DK2552410T3 - Fremgangsmåde til konservering af alunadjuvanser og vacciner med alunadjuvanser - Google Patents

Fremgangsmåde til konservering af alunadjuvanser og vacciner med alunadjuvanser Download PDF

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Publication number
DK2552410T3
DK2552410T3 DK11712653.2T DK11712653T DK2552410T3 DK 2552410 T3 DK2552410 T3 DK 2552410T3 DK 11712653 T DK11712653 T DK 11712653T DK 2552410 T3 DK2552410 T3 DK 2552410T3
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DK
Denmark
Prior art keywords
alkyl
adjuvant
sugar
ester
concentration
Prior art date
Application number
DK11712653.2T
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English (en)
Inventor
Jeffrey Drew
David Woodward
Amanda Corteyn
Original Assignee
Stabilitech Biopharma Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB1005522.6A external-priority patent/GB201005522D0/en
Priority claimed from GBGB1005518.4A external-priority patent/GB201005518D0/en
Application filed by Stabilitech Biopharma Ltd filed Critical Stabilitech Biopharma Ltd
Application granted granted Critical
Publication of DK2552410T3 publication Critical patent/DK2552410T3/da

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/095—Sulfur, selenium, or tellurium compounds, e.g. thiols
    • A61K31/10—Sulfides; Sulfoxides; Sulfones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/131—Amines acyclic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08—Oxides; Hydroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants

Claims (15)

1. Fremgangsmåde til konservering af et aluminiumsaltadjuvans under frysning eller frysetørring, der omfatter frysning eller frysetørring af en vandig suspension eller opløsning, der omfatter: (a) et aluminiumsaltadjuvans; (b) et N,N-di(Ci-6-alkyl)- eller N,N,N-tri(Ci-6-alkyl)-glycin eller et fysiologisk acceptabelt salt eller en ester deraf; og (c) ét eller flere sukkere.
2. Fremgangsmåde ifølge krav 1, hvor den vandige suspension eller opløsning endvidere omfatter mindst ét antigen.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor N,N-di(Ci-6-alkyl)- eller Ν,Ν,Ν-tri(Ci-6-alkyl)-glycin er Ν,Ν-dimethylglycin eller Ν,Ν,Ν-trimethylglycin, eller et fysiologisk acceptabelt salt eller en ester deraf.
4. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor aluminiumsaltadjuvanset er aluminiumphosphat eller aluminiumhydroxid.
5. Fremgangsmåde ifølge et hvilket som helst af krav 2 til 4, hvor antigenet eller hvert antigen tilvejebringes absorberet på adjuvanset.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af N,N-di(Ci-6-alkyl)- eller N,N,N-tri(Ci-6-alkyl)-glycin eller fysiologisk acceptable salt eller ester deraf er mindst 0,1 M.
7. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor: (i) der anvendes ét sukker; eller (ii) der anvendes ét sukker og (a) sukkeret er saccharose, koncentrationen af saccharose er fra 0,01 til 0,5M eller fra 0,01 til 0,2M og koncentrationen af N,N-di(Ci-6-alkyl)- eller N,N,N-tri(Ci-6-alkyl)-glycin eller fysiologisk acceptabelt salt eller ester deraf er fra 0,2 til 5M, eller (b) sukkeret er saccharose, koncentrationen af saccharose er fra 0,01 til 0,5M eller fra 0,01 til 0,2M og koncentrationen af N,N-di(Ci-6-alkyl)- eller N,N,N-tri(Ci-6-alkyl)-glycin eller fysiologisk acceptabelt salt eller ester deraf er fra 0,2 til 2M, eller (c) sukkeret er mannitol, koncentrationen af mannitol er fra 0,2 til 0,8M og koncentrationen af N,N-di(Ci-6-alkyl)- eller Ν,Ν,Ν-tri(Ci-6-alkyl)-glycin eller fysiologisk acceptable salt eller ester deraf er fra 0,5 til 1M, eller (d) sukkeret er saccharose og koncentrationen af saccharose er fra 0,01 til 0,7M eller 0,01 til 0,6M eller 0,01 til 0,5M.
8. Fremgangsmåde ifølge et hvilket som helst af krav 1 til 6, hvor: (i) der anvendes to eller flere sukkere; eller (ii) to eller flere sukkere anvendes og (a) saccharose er til stede sammen med et andet sukker, og det andet sukker er raffinose, stachyose eller et sukkeralkohol, eller (b) saccharose er til stede sammen med et andet sukker og det andet sukker er raffinose.
9. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor suspensionen eller opløsningen (a) frysetørres eller (b) frysetørres for at danne en amorf fast matrix.
10. Fremgangsmåde ifølge krav 9, hvor der dannes en tørret fast matrix og den faste matrix tilvejebringes i form af et pulver i et forseglet hætteglas, en ampul eller injektionssprøjte.
11. Fremgangsmåde ifølge et hvilket som helst af krav 1 til 8, hvor (a) den resulterende kage formales for at danne et pulver og pulveret tilvejebringes i et forseglet hætteglas, en ampul eller injektionssprøjte, eller (b) den faste matrix indgår en tablet eller kapsel.
12. Anvendelse af en excipiens, der omfatter (i) a N,N-di(Ci-6-alkyl)- eller N,N,N-tri(Ci-6-alkyl)-glycin som defineret i krav 1 eller 3 eller et fysiologisk acceptabelt salt eller en ester deraf og (ii) ét eller flere sukkere, til konservering af et aluminiumsaltadjuvans under tørring eller frysetørring.
13. Vaccinesammensætning, der omfatter: - et aluminiumsaltadjuvans som defineret i krav 1 eller 4; - ét eller flere antigener; - N,N-di(Ci-6-alkyl)- eller N,N,N-tri(Ci-6-alkyl)-glycin som defineret i krav 1 eller 3 eller et fysiologisk acceptabelt salt eller en ester deraf; og - ét eller flere sukkere.
14. Vaccinesammensætning, der kan opnås ved hjælp afen fremgangsmåde som defineret i et hvilket som helst af kravene 2 til 11.
15. Anvendelse af en excipiens, der omfatter (i) N,N-di(Ci-6-alkyl)- eller N,N,N-tri(Ci-6-alkyl)-glycin som defineret i krav 1 eller 3 eller et fysiologisk acceptabelt salt eller en ester deraf og (ii) ét eller flere sukkere, som et resuspensionsmiddel til en vaccinesammensætning som defineret i krav 13 eller 14.
DK11712653.2T 2010-03-31 2011-03-31 Fremgangsmåde til konservering af alunadjuvanser og vacciner med alunadjuvanser DK2552410T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1005522.6A GB201005522D0 (en) 2010-03-31 2010-03-31 Method for preserving alum-adjuvanted vaccines
GBGB1005518.4A GB201005518D0 (en) 2010-03-31 2010-03-31 Preservation of alum-adjuvanted vaccines
PCT/GB2011/000497 WO2011121305A2 (en) 2010-03-31 2011-03-31 Method for preserving alum adjuvants and alum-adjuvanted vaccines

