Injectable Development

Injectable Pharmaceutical Product Development for a Poorly Water Soluble Drug Using Multiple Formulation Methodologies

Authors: J.J. Luo, PhD, Victoria Tropina, Brian Woodrow, PhD, Craig Davies-Cutting, PhD

Significant formulation challenges exist as a result of the increasing number of poorly water-soluble drugs in development. Approximately 40% of drugs in development and 60% of compounds from discovery are poorly soluble, i.e., below 0.1 mg/L and likely to result in limited bioavailability in their therapeutic applications. The purpose of this study was to explore the impact of emulsion liposomal liquid and lyophilized liposomal formulations on drug loading, physical stability, and chemical stability.