DK2249757T3 - Monolitiske vaginalringe omfattende progesteron samt fremgangsmåder til fremstilling og anvendelse deraf. - Google Patents
Monolitiske vaginalringe omfattende progesteron samt fremgangsmåder til fremstilling og anvendelse deraf. Download PDFInfo
- Publication number
- DK2249757T3 DK2249757T3 DK09707504.8T DK09707504T DK2249757T3 DK 2249757 T3 DK2249757 T3 DK 2249757T3 DK 09707504 T DK09707504 T DK 09707504T DK 2249757 T3 DK2249757 T3 DK 2249757T3
- Authority
- DK
- Denmark
- Prior art keywords
- progesterone
- elastomer
- day
- monolithic
- ring
- Prior art date
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Classifications
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- B29C45/0001—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor characterised by the choice of material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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Claims (18)
1. Monolitisk vaginalring til anvendelse i behandlingen af lutealfasedefekt hos en patient med behov derfor, hvilken vaginalring omfatter: (a) en terapeutisk effektiv mængde progesteron; (b) en polysiloxan-elastomer; og (c) et farmaceutisk acceptabelt carbonhydrid eller glycerolestere af en fedtsyre, hvori polysiloxan-elastomeren forefindes i en koncentration på 55 % til 90 % i forhold til ringens samlede vægt.
2. Monolitisk vaginalring ifølge krav 1, hvori progesteronet er homogent fordelt i polysiloxan-elastomeren, fortrinsvis hvori polysiloxan-elastomeren er en diorganopolysiloxan-elastomer, mere foretrukket dimethylpolysiloxan-elastomer.
3. Monolitisk vaginalring ifølge krav 2, hvori dimethylpolysiloxan-elastomeren endvidere omfatter en dimethylmethylhydrogen-polysiloxan-tværbinding.
4. Monolitisk vaginalring ifølge krav 1, hvori det farmaceutisk acceptable carbonhydrid eller glycerolesterne af en fedtsyre forefindes i en koncentration på 0,1% til 10% i forhold til ringens samlede vægt.
5. Monolitisk vaginalring ifølge krav 1, hvori progesteronet forefindes i en koncentration på 15 % til 30 % i forhold til ringens samlede vægt.
6. Monolitisk vaginalring ifølge krav 1, hvori progesteronet udløses med en jævn hastighed i Idag til 14 dage, eller hvori progesteronet udløses med en jævn hastighed i 1 dag til 10 dage, eller hvori progesteronet udløses med en jævn hastighed i 1 dag til 7 dage.
7. Monolitisk vaginalring ifølge krav 1, hvori polysiloxan-elastomeren er en dimethylpolysiloxan-elastomer, og hvori forholdet mellem progesteron og elastomer er 1:1 til 1:10, progesteronet er homogent fordelt i elastomeren, forholdet mellem progesteron og carbonhydrid eller glycerolestere af en fedtsyre er 1:0,1 til 1:100, og hvori progesteronet udløses fra den monolitiske vaginalring i op til 18 dage efter administration til patienten.
8. Monolitisk vaginalring ifølge krav 1, hvori vaginalringen omfatter: (a) 15 vægt-% til 25 vægt-% af progesteronet; (b) 70 vægt-% til 80 vægt-% af en dimethylpolysiloxan-elastomer; og (c) 1 vægt-% til 10 vægt-% af det farmaceutisk acceptable carbonhydrid eller glycerolestrene af en fedtsyre, hvori progesteronet er homogent fordelt i elastomeren, og hvori progesteronet udløses fra den monolitiske vaginalring i op til 18 dage efter administration til patienten.
9. Monolitisk vaginalring ifølge krav 1 til behandling af en lutealfasedefekt hos en patient med behov derfor, hvilken ring omfatter: (a) 5 vægt-% til 40 vægt-% progesteron; (b) 55 vægt-% til 90 vægt-% polysiloxan-elastomer; og (c) 0,1 vægt-% til 10 vægt-% af et farmaceutisk acceptabelt carbonhydrid eller glycerolestere af en fedtsyre, hvori progesteronet er homogent fordelt i elastomeren.
10. Fremgangsmåde til fremstilling af en monolitisk vaginalring ifølge krav 1, hvilken fremgangsmåde omfatter: (a) blanding af progesteron, et farmaceutisk acceptabelt carbonhydrid eller glycerolestere af en fedtsyre og en polysiloxan, så der dannes en homogen blanding; (b) anbringelse af den homogene blanding i en støbeform; og (c) hærdning af støbeformen ved 60 °C til 180 °C, hvori polysiloxanen forefindes i en koncentration på 55% til 90% i forhold til ringens samlede vægt.
