ABSTRACT
Preformulation research comprises pharmaceutical and analytical investigations in acquiring knowledge base, and these investigations precede and support formulation development. The main goal for preformulation work for biologic molecules is to assess the impact of various formulation and environmental conditions expected during manufacturing, storage, and shipment of these molecules. The preformulation work for proteins consists of evaluating the chemical and physical stability of the molecule under the effects of freeze-thaw, agitation/shear, heat, light, presence of excipients/surfactants, pH, and ionic strength. The preformulation work required for development of lyophilized drug product should provide a framework for the rational formulation design and selection of initial processing parameters as well. The pH solubility of the Active Pharmaceutical Ingredient is an important part of the preformulation data package that impacts formulation design of lyophilized dosage forms. Preformulation studies of biologic molecules are intended to provide the background information and groundwork for formulation development and associated characterization work.
