Journal
ADVANCED DRUG DELIVERY REVIEWS
Volume 59, Issue 15, Pages 1482-1503Publisher
ELSEVIER
DOI: 10.1016/j.addr.2007.08.017
Keywords
excipients; formulation; pharmacokinetics; metabolism; surfactants
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Many new chemical entities are poorly soluble, requiring the use of co-solvents or excipients to produce suitable intravenous formulations for early pre-clinical development studies. There is some evidence in the literature that these formulation components can have significant physiological and physicochemical effects which may alter the distribution and elimination of co-administered drugs. Such effects have the potential to influence the results of pre-clinical pharmacokinetic studies, giving a false impression of a compound's intrinsic pharmacokinetics and frustrating attempts to predict the drug's ultimate clinical pharmacokinetics. This review describes the reported effects of commonly used co-solvents and excipients on drug pharmacokinetics and on physiological systems which are likely to influence drug disposition. Such information will be useful in study design and evaluating data from pharmacokinetic experiments, so that the potential influence of formulation components can be minimised. (c) 2007 Elsevier B.V. All rights reserved.
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