Pharmaceutical Cocrystal Drug Products: An Outlook on Product Development

Abstract

Active pharmaceutical ingredients (APIs) are most commonly formulated and delivered to patients in the solid state. Recently, an alternative API solid-state form, namely the pharmaceutical cocrystal, has witnessed increasing academic and industrial interest due to its potential to deliver bespoke physical properties in the pharmaceutical drug product. This interest has been supported by advances in cocrystal discovery, development, and approval, enabled primarily by a supportive new FDA guidance in February 2018. In this review, we describe the process of developing a pharmaceutical cocrystal drug product from screening to approval, with an emphasis on significant developments over the past decade.

Keywords: cocrystals drug product; continuous process technologies; manufacturing process; pharmaceutical cocrystal; preformulation; regulatory aspects.