Population balance models for pharmaceutical processes

Anwesha Chaudhury, Maitraye Sen, Dana Barrasso, Rohit Ramachandran

Research output: Chapter in Book/Report/Conference proceedingChapter

5 Scopus citations

Abstract

The pharmaceutical industry is predominantly dominated by the handling of particulate matter in the form of solids and emulsions. With the enforcement of the Quality by Design (QbD) initiative by the Food and Drug Association (FDA), a process systems engineering based case toward particulate process design is advantageous. This suggests the need for mechanistic modeling approaches that can be used for an accurate representation of the process dynamics. The inherent discrete nature of population balance models (PBM) makes it an appropriate framework for modeling particulate processes. With the representation of the particulate processes used for pharmaceutical product manufacturing using various modeling frameworks, advancements can be made to improved control and optimization of the process. This chapter provides a detailed review on the applicability and significance of PBMs in drug product manufacturing and is aimed to provide greater insight into the field of process systems engineering.

Original languageEnglish (US)
Title of host publicationMethods in Pharmacology and Toxicology
PublisherHumana Press Inc.
Pages43-83
Number of pages41
DOIs
StatePublished - Jan 1 2016

Publication series

NameMethods in Pharmacology and Toxicology
Volume32
ISSN (Print)1557-2153
ISSN (Electronic)1940-6053

All Science Journal Classification (ASJC) codes

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

Keywords

  • Flowsheet modeling
  • Particulate processes
  • Pharmaceutical manufacturing
  • Population balance model
  • Process systems engineering
  • Quality by Design

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