DK2129366T3 - Fast farmaceutisk og vaccinedosis - Google Patents

Fast farmaceutisk og vaccinedosis Download PDF

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Publication number
DK2129366T3
DK2129366T3 DK08718576.5T DK08718576T DK2129366T3 DK 2129366 T3 DK2129366 T3 DK 2129366T3 DK 08718576 T DK08718576 T DK 08718576T DK 2129366 T3 DK2129366 T3 DK 2129366T3
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Denmark
Prior art keywords
formulation
active material
vaccine
paste
excipients
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DK08718576.5T
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English (en)
Inventor
Charles David Ogilvy Potter
Shohre Nabahi
Original Assignee
Enesi Pharma Ltd
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Priority claimed from GB0723310A external-priority patent/GB0723310D0/en
Application filed by Enesi Pharma Ltd filed Critical Enesi Pharma Ltd
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Publication of DK2129366T3 publication Critical patent/DK2129366T3/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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
    • 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
    • A61K39/102—Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Virology (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (24)

1. Aflangt legeme til kanylefri injektion ved lav hastighed fra en anordning, hvor legemet har mindst én spids ende og omfatter mindst ét aktivt materiale, kendetegnet ved, at legemet har en trykstyrke på mere end eller svarende til 5 Newton og den spidse ende har en indesluttet vinkel på mellem ca. 10-50°, og hvor legemet er en fast vaccineformulering, der er mindst delvist krystallinsk, hvor legemet omfatter ét eller flere antigene eller immunogene midler og eventuelt ét eller flere adjuvanser.
2. Legeme ifølge krav 1 hvor trykstyrken er omtrent 10 Newton eller omtrent 30 Newton.
3. Legeme ifølge krav 1 eller 2, hvor hastigheden er mellem 0,5 og 50 m/s, eller mellem 0,5 og 20 m/s eller mellem 0,5 og 10 m/s.
4. Legeme ifølge et hvilket som helst af krav 1 til 3, hvor den spidse ende er en central ’mejselspids’.
5. Legeme ifølge et hvilket som helst af krav 1 til 4, hvor den spidse ende har en indesluttet vinkel på 46°.
6. Legeme ifølge et hvilket som helst af krav 1 til 5, hvor det aktive materiale er valgt fra gruppen, der omfatter farmaceutisk aktive forbindelser, peptider, proteiner og små DNA- og RNA- molekyler.
7. Legeme ifølge et hvilket som helst af krav 1 til 5, hvor det aktive materiale er til stede i en mængde på mellem 0,1 og 99,9 vægt-%, eller mellem 0,1 og 60 vægt-%, eller mellem 0,1 og 35 vægt-%.
8. Legeme ifølge et hvilket som helst af krav 1 til 7, hvor formuleringen omfatter en prime- og mindst én boost-dosis af det eller hvert antigene eller immunogene middel.
9. Legeme ifølge et hvilket som helst af krav 1 til 8, hvor det eller hvert antigent eller immunogent middel er valgt fra gruppen, der omfatter eliminerede, svækkede eller kombinerede mikroorganismer, inaktive toksiske forbindelser, hele eller fragmenter af proteiner eller polysaccharider, DNA og RNA.
10. Legeme ifølge et hvilket som helst af krav 1 til 9, hvor det antigene eller immunogene middel omfatter eller er Haemophilus influenza type b.
11. Legeme ifølge et hvilket som helst af krav 1 til 10, hvor legemet endvidere omfatter én eller flere excipienser.
12. Legeme ifølge krav 11, hvor den ene eller flere excipienser er udvalgt fra gruppen bestående af sukkere, carbohydrater, stabiliseringsmidler, sprængmidler og biologisk nedbrydelige polymerer.
13. Legeme ifølge et hvilket som helst af krav 1 til 12, hvor legemet har en diameter på mellem ca. 0,5 mm og 3 mm, eller mellem ca. 0,6 mm og 1,5 mm.
14. Legeme ifølge et hvilket som helst af krav 1 til 13, hvor legemet har en længde på mellem 1 mm og 15 mm eller ca. 2-8 mm.
15. Fremgangsmåde til fremstilling af det aflange legeme ifølge et hvilket som helst af krav 1 til 14, hvilken fremgangsmåde omfatter: i) blanding af det mindst ene aktive materiale og en hvilken som helst excipiens som tørmateriale med et fluid for at fremstille en pasta; ii) formning af pastaen; iii) skæring af pastaen i en form med mindst én spids ende med en indesluttet vinkel på mellem ca. 10-50° og iv) tørring pastaen enten før eller efter skæringstrinnet.
16. Fremgangsmåde ifølge krav 15, hvor en hvilken som helst af excipienseme blandes til en tør homogen blanding inden indsætning til det aktive materiale og fluidet.
17. Fremgangsmåde ifølge krav 16, hvor noget af eller alt det aktive materiale og nogle af eller samtlige af én eller flere excipienser tilsættes fluidet før blanding med det resterende tørmateriale.
18. Fremgangsmåde ifølge et hvilket som helst af krav 15 til 17, hvor pastaen dannes ved ekstrudering, tablettering eller sprøjtestøbning.
19. Anvendelse af legemet ifølge et hvilket som helst af krav 1 til 14 i fremstillingen af et lægemiddel til forbedring af et immunrespons på ét eller flere antigene eller immunologiske midler.
20. Aflangt legeme som defineret i et hvilket som helst af krav 1 til 14 til anvendelse ved vaccination af et hvirveldyr mod infektion med et patogen eller en tumorcelle.
21. Aflangt legeme som defineret i et hvilket som helst af krav 1 til 14 til anvendelse ved fremkaldelse af et forbedret immunrespons fra en antigen eller immunogen sammensætning hos et hvirveldyr ved dermal, intradermal, transdermal, subkutan eller intramuskulær administration.
22. Aflangt legeme som defineret i et hvilket som helst af krav 1 til 14 til anvendelse i forbedring af direkte eller efterfølgende immunologiske responser på ét eller flere antigene eller immunogene midler i en vaccineformulering.
23. Aflangt legeme til anvendelse ifølge et hvilket som helst af krav 20 til 22, hvor formuleringen administreres ved en hastighed, der mindre end 50 m/s, eller mindre end 20 m/s eller mindre end 10 m/s.
24. Emballeret lægemiddel, til anvendelse med en lægemiddelindgivelsesanordning, der omfatter legemet ifølge et hvilket som helst af krav 1 til 14 eller er fremstillet ved fremgangsmåden ifølge krav 15 til 18, og en emballage.
DK08718576.5T 2007-02-22 2008-02-20 Fast farmaceutisk og vaccinedosis DK2129366T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0703507A GB2446780A (en) 2007-02-22 2007-02-22 An elongate parenteral injection body having an injection point of angle 10 to 40 degrees.
GB0723310A GB0723310D0 (en) 2007-11-28 2007-11-28 Solid dosage vaccine
PCT/GB2008/000589 WO2008102136A2 (en) 2007-02-22 2008-02-20 Solid pharmaceutical and vaccine dose

