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KMID : 0377619750280040457
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Korean Jungang Medical Journal
1975 Volume.28 No. 4 p.457 ~ p.462
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Comparative Study of Bioavailability and Toleration of New Oxytetracycline IM/IV Formations
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Abstract
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Studies on the bioavailability and toleration of two new oxytetracycline IM/IV formulations (PT-A, GV-B) producted by different manufacturers were performed in comparison with the present Terramycin(Pfizer) intramuscular(KPT/IM) and intravenous(KPT/IV) formulations.
Six healthy young male volunteers were selected and employed for these study.
Bioavailability was determined from measurements of serum oxytetracycline concentration by cylinder-plate techique utilizing Bacillus cereus var. mycoides. Toleration test was conducted with observing the local and general responses after injection in each volunteer.
Results can be summarized as followings.
1). Toleration: In the case of intravenous administration, all the tested formulations showed no significant local and general responses. However, when administered intramuseulary, the incidence of local reactions developed in one hour after injection was high in the order of GV-B, KPT/IM, PT-A. Total incidence and degrees of severity of local reactions encountered in 24 hours after TM injection were higher in the two new formulations than in the present KPT/IM. In the new formulations, PT-A appeared to be well tolerated than GV-B.
2). Bioavailability: Intravenous administration of PT-A and GV-B demonstrated no significant differences in serum concentration of oxytetracycline from the present KPT/IV. In the case of intramuscular injection, however, the differences in serum concentration measured at one and two hours after injection were statistically significant among the drugs (p<0.05), while 8 and 10 hours after injection it found to be statistically insignificant.
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