Preformulation文档_推荐.pdfVIP

TRD - Your Partner for Technical RD Pharmaceutical Preformulation Wei-Qin (Tony) Tong, Ph.D. Novartis Pharmaceuticals Corporation Integrated Drug Product Development Process (3 day-course), University of Utah July 17-19, 2006 TRD - Your Partner for Technical RD Introduction Introduction Preformulation: l a stage of development during which the physicochemical properties of drug substance are characterized Some commonly evaluated parameters: l Solubility l Dissolution behavior l Stability l Partition coefficient l Ionization constant (pKa) l Solid state properties such as crystal forms/polymorphs, water sorption behavior, surface properties, particle size and shape, and other mechanical properties, et. al. TRD - Your Partner for Technical RD Why is Preformulation Important? Why is Preformulation Important? It is a capital mistake to theorize before one has data” Scandal in Bohemia, Sir Arthur Conan Doyle l developing robust formulations. TRD - Your Partner for Technical RD Learning before Doing – Develop a knowledge base Learning before Doing – Develop a knowledge base lThere are critical differences between companies at the detailed level of knowledge and their ability to learn before doing – knowledge of the underlying variables and their relationship to performance – knowledge of the future manufacturing environment and the new variables introduced by that environment G. Pisano, “The Development Factory”, Harvard Business School Press, 1996 TRD - Your Partner for Technical RD l Preformulation – A case of learning before doing TRD - Your Partner for Technical RD Preformulation in the Overall RD Process Preformulation in the Overall