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Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery

Preparation and in vitro/in vivo evaluation of mifepristone intravaginal ring formulations were investigated. In the present study, it is reported that a mifepristone intravaginal ring of reservoir design comprising of a mifepristone silicone elastomer core enclosed in a silicone layer. During the p...

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Autores principales: Duan, X., Ning, M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4502149/
https://www.ncbi.nlm.nih.gov/pubmed/26180280
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author Duan, X.
Ning, M.
author_facet Duan, X.
Ning, M.
author_sort Duan, X.
collection PubMed
description Preparation and in vitro/in vivo evaluation of mifepristone intravaginal ring formulations were investigated. In the present study, it is reported that a mifepristone intravaginal ring of reservoir design comprising of a mifepristone silicone elastomer core enclosed in a silicone layer. During the preparation of intravaginal ring solid dispersion method was employed which improved the release rate of drug from the intravaginal ring. In vitro release studies performed under sink conditions and the released drug amounts were estimated using UV spectrometry at 310 nm. In addition, the in vivo release profile of in-house devices was evaluated in female New Zealand white rabbits. The rabbit plasma samples were processed and analyzed using a validated HPLC-MS method. Norgestrel was used as internal standard, and plasma samples contained mifepristone and internal standard were deproteinized, and then subjected to HPLC-MS analysis under condition of electrospray ionization in the selected ion monitoring mode. The drug release from intravaginal ring made in house was constant for 21 days in rabbits, which suggested the mifepristone intravaginal ring release system would be useful in clinical practice in the future. The result indicated the in vitro/in vivo correlation is perfect, which explained in vitro release analysis method developed was feasible.
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spelling pubmed-45021492015-07-15 Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery Duan, X. Ning, M. Indian J Pharm Sci Research Paper Preparation and in vitro/in vivo evaluation of mifepristone intravaginal ring formulations were investigated. In the present study, it is reported that a mifepristone intravaginal ring of reservoir design comprising of a mifepristone silicone elastomer core enclosed in a silicone layer. During the preparation of intravaginal ring solid dispersion method was employed which improved the release rate of drug from the intravaginal ring. In vitro release studies performed under sink conditions and the released drug amounts were estimated using UV spectrometry at 310 nm. In addition, the in vivo release profile of in-house devices was evaluated in female New Zealand white rabbits. The rabbit plasma samples were processed and analyzed using a validated HPLC-MS method. Norgestrel was used as internal standard, and plasma samples contained mifepristone and internal standard were deproteinized, and then subjected to HPLC-MS analysis under condition of electrospray ionization in the selected ion monitoring mode. The drug release from intravaginal ring made in house was constant for 21 days in rabbits, which suggested the mifepristone intravaginal ring release system would be useful in clinical practice in the future. The result indicated the in vitro/in vivo correlation is perfect, which explained in vitro release analysis method developed was feasible. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC4502149/ /pubmed/26180280 Text en Copyright: © Indian Journal of Pharmaceutical Sciences http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Research Paper
Duan, X.
Ning, M.
Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery
title Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery
title_full Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery
title_fullStr Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery
title_full_unstemmed Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery
title_short Development and in vitro/in vivo Evaluation of a Silastic Intravaginal Ring for Mifepristone Delivery
title_sort development and in vitro/in vivo evaluation of a silastic intravaginal ring for mifepristone delivery
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4502149/
https://www.ncbi.nlm.nih.gov/pubmed/26180280
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