Formulation Development Case Studies

API Manufacture, Formulation Development, Capsule Product Manufacture Case Study

Challenge: Accelerate first-in-human and Phase II trials for an oral dosage form intended for treatment of CNS disorders. A fully integrated approach was required, to incl

Chromatographic Development & Application Case Study

Challenge: Development of a modern, single, chromatographic procedure for a marketed tablet product that would allow the resolution and quantification of four active species and e

Drug Substance Salt Selection Case Study

Challenge: To manufacture drug substance and screen a selection of corresponding pharmaceutically acceptable salt forms.  From the resulting salt forms, choose a candidate wh