HRP20110668T1 - Cjepivo sa živim, oslabljenim rotavirusom, namijenjeno za oralnu primjenu - Google Patents
Cjepivo sa živim, oslabljenim rotavirusom, namijenjeno za oralnu primjenu Download PDFInfo
- Publication number
- HRP20110668T1 HRP20110668T1 HR20110668T HRP20110668T HRP20110668T1 HR P20110668 T1 HRP20110668 T1 HR P20110668T1 HR 20110668 T HR20110668 T HR 20110668T HR P20110668 T HRP20110668 T HR P20110668T HR P20110668 T1 HRP20110668 T1 HR P20110668T1
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- Prior art keywords
- liquid
- rotavirus
- acid
- preparation
- liquid preparation
- Prior art date
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- 229960005050 live attenuated rota virus Drugs 0.000 title claims 3
- 229960005486 vaccine Drugs 0.000 title claims 2
- 239000007788 liquid Substances 0.000 claims abstract 34
- 239000000203 mixture Substances 0.000 claims abstract 23
- 241000702670 Rotavirus Species 0.000 claims abstract 12
- 150000007942 carboxylates Chemical class 0.000 claims abstract 11
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims abstract 5
- 239000000427 antigen Substances 0.000 claims abstract 5
- 102000036639 antigens Human genes 0.000 claims abstract 5
- 108091007433 antigens Proteins 0.000 claims abstract 5
- 229910019142 PO4 Inorganic materials 0.000 claims abstract 4
- 230000002163 immunogen Effects 0.000 claims abstract 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims abstract 4
- 239000010452 phosphate Substances 0.000 claims abstract 4
- 238000009472 formulation Methods 0.000 claims abstract 3
- 238000002360 preparation method Methods 0.000 claims 32
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- 229940069428 antacid Drugs 0.000 claims 5
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Abstract
Tekući rotavirusni imunogeni pripravak, pogodan za oralnu primjenu na ljudskom dojenčetu, koji sadrži rotavirusni antigen, šećer i karboksilat, naznačen time što navedena formulacija ima pH između otprilike pH 5,0 i otprilike pH 8,0 i sadrži manje od 1 mM fosfata, gdje se navedeni karboksilat dobiva iz dikarboksilne kiseline s prosječnim pKa 4. Patent sadrži još 41 patentni zahtjev.
Claims (42)
1. Tekući rotavirusni imunogeni pripravak, pogodan za oralnu primjenu na ljudskom dojenčetu, koji sadrži rotavirusni antigen, šećer i karboksilat, naznačen time što navedena formulacija ima pH između otprilike pH 5,0 i otprilike pH 8,0 i sadrži manje od 1 mM fosfata, gdje se navedeni karboksilat dobiva iz dikarboksilne kiseline s prosječnim pKa > 4.
2. Tekući pripravak u skladu s patentnim zahtjevom 1, naznačen time što navedeni pripravak sadrži manje od 0,1 mM fosfata.
3. Tekući pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što navedeni pripravak ne sadrži fosfat.
4. Tekući pripravak u skladu s bilo kojim jedan patentnih zahtjeva 1 do 3, naznačen time što je pH navedenog pripravka između otprilike pH 5,5 i otprilike pH 7,5.
5. Tekući pripravak u skladu s patentnim zahtjevom 4, naznačen time što je pH navedenog pripravka između otprilike pH 6,0 i otprilike pH 7,0.
6. Tekući pripravak u skladu s bilo kojim patentnih zahtjeva 1 do 5, naznačen time što se navedeni karboksilat bira iz skupine koju čine: adipat, malat, sukcinat, malonat, glutarat, maleat, fumarat, tartarat i bilo koja kombinacija dva ili više njih.
7. Tekući pripravak u skladu s patentnim zahtjevom 6, naznačen time što je navedeni karboksilat adipat.
8. Tekući pripravak u skladu s bilo kojim jedan patentnih zahtjeva 1 do 7, naznačen time što je navedeni karboksilat prisutan u koncentraciji između otprilike 50 mM i između otprilike 2 M.
9. Tekući pripravak u skladu s patentnim zahtjevom 8, naznačen time što je navedeni karboksilat prisutan u koncentraciji između otprilike 100 mM i između otprilike 1 M.
