A quantitative approach to understand raw material variability

Sara Koynov, Fernando J. Muzzio

Research output: Chapter in Book/Report/Conference proceedingChapter

5 Scopus citations

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.

Original languageEnglish (US)
Title of host publicationMethods in Pharmacology and Toxicology
PublisherHumana Press Inc.
Pages85-104
Number of pages20
DOIs
StatePublished - Jan 1 2016

Publication series

NameMethods in Pharmacology and Toxicology
Volume32

All Science Journal Classification (ASJC) codes

  • General Pharmacology, Toxicology and Pharmaceutics
  • Pharmacology (medical)
  • Molecular Medicine

Keywords

  • Characterization
  • Flowability
  • Powder

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