SI2198007T1 - Farmacevtski sestavki, ki vsebujejo toksoide Clostridium difficile A in B - Google Patents

Farmacevtski sestavki, ki vsebujejo toksoide Clostridium difficile A in B Download PDF

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SI2198007T1
SI2198007T1 SI200831906T SI200831906T SI2198007T1 SI 2198007 T1 SI2198007 T1 SI 2198007T1 SI 200831906 T SI200831906 T SI 200831906T SI 200831906 T SI200831906 T SI 200831906T SI 2198007 T1 SI2198007 T1 SI 2198007T1
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composition
sodium
clostridium difficile
toxoid
sucrose
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SI200831906T
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C. Russell Middaugh
Richard Fahrner
Peter Ciarametaro
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Sanofi Pasteur Biologics, Llc
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    • A61K39/02Bacterial antigens
    • A61K39/08Clostridium, e.g. Clostridium tetani
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • 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
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    • 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
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
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    • 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
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    • A61P1/12Antidiarrhoeals
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    • A61K2039/55505Inorganic adjuvants
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Claims (16)

  1. Farmacevtski sestavki, ki vsebujejo toksoide Clostridium difficile A in B Patentni zahtevki
    1. Sestavek, ki vsebuje toksoid Clostridium difficile in farmacevtsko sprejemljive ekscipiente, ki vsebujejo: (a) pufer izbran izmed pufra natrijevega ali kalijevega citrata in pufra natrijevega ali kalijevega fosfata; in (b) sukrozo, kjer farmacevtsko sprejemljivi ekscipienti povečajo termično stabilnost toksoida in/ali zmanjšajo ali odložijo agregacijo toksoida, v primerjavi s sestavkom, ki ne vsebuje omenjenih farmacevtsko sprejemljivih ekscipientov.
  2. 2. Sestavek po zahtevku 1, ki nadalje vsebuje formaldehid v koncentraciji od 0.001% do 0.020%.
  3. 3. Sestavek po zahtevku 1 ali 2, kjer: (a) omenjeni farmacevtsko sprejemljivi ekscipienti zmanjšajo ali odložijo agregacijo toksoida za 50% ali več, v primeijavi s sestavkom, ki ne vsebuje omenjenih farmacevtsko sprejemljivih ekscipientov; ali (b) omenjeni farmacevtsko sprejemljivi ekscipienti povečajo termično stabilnost toksoida za 0.5°C ali več, v primerjavi s sestavkom, ki ne vsebuje omenjenih farmacevtsko sprejemljivih ekscipientov.
  4. 4. Sestavek po kateremkoli zahtevku od 1 do 3, kjer sestavek vsebuje toksoid toksinov C. difficile A in B.
  5. 5. Sestavek po zahtevku 4, kjer: (a) so toksoidi A in B prisotni v sestavku v razmerju 5:1 (A:B) do 1:5 (A:B); ali (b) so toksoidi A in B prisotni v sestavku v razmerju 3:1 do 3:2 ali 1:1 (A:B).
  6. 6. Sestavek po kateremkoli zahtevku od 1 do 5, kjer je sestavek farmacevtski sestavek.
  7. 7. Sestavek po kateremkoli zahtevku od 1 do 6, ki nadalje vsebuje adjuvans.
  8. 8. Sestavek po zahtevku 7, kjer adjuvans vsebuje aluminijevo spojino, neobvezno, kjer je aluminijeva spojina, spojina aluminijevega hidroksida.
  9. 9. Sestavek po kateremkoli zahtevku od 1 do 8, kjer je sestavek: (a) v tekoči obliki; ali (b) v obliki suhega praška, liofiliziran, sušen z zamrzovanjem, sušen s pršenjem ali sušen s penjenjem.
