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一种设计用于多种口服给药方式的新型阿莫西林片剂的生物利用度研究。

Bioavailability study of a new amoxicillin tablet designed for several modes of oral administration.

作者信息

Cortvriendt W R, Verschoor J S, Hespe W

机构信息

Gist-brocades N.V., Research and Development, Delft, The Netherlands.

出版信息

Arzneimittelforschung. 1987 Aug;37(8):977-9.

PMID:3675699
Abstract

A new tablet of amoxicillin (Flemoxin solutab) has been formulated with galenic properties which allow it to be taken as a tablet, either swallowed, chewed or sucked, or to be taken after dispersion in water. This study was undertaken to compare the bioavailability of the new tablet (swallowed as such, or after dispersion) with a commercially available amoxicillin capsule and, for purposes of internal reference, with a Flemoxin forte suspension. Each formulation was administered to 12 volunteers according to a repeated 4 X 4 latin square design. Statistical analysis revealed that the tablet and suspension formulations tested gave significantly higher maximum plasma levels, occurring significantly faster after intake, when compared to the capsule. Furthermore, the new tablet showed a statistically significantly greater area under the plasma concentration-time curve with a highly predictable absorption when compared to the capsule. The method of intake of the new tablet appeared to be of no relevance with respect to the observed bioavailability.

摘要

一种新的阿莫西林片剂(Flemoxin solutab)已制成具有药剂学特性的剂型,使其既可以整片吞服、咀嚼或含服,也可以在水中分散后服用。本研究旨在比较这种新片剂(直接吞服或分散后服用)与市售阿莫西林胶囊的生物利用度,并以内参制剂Flemoxin forte混悬液作为对照。每种制剂根据重复的4×4拉丁方设计给予12名志愿者服用。统计分析表明,与胶囊相比,所测试的片剂和混悬液制剂的最大血药浓度显著更高,服药后达到最大血药浓度的时间显著更快。此外,与胶囊相比,新片剂的血浆浓度-时间曲线下面积在统计学上显著更大,且吸收具有高度可预测性。新片剂的服用方式似乎与所观察到的生物利用度无关。

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