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Excipient Taxonomy for the 21st Century.

Bruno C Hancock1, David J Goldfarb2

  • 1Pfizer Inc., Groton, CT, USA.

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|December 16, 2022
PubMed
Summary
This summary is machine-generated.

Pharmaceutical excipient characterization is crucial for drug product performance. Current methods are inadequate, necessitating a more systematic approach to defining and controlling excipient properties for improved drug manufacturing.

Keywords:
Drug standardsExcipient(s)FormulationQuality by design (QBD)Regulatory scienceStandardsUS pharmacopeia (USP)

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Excipient properties significantly impact pharmaceutical dosage form performance.
  • Accurate specification of excipient chemical and physical characteristics is essential for drug product development and manufacturing.
  • Existing methods for describing excipients are insufficient for modern pharmaceutical industry demands.

Purpose of the Study:

  • To highlight the limitations of current excipient characterization approaches.
  • To advocate for a systematic and comprehensive strategy for specifying and controlling excipient properties.
  • To encourage stakeholders to develop improved methods for excipient definition.

Main Methods:

  • Review and analysis of current industry practices for excipient specification.
  • Identification of key chemical and physical properties critical for excipient performance.
  • Discussion of the benefits of a standardized and enhanced approach to excipient characterization.

Main Results:

  • Current excipient description methods are outdated and do not meet 21st-century requirements.
  • A systematic approach offers significant advantages in controlling and understanding excipient behavior.
  • Enhanced characterization leads to more predictable and reliable drug product performance.

Conclusions:

  • There is a critical need to update and enhance the way excipient properties are specified and controlled.
  • Adoption of a comprehensive strategy will benefit formulators, users, suppliers, and manufacturers.
  • Implementing improved excipient characterization is vital for advancing pharmaceutical manufacturing and drug delivery.