Main Paper

Mixture and mixture–process variable experiments for pharmaceutical applications

  1. Christine M. Anderson-Cook1,
  2. Heidi B. Goldfarb2,
  3. Connie M. Borror3,
  4. Douglas C. Montgomery4,*,
  5. Kelly G. Canter5,
  6. John N. Twist6

Article first published online: 2 DEC 2004

DOI: 10.1002/pst.138

Issue

Pharmaceutical Statistics

Pharmaceutical Statistics

Volume 3, Issue 4, pages 247–260, October/December 2004

Additional Information

How to Cite

Anderson-Cook, C. M., Goldfarb, H. B., Borror, C. M., Montgomery, D. C., Canter, K. G. and Twist, J. N. (2004), Mixture and mixture–process variable experiments for pharmaceutical applications. Pharmaceut. Statist., 3: 247–260. doi: 10.1002/pst.138

Author Information

  1. 1

    Los Alamos National Laboratory, USA

  2. 2

    The Dial Corporation, USA

  3. 3

    University of Illinois, USA

  4. 4

    Arizona State University, USA

  5. 5

    Pfizer Corporation, USA

  6. 6

    Mylan Pharmaceuticals, USA

*Department of Industrial Engineering, Arizona State University, PO Box 5906, Tempe, AZ 85287, USA

Publication History

  1. Issue published online: 2 DEC 2004
  2. Article first published online: 2 DEC 2004

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Keywords:

  • analysis of variance;
  • design of experiments;
  • mixture experiments;
  • response surface methodology;
  • Scheffe model;
  • unconstrained and constrained regions

Abstract

Many experiments in research and development in the pharmaceutical industry involve mixture components. These are experiments in which the experimental factors are the ingredients of a mixture and the response variable is a function of the relative proportion of each ingredient, not its absolute amount. Thus the mixture ingredients cannot be varied independently. A common variation of the mixture experiment occurs when there are also one or more process factors that can be varied independently of each other and of the mixture components, leading to a mixture–process variable experiment. We discuss the design and analysis of these types of experiments, using tablet formulation as an example. Our objective is to encourage greater utilization of these techniques in pharmaceutical research and development. Copyright © 2004 John Wiley & Sons Ltd.

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