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PubMedDate not supplied

Effects of thyroid status and choice of USP preparation on the pharmacokinetics of propylthiouracil in the beagle dog.

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.

Animals↗
PubMed2002

Effect of hypothyroidism induced by propylthiouracil on ovarian function and structure in offspring from treated mothers (Rats).

The aim of the present study was to investigate the effects of hypothyroidism induced during the pre- and postnatal periods of life on ovarian function and structure in offspring (pups) 120 days of age. Three groups were used. In the prenatal group, treatment was given from conception to parturition. In the postnatal group, treatment was given from parturition to 25 days postpartum. Hypothyroidism was induced by administration of 0.1% 6-n-propyl-2-thiouracil (PTU) in the drinking water of mothers. Body weights of the offspring were measured weekly. In each group, ten offspring were sacrificed at 120 days of age. Postnatal PTU treated pups showed delay in eye opening, teething, fur development, and weaning (35-37 days) compared to control animals (28-30 days). Body weight of offspring in the postnatal PTU treatment group was significantly decreased (P < 0.001), while the prenatal PTU treatment group showed a significant increase (P < 0.0001) compared to control animals. There was a significant (P < 0.05) reduction in paired ovarian weight of offspring in the postnatal PTU treatment group compared to control animals. Diameter of the ovaries was not affected by any treatment. Regarding the morphometery, only offspring in the prenatal PTU treatment group showed a significant (P < 0.001) increase in the diameter of graafian follicles. No significant difference was observed in morphometery of the granulosa layer, primary, and developing follicles of control and all treated groups. Number of primary, developing, and graafian follicles of all the treated groups was similar to that of the control group. The corpora lutea of the postnatal PTU treated group contained a population of large numbers of luteal cells compared to the control group. The prenatal PTU treated group did not exhibit a profound effect on ovarian morphology, histology, and morphometery. No difference was found in the serum estradiol concentration of control and PTU treated groups. J. Exp. Zool. 293:407-413, 2002.

Animals↗
PubMed1995

Effect of hypothyroidism induced by propylthiouracil and thiourea on male and female reproductive systems of neonatal mice.

The effect of hypothyroidism induced by 6-propyl-2-thiouracil (PTU) or thiourea (TU) on the development of the reproductive system in male and female neonatal ICR mice was investigated. PTU or TU was injected subcutaneously into experimental animals from postnatal day 1 (PD1) onward. The histological changes of the reproductive organs, formation of ovarian follicles, and spermatogenesis were examined on PD 14, 21, and 28, and the fertility of the hypothyroid mice in adulthood was followed. It was found that PTU or TU treatment did not produce an effect on the histology of the neonatal uterus and oviduct. In contrast, the drugs induced a decrease in the number of primordial follicles, multilaminar follicles, and Graafian follicles in the ovary. The number of follicles with degenerated follicular cells was increased. In the testis both PTU and TU treatments brought about a decrease in the number of seminiferous tubules with developing spermatids although the mean diameter of seminiferous tubules and the histology of the testis, epididymis, seminal vesicle, and coagulating gland was unaffected. The mating between hypothyroid females and euthyroid males and that between hypothyroid males and euthyroid females were normal with regard to the pregnancy rate, litter size, and sex ratio of offspring. The somatic growth of the resulting offspring was normal. It is concluded that the retarding effect on ovarian and testicular development in mice during neonatal period was not serious enough to adversely affect reproduction in the hypothyroid animals.

Animals↗
PubMed1979

High-pressure liquid chromatographic determination of propylthiouracil in human plasma.

A high-pressure liquid chromatographic procedure was developed for the determination of prophylthiouracil in plasma. The method utilizes a reversed-phase C18 chromatographic column and UV detection at 280 nm. The method is sufficiently sensitive for most bioavailability and pharmacokinetic studies. Coinentrations between 0.1 and 5.0 microgram/ml were measured with a coefficient of variation of 0.6-5.3% for a given day. Methylthiouracil was employed as an internal standard.

Chromatography, High Pressure Liquid↗
PubMed1983

Bioavailability of propylthiouracil in humans.

Single lots of five commercially available 50-mg propyl-thiouracil formulations were evaluated in vitro and in vivo. Each product met the USP XIX specifications for drug content, content uniformity, and disintegration time. However, major differences were noted among products in their rate and extent of dissolution. Statistically significant differences (p less than 0.05) were observed in vivo among the drug formulations at all but one of the sampling times, as determined from crossover blood level studies in 12 healthy male volunteers. The differences among the areas under the plasma level-time curves for the various products were not statistically significant. No statistically significant correlations were found between the in vitro and in vivo parameters studied.

Biological Availability↗
PubMed1997

Effects of maternal exposure to 3,3',4,4'-tetrachlorobiphenyl or propylthiouracil in rats trained to discriminate apomorphine from saline.

In the present experiment drug discrimination was examined in rats after maternal exposure to 3,3',4,4'-tetrachlorobiphenyl (PCB 77) using apomorphine (APO) as the training drug at a dose reported to act on dopamine D2 receptors. A group with maternal exposure to 6n-propyl-2-thiouracil (PTU) was included as a positive control for effects induced by PCB 77 on thyroid hormones. On gestational day (GD) 19 reduced levels of free and total thyroxine (FT4, TT4) and free triiodothyronine (FT3) were detected in dams exposed to PCB 77 or PTU. In the offspring decreases in levels of FT4 and TT4 were found in both treated groups on postnatal day (PND) 21, while reductions of FT3 were observed only in the PTU group. PTU-treated rats needed more daily sessions for successful discrimination between apomorphine and saline. There were no differences between groups in generalization tests and sessions with the D2/D3 agonist quinpirole, the D2 antagonist haloperidol plus APO, or with the GABAergic drug pentobarbital and only minor differences in sessions with the D1 agonist SKF-38393. Differences between controls and groups exposed to PCB 77 or PTU were detected in a blocking test using the mixed serotonin 5-HT1A agonist and partial D2 antagonist buspirone. This outcome suggests long-lasting effects by developmental exposure to PCB 77 on the interaction between dopaminergic and serotonergic processes which may be mediated by effects on thyroid hormone levels.

Animals↗