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Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture pp 85–104Cite as

A Quantitative Approach to Understand Raw Material Variability

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

Abstract

The properties of raw materials can affect the properties and quality of intermediates and the final product. The flow behavior of powders, the form of the raw materials for solid oral drug product manufacturing processes, is poorly understood. Thus, the prediction of manufacturability and process performance is difficult. This is further complicated with variability in raw material flow properties. This chapter discusses seven properties typically characterized and the techniques used to measure them. The state of the art in applying this information to define a formulation of manufacturing process is also discussed.

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Authors and Affiliations

  1. Department of Chemical and Biochemical Engineering, Rutgers, Engineering Research Center for Structured Organic Particulate Systems (ERC-SOPS), The State University of New Jersey, 98 Brett Road, Piscataway, NJ, 08854-8058, USA

    Sara Koynov & Fernando J. Muzzio

Authors
  1. Sara Koynov
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  2. Fernando J. Muzzio
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Corresponding author

Correspondence to Fernando J. Muzzio .

Editor information

Editors and Affiliations

  1. Rutgers University, Piscataway, NJ, USA

    Marianthi G. Ierapetritou  & Rohit Ramachandran  & 

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Koynov, S., Muzzio, F.J. (2016). A Quantitative Approach to Understand Raw Material Variability. 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_3

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  • DOI: https://doi.org/10.1007/978-1-4939-2996-2_3

  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-4939-2995-5

  • Online ISBN: 978-1-4939-2996-2

  • eBook Packages: Springer Protocols

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