DK2830599T3 - Site-specifikke gastrointestinale orale vaccineformuleringer med virkning på ileum og appendix - Google Patents

Site-specifikke gastrointestinale orale vaccineformuleringer med virkning på ileum og appendix Download PDF

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DK2830599T3
DK2830599T3 DK13769010.3T DK13769010T DK2830599T3 DK 2830599 T3 DK2830599 T3 DK 2830599T3 DK 13769010 T DK13769010 T DK 13769010T DK 2830599 T3 DK2830599 T3 DK 2830599T3
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antigen
virus
vaccine
oral
capsule
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DK13769010.3T
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Mohan Kabadi
Jerome J Schentag
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Therabiome Llc
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Claims (18)

1. Oral vaccineformulering, som afgiver et antigen i nærheden af den distale ileum i mave-tarm-kanalen og appendix, hvilken formulering omfatter: (a) en flerhed af kerner, hvoraf hver omfatter: (1) et antigen; (2) en første enterisk coating, som indkapsler antigenet, som er i det væsentlige uopløselig ved en pH-værdi på mindre end et område mellem ca. 7,0 til ca. 7,6, og som består af en eller flere sammensætninger, der er udvalgt fra gruppen bestående af poly(dl-lactid-co-glycolid, chitosan (Chi) stabiliseret med PVA (polyvinylalkohol), en lipid, et alginat, carboxymethylethylcellulose (CMEC), celluloseacetattrimellitiat (CAT), hydroxypropylmethylcellulosephtha-lat (HPMCP), hydroxypropylmethylcellulose, ethylcellulose, fødevareglasur og blandinger af hydroxypropylmethylcellulose og ethylcellulose, polyvinylace-tatphthalat (PVAP), celluloseacetatphthalat (CAP), shellak, copolymerer af methacrylsyre og ethylacrylat og copolymerer af methacrylsyre og ethylacrylat, hvortil en monomer af methylacrylat er blevet tilsat under polymerisering; og (3) en anden enterisk coating, som med hensyn til sammensætning er forskellig fra den første coating, som er i det væsentlige uopløselig ved en pH-værdi på mindre end et område mellem ca. 5,0 til ca. 6,5, som er indkapslet i den første coating, og som består af en eller flere sammensætninger udvalgt fra gruppen bestående af polyvinylacetatphthalat (PVAP), celluloseacetatphthalat (CAP), shellak, copolymerer af methacrylsyre og ethylacrylat og copolymerer af methacrylsyre og ethylacrylat, hvortil en monomer af methylacrylat er blevet tilsat under polymerisering.
2. Oral vaccine formulation ifølge krav 1, hvor antigenet er et virus, der kommer ind via mave-tarm-kanalen.
3. Oral vaccineformulering ifølge krav 1, hvor antigenet er udvalgt fra gruppen bestående af: (a) et virus eller et antigen afledt deraf, udvalgt fra gruppen bestående af Adenoviridae, Flaviviridae, Herpesviridae, Herpadnaviridae, Orthomyxoviri-dae, Papovaviridae, Paramyxoviridae, Picornaviridae, Poxviridae, Reoviridae, Retroviridae, Rhabdoviridae og Togaviridae; (b) intracellulære patogener eller parasitter eller antigen afledt deraf udvalgt fra gruppen bestående af Afipia spp, Brucella spp, Burkholderia pseudomallei, Chlamydia, Coxiella burnetii, Francisella tularensis, Legionella pneumophila, Listeria monocytogenes, Mycobacterium avium, Mycobacterium leprae, Myco-bacterium tuberculosis, Neisseria gonorrhoeae, Rickettsiae, Salmonella typhi, Shigella dysenteriae, Yersinia pestis, Plasmodium spp, Theileria parva, Toxo-plasma gondii, Cryptosporidium parvum, Leishmania, Trypanosoma cruzi og Cryptococcus neoformans, Giardia, Cryptosporidia; eller (c) et vektoroverført