Characterization of the “hygroscopic” properties of active pharmaceutical ingredients

• Published in: Journal of pharmaceutical sciences Vol. 97; no. 3; pp. 1047 - 1059
• Main Authors: Newman, Ann W., Reutzel‐Edens, Susan M., Zografi, George
• Format: Journal Article
• Language: English
• Published: Hoboken Elsevier Inc 01.03.2008; Wiley Subscription Services, Inc., A Wiley Company; Wiley; American Pharmaceutical Association
• Subjects: amorphous; Biological and medical sciences; General pharmacology; hygroscopicity; Medical sciences; moisture sorption; Pharmaceutical Preparations - chemistry; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; physical characterization; preformulation; solid state; Water - chemistry; water in solids; amorphous; physical characterization; water in solids; moisture sorption; hygroscopicity; preformulation; solid state; Water; Pharmaceutical technology; Physical properties; Characterization; Sorption; Solid state; Humidity; Active ingredient

The amount of water vapor taken up by an active pharmaceutical ingredient (API) as a function of relative humidity is routinely evaluated to characterize and monitor its “hygroscopicity” throughout the drug development process. In this minireview we address the necessity of going beyond the measurem...