A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules

Stephan Laske, Amrit Paudel, Otto Scheibelhofer, Stephan Sacher, Theresa Hörmann, Johannes Khinast

Research output: Contribution to journalArticle

Abstract

Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological, and mathematical) methods for material (e.g., materials, intermediates, products) and process (e.g., temperature, pressure, throughput, etc.) analysis. This supports rational process modeling and enhanced control strategies for improved product quality and process efficiency. Therefore, it is often difficult to orient and find the relevant, integrated aspects of the current state-of-the-art. Especially, the link between fundamental research, in terms of sensor and control system development, to the application both in laboratory and manufacturing scale, is difficult to comprehend. This review compiles a nonexhaustive overview on current approaches from the recognized academia and industrial practices of PAT, including screening, selection, and final implementations in solid oral dosage manufacturing, through a wide diversity of use cases. Finally, the authors attempt to extract a common consensus toward developing PAT application guidance for different unit operations of drug product manufacturing.
Original languageEnglish
Pages (from-to)667-712
Number of pages45
JournalJournal of Pharmaceutical Sciences
Volume106
Issue number3
Early online date23 Dec 2016
DOIs
Publication statusPublished - Mar 2017

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