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Related Experiment Videos

An intravenous formulation decision tree for discovery compound formulation development.

Yung-Chi Lee1, Philip D Zocharski, Brian Samas

  • 1Pharmaceutical Sciences, Pfizer Global Research and Development, 2800 Plymouth Road, Ann Arbor, MI 48105, USA. yung-chi.lee@pfizer.com

International Journal of Pharmaceutics
|February 21, 2003
PubMed
Summary
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A systematic formulation scheme efficiently develops injectable drugs for animal studies. Nearly 85% of discovery compounds were formulated using pH adjustment or cosolvent addition, streamlining pre-clinical development.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Discovery
  • Pre-clinical Development

Background:

  • Drug discovery and pre-clinical efficacy studies face challenges with limited compound availability and tight deadlines.
  • Injectable formulation development is critical for animal studies but often resource-intensive.

Purpose of the Study:

  • To develop and propose a systematic discovery formulation scheme to streamline the development of injectable dosage forms for pre-clinical animal studies.
  • To assess the efficacy of simple formulation approaches for discovery compounds.

Main Methods:

  • Analysis of formulation data for over 300 Pfizer discovery compounds (year 2000).
  • Evaluation of formulation success rates using pH adjustment and cosolvent addition.
  • Development of a decision tree based on observed formulation strategies.

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Main Results:

  • Nearly 85% of tested discovery compounds could be formulated using either pH adjustment, cosolvent addition, or a combination of both.
  • The proposed formulation decision tree effectively utilizes these simple solubilization techniques.

Conclusions:

  • A systematic discovery formulation scheme significantly facilitates pre-clinical injectable formulation development.
  • The proposed decision tree offers a practical approach for pharmaceutical scientists to optimize formulation strategies for discovery animal studies.