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Quality and functionality of excipients.

G Pifferi1, P Santoro, M Pedrani

  • 1Instituto di Chimica Farmaceutica e Tossicologìca, Milan, Italy.

Farmaco (Societa Chimica Italiana : 1989)
|May 13, 1999
PubMed
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Pharmaceutical excipients are evolving from inert ingredients to essential formulation components. Advanced characterization and tailored materials are improving drug product quality and manufacturability.

Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Excipients, traditionally viewed as inert carriers, are now recognized as critical formulation components impacting drug quality.
  • Scientific, regulatory, and economic advancements, alongside new delivery systems and biopharmaceutics, have increased interest in excipient functionality.
  • The pharmaceutical industry utilizes over a thousand raw materials with diverse chemical structures for various functions.

Purpose of the Study:

  • To highlight emerging trends in the development of 'tailor-made' pharmaceutical excipients.
  • To emphasize the necessity of comprehensive physical characterization beyond standard pharmacopoeial tests.
  • To discuss strategies for improving excipient performance and formulation development.

Main Methods:

Related Experiment Videos

  • Review of current industry approaches for excipient development, including physical/chemical manipulation and new entity preparation.
  • Discussion of advanced analytical techniques for molecular, particulate, and bulk characterization of excipients.
  • Exploration of strategies for ensuring excipient behavior during formulation and production.

Main Results:

  • Excipients are increasingly selected for specific functions, including stability, bioavailability, and manufacturability of drug products.
  • Advanced characterization techniques enable a systematic approach to understanding and guaranteeing excipient performance.
  • Industry trends focus on developing 'tailor-made' excipients through material modification, combination, or synthesis.

Conclusions:

  • Comprehensive physical characterization is essential for modern pharmaceutical excipients.
  • The development of 'tailor-made' excipients is crucial for optimizing drug product performance and manufacturing.
  • Future advancements like excipient harmonization and expert systems will drive a more scientific formulation approach.