DK1610822T4 - Flydende farmaceutiske FSH- og LH-formuleringer sammen med et ikke-ionisk overfladeaktivt stof - Google Patents
Flydende farmaceutiske FSH- og LH-formuleringer sammen med et ikke-ionisk overfladeaktivt stof Download PDFInfo
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- DK1610822T4 DK1610822T4 DK04725385.1T DK04725385T DK1610822T4 DK 1610822 T4 DK1610822 T4 DK 1610822T4 DK 04725385 T DK04725385 T DK 04725385T DK 1610822 T4 DK1610822 T4 DK 1610822T4
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- fsh
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- cresol
- methionine
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- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
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Claims (35)
1. Flydende farmaceutisk sammensætning omfattende follikelstimulerende hormon (FSH) eller en variant deraf og et overfladeaktivt stof, som er poloxamer 188, og yderligere omfattende methionin, et bakte-riostatisk middel valgt fra phenol og m-cresol og sakkarose.
2. Flydende farmaceutisk sammensætning omfattende follikelstimulerende hormon (FSH) eller en variant deraf og luteiniserende hormon (LH) eller en variant deraf og et overfladeaktivt stof, som er poloxamer 188, og yderligere omfattende methionin, et bakteriostatisk middel valgt fra phenol og m-cresol og sakkarose.
3. Flydende farmaceutisk sammensætning omfattende luteiniserende hormon (LH) eller en variant deraf og et overfladeaktivt stof, som poloxamer 188, og yderligere omfattende methionin, et bakteriostatisk middel valgt fra phenol og m-cresol og sakkarose.
4. Flydende farmaceutisk sammensætning ifølge ethvert af de forudgående krav, hvori det follikelstimulerende hormon (FSH) viser sig ved en koncentration på eller omkring 150 IU/ml til på eller omkring 1200 IU/ml.
5. Flydende farmaceutisk sammensætning ifølge krav 4, hvori det follikelstimulerende hormon (FSH) viser sig ved en koncentration på eller omkring 300 IU/ml til på eller omkring 900 IU/ml.
6. Flydende farmaceutisk sammensætning ifølge krav 5, hvori det follikelstimulerende hormon (FSH) viser sig ved en koncentration på eller omkring 600 IU/ml.
7. Flydende farmaceutisk sammensætning ifølge krav 2 eller 3, hvori det luteiniserende hormon (LH) viser sig ved en koncentration på eller omkring 150 IU/ml til på eller omkring 1200 IU/ml.
8. Flydende farmaceutisk sammensætning ifølge krav 7, hvori det luteini-serende hormon (LM) viser sig ved en koncentration på eller omkring 300 IU/ml til på eller omkring 750 IU/ml.
9. Produkt omfattende en frysetørret formulering omfattende follikelstimulerende hormon (FSH) eller en variant deraf, et overfladeaktivt stof, som er poloxamer 188, og methionin og sakkarose, produktet omfatter yderligere et opløsningsmiddel til rekonstitution indeholdende et bakterio-statisk middel valgt fra phenol og m-cresol.
10. Produkt omfattende en frysetørret formulering omfattende det I utein ise-rende hormon (LM) eller en variant deraf, et overfladeaktivt stof, som er poloxamer 188, og methionin og sakkarose, produktet omfatter yderligere et opløsningsmiddel til rekonstitution indeholdende et bakteriosta-tisk middel valgt fra phenol og m-cresol.
11. Produkt omfattende en frysetørret formulering omfattende follikelstimulerende hormon (FSH) eller en variant deraf og luteiniserende hormon (LH) eller en variant deraf, et overfladeaktivt stof, som er poloxamer 188, og methionin og sakkarose, produktet omfatter yderligere et opløsningsmiddel til rekonstitution indeholdende et bakteriostatisk middel valgt fra phenol og m-cresol.
12. Produkt ifølge ethvert af kravene 9 til 11, hvori det follikelstimulerende hormon (FSH) viser sig ved en koncentration (w/w) på eller omkring 0,1 til 10 pg /mg af den totale formulering.
13. Produkt ifølge krav 12, hvori det follikelstimulerende hormon (FSH) viser sig ved en koncentration på eller omkring 0,3 til 5 pg /mg af den totale formulering.
14. Produkt ifølge krav 13, hvori det follikelstimulerende hormon (FSH) viser sig ved en koncentration på eller omkring 0,37 til 2 pg /mg af den totale formulering.
