DK2938332T3 - Depot-lipidprækoncentrat af gnrh-analoger og farmaceutisk sammensætning dermed - Google Patents
Depot-lipidprækoncentrat af gnrh-analoger og farmaceutisk sammensætning dermed Download PDFInfo
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- DK2938332T3 DK2938332T3 DK13867921.2T DK13867921T DK2938332T3 DK 2938332 T3 DK2938332 T3 DK 2938332T3 DK 13867921 T DK13867921 T DK 13867921T DK 2938332 T3 DK2938332 T3 DK 2938332T3
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- sorbitan
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- 238000002360 preparation method Methods 0.000 title description 4
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Claims (12)
1. Farmaceutisk sammensætning, der omfatter: a) mindst én sorbitan-umættet fedtsyreester, der har et polært hoved med mindst to eller flere -OH (hydroxyl)-grupper; b) mindst ét phospholipid; c) mindst ét væskeformigt krystalhærdemiddel, som er fri for en ioniserbar gruppe, der har en hydrofob del på 15 til 40 carbonatomer med en triacylgruppe eller en carbonringstruktur; og d) mindst én GnRH (gonadotropinfrigørende hormon)-analog som et farmakologisk aktivt stof, hvor lipidprækoncentratet forefindes som en væskefase i fravær af vandig væske og omdannes til et væskeformigt krystal i nærvær af vandig væske, hvor GnRH-analogen er en GnRH-agonist, der er valgt fra gruppen, der består af leuprolid, goserelin, triptorelin, nafarelin, buserelin, histrelin, deslorelin, meterelin, gonadrelin, et farmaceutisk acceptabelt salt deraf og en kombination deraf, eller hvor GnRH-analogen er en GnRH-antagonist, der er valgt fra gruppen, der består af degarelix, abarelix, ganirelix, cetrorelix, et farmaceutisk acceptabelt salt deraf og en kombination deraf.
2. Farmaceutisk sammensætning ifølge krav 1, hvor sorbitan- umættet fedtsyreesteren er valgt fra gruppen, der består af sorbitanmonooleat, sorbitanmonolinoleat, sorbitanmonopalmitoleat, sorbitanmonomyristoleat, sorbitansesquioleat, sorbitansesquilinoleat, sorbitansesquipalmitoleat, sorbitansesquimyristoleat, sorbitandioleat, sorbitandilinoleat, sorbitandipalmitoleat, sorbitandimyristoleat og en kombination deraf.
3. Farmaceutisk sammensætning ifølge krav 1, hvor sorbitan- umættet fedtsyreesteren er valgt fra gruppen, der består af sorbitanmonooleat, sorbitanmonolinoleat, sorbitanmonopalmitoleat, sorbitanmonomyristoleat, sorbitansesquioleat og en kombination deraf.
4. Farmaceutisk sammensætning ifølge krav 1, hvor phospholipidet indeholder en mættet eller umættet alkylestergruppe med 4 til 30 carbonatomer og er valgt fra gruppen, der består af phosphatidylcholin, phosphatidylethanolamin, phosphatidyIserin, phosphatidylglycerin, phosphatidylinositol, phosphatidsyre, sphingomyelin og en kombination deraf.
5. Farmaceutisk sammensætning ifølge krav 1, hvor det væskeformige krystalhærdemiddel er valgt fra gruppen, der består af triglycerid, retinylpalmitat, tocopherolacetat, cholesterol, benzylbenzoat, ubiquinon og en kombination deraf.
6. Farmaceutisk sammensætning ifølge krav 1, hvor det væskeformige krystalhærdemiddel er valgt fra gruppen, der består af tocopherolacetat, cholesterol og en kombination deraf.
7. Farmaceutisk sammensætning ifølge krav 1 til anvendelse til forebyggelse eller behandling af en kønshormonafhængig sygdom eller som et kontraceptiv.
8. Farmaceutisk sammensætning til anvendelse ifølge krav 7, hvor den kønshormonafhængige sygdom er valgt fra gruppen, der består af prostatacancer, brystcancer, ovariecancer, endometriose, uterusfibrom, polycystisk ovariesygdom, tidlig pubertet, hypertrikose, gonadotrope hypofyseadenomer, søvnapnøsyndrom, irritabel tarmsyndrom, præmenstruelt syndrom, benign prostatahyperplasi og infertilitet.
9. Farmaceutisk sammensætning ifølge krav 1, der omfatter: a) mindst én sorbitan-umættet fedtsyreester, der har et polært hoved med mindst to eller flere -OH (hydroxyl)-grupper, i en mængde på 9~90 vægt-%; b) mindst ét phospholipid i en mængde på 9~90 vægt-%; c) mindst ét væskeformigt krystalhærdemiddel, der er fri for en ioniserbar gruppe og har en triacylgruppe med 15 til 40 carbonatomer eller en carbonringstruktur i en hydrofob del, i en mængde på 0,1-50 vægt-%; og d) mindst én GnRH (gonadotropinfrigørende hormon)-analog i en mængde på 0,01-50 vægt-%.
10. Farmaceutisk sammensætning ifølge krav 1, der omfatter: a) mindst én sorbitan-umættet fedtsyreester, der har et polært hoved med mindst to eller flere -OH (hydroxyl)-grupper, i en mængde på 9-64 vægt-%; b) mindst ét phospholipid i en mængde på 18-76 vægt-%; c) mindst ét væskeformigt krystalhærdemiddel, der er fri for en ioniserbar gruppe og har en triacylgruppe med 15 til 40 carbonatomer eller en carbonringstruktur i en hydrofob del, i en mængde på 1-36 vægt-%; og d) leuprolid eller et farmaceutisk acceptabelt salt deraf i en mængde på 0,1-50 vægt-%.
