HRP20180054T1 - Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b - Google Patents

Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b Download PDF

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Publication number
HRP20180054T1
HRP20180054T1 HRP20180054TT HRP20180054T HRP20180054T1 HR P20180054 T1 HRP20180054 T1 HR P20180054T1 HR P20180054T T HRP20180054T T HR P20180054TT HR P20180054 T HRP20180054 T HR P20180054T HR P20180054 T1 HRP20180054 T1 HR P20180054T1
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preparation
sodium
clostridium difficile
toxoid
sucrose
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HRP20180054TT
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English (en)
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C. Russell Middaugh
Richard Fahrner
Peter Ciarametaro
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Sanofi Pasteur Biologics, Llc
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Publication of HRP20180054T1 publication Critical patent/HRP20180054T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/08Clostridium, e.g. Clostridium tetani
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • 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
    • 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
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
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  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Biotechnology (AREA)
  • Peptides Or Proteins (AREA)
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  • Wood Science & Technology (AREA)
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  • General Engineering & Computer Science (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (16)

1. Pripravak koji sadrži toksoid Clostridium difficile i farmaceutski prihvatljive ekscipijente koji sadrže (a) pufer odabran iz natrijevog ili kalijevog citratnog pufera i natrijevog ili kalijevog fosfatnog pufera; i (b) saharozu, naznačen time da navedeni farmaceutski prihvatljivi ekscipijenti povećavaju toplinsku stabilnost toksoida i/ili smanjuju ili odgađaju nakupljanje toksoida, u odnosu na pripravak bez navedenih farmaceutski prihvatljivih ekscipijenata.
2. Pripravak prema zahtjevu 1 naznačen time, da nadalje sadrži formaldehid u koncentraciji od 0.001 do 0.020%.
3. Pripravak prema zahtjevu 1 ili 2, naznačen time da: (a) navedeni farmaceutski prihvatljivi ekscipijenti redu smanjuju ili odgađaju nakupljanje toksoida za 50% ili više, u odnosu na pripravak kojem nedostaju navedeni farmaceutski prihvatljivi ekscipijenti; ili (b) navedeni farmaceutski prihvatljivi ekscipijenti povećavaju toplinsku stabilnost toksoida za 0.5°C ili više, u odnosu na pripravak kojem nedostaju navedeni farmaceutski prihvatljivi ekscipijenti.
4. Pripravak prema bilo kojem od zahtjeva 1 do 3, naznačen time da pripravak sadrži toksoid od C. difficile toksina A i B.
5. Pripravak prema zahtjevu 4, naznačen time da: (a) su toksoidi A i B prisutni u pripravku u omjeru 5:1 (A:B) do 1:5 (A:B); ili (b) su toksoidi A i B prisutni u pripravku u omjeru 3:1 do 3:2, ili 1:1 (A:B).
6. Pripravak prema bilo kojem od zahtjeva 1 do 5, naznačen time da pripravak je farmaceutski pripravak.
7. Pripravak prema bilo kojem od zahtjeva 1 do 6, naznačen time, da nadalje sadrži adjuvant.
8. Pripravak prema zahtjevu 7, naznačen time da adjuvant sadrži spoj aluminija, proizvoljno pri čemu spoj aluminija je spoj aluminijevog hidroksida.
9. Pripravak prema bilo kojem od zahtjeva 1 do 8, naznačen time da pripravak je (a) u tekućem obliku; ili (b) u obliku suhog praška, liofiliziran, osušen smrzavanjem, osušen raspršivanjem ili osušen pjenom.
10. Pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time da (a) citratni pufer je natrijev citrat; ili (b) fosfatni pufer je natrijev fosfat.
11. Pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time da pripravak sadrži: (a) toksoide Clostridium difficile A i B, 5-100 mM natrijevog ili kalijevog citrata, 2-20% saharoze, i ≤0.020% formaldehida, pH 5.5-8.5; (b) toksoide Clostridium difficile A i B, 10-30 mM natrijevog ili kalijevog citrata, 2-10% saharoze, i ≤0.020% formaldehida, pH 6.5-8.0; (c) toksoide Clostridium difficile A i B, 20 mM natrijevog citrata, 5% saharoze, i 0.016% formaldehida, pH 7.5; (d) toksoide Clostridium difficile A i B, 5-100 mM natrijevog ili kalijevog fosfata, 2- 20% saharoze, i ≤0.020% formaldehida, pH 5.5-8.5; (e) toksoide Clostridium difficile A i B, 10-30 mM natrijevog ili kalijevog fosfata, 2- 10% saharoze, i ≤0.020% formaldehida, pH 6.5-8.0; ili (f) toksoide Clostridium difficile A i B, 20 mM kalijevog fosfata, 5% saharoze, i 0.016% formaldehida, pH 7.5.
12. Pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time da je pripravak u liofiliziranom obliku i sadrži: (a) toksoide Clostridium difficile A i B, 10-30 mM natrijevog ili kalijevog citrata, 2-10% saharoze, i ≤0.020% formaldehida, pH 6.5-8.0; ili (b) toksoide Clostridium difficile A i B, 20 mM natrijevog citrata, 5% saharoze, i 0.016% formaldehida, pH 7.5.
13. Postupak za pripravu pripravka koji sadrži toksoid Clostridium difficile i farmaceutski prihvatljive ekscipijente koji sadrže (a) pufer odabran od natrijevog ili kalijevog citratnog pufera i natrijevog ili kalijevog fosfatnog pufera; i (b) saharozu, naznačen time da navedeni farmaceutski prihvatljivi ekscipijenti povećavaju toplinsku stabilnost toksoida, i/ili smanjuju ili odgađaju nakupljanje toksoida u odnosu na pripravak bez navedenih farmaceutski prihvatljivih ekscipijenata, te postupak sadrži osiguravanje toksoida Clostridium difficile i miješanje toksoida Clostridium difficile s navedenim farmaceutski prihvatljivim ekscipijentima.
14. Pripravak prema bilo kojem od zahtjeva 1 do 12 naznačen time da se koristi u postupku sprječavanja ili liječenja infekcije ili bolesti kod subjekta izazvane s C. difficile.
15. Uporaba kombinacije (a) pufera odabranog od natrijevog ili kalijevog citratnog pufera i natrijevog ili kalijevog fosfatnog pufera; i (b) saharozu, za povećanje in vitro toplinske stabilnosti i/ili smanjivanje ili odgađanje nakupljanja toksoida Clostridium difficile.
16. Uporaba prema zahtjevu 15 naznačena time da su navedene komponente (a) i (b) predviđene u pripravku, a navedeni pripravak je definiran u bilo kojem od zahtjeva 1 do 12.
HRP20180054TT 2007-09-14 2018-01-11 Farmaceutski pripravci koji sadrže toksoide clostridium difficile a i b HRP20180054T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US97249607P 2007-09-14 2007-09-14
PCT/US2008/010767 WO2009035707A1 (en) 2007-09-14 2008-09-15 Pharmaceutical compositions containing clostridium difficile toxoids a and b
EP08830210.4A EP2198007B1 (en) 2007-09-14 2008-09-15 Pharmaceutical compositions containing clostridium difficile toxoids a and b

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US (3) US9320790B2 (hr)
EP (2) EP2198007B1 (hr)
JP (3) JP5503543B2 (hr)
KR (2) KR101679812B1 (hr)
CN (2) CN101855336B (hr)
AU (1) AU2008299885C1 (hr)
BR (1) BRPI0816790A8 (hr)
CA (1) CA2699435A1 (hr)
CY (1) CY1119979T1 (hr)
DK (1) DK2198007T3 (hr)
ES (1) ES2657485T3 (hr)
HR (1) HRP20180054T1 (hr)
HU (1) HUE037932T2 (hr)
IL (1) IL204366A (hr)
MX (1) MX2010002815A (hr)
NO (1) NO2198007T3 (hr)
PL (1) PL2198007T3 (hr)
PT (1) PT2198007T (hr)
RU (1) RU2550271C2 (hr)
SI (1) SI2198007T1 (hr)
WO (1) WO2009035707A1 (hr)

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