an overview of the guidelines presented by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regarding stability testing. The practical investigation involves the preparation of diclofenac sodium 1% gel and conducting stability tests at different time intervals according to ICH guidelines. The gel samples are subjected to controlled temperature and humidity conditions within environmental chambers to simulate storage conditions. Analytical techniques such as visual inspection, pH measurement, drug content determination, and physical characterization are employed to assess stability. The results are systematically analyzed, considering changes in physical appearance, pH values, drug content, and other stability indicators over time. By comparing reference samples with established standards, the degradation kinetics and potential shelf-life of the formulation are determined. The implications of the results are discussed in terms of safety, efficacy, and clinical utility. In conclusion, this thesis provides valuable insights into the stability in use of diclofenac sodium 1% gel through a combination of theoretical foundations and practical investigations.