Case Studies

Drug Substance Salt Selection Case Study

CASE STUDY: Drug Substance Salt Selection

Challenge:

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.

Customer:

US Biopharmaceutical

Outcome:

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. 

drug substance Salt Case Study