HRP20110803T1 - Stabilizatori za cjepiva osušena zamrzavanjem - Google Patents
Stabilizatori za cjepiva osušena zamrzavanjem Download PDFInfo
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- HRP20110803T1 HRP20110803T1 HR20110803T HRP20110803T HRP20110803T1 HR P20110803 T1 HRP20110803 T1 HR P20110803T1 HR 20110803 T HR20110803 T HR 20110803T HR P20110803 T HRP20110803 T HR P20110803T HR P20110803 T1 HRP20110803 T1 HR P20110803T1
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- 239000003381 stabilizer Substances 0.000 title claims 7
- 229960005486 vaccine Drugs 0.000 title 1
- 230000002163 immunogen Effects 0.000 claims abstract 32
- 150000002772 monosaccharides Chemical class 0.000 claims abstract 22
- 230000002378 acidificating effect Effects 0.000 claims abstract 18
- 239000003963 antioxidant agent Substances 0.000 claims abstract 18
- 230000003078 antioxidant effect Effects 0.000 claims abstract 18
- 230000002238 attenuated effect Effects 0.000 claims abstract 15
- 239000000203 mixture Substances 0.000 claims abstract 11
- 101150002418 cpi-2 gene Proteins 0.000 claims abstract 8
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims abstract 6
- 235000003704 aspartic acid Nutrition 0.000 claims abstract 6
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims abstract 6
- 150000001875 compounds Chemical class 0.000 claims abstract 5
- 241001353878 Canine parainfluenza virus Species 0.000 claims abstract 2
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 claims abstract 2
- 229930091371 Fructose Natural products 0.000 claims abstract 2
- 239000005715 Fructose Substances 0.000 claims abstract 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims abstract 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract 2
- LKDRXBCSQODPBY-AMVSKUEXSA-N L-(-)-Sorbose Chemical compound OCC1(O)OC[C@H](O)[C@@H](O)[C@@H]1O LKDRXBCSQODPBY-AMVSKUEXSA-N 0.000 claims abstract 2
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 claims abstract 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims abstract 2
- 229930182830 galactose Natural products 0.000 claims abstract 2
- 239000008103 glucose Substances 0.000 claims abstract 2
- 235000006708 antioxidants Nutrition 0.000 claims 15
- 229920001542 oligosaccharide Polymers 0.000 claims 14
- 150000002482 oligosaccharides Chemical class 0.000 claims 14
- 150000005846 sugar alcohols Chemical class 0.000 claims 14
- 239000000725 suspension Substances 0.000 claims 14
- 239000000945 filler Substances 0.000 claims 9
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 8
- 241000712083 Canine morbillivirus Species 0.000 claims 8
- 241000701114 Canine adenovirus 2 Species 0.000 claims 6
- 241000701931 Canine parvovirus Species 0.000 claims 6
- 244000052769 pathogen Species 0.000 claims 6
- 230000001717 pathogenic effect Effects 0.000 claims 5
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims 4
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims 4
- 229960005070 ascorbic acid Drugs 0.000 claims 4
- 235000010323 ascorbic acid Nutrition 0.000 claims 4
- 239000011668 ascorbic acid Substances 0.000 claims 4
- 235000013922 glutamic acid Nutrition 0.000 claims 4
- 239000004220 glutamic acid Substances 0.000 claims 4
- 241000701242 Adenoviridae Species 0.000 claims 3
- 241000711573 Coronaviridae Species 0.000 claims 3
- 241000700586 Herpesviridae Species 0.000 claims 3
- 241000701945 Parvoviridae Species 0.000 claims 3
- 241000711931 Rhabdoviridae Species 0.000 claims 3
- 108700010877 adenoviridae proteins Proteins 0.000 claims 3
- 239000013600 plasmid vector Substances 0.000 claims 3
- 239000013603 viral vector Substances 0.000 claims 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 241000700625 Poxviridae Species 0.000 claims 2
- MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 2
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 claims 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- 239000000845 maltitol Substances 0.000 claims 2
- 235000010449 maltitol Nutrition 0.000 claims 2
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 2
- 229940035436 maltitol Drugs 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 229960001855 mannitol Drugs 0.000 claims 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 2
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 229960002920 sorbitol Drugs 0.000 claims 2
- 235000010356 sorbitol Nutrition 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 239000000811 xylitol Substances 0.000 claims 2
- 235000010447 xylitol Nutrition 0.000 claims 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 2