Publications (1)

Publication Number Publication Date
DK2552410T3 true DK2552410T3 (da) 2019-02-18

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DK11712653.2T DK2552410T3 (da) 2010-03-31 2011-03-31 Fremgangsmåde til konservering af alunadjuvanser og vacciner med alunadjuvanser

Country Status (13)

Country Link
US (1) US9101607B2 (da)
EP (1) EP2552410B1 (da)
JP (1) JP6023696B2 (da)
KR (1) KR101819250B1 (da)
CN (1) CN102892409B (da)
AU (1) AU2011234268B2 (da)
BR (1) BR112012025044A2 (da)
CA (1) CA2795050C (da)
DK (1) DK2552410T3 (da)
ES (1) ES2708989T3 (da)
GB (1) GB2499480A (da)
HU (1) HUE042330T2 (da)
WO (1) WO2011121305A2 (da)

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US20130156797A1 (en) 2013-06-20
BR112012025044A2 (pt) 2016-06-21
HUE042330T2 (hu) 2019-06-28
KR20130012956A (ko) 2013-02-05
WO2011121305A3 (en) 2011-11-24
EP2552410A2 (en) 2013-02-06
CA2795050C (en) 2018-05-22
CN102892409B (zh) 2015-12-09
JP2013523705A (ja) 2013-06-17
GB2499480A (en) 2013-08-21
CA2795050A1 (en) 2011-10-06
GB201216472D0 (en) 2012-10-31
ES2708989T3 (es) 2019-04-12
JP6023696B2 (ja) 2016-11-09
KR101819250B1 (ko) 2018-01-16
US9101607B2 (en) 2015-08-11
CN102892409A (zh) 2013-01-23
AU2011234268B2 (en) 2015-07-02
WO2011121305A2 (en) 2011-10-06
AU2011234268A1 (en) 2012-09-27
EP2552410B1 (en) 2018-10-24

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