Retention and distribution of two 99mTc-DTPA labelled vaginal dosage forms
Retention and distribution of two 99mTc-DTPA labelled vaginal dosage forms
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DOI：
10.1016/j.ijpharm.2003.11.006
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发表时间：
2004-03-01
影响因子：
5.8
通讯作者：
Hunt, B
中科院分区：
文献类型：
--
作者：
Chatterton, BE;Penglis, S;Hunt, B
要客观评价阴道新剂型的使用效果，确定其使用时间和分布是很重要的。本文介绍了一种参考和试验产品在这种情况下的体内特性。方法：对8名绝经前妇女在月经周期的同一阶段进行随机交叉研究。用Tc-99m-DTPA标记的市售阴道克霉唑乳膏和测试凝胶产品的保留和分布在给药后24小时通过伽马闪烁成像进行评估。通过收集和计数研究期间使用的卫生巾，尝试进行质量平衡分析。结果:在个人几乎没有间隙的变化公式,但个体间变异的范围宽81至1%的服用剂量保留24 h。损失似乎主要发生在排尿与12 + / - 8%(奶油)和20 + / - 23%(凝胶)收集卫生棉,但是46 + / - 34%(奶油)和38 + / - 22%凝胶活动不占24 h。每个产品活动的阴道内的分布是相似的。结论：放射性示踪法可用于阴道剂型的评估和比较。(C) 2003 Elsevier B.V.版权所有
To objectively evaluate the performance of new vaginal dosage forms, it is important to determine their time of residence and their distribution. This paper describes the in vivo characteristics of a reference and test product in this situation.Method: A randomised cross-over study was performed in the same phase of the menstrual cycle in eight pre-menopausal women. The retention and distribution of a commercially available vaginal clotrimazole cream and a test gel product, each "labelled" with Tc-99m-DTPA was assessed by gamma scintigraphy for 24 h after administration of the products. Mass balance analysis was attempted by collecting and counting sanitary napkins worn for the study time. Results: Within individuals there was little variation in the clearance of the formulations, but wide variation between individuals with a range between 81 and 1% of the administered doses retained by 24 h. The losses appeared to occur mainly at times of urination with 12 +/- 8% (cream) and 20 +/- 23% (gel) collected on the sanitary napkins, but 46 +/- 34% (cream) and 38 +/- 22% gel activity not accounted for by 24 h. The intravaginal distribution of activity was similar for each product.. Conclusions: Radioactive tracer methods are useful in assessing and comparing vaginal dosage forms. (C) 2003 Elsevier B.V. All rights reserved.