11. Fremgangsmåde ifølge krav 10, hvori polysiloxanen er vinyltermineret.
12. Fremgangsmåde ifølge krav 10, hvori polysiloxanen er dimethylpolysiloxan.
13. Fremgangsmåde ifølge krav 10 endvidere omfattende iblanding af en anden polysiloxan i den homogene blanding, før den anbringes i støbeformen, hvori den anden polysiloxan fortrinsvis er en tværbinder, fortrinsvis dimethylmethylhydrogen-polysiloxan.
14. Fremgangsmåde ifølge krav 10, hvori anbringelsen af den homogene blanding er ved injektion.
15. Monolitisk vaginalring ifølge krav 7, hvori progesteronet udløses fra vaginalringen med 10 mg/dag til 40 mg/dag in vivo, eller hvori progesteronet udløses fra vaginalringen med 10 mg/dag til 30 mg/dag in vivo, eller hvori progesteronet udløses fra vaginalringen med 15 mg/dag til 25 mg/dag in vivo.
16. Monolitisk vaginalring ifølge krav 7, hvori vaginalringen udskiftes efter 7 dage efter administration til patienten.
17. Monolitisk vaginalring ifølge krav 15, hvori vaginalringen udskiftes efter 7 dage efter administration til patienten.
18. Monolitisk vaginalring ifølge krav 1, hvori det farmaceutisk acceptable carbonhydrid eller glycerolesterne af en fedtsyre er en mineralsk olie.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US2611508P | 2008-02-04 | 2008-02-04 | |
| US13945408P | 2008-12-19 | 2008-12-19 | |
| PCT/US2009/000672 WO2009099586A2 (en) | 2008-02-04 | 2009-02-03 | Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2249757T3 true DK2249757T3 (da) | 2017-10-16 |
Family
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| Application Number | Title | Priority Date | Filing Date |
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| DK10187686.0T DK2359807T3 (da) | 2008-02-04 | 2009-02-03 | Monolitiske vaginalringe omfattende progesteron samt fremgangsmåder til fremstilling og anvendelse deraf |
| DK09707504.8T DK2249757T3 (da) | 2008-02-04 | 2009-02-03 | Monolitiske vaginalringe omfattende progesteron samt fremgangsmåder til fremstilling og anvendelse deraf. |
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| Application Number | Title | Priority Date | Filing Date |
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| DK10187686.0T DK2359807T3 (da) | 2008-02-04 | 2009-02-03 | Monolitiske vaginalringe omfattende progesteron samt fremgangsmåder til fremstilling og anvendelse deraf |
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| PL2359807T3 (pl) | 2008-02-04 | 2017-12-29 | Ferring B.V. | Monolityczne pierścienie dopochwowe zawierające progesteron oraz metody ich wytwarzania i stosowania |
| EP2585011A4 (en) * | 2010-06-22 | 2014-10-15 | Teva Womens Health Inc | INTRAVAGINAL DEVICES HAVING CHOLINOLYTIC AGENTS AND METHODS OF MAKING SAME |
| US8580294B2 (en) | 2010-10-19 | 2013-11-12 | International Partnership For Microbicides | Platinum-catalyzed intravaginal rings |
| EP2641602A1 (en) * | 2012-03-23 | 2013-09-25 | PregLem S.A. | Method for treating gynecological diseases |
| HUE049219T2 (hu) * | 2013-02-08 | 2020-09-28 | Qpharma Ab | Intravaginális eszköz, valamint eljárás az intravaginális eszközben lévõ hatóanyag diffúziós sebességének csökkentésére |
| CN103445892A (zh) * | 2013-08-02 | 2013-12-18 | 苏州市马尔泰新材料有限公司 | 一种含有甲酯树脂和雌酚的阴道模具 |
| CN103431930A (zh) * | 2013-08-02 | 2013-12-11 | 苏州市马尔泰新材料有限公司 | 一种含有甲酯树脂的阴道模具 |
| CN103394128A (zh) * | 2013-08-02 | 2013-11-20 | 苏州市马尔泰新材料有限公司 | 一种含有川芎的模具材料 |
| CN103394127A (zh) * | 2013-08-02 | 2013-11-20 | 苏州市马尔泰新材料有限公司 | 一种含有中西医药的阴道模具材料 |
| CN103405810A (zh) * | 2013-08-02 | 2013-11-27 | 苏州市马尔泰新材料有限公司 | 一种含有甲基丙烯酸甲酯树脂的阴道模具 |
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| TWI791347B (zh) * | 2020-12-11 | 2023-02-01 | 酷氏基因生物科技股份有限公司 | 一種用於評估胚胎植入成功率的預測方法 |
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