- 229960002675 xylitol Drugs 0.000 claims 2
- 229920002307 Dextran Polymers 0.000 claims 1
- 229920001612 Hydroxyethyl starch Polymers 0.000 claims 1
- 229920002774 Maltodextrin Polymers 0.000 claims 1
- 239000005913 Maltodextrin Substances 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 229940050526 hydroxyethylstarch Drugs 0.000 claims 1
- 229940035034 maltodextrin Drugs 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 238000000859 sublimation Methods 0.000 claims 1
- 230000008022 sublimation Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 241000282465 Canis Species 0.000 abstract 1
- 241000700605 Viruses Species 0.000 abstract 1
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K39/12—Viral antigens
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/155—Paramyxoviridae, e.g. parainfluenza virus
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
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- A61K39/175—Canine distemper virus
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- A61K47/00—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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- 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
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- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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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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- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
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- C12N2710/00011—Details
- C12N2710/10011—Adenoviridae
- C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
- C12N2710/10334—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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Abstract
Stabilizator za zamrzavanjem osušenu živu atenuiranu imunogenu smjesu virusa štenećaka pasa (CDV) i virusa parainfluence pasa tipa 2 (cPi2) koja sadrži najmanje jedan redukcijski monosaharid i najmanje jedan spoj kiselog antioksidansa, pri čemu taj najmanje jedan spoj kiselog antioksidansa sadrži asparaginsku kiselinu; i pri čemu najmanje jedan redukcijski monosaharid sadrži glukozu, galaktozu, fruktozu, manozu, sorbozu ili njihove kombinacije; i pri čemu je najmanje jedan redukcijski monosaharid u koncentraciji od oko 20% do oko 50% tež./tež. i najmanje jedan kiseli antioksidans je u koncentraciji od oko 1.5% do oko 6% tež./tež. Patent sadrži još 14 patentnih zahtjeva.
Claims (15)
1. Stabilizator za zamrzavanjem osušenu živu atenuiranu imunogenu smjesu virusa štenećaka pasa (CDV) i virusa parainfluence pasa tipa 2 (cPi2) koja sadrži najmanje jedan redukcijski monosaharid i najmanje jedan spoj kiselog antioksidansa, pri čemu taj najmanje jedan spoj kiselog antioksidansa sadrži asparaginsku kiselinu; i pri čemu najmanje jedan redukcijski monosaharid sadrži glukozu, galaktozu, fruktozu, manozu, sorbozu ili njihove kombinacije; i pri čemu je najmanje jedan redukcijski monosaharid u koncentraciji od oko 20% do oko 50% tež./tež. i najmanje jedan kiseli antioksidans je u koncentraciji od oko 1.5% do oko 6% tež./tež.
2. Stabilizator prema patentnom zahtjevu 1, koji dalje sadrži
(a) najmanje jedno punilo ili
(b) najmanje jedno punilo pri čemu to najmanje jedno punilo sadrži dekstran, maltodekstrin, polivinilpirolidon, hidroksietil škrob ili njihove kombinacije ili
(c) najmanje jedan šećerni alkohol ili
(d) najmanje jedan šećerni alkohol pri čemu šećerni alkohol sadrži sorbitol, manitol, ksilitol, maltitol ili njihove kombinacije ili
(e) najmanje jedan ne-redukcijski oligosaharid ili
(f) najmanje jedan ne-redukcijski oligosaharid pri čemu najmanje jedan ne-redukcijski oligosaharid sadrži trehalozu, saharozu, rafinozu ili njihove kombinacije ili
(g) najmanje jedan šećerni alkohol i najmanje jedan ne-redukcijski oligosaharid ili
(h) najmanje jedan šećerni alkohol i najmanje jedan ne-redukcijski oligosaharid pri čemu najmanje jedan šećerni alkohol sadrži sorbitol, manitol ksilitol, maltitol ili njihove kombinacije, i pri čemu najmanje jedan ne-redukcijski oligosaharid sadrži trehalozu, saharozu, rafinozu ili njihove kombinacije.
3. Imunogena suspenzija ili otopina koji sadrži živi atenuirani paramiksovirus koji sadrži CDV i cPi2, pomiješan sa stabilizatorom prema patentnom zahtjevu 1 ili 2.
4. Imunogena suspenzija ili otopina prema patentnom zahtjevu 3, gdje je imunogena suspenzija ili otopina multivalentna immunogena suspenzija ili otopina koja dalje sadrži najmanje jednu aktivnu imunogenu komponentu porijeklom od patogena koji se razlikuje od paramiksovirusa.
