SI2114421T1 - Bakterijski ekstrakt za respiratorne motnje in postopek za njegovo pripravo - Google Patents

Bakterijski ekstrakt za respiratorne motnje in postopek za njegovo pripravo Download PDF

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SI2114421T1
SI2114421T1 SI200831936T SI200831936T SI2114421T1 SI 2114421 T1 SI2114421 T1 SI 2114421T1 SI 200831936 T SI200831936 T SI 200831936T SI 200831936 T SI200831936 T SI 200831936T SI 2114421 T1 SI2114421 T1 SI 2114421T1
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extract
pneumoniae
streptococcus
staphylococcus aureus
lysis
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SI200831936T
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English (en)
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Jacques Alain Bauer
Marco Salvagni
Jean-Pierre Leon Vigroux
Laetitia Chalvet
Carlo Chiavaroli
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Om Pharma
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    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20—Bacteria; Culture media therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological 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
    • A61P37/08—Antiallergic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P1/00—Preparation of compounds or compositions, not provided for in groups C12P3/00 - C12P39/00, by using microorganisms or enzymes
    • C12P1/04—Preparation of compounds or compositions, not provided for in groups C12P3/00 - C12P39/00, by using microorganisms or enzymes by using bacteria
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P39/00—Processes involving microorganisms of different genera in the same process, simultaneously
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Claims (27)

