DK2624815T3 - Oral vaccine i hurtigt opløsende doseringsform under anvendelse af stivelse - Google Patents

Oral vaccine i hurtigt opløsende doseringsform under anvendelse af stivelse Download PDF

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Publication number
DK2624815T3
DK2624815T3 DK11779263.0T DK11779263T DK2624815T3 DK 2624815 T3 DK2624815 T3 DK 2624815T3 DK 11779263 T DK11779263 T DK 11779263T DK 2624815 T3 DK2624815 T3 DK 2624815T3
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dosage form
fast
starch
oral solid
immune response
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DK11779263.0T
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English (en)
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Wei Tian
Rosie Mclaughlin
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Scherer Technologies Llc R P
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/145Orthomyxoviridae, e.g. influenza virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541Mucosal route
    • A61K2039/542Mucosal route oral/gastrointestinal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55583Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6087Polysaccharides; Lipopolysaccharides [LPS]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/16011Orthomyxoviridae
    • C12N2760/16111Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/16011Orthomyxoviridae
    • C12N2760/16111Influenzavirus A, i.e. influenza A virus
    • C12N2760/16151Methods of production or purification of viral material

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pulmonology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (15)

1. Hurtigt opløsende oral fast vaccinedoseringsform omfattende: (a) en immunogen mængde af et antigenpræparat; og (b) i det mindste ét immunreaktionsforstærkende matrixdannende middel, hvor det i det mindste ene immunreaktionsforstærkende matrixdannende middel er en stivelse, og hvor doseringsformen fremmer mundhuleoptagelse af et antigen i antigenpræparatet.
2. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 1, hvor stivelsen foreligger i en mængde på 2 til 90 vægt%.
3. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 1, hvor doseringsformen desintegrerer indenfor 10 sekunder efter anbringelse i mundhulen.
4. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 1, fremstillet ved frysetørring.
5. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 1, som yderligere omfatter i det mindste ét yderligere matrixdannende middel.
6. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 5, hvor det i det mindste ene yderligere matrixdannende middel er mannitol.
7. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 6, hvor det i det mindste ene yderligere matrixdannende middel yderligere omfatter gelatine.
8. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 7, hvor gelatinen foreligger i en mængde på 2,5 til 65 vægt%; mannitolet foreligger i en mængde på 5 til 80 vægt%; og stivelsen foreligger i en mængde på 5 til 80 vægt%.
9. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 8, hvor gelatinen foreligger i en mængde på 3 til 55 vægt%, mannitolet foreligger i en mængde på 7 til 65 vægt% og stivelsen foreligger i en mængde på 7 til 75 vægt%.
10. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 1, som yderligere omfatter i det mindste ét yderligere matrixdannende middel valgt fra gruppen bestående af gummier.
11. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 1, som yderligere omfatter et overfladeaktivt stof.
12. Hurtigt opløsende oral fast vaccinedoseringsform ifølge krav 1, som er konfigureret til at udløse en immunreaktion ved indgivelse til en patient ved placering i mundhulen.
13. Fremgangsmåde til inducering afen immunreaktion i en patient, hvilken fremgangsmåde omfatter følgende trin: anbringelse af den hurtigt opløsende orale faste vaccinedoseringsform ifølge ethvert af kravene 1-12 i mundhulen på en person, som har behov for immunreaktionen.
14. Fremgangsmåde til inducering af en immunreaktion i en patient ifølge krav 13, hvor fremgangsmåden inducerer en influenzaspecifik antistofreaktion.
15. Fremgangsmåde til inducering af en influenzaspecifik antistofreaktion i en patient ifølge krav 14, hvor anbringelsen i mundhulen er anbringelse på eller under tungen eller i kind- eller svælgområdet.
DK11779263.0T 2010-10-08 2011-10-11 Oral vaccine i hurtigt opløsende doseringsform under anvendelse af stivelse DK2624815T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US39123810P 2010-10-08 2010-10-08
PCT/US2011/055689 WO2012048333A1 (en) 2010-10-08 2011-10-11 Oral vaccine fast-dissolving dosage form using starch

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DK2624815T3 true DK2624815T3 (da) 2016-11-07

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DK11779263.0T DK2624815T3 (da) 2010-10-08 2011-10-11 Oral vaccine i hurtigt opløsende doseringsform under anvendelse af stivelse

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US (1) US9956169B2 (da)
EP (2) EP2624815B8 (da)
JP (2) JP6061859B2 (da)
KR (1) KR101751964B1 (da)
CN (2) CN103347494A (da)
AR (1) AR083361A1 (da)
AU (1) AU2011312107B2 (da)
BR (1) BR112013009255B1 (da)
CA (1) CA2813146C (da)
DK (2) DK3095441T3 (da)
ES (2) ES2602506T3 (da)
HK (1) HK1253541A1 (da)
HU (1) HUE052853T2 (da)
MX (1) MX347101B (da)
PL (1) PL3095441T3 (da)
PT (1) PT3095441T (da)
RU (2) RU2639447C2 (da)
WO (1) WO2012048333A1 (da)

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US20120087944A1 (en) 2012-04-12
CA2813146A1 (en) 2012-04-12
CN108434089B (zh) 2020-06-16
MX2013003875A (es) 2013-06-24
RU2013119946A (ru) 2014-11-20
AU2011312107A1 (en) 2013-05-02
PT3095441T (pt) 2021-01-14
MX347101B (es) 2017-04-12
RU2017137357A (ru) 2019-04-25
ES2842290T3 (es) 2021-07-13
RU2017137357A3 (da) 2019-04-25
CA2813146C (en) 2018-12-18
CN108434089A (zh) 2018-08-24
PL3095441T3 (pl) 2021-06-14
EP3095441B1 (en) 2020-12-02
ES2602506T3 (es) 2017-02-21
JP6403738B2 (ja) 2018-10-10
EP3095441A1 (en) 2016-11-23
WO2012048333A1 (en) 2012-04-12
EP2624815B1 (en) 2016-08-10
HUE052853T2 (hu) 2021-05-28
BR112013009255B1 (pt) 2021-02-23
JP6061859B2 (ja) 2017-01-18
BR112013009255A2 (pt) 2016-07-26
EP2624815A1 (en) 2013-08-14
JP2016199605A (ja) 2016-12-01
AU2011312107B2 (en) 2016-06-23
RU2639447C2 (ru) 2017-12-21
EP2624815B8 (en) 2016-09-21
HK1253541A1 (zh) 2019-06-21
KR101751964B1 (ko) 2017-06-28
JP2013539766A (ja) 2013-10-28
CN103347494A (zh) 2013-10-09
US9956169B2 (en) 2018-05-01
AR083361A1 (es) 2013-02-21
KR20140091461A (ko) 2014-07-21
DK3095441T3 (da) 2021-01-11

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