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Regulatory issues with excipients.

M I Robertson1

  • 1Medicines Control Agency, London, UK.

International Journal of Pharmaceutics
|September 30, 1999
PubMed
Summary
This summary is machine-generated.

Regulatory controls for pharmaceutical ingredients, including excipients, are reviewed. Inappropriate excipient choices can have unexpected consequences, highlighting the need for strict standards in UK-licensed medicines.

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Area of Science:

  • Pharmaceutical Science
  • Regulatory Affairs

Background:

  • A review of the historical regulatory control of pharmaceutical ingredients.
  • Discussion of legislation, European and international guidelines, and licensing policies.

Purpose of the Study:

  • To recognize the critical role of excipients in modern pharmaceutical formulations.
  • To provide data on excipient and active ingredient prevalence in UK-licensed medicines.

Main Methods:

  • Literature review of regulatory history and guidelines.
  • Analysis of data on pharmaceutical ingredients in UK medicines.
  • Examination of pharmacopoeial and non-official reference standards for excipients.

Main Results:

  • Excipients play a vital role in drug formulations, with potential for unintended consequences from poor selection.

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  • Data presented on the presence of excipients and active ingredients in UK-licensed medicines.
  • Overview of reference standards used for excipient control.

    • Conclusions:

    • Understanding regulatory history is crucial for pharmaceutical ingredient control.
    • Careful selection of excipients is essential to avoid adverse formulation outcomes.
    • Adherence to appropriate reference standards ensures the quality and safety of pharmaceutical products.