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DK2477603T3 - Stabil co-formulering af hyaluronidase og immunoglobulin, og fremgangsmåder til anvendelse deraf - Google Patents

Stabil co-formulering af hyaluronidase og immunoglobulin, og fremgangsmåder til anvendelse deraf Download PDF

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Publication number
DK2477603T3
DK2477603T3 DK10760140.3T DK10760140T DK2477603T3 DK 2477603 T3 DK2477603 T3 DK 2477603T3 DK 10760140 T DK10760140 T DK 10760140T DK 2477603 T3 DK2477603 T3 DK 2477603T3
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hyaluronidase
formulation
stable
formulation according
administration
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DK10760140.3T
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Wolfgang Teschner
Sonja Svatos
Leopold Bruckschwaiger
Alfred Weber
Hans-Peter Schwarz
Laura Lei
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Baxalta Inc
Baxalta GmbH
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    • A61K39/39591—Stabilisation, fragmentation
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    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2474—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
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Claims (28)

1. Stabil sammensætning formuleret til subkutan administration, hvor: den stabile sammensætning er en flydende co-formulering; sammensætningen har en pH på mellem 4 til 5, inklusiv; og sammensætningen omfatter: immunoglobulin (IG) ved en koncentration der er mindst 10 % vægt/volumen; en opløselig hyaluronidase ved en koncentration der er mindst 50 U/mL og til stede i en mængde tilstrækkelig til at tillade den subkutane administration af sammensætningen på et enkelt injektionssted ved en infusionshastighed lig med ellerstørre end den intravenøse infusionshastighed for intravenøs immunoglobulin; og et alkalimetalchloridsalt ved en koncentration på mindst 0,05 M, hvorved co-formuleringen er stabil ved temperaturer op til 32°C i mindst 6 måneder.
2. Stabil sammensætning formuleret til subkutan administration, hvor: den stabile sammensætning er en flydende co-formulering; sammensætningen har en pH på mellem 4 til 5, inklusive; og sammensætningen omfatter: immunoglobulin (IG) ved en koncentration der er mindst 10 % vægt/volumen; en opløselig hyaluronidase ved en koncentration der er mindst 50 U/mL og er til stede ved et forhold på mindst 100 units/gram (U/g) IG; og et alkalimetalchloridsalt ved en koncentration på mindst 0,05 M, hvorved co-formuleringen er stabil ved temperaturer op til 32° C i mindst 6 måneder.
3. Stabil, flydende co-formulering ifølge krav 1 eller krav 2, yderligere omfattende en aminosyrestabilisator i en mængde der er mindst 0,1 M, fortrinsvis hvor aminosyrestabilisatoren er valgt blandt alanin, histidin, arginin, lysin, ornithin, isoleucin, valin, methionin, glycin og prolin, mere fortrinsvis, hvor aminosyrestabilisatoren er glycin eller prolin.
4. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-3, hvor aminosyrestabilisatoren er mindst 0,1 M, 0,15 M, 0,2 M, 0,25 M, 0,3 M, 0,35 M, 0,4 M, 0,45 M, 0,5 M, 0,6 M, 0,7 M or 0,75 M, fortrinsvis hvor aminosyrestabilisatoren er 0,25 M.
5. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-4, hvor IG er mindst 10 % vægt/volumen, 11 % vægt/volumen, 12 % vægt/volumen, 13 % vægt/volumen, 14 % vægt/volumen, 15 % vægt/volumen, 16 % vægt/volumen, 17 % vægt/volumen, 18 % vægt/volumen, 19 % vægt/volumen, 20 % vægt/volumen, 21 % vægt/volumen, 22 % vægt/volumen eller derover, fortrinsvis hvor IG er mellem 10 % vægt/volumen til 20 % vægt/volumen.
6. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-5, hvor IG er fra humant plasma, fortrinsvis hvor IG er oprenset fra humant plasma ved en oprensningsfremgangsmåde omfattende alkoholfraktionering, mere fortrinsvis hvor IG er yderligere oprenset ved én eller flere af polyethylenglycol (PEG) præcipitation, ionombytterkromatografi, enzymatisk spaltning, diafiltrering eller ultrafiltrering.
7. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-6, hvor IG underkastes et virareduktions-trin valgt blandt inkubation ved pH 4,0 med eller uden pepsin, opløsningsmiddel-detergentbehandling og nanofiltrering.
8. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-7, hvor IG indeholder IgG, IgA og IgM, fortrinsvis hvor IG indeholder mere end 95% IgG.
9. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-8, hvor alkalimetal chloridsaltet er valgt blandt KCI og NaCI, fortrinsvis hvor alkalimetal chloridsaltet er NaCI og NaCI er 0,025 M, 0,03 M, 0,04 M, 0,05 M, 0,08 M, 0,09 M, 0,1 M, 0,15 M, 0,2 M, eller 0,25 M, mere fortrinsvis hvor NaCI er 0,15 M.
10. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-9, hvor den opløselige hyaluronidase er en PH20, eller en trunkeret form deraf, fortrinsvis hvor PH20 er valgt fra en får, kvæg eller trunkeret human PH20, mere fortrinsvis hvor PH20 er en trunkeret human PH20 og den trunkerede humane PH20 er valgt blandt polypeptider med en sekvens af aminosyrer som vist i en hvilken som helst af SEQ ID NOS:4-9, eller allel varianter eller andre varianter deraf.
11. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-10, hvor den opløselige hyaluronidase er designeret rHuPH20,
12. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-11, hvor den opløselige hyaluronidase er ved en koncentration på 50 U/mL, 100 U/mL, 200 U/mL, 300 U/mL, 400 U/mL, 500 U/ mL eller derover, fortrinsvis hvor den opløselige hyaluronidase er ved en koncentration på 75 U/mL til 350 U/mL.
13. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-12, hvor den opløselige hyaluronidase er ved et forhold på 100 U/g IG, 150 U/g IG, 200 U/g IG, 250 U/g IG, 300 U/g IG, 400 U/g IG, 500 U/g IG, 600 U/g IG, 700 U/g IG, 800 U/g IG, 900 U/g IG, 1000 U/g IG, 1200 U/g IG, 1500 U/g IG, 1800 U/g IG, 2000 U/g IG, 3000 U/g IG, 4000 U/g IG eller 5000 U/g IG, fortrinsvis hvor den opløselige hyaluronidase er ved et forhold på 250 U/g IG, 500 U/g IG, 1000 U/g IG, 1500 U/g IG eller 3000 U/g IG.
14. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-13 der har en pH på 4,4 til 4,9 i koncentreret form.
15. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-14, hvor co-formuleringen er til flerdosis-administration eller til enkeltdosis-administration.
16. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-15, hvor IG er i en mængde tilstrækkelig til at enkeltdosis-administration behandler en IG-behandlelig sygdom eller tilstand, fortrinsvis hvor mængden af IG er i en mængde tilstrækkelig til enkeltdosis-administration daglig, ugentlig, hver anden uge, hver 2-3 uge, hver 3-4 uge eller månedlig til behandling afen IG-behandlelig sygdom eller tilstand.
17. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-16, hvor mængden af IG i co-formuleringen i det væsentlige er den samme som mængden i en enkeltdosis-administration når den administreres intravenøst til behandling afen IG-behandlelig sygdom eller tilstand.
18. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-17, hvor co-formuleringen er til enkeltdosis-administration og mængden af IG er mindst 1 gram (g), 2 g, 3 g, 4 g, 5 g, 10 g, 20 g, 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g eller 200 g eller er 1-200 g, 1-100 g, 10-100 g, 5-50 g, 6-50 g eller 5-100 g.
19. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-18, hvor co-formuleringen er til enkeltdosis-administration og mængden af hyaluronidase i sammensætningen er mindst 500 units, 1000 units, 2000 units, 5000 units, 10000 units, 30000 units, 40000 units, 50000 units, 60000 units, 70000 units, 80000 units, 90000 units, 100000 units eller derover.
20. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-19 der er stabil ved 28-32°C i 6 måneder, 7 måneder, 8 måneder, 9 måneder, 10 måneder, 11 måneder, 12 måneder eller derover.
21. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-20 der yderligere er stabil ved 0-10°C i 6 måneder, 1 år, 2 år eller derover.
22. Kit, omfattende en stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-21, og eventuelt instruktioner til anvendelse.
23. Beholder, omfattende en stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-21, fortrinsvis hvor beholderen er et rør, flaske, hætteglas eller sprøjte.
24. Beholderen ifølge krav 23, yderligere omfattende en nål til injektion.
25. Beholderen ifølge krav 23 eller 24, hvor den stabile, flydende co-formulering er tilvejebragt til en enkeltdosis-administration eller flerdosis-administration.
26. Kit, omfattende beholderen ifølge et hvilket som helst af kravene 23-25, og en indretning til infusion af sammensætningen.
27. Anvendelse afen stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-21 til formulering af et medikament til behandling afen IG-behandlelig sygdom eller tilstand, fortrinsvis hvor den IG-behandlelige sygdom eller tilstand er valgt blandt primære immundefekt sygdomme, sekundære immundefekt sygdomme, inflammatoriske sygdomme, autoimmune sygdomme og akutte infektioner.
28. Stabil, flydende co-formulering ifølge et hvilket som helst af kravene 1-21 til anvendelse i behandling afen IG-behandlelig sygdom eller tilstand, fortrinsvis hvor den IG-behandlelige sygdom eller tilstand er valgt blandt primære immundefekt sygdomme, sekundære immundefekt sygdomme, inflammatoriske sygdomme, autoimmune sygdomme og akutte infektioner.
DK10760140.3T 2009-09-17 2010-09-16 Stabil co-formulering af hyaluronidase og immunoglobulin, og fremgangsmåder til anvendelse deraf DK2477603T3 (da)

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PCT/US2010/002545 WO2011034604A2 (en) 2009-09-17 2010-09-16 Stable co-formulation of hyaluronidase and immunoglobulin, and methods of use thereof

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EP (1) EP2477603B1 (da)
JP (1) JP5734985B2 (da)
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