10. Tekući pripravak u skladu s patentnim zahtjevom 9, naznačen time što je navedeni karboksilat prisutan u koncentraciji između otprilike 400 mM i otprilike 700 mM.
11. Tekući pripravak u skladu s bilo kojim jedan patentnih zahtjeva 1 do 10, naznačen time što se navedeni šećer bira sa spiska koji čine: glicerol, eritroza, eritriol, ksilitol, arabitol, riboza, ksiloza, arabinoza, glukoza, tagaloza, manoza, galaktoza, fruktoza, inozitol, sorbitol, manitol, galaktitol, kombinacija glukoze i fruktoze, maltoza, soforoza, laktoza, celobioza, melibioza, trehaloza, saharoza, palatinoza, maltuloza, laktuloza, maltitol, laktitol, rafinoza, maltotrioza, melezitoza, celotrioza, ciritol, maltotetraoza, stahioza, celotetraoza, maltopentaoza, celopentaoza, maltoheksaoza, celoheksaoza, oligosaharidi.
12. Tekući pripravak of patentni zahtjev 11, naznačen time što je navedeni šećer saharoza ili dekstroza.
13. Tekući pripravak u skladu s bilo kojim jedan patentnih zahtjeva 1 do 12, naznačen time što je koncentracija navedenog šećera između otprilike 1 %, težinski, i otprilike 70%, težinski.
14. Tekući pripravak u skladu s patentnim zahtjevom 13, naznačen time što je koncentracija navedenog šećera između otprilike 25, težinski, i otprilike 60%, težinski.
15. Tekući pripravak u skladu s patentnim zahtjevom 14, naznačen time što je koncentracija navedenog šećera 50%, težinski, ili 55%, težinski.
16. Tekući pripravak u skladu s bilo kojim jedan patentnih zahtjeva 1 do 15, naznačen time što dodatno sadrži karboksilnu kiselinu.
17. Tekući pripravak u skladu s patentnim zahtjevom 16, naznačen time što se navedenu karboksilnu kiselinu bira sa spiska koji čine: adipinska kiselina, jabučna kiselina, octena kiselina, jantarna kiselina, ugljična kiselina, propionska kiselina, maslačna kiselina, malonska kiselina, glutarinska kiselina, maleinska kiselina, glikolna kiselina, mliječna kiselina, glukonska kiselina, fumarna kiselina, vinska kiselina.
18. Tekući pripravak u skladu s bilo kojim jedan patentnih zahtjeva 1 do 17, naznačen time što dodatno sadrži kalcijeve ione.
19. Tekući pripravak u skladu s bilo kojim jedan patentnih zahtjeva 1 do 18, naznačen time što je navedeni rotavirusni antigen živi rotavirus, such as živi oslabljeni rotavirus.
20. Tekući pripravak u skladu s patentnim zahtjevom 19, naznačen time što je navedeni živi oslabljeni rotavirus živi oslabljeni ljudski rotavirus.
21. Tekući pripravak u skladu s patentnim zahtjevom 20, naznačen time što navedeni živi oslabljeni ljudski rotavirus se bira iz skupine koju čine: soj HRV 89-12C2, deponiran pod pristupnim brojem ATCC VR 2272, njegovo potomstvo, reasortanti i imunološki aktivni derivati; soj HRV P43, deponiran pod pristupnim brojem ECACC 99081301, njegovo potomstvo, reasortanti i imunološki aktivni derivati.
22. Tekući pripravak u skladu s bilo kojim patentnih zahtjeva 1 do 21, naznačen time što navedeni pripravak može djelovati kao antacid najmanje 8 minuta, kao što je procijenjeno u Baby Rosett-Rice testu.
23. Tekući pripravak u skladu s patentnim zahtjevom 22, naznačen time što navedeni pripravak može djelovati kao antacid najmanje 12 minuta, kao što je procijenjeno u Baby Rosett-Rice testu.
24. Tekući pripravak u skladu s patentnim zahtjevom 22, naznačen time što navedeni pripravak može djelovati kao antacid između 8 i 23 minuta, kao što je procijenjeno u Baby Rosett-Rice testu.
