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Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations.
Journal article

Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations.

  • Elder DP GlaxoSmithKline, Park Road, Ware, Hertfordshire SG12 0DP, United Kingdom. Electronic address: david.p.elder@gsk.com.
  • Kuentz M University of Applied Sciences and Arts Northwestern Switzerland, Institute of Pharmaceutical Technology, Gründenstr. 40, CH-4132 Muttenz, Switzerland.
  • Holm R H. Lundbeck A/S, Biologics and Pharmaceutical Science, Ottiliavej 9, 2500 Valby, Denmark.
  • 2015-12-25
Published in:
  • European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. - 2016
Biowaiver
Excipients
FDA
ICH
IPEC
Pharmacopoeial considerations
Quality
SUPAC
Safety
Biopharmaceutics
Chemistry, Pharmaceutical
Excipients
Legislation, Drug
Pharmacokinetics
Technology, Pharmaceutical
English Practically all medications contain excipients, which are added for the purpose of production enhancement, patient acceptability, improving stability, controlling release etc. Typically excipients are the major components of a drug product, with the active molecule only present in relatively small amounts. Historically, excipients were termed inactive components. However, as highlighted in the present paper; excipients can have an impact on the absorption, distribution, metabolism and elimination (ADME) processes of the co-administered drug, which is important information when selecting excipients for any new formulation. Further, this review also provides a description of the regulatory processes to get new excipients approved in different regions and a discussion of the recent regulatory initiatives, e.g. excipients for paediatric formulations, thereby providing points to consider for the pharmaceutical scientist when selecting excipients for a new drug formulation.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/177534
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