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An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

  • Protocol
Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

Abstract

In this chapter, the main processing steps and manufacturing aspects of solid dosage forms are described and the relevant literature is reviewed. Starting with powder feeding, powder blending, granulation (dry and wet), and drying the most important unit operations to make compactable granules are reviewed. As an alternative to granulation, hot-melt extrusion is introduced, together with the various downstream processing choices. Next, tableting and capsule filling—for making a final dosage form—are discussed, followed by a section on coating. In all sections scale-up methods are reviewed and an outlook for future developments is provided. The last two sections are devoted to process analytical technology (PAT) and continuous manufacturing.

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Acknowledgement

The authors acknowledge the significant contributions of Diana Dujmovic, Andreas Eitzlmayr, Eva Faulhammer, Johannes Gursch, Dr. Gerold Koscher, Dr. Marcos Llusa, Daniel Markl, Dr. Sharareh Salar-Behzadi, Dr. Otto Scheibelhofer, Daniel Treffer, Dr. Gregor Toschkoff, and Dr. Patrick Wahl. Much of the work presented in this chapter was funded through the Austrian COMET Program by the Austrian Federal Ministry of Transport, Innovation and Technology (BMVIT), the Austrian Federal Ministry of Economy, Family and Youth (BMWFJ) and by the State of Styria (Styrian Funding Agency SFG).

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  1. Research Center Pharmaceutical Engineering (RCPE), Inffeldg. 13, A-8010, Graz, Austria

    Stephan Sacher & Johannes G. Khinast

  2. Institute for Process and Particle Engineering, Graz University of Technology, A-8010, Graz, Austria

    Johannes G. Khinast

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  1. Stephan Sacher
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Correspondence to Johannes G. Khinast .

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    Marianthi G. Ierapetritou  & Rohit Ramachandran  & 

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Sacher, S., Khinast, J.G. (2016). An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms. In: Ierapetritou, M.G., Ramachandran, R. (eds) Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture. Methods in Pharmacology and Toxicology. Humana, New York, NY. https://doi.org/10.1007/978-1-4939-2996-2_10

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