25. Tekući pripravak u skladu s patentnim zahtjevom 24, naznačen time što navedeni pripravak može djelovati kao antacid između 12 i 23 minuta, kao što je procijenjeno u Baby Rosett-Rice testu.
26. Tekući pripravak u skladu s patentnim zahtjevom 23 ili patentnim zahtjevom 25, naznačen time što navedeni pripravak može djelovati kao antacid između 12 i 20 minuta, kao što je procijenjeno u Baby Rosett-Rice testu.
27. Tekući pripravak u skladu s bilo kojim patentnih zahtjeva 1 do 26, naznačen time što je navedeni pripravak stabilan u najmanje jednom od sljedećih uvjeta: 7 dana na 37 °C, godinu dana na 4 °C, dvije godine na 4 °C.
28. Tekući pripravak u skladu s bilo kojim patentnih zahtjeva 1 do 27, naznačen time što je cjepivo.
29. Tekući pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 28, naznačen time što se navedeni pripravak daje u volumnoj dozi između 0,2 ml i 2,0 ml.
30. Tekući pripravak u skladu s patentnim zahtjevom 29, naznačen time što se navedeni pripravak daje u volumnoj dozi između 0,5 ml i 1,5 ml.
31. Tekući pripravak u skladu s patentnim zahtjevom 30, naznačen time što se navedeni pripravak daje u volumnoj dozi od otprilike 1,5 ml.
32. Tekući pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 31, naznačen time što je namijenjen upotrebi u medicini.
33. Upotreba rotavirusnog antigena, šećera i karboksilata u proizvodnji imunogenog pripravka za liječenje ili sprječavanje bolesti uzrokovanih rotavirusom, naznačena time što navedeni imunogeni pripravak je kao što je definirano u bilo kojem od patentnih zahtjeva 1 do 31.
34. Upotreba u skladu s patentnim zahtjevom 33, naznačena time što se navedeno liječenje ili sprječavanje sastoji u primjeni dvije oralne doze sigurne i djelotvorne količine pripravka živog oslabljenog ljudskog rotavirusa na dojenčetu unutar 4-15 tjedana starosti u vrijeme 1. doze.
35. Upotreba u skladu s patentnim zahtjevom 33 ili 34, naznačena time što je namijenjena sprječavanju infekcije rotavirusom kod ljudi.
36. Upotreba u skladu s bilo kojim od patentnih zahtjeva 33 do 35, naznačena time što je namijenjena sprječavanju rotavirusnog gastroenteritisa kod ljudi.
37. Upotreba u skladu s patentnim zahtjevom 36, naznačena time što je namijenjena sprječavanju teškog rotavirusnog gastroenteritisa kod ljudi.
38. Upotreba u skladu s patentnim zahtjevom 36 ili 37, naznačena time što je navedeni gastroenteritis ili teški gastroenteritis uzrokovan sojem rotavirusa koji je drugačijeg serotipa od soja rotavirusa kojeg sadrži navedena tekuća formulacija.
39. Upotreba u skladu s bilo kojim od patentnih zahtjeva 33 do 38 ili, naznačena time što se navedeni pripravak daje u volumnoj dozi između 0,2 ml i 2,0 ml.
40. Upotreba u skladu s patentnim zahtjevom 39, naznačena time što se navedeni pripravak daje u volumnoj dozi između 0,5 ml i 1,5 ml.
41. Upotreba u skladu s patentnim zahtjevom 39 ili patentnim zahtjevom 40, naznačena time što se navedeni pripravak daje u volumnoj dozi od otprilike 1,5 ml.
42. Postupak priprave tekućeg rotavirusnog pripravka u skladu s bilo kojim patentnih zahtjeva 1 do 31, naznačen time što se sastoji u miješanju rotavirusnog antigena, šećera i karboksilata s farmaceutski prihvatljivim razrjeđivačem.