Publications (1)

Publication Number Publication Date
DK2129366T3 true DK2129366T3 (da) 2019-04-15

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Application Number Title Priority Date Filing Date
DK08718576.5T DK2129366T3 (da) 2007-02-22 2008-02-20 Fast farmaceutisk og vaccinedosis

Country Status (20)

Country Link
US (3) US20100119570A1 (da)
EP (1) EP2129366B1 (da)
JP (1) JP5541927B2 (da)
KR (1) KR20090114448A (da)
CN (1) CN101657188A (da)
AU (1) AU2008217594A1 (da)
BR (1) BRPI0807544B8 (da)
CA (1) CA2679016C (da)
DK (1) DK2129366T3 (da)
EA (1) EA200901128A1 (da)
ES (1) ES2715767T3 (da)
GB (2) GB2446780A (da)
HR (1) HRP20190504T1 (da)
HU (1) HUE043578T2 (da)
IL (1) IL200551A0 (da)
MX (1) MX2009008977A (da)
PL (1) PL2129366T3 (da)
PT (1) PT2129366T (da)
WO (1) WO2008102136A2 (da)
ZA (1) ZA200906347B (da)

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BRPI0807544B1 (pt) 2020-09-15
US20160310413A1 (en) 2016-10-27
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GB2446780A (en) 2008-08-27
GB0703507D0 (en) 2007-04-04
EA200901128A1 (ru) 2009-12-30
MX2009008977A (es) 2009-09-28
JP5541927B2 (ja) 2014-07-09
ZA200906347B (en) 2015-04-29
CA2679016A1 (en) 2008-08-28
WO2008102136A2 (en) 2008-08-28
HUE043578T2 (hu) 2019-08-28
EP2129366B1 (en) 2019-01-02
IL200551A0 (en) 2010-05-17
US9693951B2 (en) 2017-07-04
US20100119570A1 (en) 2010-05-13
PT2129366T (pt) 2019-03-26
US9693952B2 (en) 2017-07-04
WO2008102136A3 (en) 2009-01-15
PL2129366T3 (pl) 2019-06-28
JP2010519282A (ja) 2010-06-03
HRP20190504T1 (hr) 2019-05-03
BRPI0807544A2 (pt) 2014-06-17
CN101657188A (zh) 2010-02-24
ES2715767T3 (es) 2019-06-06
US20140093553A1 (en) 2014-04-03
KR20090114448A (ko) 2009-11-03
AU2008217594A1 (en) 2008-08-28
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CA2679016C (en) 2016-01-05
BRPI0807544B8 (pt) 2021-05-25

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