Professor and William and Mildred Peters Endowed Chair College of Pharmacy/University of Minnesota Minneapolis, Minnesota
The phase behavior of the active pharmaceutical ingredient (API) and excipients in multi-component pharmaceutical systems, during the various stages of freeze-drying, is a complex interplay of formulation variables and processing conditions. Rational drug product and process development necessitate: (i) a thorough characterization of the phase transitions of API and the excipients in the frozen state and during freeze-drying, (ii) gaining an understanding of the crystallization tendency of API and excipients during processing including the effect of annealing, and (iii) identifying the physicochemical stability requirements and critical quality attributes of the product.
Case studies will be presented in three areas: (i) Crystallization of the widely used lyoprotectant, sucrose and its implications on protein stability . (ii) Use of arginine as a potential stabilizer. (iii) Poloxamer 188 as an alternative to polysorbates.
Learning Objectives:
to identify the physicochemical stability requirements and critical quality attributes of the product.
To review a thorough characterization of the phase transitions of excipients in the frozen state and during freeze-drying
To gain an understanding of the crystallization tendency of API and excipients during processing including the effect of annealing