title: Drug solubility classification in the dog.
abstract: Similar to human drugs, oral drug delivery is a major route of drug administration in dogs. Therefore, it is important to consider how the physiological characteristics of the dog may influence the considerations that go into the classification of drug solubility. In this manuscript, we discuss the impact of body size vs. administered dose and gastric volume on the estimated gastric drug concentration that needs to be considered. However, when using a dose number (Do) paradigm, there are very few drugs for which the different methods of estimating gastric volume will alter the drug solubility classification. We also evaluate the range of pH values under which a solubility assessment should be generated and conclude that despite specific differences in the pH values of the gastrointestinal environment of people and dogs, the human pH criteria for evaluating drug solubility can be used when evaluating drug solubility of oral medications in dogs.
authors.affiliation: Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855, USA. marilyn.martinez@fda.hhs.gov
authors.forename: M N
authors.initials: MN
authors.lastname: Martinez
authors.forename: M G
authors.initials: MG
authors.lastname: Papich
mesh_terms: D000284:Administration, Oral; D000818:Animals; D004285:Dogs; D004304:Dosage Forms; D041981:Gastrointestinal Tract / Q000502:physiology*; D006801:Humans; D012995:Solubility; D019155:Veterinary Drugs / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics* / Q000494:pharmacology
chemical_list: D004304:Dosage Forms; D019155:Veterinary Drugs