5. Imunogena suspenzija ili otopina prema patentnom zahtjevu 4, gdje
(a) najmanje jedna aktivna imunogena komponenta porijeklom je od patogena koji sadrži Adenoviridae, Parvoviridae, Coronaviridae, Herpesviridae, Poxvirididae, Rhabdoviridae ili njihove kombinacije ili
(b) najmanje jedna aktivna imunogena komponenta sadrži živi atenuirani adenovirus pasa tipa 2 (CAV2) i živi atenuirani parvovirus pasa (CPV) ili
(c) najmanje jedna aktivna imunogena komponenta sadrži virusni vektor koji sadrži jedan ili više heterolognih imunogena ili
(d) najmanje jedna aktivna imunogena komponenta sadrži plazmidni vektor koji sadrži jedan ili više heterolognih imunogena.
6. Imunogena suspenzija ili otopina prema bilo kojem od patentnih zahtjeva 3 do 5, pri čemu stabilizator sadrži
(a) najmanje jedan redukcijski monosaharid u konačnoj koncentraciji od
oko 1% do oko 5% tež./vol. ili
oko 1.5% do oko 5% tež./vol. ili
oko 1.5% do oko 4% tež./vol. ili
oko 2.5% do oko 3% tež./vol. ili
oko 0.1% do oko 0.3% tež./vol. ili
(b) najmanje jedan spoj kiselog antioksidansa u konačnoj koncentraciji od oko 0.1% do oko 0.25% tež./vol. ili
od oko 0.2% tež./vol. ili
od oko 0.5% do oko 7.5% tež./vol. ili
(c) najmanje jedno punilo u konačnoj koncentraciji od oko 1.5% do oko 5% tež./vol. ili
(d) najmanje jedan šećerni alkohol u konačnoj koncentraciji od oko 0.5% do oko 5% tež./vol. i najmanje jedan redukcijski monosaharid, uz uvjet da je konačna koncentracija najmanje jednog redukcijskog monosaharida i najmanje jednog šećernog alkohola jednaka ili manja od oko 7.5% tež./vol. ili
(e) najmanje jedan ne-redukcijski oligosaharid od oko 0.5% do oko 5% tež./vol. konačne koncentracije i najmanje jedan redukcijski monosaharid, uz uvjet da je konačna koncentracija redukcijskog monosaharida i ne-redukcijskog oligosaharida jednaka ili manja od oko 7.5% tež./vol. Ili
(f) najmanje jedan šećerni alkohol u konačnoj koncentraciji od oko 0.5% do oko 5% tež./vol., najmanje jedan ne-redukcijski oligosaharid u konačnoj koncentraciji od oko 0.5% do oko 5% tež./vol., i najmanje jedan redukcijski monosaharid, uz uvjet da je konačna koncentracija redukcijskog monosaharida, šećernog alkohola i ne-redukcijskog oligosaharida jednaka ili manja od oko 12.5% tež./vol.
7. Imunogena suspenzija ili otopina prema bilo kojem od patentnih zahtjeva 3 do 5, pri čemu stabilizator sadrži:
(a) (i) konačnu koncentraciju od oko 1% do oko 5% tež./vol. smjese dva redukcijska monosaharida, (ii) konačnu koncentraciju od oko 0.1% do oko 0.3% tež./vol. najmanje jednog kiselog antioksidansa, i (iii) konačnu koncentraciju od oko 0.5% do oko 7.5% tež./vol. najmanje jednog punila ili
(b) (i) konačnu koncentraciju od oko 1% do oko 5% tež./vol. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 0.5% do oko 5% tež./vol. najmanje jednog ne-redukcijskog oligosaharida, (iii) konačnu koncentraciju od oko 0.1% do oko 0.3% tež./vol. najmanje jednog kiselog antioksidansa, i (iv) konačnu koncentraciju od oko 0.5% do oko 7.5% tež./vol. najmanje jednog punila, uz uvjet da je konačna koncentracija (i) i (ii) jednaka ili manja od oko 7.5% tež./vol. ili
(c) (i) konačnu koncentraciju od oko 1.5% do oko 4% tež./vol. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 0.5% do oko 2.5% tež./vol. najmanje jednog ne-redukcijskog oligosaharida, (iii) konačnu koncentraciju od oko 0.1% do oko 0.25% tež./vol. najmanje jednog kiselog antioksidansa, i (iv) konačnu koncentraciju od oko 1.5% do oko 5% tež./vol. najmanje jednog punila, uz uvjet da je konačna koncentracija (i) i (ii) jednaka ili manja od oko 5% tež./vol. ili
