DK2729127T3 - Fremgangsmåder til fremstilling af liposomer - Google Patents

Fremgangsmåder til fremstilling af liposomer Download PDF

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Publication number
DK2729127T3
DK2729127T3 DK12746008.7T DK12746008T DK2729127T3 DK 2729127 T3 DK2729127 T3 DK 2729127T3 DK 12746008 T DK12746008 T DK 12746008T DK 2729127 T3 DK2729127 T3 DK 2729127T3
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Denmark
Prior art keywords
liposomes
lipid
dda
tdb
liposome
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DK12746008.7T
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English (en)
Inventor
Lars Vibe Andreasen
Grith Krøyer Wood
Dennis Christensen
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Statens Seruminstitut
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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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/04—Mycobacterium, e.g. Mycobacterium tuberculosis
    • 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
    • A61K39/118—Chlamydiaceae, e.g. Chlamydia trachomatis or Chlamydia psittaci
    • 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
    • A61K39/12—Viral antigens
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1277—Processes for preparing; Proliposomes
    • 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
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/16011—Human Immunodeficiency Virus, HIV
    • C12N2740/16211—Human Immunodeficiency Virus, HIV concerning HIV gagpol
    • C12N2740/16234—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dispersion Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (15)

1. Fremgangsmåde til fremstilling af liposomer fri for organiske opløsningsmidler, hvilken fremgangsmåde er uden anvendelsen af organiske opløsningsmidler under "high shear"-blanding til hydrering af et lipidpulver i en vandig opløsning, hvor lipidpulveret er en homogen blanding hvor én lipidkomponent er en kvaternær ammoniumforbindelse med den almene formel NfVR^fV-X, hvor R1 og R2 uafhængigt hver er en kortkædet alkylgruppe indeholdende fra 1 til 3 carbonatomer, R3 er uafhængigt hydrogen eller en methyl eller en alkylgruppe indeholdende fra 12 til 20 carbonatomer, fortrinsvis 14 til 18 carbonatomer, R4 er uafhængigt en carbonhydridgruppe indeholdende fra 12 til 20 carbonatomer, fortrinsvis from 14 til 18 carbonatomer, og X er en ikke-toxisk farmaceutisk acceptabel anion, og en komponent er en neutral lipid eller et glycolipid, hvor lipidpulveret er opnået uden anvendelsen af organiske opløsningsmidler fra et superkritisk fluid eller ved afkøling af en smelte, og hvor "high shear"-blandingen er baseret på rotor-stator-princippet.
2. Fremgangsmåde til fremstilling af liposomer ifølge krav 1, hvor "high shear"-blandingen er baseret på rotor-stator-princippet hvor rotationshastigheden af rotoren er mindst 3400 omdr/min.
3. Fremgangsmåde til fremstilling af liposomer ifølge krav 1 eller 2, hvor lipidpulveret er fremstillet ved en superkritisk fluid-fremgangsmåde.
4. Fremgangsmåde til fremstilling af liposomer ifølge et hvilket som helst af kravene 1-3, hvor den kvaternære ammoniumforbindelse er dimethyldioctadecylammonium (DDA), eller dimethyldioctadecenylammonium (DODA), eller l,2-dioleoyl-3-trimethylammoniumpropan (DOTAP), 1,2-dimyristoyl-3-trimethylammoniumpropan, l,2-dipalmitoyl-3-trimethylammoniumpropan, l,2-distearoyl-3-trimethylammoniumpropan og dioleoyl-3-dimethylammoniumpropan (DODAP), N-[l-(2,3-dioleyloxy)propyl]-Ν,Ν,Ν-trimethylammonium (DOTMA).
5. Fremgangsmåde til fremstilling af liposomer ifølge et hvilket som helst af kravene 1-4, hvor glycolipidet er alfa,alfa'-trehalose 6,6'-dibehenat (TDB) eller syntetisk monomycolylglycerol (MMG).
6. Fremgangsmåde til fremstilling af liposomer ifølge krav 5, hvor den syntetiske MMG er 3-hydroxy-2-tetradecyl-octadecansyre-2,3-dihydroxypropylester.
7. Fremgangsmåde til fremstilling af liposomer ifølge et hvilket som helst af kravene 1-6, hvor liposomerne yderligere omfatter en immunopotentiator.
8. Fremgangsmåde til fremstilling af liposomer ifølge krav 7, hvor immunpotentiatoren er valgt fra C-type lektinreceptorerne, nukleotid-bindings-oligomerisationsdomæne (NOD) proteiner og toll-lignende receptor (TLR) familien, såsom cord factor (TDM) eller den syntetisk analoge TDB, syntetisk monomycolylglycerol (MMG), flagellin, lipopolysaccharid, peptidoglycaner eller cytosin:phosphat:guanin (CpG) oligodeoxynukleotider og polyinosinsyre:polycytidylsyre (poly(I:C)).
9. Fremgangsmåde til fremstilling af liposomer ifølge et hvilket som helst af kravene 1-8, hvor liposomerne er kompleksbundet med makromolekyler såsom oligonukleotider, peptider, proteiner, kulhydrater og/eller lipider.
10. Liposomprodukt fremstillet ifølge et hvilket som helst af de foregående krav.
11. Liposomprodukt ifølge krav 10, hvor liposomet omfatter DDA og TDB eller syntetisk MMG eller 3-hydroxy-2-tetradecyl-octadecansyre-2,3-dihydroxypropylester.
12. Liposomprodukt ifølge krav 10 eller 11, hvor liposomet yderligere omfatter poly(I:C).
13. Liposomprodukt ifølge et hvilket som helst af kravene 10-12 omfattende et antigen.
14. Liposomprodukt ifølge krav 13, hvor antigenet er ESAT6-Ag85B eller ESAT6-Ag85B-Rv2660.
15. Liposomprodukt ifølge et hvilket som helst af kravene 10-14 til anvendelse som en adjuvans, en vaccine, et delivery system, et farmaceutikum eller kosmetikum.
DK12746008.7T 2011-07-04 2012-07-03 Fremgangsmåder til fremstilling af liposomer DK2729127T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA201100507 2011-07-04
PCT/DK2012/000080 WO2013004234A2 (en) 2011-07-04 2012-07-03 Methods for producing liposomes

Publications (1)

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DK2729127T3 true DK2729127T3 (da) 2018-08-06

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US (2) US20140112979A1 (da)
EP (1) EP2729127B1 (da)
CN (1) CN103619325A (da)
DK (1) DK2729127T3 (da)
WO (1) WO2013004234A2 (da)

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US20140112979A1 (en) 2014-04-24
EP2729127A2 (en) 2014-05-14
WO2013004234A2 (en) 2013-01-10
US20190201340A1 (en) 2019-07-04
CN103619325A (zh) 2014-03-05
WO2013004234A3 (en) 2013-05-02
EP2729127B1 (en) 2018-05-02

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