In vitro release testing methods for drug-releasing vaginal rings
Copyright © 2019 Elsevier B.V. All rights reserved..
Drug-releasing vaginal rings are torus-shaped devices, generally fabricated from thermoplastic polymers or silicone elastomers, used to administer pharmaceutical drugs to the human vagina for periods typically ranging from three weeks to twelve months. One of the most important product performance tests for vaginal rings is the in vitro release test. Although it has been fifty years since a vaginal ring device was first described in the scientific literature, and despite seven drug-releasing vaginal rings having been approved for market, there is no universally accepted method for testing in vitro drug release, and only one non-compendial shaking incubator method (for the estradiol-releasing ring Estring®) is described in the US Food and Drug Administration's Dissolution Methods Database. Here, for the first time, we critically review the diverse range of test methods that have been described in the scientific literature for testing in vitro release of drug-releasing vaginal rings. Issues around in vitro-in vivo correlation and modelling of in vitro release data are also discussed.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:313 |
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| Enthalten in: |
Journal of controlled release : official journal of the Controlled Release Society - 313(2019) vom: 10. Nov., Seite 54-69 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Boyd, Peter [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 08.10.2020 Date Revised 08.10.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jconrel.2019.10.015 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM302331972 |
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| 520 | |a Drug-releasing vaginal rings are torus-shaped devices, generally fabricated from thermoplastic polymers or silicone elastomers, used to administer pharmaceutical drugs to the human vagina for periods typically ranging from three weeks to twelve months. One of the most important product performance tests for vaginal rings is the in vitro release test. Although it has been fifty years since a vaginal ring device was first described in the scientific literature, and despite seven drug-releasing vaginal rings having been approved for market, there is no universally accepted method for testing in vitro drug release, and only one non-compendial shaking incubator method (for the estradiol-releasing ring Estring®) is described in the US Food and Drug Administration's Dissolution Methods Database. Here, for the first time, we critically review the diverse range of test methods that have been described in the scientific literature for testing in vitro release of drug-releasing vaginal rings. Issues around in vitro-in vivo correlation and modelling of in vitro release data are also discussed | ||
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| 650 | 4 | |a Dissolution testing | |
| 650 | 4 | |a IVIVC | |
| 650 | 4 | |a In vitro release testing | |
| 650 | 4 | |a Intravaginal rings | |
| 650 | 4 | |a Novel dosage form | |
| 650 | 4 | |a Release models | |
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| 700 | 1 | |a Murphy, Diarmaid J |e verfasserin |4 aut | |
| 700 | 1 | |a Dallal Bashi, Yahya H |e verfasserin |4 aut | |
| 700 | 1 | |a Malcolm, R Karl |e verfasserin |4 aut | |
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