(d) (i) konačnu koncentraciju od oko 1% do oko 5% tež./vol. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 0.5% do oko 5% tež./vol. najmanje jednog šećernog alkohola, (iii) konačnu koncentraciju od oko 0.1 % do oko 0.3% tež./vol. najmanje jednog kiselog antioksidansa, uz uvjet da je konačna koncentracija (i) i (ii) jednaka ili manja od oko 7.5% tež./vol. ili
(e) (i) konačnu koncentraciju od oko 1.5% do oko 4% tež./vol. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 1.5% do oko 3% tež./vol. najmanje jednog šećernog alkohola, i (iii) konačnu koncentraciju od oko 0.1% do oko 0.25% tež./vol. najmanje jednog kiselog antioksidansa, uz uvjet da je konačna koncentracija (i) i (ii) jednaka ili manja od oko 5% tež./vol. ili
(f) (i) konačnu koncentraciju od oko 1% do oko 5% tež./vol. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 0.5% do oko 5% tež./vol. najmanje jednog šećernog alkohola, (iii) konačnu koncentraciju od oko 0.5% do oko 5% tež./vol. najmanje jednog ne-redukcijskog oligosaharida, i (iv) konačnu koncentraciju od oko 0.1% do oko 0.3% tež./vol. najmanje jednog kiselog antioksidansa, uz uvjet da je konačna koncentracija (i), (ii) i (iii) jednaka ili manja od oko 12.5% tež./vol. ili
(g) (i) konačnu koncentraciju od oko 1.5% do oko 4% tež./vol. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 0.5% do oko 5% tež./vol. najmanje jednog šećernog alkohola, (iii) konačnu koncentraciju od oko 0.5% do oko 2.5% tež./vol. najmanje jednog ne-redukcijskog oligosaharida, i (iv) konačnu koncentraciju od oko 0.1% do oko 0.25% tež./vol. najmanje jednog kiselog antioksidansa, uz uvjet da je konačna koncentracija (i), (ii) i (iii) jednaka ili manja od oko 10% tež./vol.
8. Zamrzavanjem osušena stabilizirana živa atenuirana CDV i cPi2 imunogena smjesa koja sadrži (i) konačnu koncentraciju od oko 20% do oko 50% tež./tež. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 1.5% do oko 6% tež./tež. najmanje jednog kiselog antioksidansa koji sadrži asparaginsku kiselinu, glutaminsku kiselinu, askorbinsku kiselinu ili njihove kombinacije.
9. Imunogena smjesa prema patentnom zahtjevu 8, gdje je (ii) konačna koncentracija najmanje jednog kiselog antioksidansa koji sadrži asparaginsku kiselinu, glutaminsku kiselinu, askorbinsku kiselinu ili njihove kombinacije od oko 2% do oko 6% tež./tež. od najmanje jednog kiselog antioksidansa koji sadrži asparaginsku kiselinu, glutaminsku kiselinu, askorbinsku kiselinu ili njihove kombinacije, i dalje sadrži (iii) konačnu koncentraciju od oko 15% do oko 70% tež./tež. najmanje jednog punila.
10. Imunogena smjesa prema patentnom zahtjevu 8, koja dalje sadrži najmanje jednu aktivnu imunogenu komponentu porijeklom od patogena osim paramiksovirusa.
11. Imunogena smjesa prema patentnom zahtjevu 10, gdje je najmanje jedna aktivna imunogena komponenta
(a) porijeklom od patogena koji sadrži Adenoviridae, Parvoviridae, Coronaviridae, Herpesviridae, Poxviridae, Rhabdoviridae ili njihove kombinacije ili
(b) sadrži živi atenuirani adenovirus tipa 2 pasa (CAV2) i živi atenuirani parvovirus pasa (CPV) ili
(c) sadrži virusni vektor koji sadrži jedan ili više heterolognih imunogena ili
(d) sadrži plazmidni vektor koji sadrži jedan ili više heterolognih imunogena.
