Separation of Active Pharmaceutical Ingredients (APIs) from Excipients in Pharmaceutical Formulations

Abstract

The active pharmaceutical ingredient (API) may be physically separated from the excipients in a pharmaceutical formulation by making use of the difference in density of the API and that of the excipients. The API may then be fully characterized by standard techniques. In the density separation process, the API is not dissolved, and the crystal form of the API is not changed. As examples, Form I fexofenadine hydrochloride is separated from Allegra Allergy 24 h Tablets, and Form I lansoprazole is separated from Equate Lansoprazole Delayed Release Capsules.