  10. 10. Sestavek po kateremkoli zahtevku od 1 do 9, kjer: (a) je citratni pufer natrijev citrat; ali (b) je fosfatni pufer natrijev fosfat.
  11. 11. Sestavek po kateremkoli zahtevku od 1 do 9, kjer sestavek vsebuje: (a) toksoide Clostridium difficile A in B, 5-100 mM natrijevega ali kalijevega citrata, 2-20% sukroze in <0.020% formaldehida, pH 5.5-8.5; (b) toksoide Clostridium difficile A in B, 10-30 mM natrijevega ali kalijevega citrata, 2-10% sukroze in <0.020% formaldehida, pH 6.5-8.0; (c) toksoide Clostridium difficile A in B, 20 mM natrijevega citrata, 5% sukroze in 0.016% formaldehida, pH 7.5; (d) toksoide Clostridium difficile A in B, 5-100 mM natrijevega ali kalijevega fosfata, 2- 20% sukroze in <0.020% formaldehida, pH 5.5-8.5; (e) toksoide Clostridium difficile A in B, 10-30 mM natrijevega ali kalijevega fosfata, 2- 10% sukroze in <0.020% formaldehida, pH 6.5-8.0; ali (f) toksoide Clostridium difficile A in B, 20 mM kalijevega fosfata, 5% sukroze in 0.016% formaldehida, pH 7.5.
  12. 12. Sestavek po kateremkoli zahtevku od 1 do 9, kjer je sestavek v liofilizirani obliki in vsebuje: (a) toksoide Clostridium difficile A in B, 10-30 mM natrijevega ali kalijevega citrata, 2-10% sukroze in <0.020% formaldehida, pH 6.5-8.0; ali (b) toksoide Clostridium difficile A in B, 20 mM natrijevega citrata, 5% sukroze in 0.016% formaldehida, pH 7.5.
  13. 13. Postopek izdelave sestavka, ki vsebuje toksoid Clostridium difficile in farmacevtsko sprejemljiv ekscipiente, ki vsebujejo: (a) pufer izbran izmed pufra natrijevega ali kalijevega citrata in pufra natrijevega ali kalijevega fosfata; in (b) sukrozo, kjer omenjeni farmacevtsko sprejemljivi ekscipienti povečajo termično stabilnost toksoida in/ali zmanjšajo ali odložijo agregacijo toksoida, v primerjavi s sestavkom, ki ne vsebuje omenjenih farmacevtsko sprejemljivih ekscipientov, kjer postopek obsega zagotavljanje toksoida Clostridium difficile in mešanje omenjenega toksoida Clostridium difficile z omenjenimi farmacevtsko sprejemljivimi ekscipienti.
  14. 14. Sestavek po kateremkoli zahtevku od 1 do 12, za uporabo v postopku preventive ali zdravljenja okužbe s C. difficile ali bolezni v subjektu.
  15. 15. Uporaba kombinacije: (a) pufra izbranega izmed pufra natrijevega ali kalijevega citrata in pufra natrijevega ali kalijevega fosfata; in (b) sukroze, za povečanje termične stabilnosti in/ali zmanjšanje ali zavlačevanja agregacija toksoida, Clostridium difficile in vitro. ' ' * **» 4
  16. 16. Uporaba po zahtevku 15, kjer sta omenjeni komponenti (a) in (b) zagotovljeni v sestavku, kjer je omenjeni sestavek kot je opisano v kateremkoli zahtevku od 1 do 12.
SI200831906T 2007-09-14 2008-09-15 Farmacevtski sestavki, ki vsebujejo toksoide Clostridium difficile A in B SI2198007T1 (sl)

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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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EP (2) EP2198007B1 (sl)
JP (3) JP5503543B2 (sl)
KR (2) KR101679812B1 (sl)
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AU (1) AU2008299885C1 (sl)
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SI2198007T1 (sl) 2007-09-14 2018-04-30 Sanofi Pasteur Biologics, Llc Farmacevtski sestavki, ki vsebujejo toksoide Clostridium difficile A in B
RU2011126602A (ru) 2008-12-03 2013-01-10 Берингер Ингельхайм Ветмедика Гмбх Способ получения вакцин

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