Retention and distribution of two 99mTc-DTPA labelled vaginal dosage forms.

Abstract:

UNLABELLED: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 99mTc-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.

journal_name

Int J Pharm

authors

Chatterton BE,Penglis S,Kovacs JC,Presnell B,Hunt B

doi

10.1016/j.ijpharm.2003.11.006

keywords:

subject

Has Abstract

pub_date

2004-03-01 00:00:00

pages

137-43

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(03)00619-7

journal_volume

271

pub_type

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