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| GBGB0503337.8A GB0503337D0 (en) | 2005-02-17 | 2005-02-17 | Compositions |
| PCT/EP2006/001442 WO2006087205A1 (en) | 2005-02-17 | 2006-02-15 | Live attenuated rotavirus vaccine for oral administration |
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| HRP20110668T1 true HRP20110668T1 (hr) | 2011-10-31 |
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| HR20110668T HRP20110668T1 (hr) | 2005-02-17 | 2011-09-15 | Cjepivo sa živim, oslabljenim rotavirusom, namijenjeno za oralnu primjenu |
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| EP (2) | EP2322211A1 (hr) |
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| KR (1) | KR101319846B1 (hr) |
| CN (2) | CN101300028B (hr) |
| AP (1) | AP2692A (hr) |
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| DK (1) | DK1863526T3 (hr) |
| EA (1) | EA012046B1 (hr) |
| ES (1) | ES2369246T3 (hr) |
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| HR (1) | HRP20110668T1 (hr) |
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| MA (1) | MA29321B1 (hr) |
| MX (1) | MX2007010075A (hr) |
| MY (1) | MY145790A (hr) |
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| PE (1) | PE20061094A1 (hr) |
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-
2005
- 2005-02-17 GB GBGB0503337.8A patent/GB0503337D0/en not_active Ceased
-
2006
- 2006-02-15 PT PT06707035T patent/PT1863526E/pt unknown
- 2006-02-15 ES ES06707035T patent/ES2369246T3/es active Active
- 2006-02-15 NZ NZ560314A patent/NZ560314A/en not_active IP Right Cessation
- 2006-02-15 MX MX2007010075A patent/MX2007010075A/es active IP Right Grant
- 2006-02-15 UY UY29377A patent/UY29377A1/es unknown
- 2006-02-15 CA CA2598290A patent/CA2598290C/en active Active
- 2006-02-15 EA EA200701519A patent/EA012046B1/ru not_active IP Right Cessation
- 2006-02-15 TW TW095105102A patent/TWI358303B/zh not_active IP Right Cessation
- 2006-02-15 DK DK06707035.9T patent/DK1863526T3/da active
- 2006-02-15 PL PL06707035T patent/PL1863526T3/pl unknown
- 2006-02-15 UA UAA200708765A patent/UA91044C2/uk unknown
- 2006-02-15 EP EP10180343A patent/EP2322211A1/en not_active Withdrawn
- 2006-02-15 AT AT06707035T patent/ATE516044T1/de active
- 2006-02-15 MY MYPI20060654A patent/MY145790A/en unknown
- 2006-02-15 WO PCT/EP2006/001442 patent/WO2006087205A1/en active Application Filing
- 2006-02-15 BR BRPI0608877A patent/BRPI0608877B8/pt active IP Right Grant
- 2006-02-15 CN CN200680005318.2A patent/CN101300028B/zh active Active
- 2006-02-15 AP AP2007004087A patent/AP2692A/xx active
- 2006-02-15 EP EP06707035A patent/EP1863526B1/en active Active
- 2006-02-15 AR ARP060100551A patent/AR053680A1/es not_active Application Discontinuation
- 2006-02-15 SI SI200631128T patent/SI1863526T1/sl unknown
- 2006-02-15 JP JP2007555532A patent/JP5118977B2/ja active Active
- 2006-02-15 PE PE2006000184A patent/PE20061094A1/es not_active Application Discontinuation
- 2006-02-15 US US11/816,443 patent/US8192747B2/en active Active
- 2006-02-15 CN CN2013103024516A patent/CN103357005A/zh active Pending
- 2006-02-15 KR KR1020077021142A patent/KR101319846B1/ko active IP Right Grant
- 2006-02-15 AU AU2006215761A patent/AU2006215761B2/en active Active
-
2007
- 2007-07-24 NO NO20073868A patent/NO341789B1/no unknown
- 2007-07-24 IL IL184802A patent/IL184802A0/en active IP Right Grant
- 2007-08-10 ZA ZA200706668A patent/ZA200706668B/xx unknown
- 2007-09-10 MA MA30201A patent/MA29321B1/fr unknown
-
2011
- 2011-09-15 HR HR20110668T patent/HRP20110668T1/hr unknown
- 2011-10-06 CY CY20111100959T patent/CY1111916T1/el unknown
-
2012
- 2012-06-01 US US13/486,039 patent/US8821891B2/en active Active
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