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Drug solubility classification in the bovine

Authors


Marilyn N. Martinez, Food and Drug Administration Center for Veterinary Medicine, HFV-130, 7500 Standish Place, Rockville, MD 20855, USA. E-mail:marilyn.martinez@fda.hhs.gov

Abstract

Martinez, M. N., Apley, M. D. Drug solubility classification in the bovine. J. vet. Pharmacol. Therap.35 (Suppl. 1), 93–97.

Currently, the basis for solubility test conditions and the corresponding solubility criteria is derived from the tremendous wealth of information developed to support human pharmaceutical product development and regulation. However, there are several critical differences between the gastrointestinal tract of ruminants and monogastric species that can affect the conditions and criteria to be applied to the classification of drug solubility in cattle. These include the pH of the stomach, the volume of the stomach, the types of oral formulations, and the definition of ‘highest dose’. These points are discussed below and alternative perspectives for consideration with regard to possible modification of solubility criteria for ruminants are presented.

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