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Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets
The aim of present study was to design oxycodone once-a-day controlled-release (CR) tablets and to perform in vitro/in vivo characterizations. Release profiles to achieve desired plasma concentration versus time curves were established by using simulation software and reported pharmacokinetic parame...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322610/ https://www.ncbi.nlm.nih.gov/pubmed/25678774 http://dx.doi.org/10.2147/DDDT.S77356 |
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author | Kim, Ju-Young Lee, Sung-Hoon Park, Chun-Woong Rhee, Yun-Seok Kim, Dong-Wook Park, Junsang Lee, Moonseok Seo, Jeong-Woong Park, Eun-Seok |
author_facet | Kim, Ju-Young Lee, Sung-Hoon Park, Chun-Woong Rhee, Yun-Seok Kim, Dong-Wook Park, Junsang Lee, Moonseok Seo, Jeong-Woong Park, Eun-Seok |
author_sort | Kim, Ju-Young |
collection | PubMed |
description | The aim of present study was to design oxycodone once-a-day controlled-release (CR) tablets and to perform in vitro/in vivo characterizations. Release profiles to achieve desired plasma concentration versus time curves were established by using simulation software and reported pharmacokinetic parameters of the drug. Hydroxypropyl methylcellulose (HPMC) 100,000 mPa·s was used as a release modifier because the polymer was found to be resistant to changes in conditions of the release study, including rotation speed of paddle and ion strength. The burst release of the drug from the CR tablets could be suppressed by applying an additional HPMC layer as a physical barrier. Finally, the oxycodone once-a-day tablet was comprised of two layers, an inert HPMC layer and a CR layer containing drug and HPMC. Commercial products, either 10 mg bis in die (bid [twice a day]) or once-a-day CR tablets (20 mg) were administered to healthy volunteers, and calculated pharmacokinetic parameters indicated bioequivalence of the two different treatments. The findings of the present study emphasize the potential of oxycodone once-a-day CR tablets for improved patient compliance, safety, and efficacy, which could help researchers to develop new CR dosage forms of oxycodone. |
format | Online Article Text |
id | pubmed-4322610 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-43226102015-02-12 Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets Kim, Ju-Young Lee, Sung-Hoon Park, Chun-Woong Rhee, Yun-Seok Kim, Dong-Wook Park, Junsang Lee, Moonseok Seo, Jeong-Woong Park, Eun-Seok Drug Des Devel Ther Original Research The aim of present study was to design oxycodone once-a-day controlled-release (CR) tablets and to perform in vitro/in vivo characterizations. Release profiles to achieve desired plasma concentration versus time curves were established by using simulation software and reported pharmacokinetic parameters of the drug. Hydroxypropyl methylcellulose (HPMC) 100,000 mPa·s was used as a release modifier because the polymer was found to be resistant to changes in conditions of the release study, including rotation speed of paddle and ion strength. The burst release of the drug from the CR tablets could be suppressed by applying an additional HPMC layer as a physical barrier. Finally, the oxycodone once-a-day tablet was comprised of two layers, an inert HPMC layer and a CR layer containing drug and HPMC. Commercial products, either 10 mg bis in die (bid [twice a day]) or once-a-day CR tablets (20 mg) were administered to healthy volunteers, and calculated pharmacokinetic parameters indicated bioequivalence of the two different treatments. The findings of the present study emphasize the potential of oxycodone once-a-day CR tablets for improved patient compliance, safety, and efficacy, which could help researchers to develop new CR dosage forms of oxycodone. Dove Medical Press 2015-01-30 /pmc/articles/PMC4322610/ /pubmed/25678774 http://dx.doi.org/10.2147/DDDT.S77356 Text en © 2015 Kim et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Kim, Ju-Young Lee, Sung-Hoon Park, Chun-Woong Rhee, Yun-Seok Kim, Dong-Wook Park, Junsang Lee, Moonseok Seo, Jeong-Woong Park, Eun-Seok Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets |
title | Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets |
title_full | Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets |
title_fullStr | Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets |
title_full_unstemmed | Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets |
title_short | Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets |
title_sort | design and in vivo evaluation of oxycodone once-a-day controlled-release tablets |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322610/ https://www.ncbi.nlm.nih.gov/pubmed/25678774 http://dx.doi.org/10.2147/DDDT.S77356 |
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