title: Pharmaceutical salts: a summary on doses of salt formers from the Orange Book.
abstract: 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.
authors.affiliation: Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany. christoph.saal@merckgroup.com
authors.forename: C
authors.initials: C
authors.lastname: Saal
authors.forename: A
authors.initials: A
authors.lastname: Becker
mesh_terms: D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D012492:Salts / Q000008:administration & dosage* / Q000633:toxicity
chemical_list: D004364:Pharmaceutical Preparations; D012492:Salts
keywords: Counter ions; Drug development; Pharmaceutical salts; Salt screening; Salt selection; Toxicology