Bioavailability of estradiol from a new matrix and a conventional reservoir-type transdermal therapeutic system |
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Authors: | P. Müller L. Botta F. Ezzet |
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Affiliation: | (1) Human Pharmacology, K-1372.2.72, Ciba-Geigy Limited, CH-4002 Basel, Switzerland, CH;(2) Pharma Division of Ciba-Geigy Limited, Research and Development Departments, CH-4002 Basel, Switzerland, CH |
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Abstract: | Objective: Bioavailability of estradiol delivered from a newly developed matrix-type transdermal therapeutic system (MTTS) was compared with that of the conventional reservoir-type system (RTTS). Both formulations have a nominal delivery rate of 50 μg per day of 17β-estradiol (E2). Plasma concentrations of E2 and estrone (E1) were determined at steady state during a 96-h application of each formulation to 34 postmenopausal volunteers, using a two-stage randomized two-period crossover design. Results: The MTTS proved to be equivalent to the RTTS with respect to the extent of E2 absorption. Due to differences in patch design and composition, the rate of absorption was different between the two systems, with less fluctuating E2 plasma levels during application of the matrix system. Local tolerability and adhesion of MTTS appeared to be better than those of the reservoir system. Received: 29 February 1996/Accepted in revised form: 22 May 1996 |
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Keywords: | Hormone replacement therapy estradiol pharmacokinetics bioequivalence postmenopausal volunteers |
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