15. Produkt ifølge ethvert af kravene 9 til 11, hvori det luteiniserende hormon (LH) viser sig ved en koncentration på eller omkring 0,1 til 3 pg /mg af den totale formulering.
16. Produkt ifølge krav 15, hvori det luteiniserende hormon (LH) viser sig ved en koncentration på eller omkring 0,1 til 1 pg/mg af den totale formulering.
17. Produkt ifølge krav 16, hvori det luteiniserende hormon (LH) viser sig ved en koncentration på eller omkring 0,1 til 0,6 pg/mg af den totale formulering.
18. Farmaceutisk sammensætning eller produkt ifølge ethvert af de forudgående krav, hvori det follikelstimulerende hormon er humant follikelstimulerende hormon, og/eller det luteiniserende hormon (LH) er humant luteiniserende hormon (LH).
19. Farmaceutisk sammensætning eller produkt ifølge krav 18, hvori det follikelstimulerende hormon er humant follikelstimulerende hormon oprenset fra urin, og/eller det luteiniserende hormon (LH) er humant luteiniserende hormon (LH) oprenset fra urin.
20. Farmaceutisk sammensætning eller produkt ifølge krav 18, hvori det follikelstimulerende hormon er rekombinant humant follikelstimulerende hormon, og/eller det luteiniserende hormon (LH) er rekombinant humant luteiniserende hormon (LH).
21 .Farmaceutisk sammensætning eller produkt ifølge ethvert af de forudgående krav, hvori FSH-LH-forholdet ligger i intervallet af eller omkring 6:1 til af eller omkring 1:6.
22. Farmaceutisk sammensætning eller produkt ifølge krav 21, hvori FSH-LH-forholdet ligger i intervallet af eller omkring 4:1 til af eller omkring 1:2.
23. Farmaceutisk sammensætning eller produkt ifølge krav 22, hvori FSH-LM-forholdet ligger i intervallet af eller omkring 3:1 til af eller omkring 1:1.
24. Farmaceutisk sammensætning eller produkt ifølge krav 23, hvori FSH-LH-forholdet ligger i intervallet af eller omkring 2:1 til af eller omkring 1:1.
25. Farmaceutisk sammensætning eller produkt ifølge ethvert af de forudgående krav, hvori det bakteriostatiske middel er m-cresol
26. Farmaceutisk sammensætning eller produkt ifølge krav 25 omfattende m-cresol i en koncentration på eller omkring 0,3% (masse/massen af opløsningsmiddel).
27. Farmaceutisk sammensætning eller produkt ifølge ethvert af de forudgående krav yderligere omfattende en fosfatbuffer med en pH på eller omkring 6,0 til på eller omkring 8,0.
28. Farmaceutisk sammensætning eller produkt ifølge krav 27 yderligere omfattende en fosfatbuffer med en pH på eller omkring 7,0.
29. Farmaceutisk sammensætning eller produkt ifølge krav 28 indeholdende følgende bestanddele: rFSH, poloxamer 188, sakkarose, methionin, m-cresol og en vandig fosfatbuffer med en pH på eller omkring 7,0.
30. Farmaceutisk sammensætning eller produkt ifølge krav 29, hvori rFSH viser sig ved en koncentration på eller omkring 600 IU/ml, poloxamer 188 viser sig ved en koncentration på eller omkring 0,1 mg/ml, sakkarose viser sig ved en koncentration på eller omkring 60 mg/ml, methionin viser sig ved en koncentration på eller omkring 0,1 mg/ml, m-cresol viser sig ved en koncentration på eller omkring 3 mg/ml, og fosfatbufferen er på eller omkring 10 mM fosfat.
31. Produkt ifølge krav 11 omfattende 32,75 pg af den rekombinante FSH, 9,0 pg af den rekombinante LH, 15,0 mg sakkarose, 0,052 mg NaH2PO4 H2O, 0,825 mg Na2HPC>4 2H2O, 0,05 mg poloxamer 188 og 0,05 mg L-methionin.
32. Produkt ifølge krav 11 omfattende 65,5 pg af den rekombinante FSH, 18,0 pg af den rekombinante LH, 30,0 mg sakkarose, 0,104 mg NaH2PO4H20,1,85 mg Na2HPC>4 2H20,0,10 mg poloxamer 188 og 0,10 mg L-methionin.