12. Zamrzavanjem osušena stabilizirana multivalentna imunogena smjesa koja sadrži živi atenuirani CDV, živi atenuirani cPi2 i najmanje jednu aktivnu imunogenu komponentu porijeklom od patogena osim paramiksovirusa, i koja sadrži:
(i) konačnu koncentraciju od oko 20% do oko 50% tež./tež. najmanje jednog redukcijskog monosaharida, (ii) konačnu koncentraciju od oko 2% do oko 6% tež./tež. najmanje jednog kiselog antioksidansa koji sadrži asparaginsku kiselinu, glutaminsku kiselinu, askorbinsku kiselinu ili njihove kombinacije, i (iii) konačnu koncentraciju od oko 15% do oko 70% tež./tež. najmanje jednog punila.
13. Multivalentna imunogena smjesa prema patentnom zahtjevu 12, gdje je najmanje jedna aktivna imunogena komponenta
(a) porijeklom od patogena koji sadrži Adenoviridae, Parvoviridae, Coronaviridae, Herpesviridae, Poxviridae, Rhabdoviridae ili njihove kombinacije ili
(b) sadrži živi atenuirani adenovirus pasa tipa 2 (CAV2) i živi atenuirani parvovirus pasa (CPV) ili
(c) sadrži virusni vektor koji sadrži jedan ili više heterolognih imunogena ili
(d) sadrži plazmidni vektor koji sadrži jedan ili više heterolognih imunogena.
14. Postupak za sušenje zamrzavanjem imunogene suspenzije ili otopine živog atenuiranog CDV i cPi2, a obuhvaća (a) dovođenje u kontakt suspenzije ili otopine živog atenuiranog CDV i cPi2 sa stabilizatorom prema patentnom zahtjevu 1 ili 2, čime se formira stabilizirana imunogena suspenzija ili otopina; (b) hlađenje, na atmosferskom tlaku, stabilizirane imunogene suspenzije ili otopine do temperature manje od oko Tg vrijednosti stabilizirane imunogene suspenzije; (c) sušenje stabilizirane imunogene suspenzije ili otopine sublimacijom leda na niskom tlaku; i (d) uklanjanje viška preostale vode dodatnim snižavanjem tlaka i povećavanjem temperature stabilizirane imunogene suspenzije ili otopine.
15. Komplet koji sadrži prvu bočicu koja sadrži zamrzavanjem osušenu stabiliziranu živu atenuiranu CDV i cPi2 imunogenu smjesu kako je definirano u bilo kojem od patentnih zahtjeva 8 do 11 ili zamrzavanjem osušenu multivalentnu imunogenu smjesu kako je definirano u patentnom zahtjevu 12, i drugu bočicu koja sadrži otapalo.
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AT (1) | ATE523207T1 (hr) |
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ME (1) | ME01965B (hr) |
PL (1) | PL1954308T3 (hr) |
PT (1) | PT1954308E (hr) |
RS (1) | RS51996B (hr) |
SI (1) | SI1954308T1 (hr) |
WO (1) | WO2007035455A2 (hr) |
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- 2006-09-15 ME MEP-2011-471A patent/ME01965B/me unknown
- 2006-09-15 DK DK06814694.3T patent/DK1954308T3/da active
- 2006-09-15 WO PCT/US2006/035944 patent/WO2007035455A2/en active Application Filing
- 2006-09-15 EP EP06814694A patent/EP1954308B1/en active Active
-
2011
- 2011-11-02 HR HR20110803T patent/HRP20110803T1/hr unknown
- 2011-12-02 CY CY20111101189T patent/CY1112490T1/el unknown
Also Published As
Publication number | Publication date |
---|---|
PL1954308T3 (pl) | 2012-01-31 |
JP2009508866A (ja) | 2009-03-05 |
WO2007035455A2 (en) | 2007-03-29 |
JP5275803B2 (ja) | 2013-08-28 |
ES2373238T3 (es) | 2012-02-01 |
EP1954308B1 (en) | 2011-09-07 |
CY1112490T1 (el) | 2015-12-09 |
SI1954308T1 (sl) | 2011-12-30 |
DK1954308T3 (da) | 2011-10-24 |
CN101312742B (zh) | 2012-07-25 |
US20100260796A1 (en) | 2010-10-14 |
EP1954308A2 (en) | 2008-08-13 |
US8784843B2 (en) | 2014-07-22 |
WO2007035455A3 (en) | 2007-07-26 |
ATE523207T1 (de) | 2011-09-15 |
PT1954308E (pt) | 2011-11-03 |
RS51996B (en) | 2012-04-30 |
CN101312742A (zh) | 2008-11-26 |
ME01965B (me) | 2012-04-30 |
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