Relevance of solid forms and its implication on the performance of pharmaceutical drug products
Appropriate selection of the crystalline form of an Active Pharmaceutical Ingredient (API) is a key decision in developing patient-centered drug products as this influences the safety, efficacy and performance of the pharmaceutical product. On top of these considerations, it is aimed also to facilitate development of robust drug manufacturing processes while guarantying appropriate key quality criterion during the shelf life of the drug product1. Advanced characterization tools are needed to analyze the crystalline drug substance in formulated drug products, especially when multicomponent systems and low concentrations are involved. Laboratory and synchrotron-X-ray powder diffraction are seen as complementary techniques among the tools that involve different vibrational spectroscopic techniques and imaging technologies. This presentation will exhibit case studies aiming to illustrate applications of recent development of these methods and continuous innovations that are deployed to assess and mitigate risks when unpredictable event occurs.
[1] P.H. Stahl, B. Sutter, A. Grandeury, M. Mutz, ‘Alternative salt forms: Salts’ in Polymorphism in the Pharmaceutical Industry: Solid Form and Drug Development, 2019, Wiley-VCH , R. Hilfiker, M. von Raumer (Eds.)