Portal de Periódicos da CAPES

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

2016; Elsevier BV; Volume: 106; Issue: 3 Linguagem: Inglês

10.1016/j.xphs.2016.11.011

1520-6017

Stephan Laske, Amrit Paudel, Otto Scheibelhofer, Stephan Sacher, Theresa Hoermann, Johannes Khinast, Adrian Kelly, Jukka Rantannen, Ossi Korhonen, F. J. Stauffer, Fien De Leersnyder, Thomas De Beer, Jérôme Mantanus, Pierre-François Chavez, Benjamin Thoorens, Patrizia Ghiotti, M. Schubert, Pirjo Tajarobi, Gunnar Haeffler, Satu Lakio, Magnus Fransson, Anders Sparén, Susanna Abrahmsén‐Alami, Staffan Folestad, Adrian Funke, Ivo Backx, Barbara Kavsek, Francois Kjell, Marc Michaelis, Trevor Page, John P. Palmer, Alexander Schaepman, Sonja Sekulic, Steve Hammond, Birgit Braun, Brenda Thies Colegrove,

Protein purification and stability

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.