33. Fremgangsmåde til frembringelse afen farmaceutisk sammensætning omfattende trinnet at lave en opløsning af FSH, et overfladeaktivt stof, som er poloxamer 188, og et flydende fortyndingsmiddel og yderligere at tilføre methionin, et bakteriostatisk middel valgt fra phenol og m-cre-sol og sakkarose.
34. Fremgangsmåde til frembringelse af en samlet farmaceutisk sammensætning omfattende at anbringe en opløsning indeholdende FSH, et overfladeaktivt stof, som er poloxamer 188, og yderligere at anbringe methionin, et bakteriostatisk middel valgt fra phenol og m-cresol og sakkarose i et hætteglas, ampul eller hylster.
35. Fremgangsmåde til frembringelse af et produkt ifølge ethvert af kravene 9 til 11 omfattende trinnet at lave en blanding af FSH med eller uden LH, eller LH alene, og et overfladeaktivt stof, som er poloxamer 188, at tilføre methionin og sakkarose og udsætte blandingen for frysetørring og at tilvejebringe et opløsningsmiddel til rekonstitution indeholdende et bakteriostatisk middel valgt fra phenol og m-cresol.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03100882 | 2003-04-02 | ||
| EP03101543 | 2003-05-27 | ||
| EP03101828 | 2003-06-20 | ||
| PCT/EP2004/050432 WO2004087213A1 (en) | 2003-04-02 | 2004-04-02 | Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant |
Publications (2)
| Publication Number | Publication Date |
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| DK1610822T3 DK1610822T3 (da) | 2011-01-31 |
| DK1610822T4 true DK1610822T4 (da) | 2019-01-14 |
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| DK04725385.1T DK1610822T4 (da) | 2003-04-02 | 2004-04-02 | Flydende farmaceutiske FSH- og LH-formuleringer sammen med et ikke-ionisk overfladeaktivt stof |
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-
2004
- 2004-04-02 DK DK04725385.1T patent/DK1610822T4/da active
- 2004-04-02 EP EP04725385.1A patent/EP1610822B2/en not_active Expired - Lifetime
- 2004-04-02 PL PL04725385T patent/PL1610822T5/pl unknown
- 2004-04-02 NZ NZ542247A patent/NZ542247A/en not_active IP Right Cessation
- 2004-04-02 AR ARP040101138A patent/AR043972A1/es not_active Application Discontinuation
- 2004-04-02 KR KR1020057018794A patent/KR101105486B1/ko not_active Expired - Lifetime
- 2004-04-02 HR HRP20100727TT patent/HRP20100727T4/hr unknown
- 2004-04-02 ME MEP-2008-317A patent/ME00217B/me unknown
- 2004-04-02 CA CA2518903A patent/CA2518903C/en not_active Expired - Fee Related
- 2004-04-02 US US10/551,840 patent/US7741268B2/en not_active Expired - Lifetime
- 2004-04-02 DE DE602004030673T patent/DE602004030673D1/de not_active Expired - Lifetime
- 2004-04-02 AT AT04725385T patent/ATE492292T2/de active
- 2004-04-02 RS YUP-2005/0737A patent/RS20050737A/sr unknown
- 2004-04-02 EA EA200501531A patent/EA012565B1/ru unknown
- 2004-04-02 BR BRPI0409532A patent/BRPI0409532B8/pt not_active IP Right Cessation
- 2004-04-02 PT PT04725385T patent/PT1610822E/pt unknown
- 2004-04-02 SI SI200431587T patent/SI1610822T2/sl unknown
- 2004-04-02 WO PCT/EP2004/050432 patent/WO2004087213A1/en not_active Ceased
- 2004-04-02 RS RS20050737A patent/RS57872B1/sr unknown
- 2004-04-02 AU AU2004226666A patent/AU2004226666B9/en not_active Expired
- 2004-04-02 JP JP2006505517A patent/JP4699991B2/ja not_active Expired - Lifetime
- 2004-04-02 MX MXPA05010635A patent/MXPA05010635A/es active IP Right Grant
-
2005
- 2005-09-28 IL IL171151A patent/IL171151A/en active IP Right Grant
- 2005-10-26 NO NO20054982A patent/NO330214B1/no unknown
-
2011
- 2011-01-12 CY CY20111100039T patent/CY1111291T1/el unknown
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