title: Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations.
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.
authors.affiliation: GlaxoSmithKline, Park Road, Ware, Hertfordshire SG12 0DP, United Kingdom. Electronic address: david.p.elder@gsk.com.
authors.forename: David P
authors.initials: DP
authors.lastname: Elder
authors.affiliation: University of Applied Sciences and Arts Northwestern Switzerland, Institute of Pharmaceutical Technology, Gründenstr. 40, CH-4132 Muttenz, Switzerland.
authors.forename: Martin
authors.initials: M
authors.lastname: Kuentz
authors.affiliation: H. Lundbeck A/S, Biologics and Pharmaceutical Science, Ottiliavej 9, 2500 Valby, Denmark.
authors.forename: René
authors.initials: R
authors.lastname: Holm
mesh_terms: D001702:Biopharmaceutics; D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry*; D007880:Legislation, Drug; D010599:Pharmacokinetics; D013678:Technology, Pharmaceutical
chemical_list: D005079:Excipients
keywords: Biowaiver; Excipients; FDA; ICH; IPEC; Pharmacopoeial considerations; Quality; SUPAC; Safety