Case Study 8
Formulation of a Very Poorly Soluble Drug for Parenteral Administration

Previous attempts by the sponsor at formulating a poorly soluble API for intravenous administration were unsuccessful.

Xcelience determined the solubility of the drug in solvents, surfactants and mixtures selected with consideration of excipient safety and the functional groups of the drug molecule.

Physical and chemical stability studies of concentrated non-aqueous solutions of the drug and dilutions of these concentrates in intravenous fluids were performed.

This information was then used to provide a number of prototypes for developmental stability.