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Effects of Thyroid Status and Choice of USP Preparation on the Pharmacokinetics of Propylthiouracil in the Beagle Dog
Author(s) -
RINGHAND PAUL,
MAXON HARRY R.,
RITSCHEL WOLFGANG A.,
CHEN IWEN,
BAUMAN DAVID H.
Publication year - 1980
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1980.tb02530.x
Subject(s) - beagle , propylthiouracil , pharmacokinetics , medicine , pharmacology , thyroid , endocrinology
In vitro dissolution profile testing of 12 generic 6-propyl-2-thiouracil (PTU) formulations indicated significant differences in their solubilities in water and in 0.1N hydrochloric acid. Two products, representing the extremes of solubility, were subsequently tested for bioavailability. Bioavailability data from euthyroid, hyperthyroid, and hypothyroid beagle dogs indicated that the rate of PTU absorption varied appreciably between the two generic products studied. These results were consistent with the in vitro dissolution data. Comparisons of the pharmacokinetic parameters obtained for the euthyroid beagle dog to those reported for euthyroid man12 indicated that the beagle dog is an adequate model for PTU disposition in man. These combined results suggest that all generic formulations of PTU are not the same and that the most soluble product may be desirable in situations where rapid absorption is important, such as thyroid storm.