2. Academic Validation
  3. Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations

Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations

  • Eur J Pharm Sci. 2016 May 25;87:88-99. doi: 10.1016/j.ejps.2015.12.018.
David P Elder 1,  Martin Kuentz 2,  René Holm 3
Affiliations

Affiliations

  • 1 GlaxoSmithKline, Park Road, Ware, Hertfordshire SG12 0DP, United Kingdom. Electronic address: [email protected].
  • 2 University of Applied Sciences and Arts Northwestern Switzerland, Institute of Pharmaceutical Technology, Gründenstr. 40, CH-4132 Muttenz, Switzerland.
  • 3 H. Lundbeck A/S, Biologics and Pharmaceutical Science, Ottiliavej 9, 2500 Valby, Denmark.
PMID: 26699228 DOI: 10.1016/j.ejps.2015.12.018
Abstract

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.

Keywords

Biowaiver; Excipients; FDA; ICH; IPEC; Pharmacopoeial considerations; Quality; SUPAC; Safety.

Figures
Products