Journal
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 49, Issue 4, Pages 614-623Publisher
ELSEVIER
DOI: 10.1016/j.ejps.2013.05.026
Keywords
Pharmaceutical salts; Counter ions; Drug development; Toxicology; Salt selection; Salt screening
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Over half of the active pharmaceutical ingredients currently approved within the US are pharmaceutical salts. Selection of suitable pharmaceutical salts is carried out during late research or early development phase. Therefore several properties of different pharmaceutical salts of a new chemical entity are assessed during salt screening and salt selection. This typically includes physico-chemical behavior, dissolution rate and pharmacokinetics of a pharmaceutical salt. Beyond these properties also toxicological aspects have to be taken into account. As a starting point for a toxicological assessment we present an overview of the usage of pharmaceutical salts as described in the FDA's Orange Book including maximum daily doses for the most important administration routes. (C) 2013 Elsevier B.V. All rights reserved.
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