Drug Substance Salt Selection Case Study
CASE STUDY: Drug Substance Salt Selection
To manufacture drug substance and screen a selection of corresponding pharmaceutically acceptable salt forms. From the resulting salt forms, choose a candidate which exhibits optimal characteristics for formulation and bioavailability.
API was manufactured at ARCINOVA and a series of salts subsequently produced. Each salt form was assessed with respect to salt formation, solubility, hygroscopicity, crystallinity, polymorph tendency, chemical stability and particle size/morphology. An optimal salt form was identified and manufactured at ARCINOVA.