DK1817051T3 - Farmaceutisk sammensætning omfattende botulinum-neurotoksin, et ikke-ionisk overfladeaktivt stof, natriumchlorid og saccharose - Google Patents

Farmaceutisk sammensætning omfattende botulinum-neurotoksin, et ikke-ionisk overfladeaktivt stof, natriumchlorid og saccharose Download PDF

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DK1817051T3
DK1817051T3 DK05757842.9T DK05757842T DK1817051T3 DK 1817051 T3 DK1817051 T3 DK 1817051T3 DK 05757842 T DK05757842 T DK 05757842T DK 1817051 T3 DK1817051 T3 DK 1817051T3
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pharmaceutical composition
botulinum neurotoxin
disorders
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liquid
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DK1817051T4 (da
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Paul Webb
Mary White
Julie Partington
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Ipsen Biopharm Ltd
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    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
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    • C12Y304/24069—Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
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Claims (23)

1. Fast eller flydende farmaceutisk sammensætning, omfattende: a) botulinum-neurotoksin-kompleks (type A, B, C, D, E, F eller G) eller (type A, B, C, D, E, F eller G) med høj renhed, b) et overfladeaktivt stof som stabiliseringsmiddel, c) natriumchlorid og d) en buffer til at opretholde pFI-værdien mellem 5,5 og 7,5 hvor den faste eller flydende farmaceutiske sammensætning ikke omfatter albumin.
2. Fast eller flydende farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen består af: a) botulinum-neurotoksin-kompleks (type A, B, C, D, E, F eller G) eller botulinum-neurotoksin (type A, B, C, D, E, F eller G) med høj renhed, b) et overfladeaktivt stof, c) natriumchlorid, d) en buffer til at opretholde pFI-værdien mellem 5,5 og 7,5 eventuelt e) vand og eventuelt f) et disaccharid.
3. Fast eller flydende farmaceutisk sammensætning ifølge krav 1 eller 2, hvor bufferen opretholder en pFI-værdi fra 5,8 til 7,0.
4. Fast eller flydende farmaceutisk sammensætning ifølge krav 1, der yderligere omfatter et disaccharid.
5. Fast eller flydende farmaceutisk sammensætning ifølge krav 4, hvor disaccharidet er udvalgt fra gruppen bestående af saccharose, trehalose, lactose og mannitol.
6. Fast eller flydende farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 5, der indeholder botulinum-neurotoksin-kompleks type A.
7. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 5, der indeholder botulinum-neurotoksin type A med høj renhed.
8. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 7, hvor det overfladeaktive stof er et ikke-ionisk overfladeaktivt stof.
9. Farmaceutisk sammensætning ifølge krav 8, hvor det ikke-ioniske overfladeaktive stof er et polysorbat, fx polysorbat 80, eller en blokpolymer, især en poloxamer.
10. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 9, hvor - det overfladeaktive stof er polysorbat 80, - bufferen er histidin, - pH- værdien opretholdes på ca. 6,5, hvor sammensætningen omfatter et disaccharid, og hvor disaccharidet er saccharose.
11. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 10, der er flydende, og som er forseglet i en anordning af sprøjtetypen uden væske/gas-interface.
12. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11 til anvendelse ved behandling af en sygdom udvalgt fra oftalmologiske forstyrrelser, bevægelsesforstyrrelser, otorhinolaryngologiske forstyrrelser, gastrointestinale forstyrrelser, urogenitale forstyrrelser, dermatologiske forstyrrelser, smerteforstyrrelser, inflammatoriske forstyrrelser, sekretoriske forstyrrelser, åndedrætsforstyrrelser, hypertrofiske forstyrrelser, artikulære forstyrrelser, endokrine forstyrrelser, autoimmunsygdomme, proliferativ sygdom og traumatiske skader.