  1. Bakterijski ekstrakt za respiratorne motnje in postopek za njegovo pripravo Patentni zahtevki
    1. Ekstrakt iz vseh bakterijskih vrst, izbranih izmed Morcccelle catarrhalisa, Haemophilusa influenzae, Klebsielle pneumoniae, Staphylococcusa aureusa, Streptococcusa pneumoniae, Streptococcusa pyogenesa in Streptococcusa sanguinisa, pridobljiv z lizo bakterijske vrste pri začetnem pH višjem od 12, kjer ekstrakt obsega manj kot 100 pg/ml nukleinskih kislin, vsaj 0,3 mg/ml saharidov in kjer ekstrakt ne povzroči tveganja za prionske bolezni.
  2. 2. Ekstrakt po zahtevku 1, kjer je območje saharidov med 0,3 mg/ml in 4,5 mg/ml, ali med 0,3 mg/ml in 4 mg/ml, ali med 0,4 mg/ml in 4 mg/ml, ali med 0,5 mg/ml in 3,5 mg/ml, ali med 0,6 mg/ml in 3 mg/ml, ali med 0,3 mg/ml in 1 mg/ml.
  3. 3. Ekstrakt po zahtevku 1 ali 2, kjer je vsaj en saharid izbran izmed monosaharidov, disaharidov, polisaharidov in lipopolisaharidov (LPS).
  4. 4. Ekstrakt po katerem koli od prejšnjih zahtevkov, kjer se liza izvede pri začetnem pH od 12,6 do 13,4.
  5. 5. Ekstrakt po katerem koli od prejšnjih zahtevkov, kjer ekstrakt obsega med 5 mg/ml in 75 mg/ml, med 10 mg/ml in 65 mg/ml, ali med 20 mg/ml in 45 mg/ml, ali med 5 mg/ml in 20 mg/ml, ali med 5 mg/ml in 10 mg/ml, ali med 6 mg/ml in 8 mg/ml proteinov, kjer imajo en ali več proteinov molekulsko maso manj kot 30 kDa.
  6. 6. Ekstrakt po katerem koli od prejšnjih zahtevkov, kjer ekstrakt obsega med 1 % in 80 %, ali med 10 % in 45 %, ali med 25 % in 35 % D-aminokislin.
  7. 7. Ekstrakt po katerem koli od zahtevkov 1-6, kjer ekstrakt obsega med 1,5 mg/ml in 2,5 mg/ml aminokislin v ekvivalentih glutaminske kisline (147,1 g/mol).
  8. 8. Ekstrakt po zahtevku 7, kjer ekstrakt obsega 2-2,5 mg/ml ali 1,5-2 mg/ml aminokislin v ekvivalentih glutaminske kisline (147,1 g/mol).
  9. 9. Ekstrakt po katerem koli od prejšnjih zahtevkov, ki obsega 6-8 mg/ml proteinov, 1,5-2,5 mg/ml proste aminokisline v ekvivalentih glutaminske kisline (147,1 g/mol) in 0,4-0,5 mg/ml polisaharidov in monosaharidov.
  10. 10. Ekstrakt po katerem koli od prejšnjih zahtevkov, kjer so sevi bakterijske vrste izbrani izmed naslednjih sevov: Moraxella catarrhalis 3622, Moraxella catarrhalis 3625, Moraxella catarrhalis 1-045, Haemophilus influenzae 8467, Klebsiella pneumoniae ssp. ozaenae 5050, Klebsiella pneumoniae ssp. pneumoniae 204, Klebsiella pneumoniae ssp. pneumoniae 5056, Staphylococcus aureus 1-049, Staphylococcus aureus 1-050, Staphylococcus aureus 1-051, Staphylococcus aureus 1-052, Staphylococcus aureus 1-053, Staphylococcus aureus 1-054, Streptococcus pneumoniae 7465, Streptococcus pneumoniae 7466, Streptococcus pneumoniae 7978, Streptococcus pneumoniae 10319, Streptococcus pyogenes 8191, Streptococcus sanguinis 1-046, Streptococcus sanguinis 1-047 in Streptococcus sanguinis 1-048.
  11. 11. Ekstrakt po katerem koli od prejšnjih zahtevkov, ki je topen ekstrakt.
  12. 12. Farmacevtski sestavek, ki obsega ekstrakt po katerem koli od zahtevkov 1-10.
  13. 13. Ekstrakt po katerem koli od zahtevkov 1-10 za uporabo pri postopku zdravljenja in/ali preprečevanja respiratorne motnje ali alergijskega stanja pri individuumu.
  14. 14. Ekstrakt po katerem koli od zahtevkov 1-10 za uporabo pri postopku za zaščito pred respiratorno motnjo ali alergijskim stanjem pri individuumu s tveganjem za razvoj respiratorne motnje ali alergijskega stanja.
  15. 15. Ekstrakt za uporabo pri postopku po zahtevku 13 ali 14, kjer je respiratorna motnja ali alergijsko stanje izbrano izmed infekcij zgornjih in spodnjih dihalnih poti, atopičnega dermatitisa, nazofaringitisa, sinuzitisa, faringitisa, tonzilitisa, laringitisa, traheitisa, laringofaringitisa, influence, pljučnice, bronhopnevmonije, bronhitisa, infekcije spodnje dihalne poti, alergijskega rinitisa, alergijske astme, astme, rinitisa, nazofaringitisa, faringitisa, sinuzitisa, tonzilitisa, laringitisa, laringotraheitisa, bronhitisa, obstruktivne pljučne bolezni z akutno infekcijo spodnje dihalne poti in obstruktivne pljučne bolezni z akutno eksacerbacijo.
  16. 16. Ekstrakt za uporabo pri postopku po katerem koli od zahtevkov 13-14, kjer je individuum človek ali domači sesalec.
  17. 17. Postopek za pripravo ekstrakta po katerem koli od zahtevkov 1-10 iz zmesi vseh bakterijskih vrst, izbranih izmed: Moraxelle catarrhalisa, Haemophilusa influenzae, Klebsielle pneumoniae, Staphylococcusa aureusa, Streptococcusa pneumoniae, Streptococcusa pyogenesa in Streptococcusa sanguinisa, obsegajoč: (a) kultiviranje vsake od navedenih bakterijskih vrst v mediju, ki ne povzroči tveganja za prionske bolezni; (b) lizo vsake od navedenih bakterijskih vrst pri začetnem pH višjem od 12; in (c) prepuščanje proizvoda iz (b) vsaj enkrat skozi mikrofilter in vsaj enkrat skozi ultrafilter.
  18. 18. Postopek po zahtevku 17, kjer izvedemo lizo v obdobju od 40 h do 10 dni pri temperaturi 30-60 °C.
  19. 19. Postopek po zahtevku 17, kjer izvedemo lizo v obdobju od 20 h do 240 h pri temperaturi 30-40 °C.
  20. 20. Postopek po katerem koli od zahtevkov 17-19, kjer izvedemo lizo pri začetnem pH višjem od 12,5.
  21. 21. Postopek po katerem koli od zahtevkov 17-20, kjer izvedemo lizo pri začetnem pH od 12,6 do 13,4.
  22. 22. Postopek po katerem koli od zahtevkov 17-21, kjer je mikrofilter 0,45 pm in je ultrafilter 30 kDa.
  23. 23. Postopek po katerem koli od zahtevkov 17-22, kjer del (c) obsega tangencialno pretočno filtracijo.
  24. 24. Postopek po zahtevku 23, kjer izvedemo tangencialno pretočno filtracijo v 5-15 ciklih.
  25. 25. Postopek po katerem koli od zahtevkov 17-24, ki nadalje obsega prepuščanje proizvoda iz (c) skozi drugi mikrofilter pri 0,2 pm.
  26. 26. Postopek po katerem koli od zahtevkov 17-25, kjer izvedemo del (b) s 5-120 g/1 bakterijske suhe mase materiala.
  27. 27. Postopek po zahtevku 26, kjer izvedemo del (b) s 5-90 g/1 bakterijske suhe mase materiala.
SI200831936T 2007-03-05 2008-03-05 Bakterijski ekstrakt za respiratorne motnje in postopek za njegovo pripravo SI2114421T1 (sl)