11. Farmaceutisk sammensætning ifølge krav 1, der omfatter: a) mindst én sorbitan-umættet fedtsyreester, der har et polært hoved med mindst to eller flere -OH (hydroxyl)-grupper, i en mængde på 9-64 vægt-%; b) mindst ét phospholipid i en mængde på 18-76 vægt-%; c) mindst ét væskeformigt krystalhærdemiddel, der er fri for en ioniserbar gruppe og har en triacylgruppe med 15 til 40 carbonatomer eller en carbonringstruktur i en hydrofob del, i en mængde på 1-36 vægt-%; og d) goserelin eller et farmaceutisk acceptabelt salt deraf i en mængde på 0,1-50 vægt-%.
12. Farmaceutisk sammensætning ifølge krav 1, der omfatter: a) mindst én sorbitan-umættet fedtsyreester, der har et polært hoved med mindst to eller flere -OH (hydroxyl)-grupper, i en mængde på 9-64 vægt-%; b) mindst ét phospholipid i en mængde på 18-76 vægt-%; c) mindst ét væskeformigt krystalhærdemiddel, der er fri for en ioniserbar gruppe og har en triacylgruppe med 15 til 40 carbonatomer eller en carbonringstruktur i en hydrofob del, i en mængde på 1-36 vægt-%; og d) degarelix eller et farmaceutisk acceptabelt salt deraf i en mængde på 2~50 vægt-%.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020120157583A KR101586791B1 (ko) | 2012-12-28 | 2012-12-28 | GnRH 유도체의 서방성 지질 초기제제 및 이를 포함하는 약제학적 조성물 |
| PCT/KR2013/012269 WO2014104791A1 (en) | 2012-12-28 | 2013-12-27 | Sustained-release lipid pre-concentrate of gnrh analogues and pharmaceutical composition comprising the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2938332T3 true DK2938332T3 (da) | 2018-06-06 |
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| DK13867921.2T DK2938332T3 (da) | 2012-12-28 | 2013-12-27 | Depot-lipidprækoncentrat af gnrh-analoger og farmaceutisk sammensætning dermed |
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| EP (1) | EP2938332B1 (da) |
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| BR (1) | BR112015015518B1 (da) |
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| DK (1) | DK2938332T3 (da) |
| ES (1) | ES2664598T3 (da) |
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| LT (1) | LT2938332T (da) |
| MX (1) | MX364595B (da) |
| NO (1) | NO2938332T3 (da) |
| NZ (1) | NZ710468A (da) |
| PH (1) | PH12015500936B1 (da) |
| PL (1) | PL2938332T3 (da) |
| PT (1) | PT2938332T (da) |
| RU (1) | RU2646487C2 (da) |
| SI (1) | SI2938332T1 (da) |
| TR (1) | TR201806985T4 (da) |
| WO (1) | WO2014104791A1 (da) |
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| KR101586789B1 (ko) * | 2012-12-28 | 2016-01-19 | 주식회사 종근당 | 양이온성 약리학적 활성물질의 서방성 지질 초기제제 및 이를 포함하는 약제학적 조성물 |
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- 2013-12-27 US US14/440,060 patent/US10722585B2/en active Active
- 2013-12-27 NZ NZ710468A patent/NZ710468A/en unknown
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2015
- 2015-04-27 PH PH12015500936A patent/PH12015500936B1/en unknown
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|---|---|
| LT2938332T (lt) | 2018-05-25 |
| JP2016504353A (ja) | 2016-02-12 |
| EP2938332A4 (en) | 2016-08-17 |
| BR112015015518B1 (pt) | 2022-08-23 |
| MX2015008401A (es) | 2016-02-16 |
| EP2938332B1 (en) | 2018-02-21 |
| MX364595B (es) | 2019-05-02 |
| KR101586791B1 (ko) | 2016-01-19 |
| KR20140086741A (ko) | 2014-07-08 |
| CN105188680A (zh) | 2015-12-23 |
| BR112015015518A2 (pt) | 2017-07-11 |
| PH12015500936A1 (en) | 2015-07-06 |
| ES2664598T3 (es) | 2018-04-20 |
| HUE036932T2 (hu) | 2018-08-28 |
| PH12015500936B1 (en) | 2019-01-30 |
| RU2646487C2 (ru) | 2018-03-05 |
| JP6078660B2 (ja) | 2017-02-08 |
| SI2938332T1 (sl) | 2018-10-30 |
| CA2888863A1 (en) | 2014-07-03 |
| RU2015131107A (ru) | 2017-02-01 |
| PL2938332T3 (pl) | 2018-08-31 |
| NZ710468A (en) | 2016-04-29 |
| WO2014104791A1 (en) | 2014-07-03 |
| AU2013371101A1 (en) | 2015-08-13 |
| CN113350480A (zh) | 2021-09-07 |
| TR201806985T4 (tr) | 2018-06-21 |
| AU2013371101B2 (en) | 2017-01-05 |
| NO2938332T3 (da) | 2018-07-21 |
| CA2888863C (en) | 2018-04-03 |
| US10722585B2 (en) | 2020-07-28 |
| EP2938332A1 (en) | 2015-11-04 |
| PT2938332T (pt) | 2018-04-06 |
| US20150297726A1 (en) | 2015-10-22 |
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