NDLI: Classification of the Crystallization Behavior of Amorphous Active Pharmaceutical Ingredients in Aqueous Environments

Content Provider	Springer Nature Link
Author	Eerdenbrugh, Bernard Raina, Shweta Hsieh, Yi Ling Augustijns, Patrick Taylor, Lynne S.
Copyright Year	2013
Abstract	To classify the crystallization behavior of amorphous active pharmaceutical ingredients (API) exposed to aqueous environments.A set of approximately 50 chemically and physically diverse active pharmaceutical ingredients (APIs) was selected for this study. Two experimental setups were employed to characterize the crystallization behavior of the amorphous API in an aqueous environment. For the first approach, precipitation, as evidenced by the development of turbidity, was induced using the solvent shift method, by mixing concentrated API solutions in DMSO with an aqueous buffer in a capillary. Subsequently, crystallization was monitored in situ over time using synchrotron radiation (simultaneous SAXS/WAXS beamline 12-ID-B at the Advanced Photon Source, Argonne National Laboratories, Argonne, IL). In the second approach, amorphous films were prepared by melt quenching; after adding buffer, crystallization was monitored with time using polarized light microscopy.In general, the crystallization behavior of a given compound was similar irrespective of the experimental method employed. However, the crystallization behavior among different compounds varied significantly, ranging from immediate and complete crystallization to no observable crystallization over biorelevant time scales. Comparison of the observed behavior with previous studies of crystallization tendency in non-aqueous environments revealed that the crystallization tendency of individual APIs was somewhat similar regardless of the crystallization environment.API properties, rather than the method by which amorphous materials are generated, tend to dictate crystallization behavior in aqueous media.
Starting Page	969
Ending Page	982
Page Count	14
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	31
Issue Number	4
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2013-11-23
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Pharmacy Biochemistry Medical Law Biomedical Engineering
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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