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Optimization Methodologies for the Production of Pharmaceutical Products

  • M. Sebastian Escotet-Espinoza
  • Amanda Rogers
  • Marianthi G. IerapetritouEmail author
Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

Finding the most beneficial conditions during the development of a given product or process is among one of the top goals for both scientist and engineers across all industries. In the pharmaceutical industry, as global competition increases and there is a higher demand for accessible quality products, it is important to focus on the improvement of product development and manufacturing. Optimization methodologies can greatly aid the production of pharmaceutical products by providing a systematic framework to process improvement. In this review, general concepts regarding the implementation of optimization methods are introduced along with examples of their application in pharmaceutical manufacturing process design and formulation development. An overview of optimization methodologies used for the improvement of batch and continuous pharmaceutical manufacturing is presented. Challenges in the application of optimization methods in pharmaceutical manufacturing are discussed along with a future outlook of the field and its place in pharmaceutical process and product design. Overall the review points to optimization as a critical component in the design of improved and effective pharmaceutical products, in alignment with the common goals of both regulatory agencies and industry.

Key words

Optimization Manufacturing Formulation Surrogate-based Direct search methods 

Notes

Acknowledgments

The authors would like to thank the funding provided by the Engineering Research Center for Structure Organic Particulate Systems “ERC-SOPS” (NSF-0504497, NSF-ECC 0540855).

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • M. Sebastian Escotet-Espinoza
    • 1
  • Amanda Rogers
    • 1
  • Marianthi G. Ierapetritou
    • 1
    Email author
  1. 1.Department of Chemical and Biochemical EngineeringRutgers, The State University of New JerseyPiscatawayUSA

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