Methodology of oral formulation selection in the pharmaceutical industry

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Authors
Holm, Rene
Elder, David
Author (Corporation)
Publication date
25.05.2016
Typ of student thesis
Course of study
Type
01A - Journal article
Editors
Editor (Corporation)
Supervisor
Parent work
European Journal of Pharmaceutical Sciences
Special issue
DOI of the original publication
Link
Series
Series number
Volume
87
Issue / Number
Pages / Duration
136-163
Patent number
Publisher / Publishing institution
Elsevier
Place of publication / Event location
Edition
Version
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Practice partner / Client
Abstract
Pharmaceutical formulations have to fulfil various requirements with respect to their intended use, either in the development phase or as a commercial product. New drug candidates with their specific properties confront the formulation scientist with industrial challenges for which a strategy is needed to cope with limited resources, stretched timelines as well as regulatory requirements. This paper aims at reviewing different methodologies to select a suitable formulation approach for oral delivery. Exclusively small-molecular drugs are considered and the review is written from an industrial perspective. Specific cases are discussed starting with an emphasis on poorly soluble compounds, then the topics of chemically labile drugs, low-dose compounds, and modified release are reviewed. Due to the broad scope of this work, a primary focus is on explaining basic concepts as well as recent trends. Different strategies are discussed to approach industrial formulation selection, which includes a structured product development. Examples for such structured development aim to provide guidance to formulators and finally, the recent topic of a manufacturing classification system is presented. It can be concluded that the field of oral formulation selection is particularly complex due to both multiple challenges as well as opportunities so that industrial scientists have to employ tailored approaches to design formulations successfully.
Keywords
Formulation selection, Oral bioavailability, Poorly soluble, Formulation strategy
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ISBN
ISSN
0928-0987
1879-0720
Language
English
Created during FHNW affiliation
Yes
Publication status
Published
Review
Peer review of the complete publication
Open access category
License
Citation
KUENTZ, Martin, Rene HOLM und David ELDER, 2016. Methodology of oral formulation selection in the pharmaceutical industry. European Journal of Pharmaceutical Sciences. 25 Mai 2016. Bd. 87, S. 136–163. Verfügbar unter: http://hdl.handle.net/11654/23708