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Hydrolysis in pharmaceutical formulations.

Kenneth C Waterman1, Roger C Adami, Karen M Alsante

  • 1Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA. ken_waterman@groton.pfizer.com

Pharmaceutical Development and Technology
|June 18, 2002
PubMed
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This review covers hydrolysis of active pharmaceutical ingredients and excipients, impacting drug product stability. It details mechanisms, measurement techniques, and strategies for formulation stabilization.

Area of Science:

  • Pharmaceutical Chemistry
  • Drug Delivery
  • Physical Pharmacy

Background:

  • Hydrolysis is a critical degradation pathway for many active pharmaceutical ingredients (APIs).
  • Excipient hydrolysis can also compromise drug product stability and performance.
  • Understanding these processes is vital for developing stable pharmaceutical formulations.

Purpose of the Study:

  • To review the hydrolysis of APIs and its impact on drug product stability.
  • To examine the effects of excipient hydrolysis on dosage form integrity.
  • To provide recommendations for enhancing formulation stability against hydrolysis.

Main Methods:

  • Comprehensive literature search on hydrolysis mechanisms and stability studies.
  • Analysis of reported measurement techniques for hydrolysis.

Related Experiment Videos

  • Synthesis of formulation strategies to mitigate hydrolysis.

    • Main Results:

    • Detailed discussion of hydrolysis mechanisms for common APIs and excipients.
    • Overview of analytical methods for detecting and quantifying hydrolysis.
    • Identification of key factors influencing hydrolysis rates in dosage forms.

    Conclusions:

    • Hydrolysis of both APIs and excipients poses significant challenges to drug product shelf-life.
    • Careful selection of excipients and formulation design is crucial for stability.
    • Implementing appropriate stabilization strategies can ensure drug product efficacy and safety.