Comparative bioavailability study of an once-a-week matrix versus a twice-a-week reservoir transdermal estradiol delivery systems in postmenopausal women
An open-label, randomised, crossover study was conducted with in healthy postmenopausal women to compare the relative bioavailability of a matrix transdermal estradiol delivery system worn for 7 consecutive days, versus a reservoir transdermal patch worn for 4 days followed by its immediate replacem...
| Autores: | , , , , , , , |
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| Tipo de documento: | artigo |
| Estado: | Versão publicada |
| Data de publicação: | 1996 |
| País: | Brasil |
| Recursos: | Universidade Federal de São Paulo (UNIFESP) |
| Repositório: | Repositório Institucional da UNIFESP |
| Idioma: | inglês |
| OAI Identifier: | oai:repositorio.unifesp.br:11600/25571 |
| Acesso em linha: | http://dx.doi.org/10.1016/0378-5122(95)00987-6 http://repositorio.unifesp.br/handle/11600/25571 |
| Access Level: | Acceso aberto |
| Palavra-chave: | estrogen replacement therapy postmenopause estradiol bioavailability transdermal |
| Resumo: | An open-label, randomised, crossover study was conducted with in healthy postmenopausal women to compare the relative bioavailability of a matrix transdermal estradiol delivery system worn for 7 consecutive days, versus a reservoir transdermal patch worn for 4 days followed by its immediate replacement by another patch worn for further 3 consecutive days. There was a minimum 7-day washout period between the two study periods. Both systems were labelled to release approximately 50 mu g/day of estradiol. Twenty-six subjects were evaluated with regard to estradiol serum levels. Blood samples were taken immediately before and at regular intervals until 192 h after the initiation of each study treatment (patch application) and assayed for estradiol. There was no difference between the patches with regard to C-max. Based on the relative bioavailability, one matrix patch proved to be bioequivalent to two reservoir patches worn consecutively for 7 days. These results demonstrate the ability of one matrix patch to deliver consistent therapeutic levels of estradiol over a 7-day period. |
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