HRP20151203T1 - Formulacije koje stabiliziraju i inhibiraju taloženje imunogenih pripravaka - Google Patents
Formulacije koje stabiliziraju i inhibiraju taloženje imunogenih pripravaka Download PDFInfo
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- HRP20151203T1 HRP20151203T1 HRP20151203TT HRP20151203T HRP20151203T1 HR P20151203 T1 HRP20151203 T1 HR P20151203T1 HR P20151203T T HRP20151203T T HR P20151203TT HR P20151203 T HRP20151203 T HR P20151203T HR P20151203 T1 HRP20151203 T1 HR P20151203T1
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- Prior art keywords
- polysaccharide
- pneumoniae serotype
- conjugated
- crm197
- polypeptide
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 44
- 238000009472 formulation Methods 0.000 title claims 43
- 230000002163 immunogen Effects 0.000 title 1
- 238000001556 precipitation Methods 0.000 title 1
- 229920001282 polysaccharide Polymers 0.000 claims 49
- 239000005017 polysaccharide Substances 0.000 claims 49
- 150000004676 glycans Chemical class 0.000 claims 47
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 claims 33
- 229920001184 polypeptide Polymers 0.000 claims 33
- 102000004196 processed proteins & peptides Human genes 0.000 claims 33
- 108090000765 processed proteins & peptides Proteins 0.000 claims 33
- 241000894006 Bacteria Species 0.000 claims 14
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 8
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 8
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 8
- 229920000053 polysorbate 80 Polymers 0.000 claims 8
- 229940068968 polysorbate 80 Drugs 0.000 claims 8
- 239000000243 solution Substances 0.000 claims 7
- 239000000872 buffer Substances 0.000 claims 6
- 239000002671 adjuvant Substances 0.000 claims 5
- 239000011521 glass Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 239000011780 sodium chloride Substances 0.000 claims 4
- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 claims 3
- 150000003890 succinate salts Chemical group 0.000 claims 3
- -1 19A polysaccharide Chemical class 0.000 claims 2
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical group [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 claims 2
- 230000000890 antigenic effect Effects 0.000 claims 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 241000193998 Streptococcus pneumoniae Species 0.000 claims 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical group [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims 1
- DIZPMCHEQGEION-UHFFFAOYSA-H aluminium sulfate (anhydrous) Chemical compound [Al+3].[Al+3].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O DIZPMCHEQGEION-UHFFFAOYSA-H 0.000 claims 1
- 239000003708 ampul Substances 0.000 claims 1
- 239000007975 buffered saline Substances 0.000 claims 1
- 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 1
- 229910052751 metal Inorganic materials 0.000 claims 1
- 239000002184 metal Substances 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 125000002467 phosphate group Chemical group [H]OP(=O)(O[H])O[*] 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 239000001103 potassium chloride Substances 0.000 claims 1
- 235000011164 potassium chloride Nutrition 0.000 claims 1
- 239000008362 succinate buffer Substances 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- 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
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- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
- A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
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Claims (31)
1. Formulacija koja stabilizira polisaharidno-proteinski konjugat, naznačena time što formulacija sadrži (i) fiziološku otopinu s puferiranim pH, gdje pufer ima pKa od 3,5 do 7,5, (ii) polisorbat 80 u konačnoj koncentraciji od 0,01% do 0,05% polisorbata 80, težinski, po volumenu formulacije i (iii) jedan ili više polisaharidno-proteinskih konjugata, gdje polisaharidno-proteinski konjugat sadrži jedan ili više pneumokoknih polisaharida.
2. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što navedena fiziološka otopina s puferiranim pH ima pH od 5,5 do 7,5.
3. Formulacija u skladu s bilo kojim patentnim zahtjevom 1 do 2, naznačena time što je navedeni pufer fosfatni, sukcinatni, histidinski ili citratni.
4. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što je pufer sukcinatni, u konačnoj koncentraciji od 1 mM do 10 mM, uz pH od 5,8 do 6,0.
5. Formulacija u skladu s patentnim zahtjevom 4, naznačena time što je konačna koncentracija sukcinatnog pufera 5 mM.
6. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačena time što sol u fiziološkoj otopini s puferiranim pH sadrži magnezijev klorid, kalijev klorid, natrijev klorid ili njihovu kombinaciju.
7. Formulacija u skladu s patentnim zahtjevom 6, naznačena time što je sol u fiziološkoj otopini s puferiranim pH natrijev klorid.
8. Formulacija u skladu s patentnim zahtjevom 3, naznačena time što navedena fiziološka otopina s puferiranim pH ima pH od 5,5 do 7,5, gdje je navedeni pufer histidin i gdje je sol u fiziološkoj otopini s puferiranim pH natrijev klorid.
9. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačena time što je konačna koncentracija polisorbata 80 u formulaciji 0,01 % polisorbata 80, težinski, po volumenu formulacije.
10. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačena time što je konačna koncentracija polisorbata 80 u formulaciji 0,05 % polisorbata 80, težinski, po volumenu formulacije.
11. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačena time što dodatno sadrži jedan ili više meningokoknih polisaharida, jedan ili više meningokoknih antigenih proteina, ili njihovu kombinaciju.
12. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačena time što dodatno sadrži jedan ili više streptokoknih polisaharida, jedan ili više streptokoknih antigenih proteina, ili njihovu kombinaciju.
13. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačena time što navedeni jedan ili više pneumokoknih polisaharida sadrže polisaharid iz bakterije S. pneumoniae serotip 4, polisaharid iz bakterije S. pneumoniae serotip 6B, polisaharid iz bakterije S. pneumoniae serotip 9V, polisaharid iz bakterije S. pneumoniae serotip 14, polisaharid iz bakterije S. pneumoniae serotip 18C, polisaharid iz bakterije S. pneumoniae serotip 19F, polisaharid iz bakterije S. pneumoniae serotip 23F, polisaharid iz bakterije S. pneumoniae serotip 1, polisaharid iz bakterije S. pneumoniae serotip 3, polisaharid iz bakterije S. pneumoniae serotip 5, polisaharid iz bakterije S. pneumoniae serotip 6A, polisaharid iz bakterije S. pneumoniae serotip 7F i polisaharid iz bakterije S. pneumoniae serotip 19A.
14. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačena time što je formulacija polisaharidno-proteinskog konjugata formulacija 7-valentnog pneumokoknog konjugata (7vPnC) koja sadrži polisaharid iz bakterije S. pneumoniae serotip 4 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 6B konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 9V konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 14 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 18C konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 19F konjugiran s polipeptidom CRM197 i polisaharid iz bakterije S. pneumoniae serotip 23F konjugiran s polipeptidom CRM197.
15. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačena time što je formulacija polisaharidno-proteinskog konjugata formulacija 13-valentnog pneumokoknog konjugata (13vPnC) koja sadrži polisaharid iz bakterije S. pneumoniae serotip 4 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 6B konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 9V konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 14 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 18C konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 19F konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 23F konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 1 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 3 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 5 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 6A konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 7F konjugiran s polipeptidom CRM197 i polisaharid iz bakterije S. pneumoniae serotip 19A konjugiran s polipeptidom CRM197.
16. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 15, naznačena time što formulacija dodatno sadrži jedan ili više adjuvansa.
17. Formulacija u skladu s patentnim zahtjevom 16, naznačena time što je navedeni adjuvans aluminijeva sol.
18. Formulacija u skladu s patentnim zahtjevom 17, naznačena time što je navedena aluminijeva sol aluminijev hidroksid, aluminijev fosfat ili aluminijev sulfat.
19. Formulacija u skladu s patentnim zahtjevom 16, naznačena time što je adjuvans aluminijev fosfat.
20. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što sadrži
(i) fiziološku otopinu s puferiranim pH, gdje je pufer sukcinatni, u konačnoj koncentraciji od 1 mM do 10 mM, uz pH od 5,8 do 6,0,
(ii) polisorbat 80 u konačnoj koncentraciji od 0,01% do 0,05% polisorbata 80, težinski, po volumenu formulacije i
(iii) formulaciju 13-valentnog pneumokoknog konjugata (13vPnC) koja sadrži polisaharid iz bakterije S. pneumoniae serotip 4 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 6B konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 9V konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 14 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 18C konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 19F konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 23F konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 1 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 3 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 5 konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 6A konjugiran s polipeptidom CRM197, polisaharid iz bakterije S. pneumoniae serotip 7F konjugiran s polipeptidom CRM197 i polisaharid iz bakterije S. pneumoniae serotip 19A konjugiran s polipeptidom CRM197.
21. Formulacija u skladu s patentnim zahtjevom 20, naznačena time što je pufer sukcinatni, u konačnoj koncentraciji od 5 mM.
22. Formulacija u skladu s patentnim zahtjevom 21, naznačena time što sol u fiziološkoj otopini s puferiranim pH sadrži natrijev klorid.
23. Formulacija u skladu s patentnim zahtjevom 22, naznačena time što formulacija dodatno sadrži adjuvans, te što je adjuvans aluminijev fosfat.
24. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 23, naznačena time što se formulacija polisaharidno-proteinskog konjugata nalazi u sredstvu za spremanje, koje se bira između jednog ili više iz skupine koju čine vijala, čep za vijalu, zatvarač za vijalu, stakleni zatvarač, gumeni zatvarač, plastični zatvarač, šprica, čep za špricu, klip za špricu, tikvica, čaša, menzura, fermentor, bioreaktor, tuba, cijev, vrećica, posuda, ampula, patrona i jednokratni injektor.
25. Formulacija u skladu s patentnim zahtjevom 24, naznačena time što je spremnik silikoniziran.
26. Spremnik, naznačen time što je napunjen formulacijom u skladu s bilo kojim od patentnih zahtjeva 1 do 23.
27. Spremnik u skladu s patentnim zahtjevom 26, naznačen time što ga se bira iz skupine koju čine tikvice, čaše, menzure, fermentori, bioreaktori, tube, cijevi, vrećice, posude, vijale, ampule, šprice.
28. Spremnik u skladu s patentnim zahtjevom 27, naznačena time što je navedeni spremnik načinjen od stakla, metala ili polimera.
29. Spremnik u skladu s patentnim zahtjevom 27, naznačena time što je navedeni spremnik šprica.
30. Spremnik u skladu s patentnim zahtjevom 27, naznačena time što je navedeni spremnik staklena šprica.
31. Formulacija u skladu s bilo kojim od patentnih zahtjeva 27 do 30, naznačena time što je navedeni spremnik silikoniziran.
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EP07760907.1A EP2010219B1 (en) | 2006-04-26 | 2007-04-19 | Formulations which stabilize and inhibit precipitation of immunogenic compositions |
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HRP20211417TT HRP20211417T1 (hr) | 2006-04-26 | 2021-09-07 | Formulacije koje stabiliziraju i sprječavaju taloženje imunogenih pripravaka |
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HRP20211417TT HRP20211417T1 (hr) | 2006-04-26 | 2021-09-07 | Formulacije koje stabiliziraju i sprječavaju taloženje imunogenih pripravaka |
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EP2589392B1 (en) | 2008-03-05 | 2016-11-30 | Sanofi Pasteur | Process for stabilizing an adjuvant containing vaccine composition |
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