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US90478907P 2007-03-05 2007-03-05
PCT/US2008/055906 WO2008109669A2 (en) 2007-03-05 2008-03-05 Bacterial extract for respiratory disorders and proces for its preparation
EP08731433.2A EP2114421B1 (en) 2007-03-05 2008-03-05 Bacterial extract for respiratory disorders and proces for its preparation

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EP2114421A2 (en) 2009-11-11
CA2679843C (en) 2018-10-02
WO2008109669A3 (en) 2008-12-18
US9463209B2 (en) 2016-10-11
JP5693010B2 (ja) 2015-04-01
US20100227013A1 (en) 2010-09-09
KR101527483B1 (ko) 2015-06-09
ES2665002T3 (es) 2018-04-24
CN101663041B (zh) 2012-05-23
KR20090122940A (ko) 2009-12-01
IL200666A (en) 2016-12-29
BRPI0808333B1 (pt) 2020-03-10
PT2114421T (pt) 2018-04-17
EP2114421A4 (en) 2010-09-22
BRPI0808333A2 (pt) 2017-05-30
CN101663041A (zh) 2010-03-03
CA2679843A1 (en) 2008-09-12
BRPI0808333B8 (pt) 2021-05-25
US8697154B2 (en) 2014-04-15
EP2114421B1 (en) 2018-01-10
TWI434693B (zh) 2014-04-21
ZA200906029B (en) 2010-11-24
AR070307A1 (es) 2010-03-31
MX2009009452A (es) 2009-09-14
HUE038598T2 (hu) 2018-10-29
US20140205693A1 (en) 2014-07-24
AU2008222865A1 (en) 2008-09-12
IL200666A0 (en) 2010-05-17
WO2008109669A2 (en) 2008-09-12
EP3332791A1 (en) 2018-06-13
TW200938212A (en) 2009-09-16
RU2009136577A (ru) 2011-04-10
AR111836A2 (es) 2019-08-21
AU2008222865B2 (en) 2013-01-31
JP2010520302A (ja) 2010-06-10
DK2114421T3 (en) 2018-04-23
PL2114421T3 (pl) 2018-07-31
RU2456007C2 (ru) 2012-07-20

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