White Paper

Manufacturing Of Sterile Aqueous Suspensions: A Primer

Source: Pfizer CentreOne Contract Manufacturing

By Omar A. Salman, Ph.D., Sr. Research Advisor, Pfizer/Pfizer CentreOne

Manufacturing of sterile aqueous suspensions requires thorough understanding of the factors that influence their physical and chemical stability. Particle morphology of the active pharmaceutical ingredient (API) plays a key factor in drug product dissolution rate, resuspendability, and syringeability. The type and concentration of surfactants used in the formulation impact drug product resuspendability and chemical stability. Additionally, technologies used in API particle size reduction and in high-shear mixing for drug product formulation should be evaluated because of their impact on the API and drug-product quality attributes.

A concise review of these factors is presented in this paper.