13. Anvendelse af en farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11 i kosmetik.
14. Anvendelse af et overfladeaktivt stof til stabilisering af en fast eller flydende farmaceutisk sammensætning, der som virksomt stof indeholder et botulinum-toksin, og som ikke omfatter albumin.
15. Anvendelse ifølge krav 14, hvor det overfladeaktive stof er et ikke-ionisk overfladeaktivt stof.
16. Anvendelse ifølge krav 15, hvor det ikke-ioniske overfladeaktive stof er et polysorbat, fx polysorbat 80, eller en blokpolymer, især en poloxamer.
17. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor botulinum-neurotoksinet er botulinum-neurotoksin type A1, A2 eller A3.
18. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor den farmaceutiske sammensætning omfatter 50 til 10.000 LD50-enheder/ml, fortrinsvis 50 til 3.000 LD50-enheder/ml, botulinum-neurotoksin-kompleks (type A, B, C, D, E, F eller G) eller botulinum-neurotoksin (type A, B, C, D, E, F eller G) med høj renhed.
19. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor koncentrationen af overfladeaktivt stof vil være fra over den kritiske micellekoncentration til en koncentration på 1 % v/v.
20. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor den farmaceutiske sammensætning er flydende, har en pFI-værdi på 6,5, og omfatter: • 2000 LD50-enheder/ml Clostridium-botulinum-neurotoksin-type-A1-kompleks • 11,7 mM saccharose • 10 mM histidin • 0,3 M natriumchlorid • 0,01 % v/v Polysorbat 80.
21. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor den farmaceutiske sammensætning er flydende, har en pH-værdi på 6.5 og omfatter: • 500 LD50-enheder/ml Clostridium-botulinum-neurotoksin-type-A1-kompleks • 11,7 mM saccharose • 10 mM histidin • 0,3 M natriumchlorid • 0,01 % v/v Polysorbat 80.
22. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor den farmaceutiske sammensætning er flydende, har en pFI-værdi på 6.5 og omfatter: • 500 LD50-enheder/ml Clostridium-botulinum-neurotoksin-typeAl-kompleks • 11,7 mM saccharose • 10 mM histidin • 0,15 M natriumchlorid • 0,01 % v/v Polysorbat 80.
23. Farmaceutisk sammensætning ifølge krav 12 til anvendelse ved behandling af en sygdom udvalgt fra blefarospasme, hemifacial spasme, torticollis, spasticitet hos barnet eller den voksne, detrusorhyperrefleksi, neurogen blæredysfunktion, blærespasmer, urininkontinens og hyperhidrose.
DK05757842.9T 2004-07-12 2005-07-06 Farmaceutiske sammensætninger, der omfatter botulinum-neurotoksin, et ikke-ionisk overfladeaktivt stof, natriumchlorid og saccharose DK1817051T4 (da)

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Application Number Priority Date Filing Date Title
GB0415491A GB2416122A (en) 2004-07-12 2004-07-12 Botulinum neurotoxin composition
PCT/GB2005/002653 WO2006005910A2 (en) 2004-07-12 2005-07-06 Pharmaceutical composition comprising botulinum, a non ionic surfactant, sodium chloride and sucrose

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DK1817051T3 true DK1817051T3 (da) 2015-06-01
DK1817051T4 DK1817051T4 (da) 2024-05-06

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DK10010686.3T DK2269631T4 (da) 2004-07-12 2005-07-06 Farmaceutiske sammensætninger, omfattende botulinumneurotoksin, til anvendelse inden for medicin og kosmetik
DK05757842.9T DK1817051T4 (da) 2004-07-12 2005-07-06 Farmaceutiske sammensætninger, der omfatter botulinum-neurotoksin, et ikke-ionisk overfladeaktivt stof, natriumchlorid og saccharose
DK15000178.2T DK2939688T3 (da) 2004-07-12 2005-07-06 Farmaceutiske sammensætninger omfattende botulinumneurotoksin

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EP (4) EP3446701B1 (da)
JP (2) JP5301830B2 (da)
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