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Biorelevant intrinsic dissolution profiling in early drug development: Fundamental, methodological, and industrial aspects
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.ORCID iD: 0000-0002-8917-2612
PION Inc, Forest Row Business Pk, Forest Row RH18 5DW, E Sussex, England.
Johnson & Johnson, Janssen R&D, Drug Prod Dev, Turnhoutseweg 30, B-2340 Beerse, Belgium.
GlaxoSmith Kline Med Res Ctr, Dept Prod Dev, 2G118,Gunnels Wood Rd, Stevenage, Herts, England.
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2019 (English)In: European journal of pharmaceutics and biopharmaceutics, ISSN 0939-6411, E-ISSN 1873-3441, Vol. 139, p. 101-114Article, review/survey (Refereed) Published
Abstract [en]

Intrinsic dissolution rate (IDR) is the surface specific dissolution rate of a drug. In early drug development, this property (among other parameters) is measured in order to compare different polymorphs and salt forms, guide formulation decisions, and to provide a quality marker of the active pharmaceutical ingredient (API) during production. In this review, an update on different methods and small-scale techniques that have recently evolved for determination of IDR is provided. The importance of biorelevant media and the hydrodynamic conditions of dissolution are also discussed. Different preparation techniques for samples are presented with a focus on disc, particle- and crystal-based methods. A number of small-scale techniques are then described in detail, and their applicability domains are identified. Finally, an updated industrial perspective is provided about IDR's place in the early drug development process.

Place, publisher, year, edition, pages
Elsevier, 2019. Vol. 139, p. 101-114
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-386370DOI: 10.1016/j.ejpb.2019.03.011ISI: 000468711400011PubMedID: 30862481OAI: oai:DiVA.org:uu-386370DiVA, id: diva2:1329101
Funder
EU, FP7, Seventh Framework Programme, 115369Available from: 2019-06-24 Created: 2019-06-24 Last updated: 2019-06-24Bibliographically approved

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Bergström, ChristelTeleki, Alexandra

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