antigen, herunder Plasmodium eller borrelia', eller (d) tarmbakterie eller antigen afledt deraf, herunder kolera, salmonella, Shigella, Campylobacter, Leptospirosis, Helicobacter pylori og enterotoksigen e-coli, herunder E. Coli 0157, og L/ster/a-bakterier, herunder staphylococcus au-reus og Streptococcus pneumoniae·, og (e) et cancerrelateret antigen, som er påvist at være immunogent hos humane patienter, og mere specifikt er udvalgt fra gruppen bestående af ONT-10, rettet mod MUC1, og andre målrettede terapeutiske vacciner af Oncothyreon med eller uden den ledsagende adjuvans PET-Lipid A; NY-ESO-1-antigen til blære-, hjerne-, bryst-, øsofagus-, gastrointestinale, hepatocellulære, nyre-, lunge-, melanom-, ovarie-, prostata-, sarkom og livmodertumorer, GD2-gang-liosid, 47-LDA-mimotop af GD2, varmechokproteiner, cancer testis (CT)-anti-gener, epitelial ovariecancer (EOC)-antigen; cervikal og ovarie-, pancreas-, hepatocellulære, colon-, bryst-, lunge- og hjernecancer-antigener.
4. Oral vaccineformulering ifølge krav 2, hvor antigenet er en komponent af et virus, som er påvist at være immunogent hos humane patienter, og mere specifikt udvalgt fra gruppen bestående af adenovirus, herpes simplex, varicella zoster, cytomegalovirus, Epstein Barr-virus, hepatitis A-virus, hepatitis B-virus, hepatitis C-virus, influenzavirus, humane papillomavira, parainfluenzavirus, mæslingevirus, respiratorisk syncytialvirus, poliovirus, Coxsackie-virus, rhino-virus, vacciniavirus, variolavirus, rotavirus, human T-lymfotrofisk virus-1, human immundefektvirus (HIV), rabiesvirus, rubellavirus, arbovirus, enterovira, såsom polio-, cocksackie- og Norwalk-virus.
5. Oral vaccineformulering ifølge krav 2, hvor antigenet er et svækket levende virus.
6. Oral vaccineformulering ifølge et hvilket som helst af kravene 1-5, hvor antigenet er iblandet et adjuvansstof til forstærkning af immunreaktion.
7. Kapsel i en oral vaccineformulering i kapselform, som afgiver et antigen i nærheden af den distale ileum og højre tyktarm eller appendix, hvilken formulering omfatter: (a) en første kapsel omfattende: (1) et antigen og eventuelt en adjuvans; (2) en første enterisk coating, som indkapsler den første kapsel, som er i det væsentlige uopløselig ved en pH-værdi på mindre end et område mellem ca. 7,0 til ca. 7,6, og som består af en eller flere sammensætninger, der er udvalgt fra gruppen bestående af poly(dl-lactid)-co-glycolid, chitosan (Chi) stabiliseret med PVA (polyvinylalkohol), en lipid, et alginat, carboxymethylethylcellulose (CMEC), celluloseacetattrimellitiat (CAT), hydroxypropylmethylcellulosephtha-lat (HPMCP), hydroxypropylmethylcellulose, ethylcellulose, fødevareglasur og blandinger af hydroxypropylmethylcellulose og ethylcellulose, polyvinylace-tatphthalat (PVAP), celluloseacetatphthalat (CAP), shellak, copolymerer af methacrylsyre og ethylacrylat og copolymerer af methacrylsyre og ethylacrylat, hvortil en monomer af methylacrylat er blevet tilsat under polymerisering; og (b) en anden kapsel, der er indkapslet i den første kapsel, omfattende: (1) antigenet og eventuelt en adjuvans; og (2) en enterisk coating, som indkapsler den anden kapsel, som er i det væsentlige uopløselig ved en pH-værdi på mindre end et område mellem ca. 5,0 til ca. 6,5, og som er udvalgt fra gruppen bestående af shellak, copolymerer af methacrylsyre og ethylacrylat og copolymerer af methacrylsyre og ethylacrylat, hvortil en monomer af methylacrylat er blevet tilsat under polymerisering; hvor den anden kapsel eksponeres, når den første kapsel er opløst i den distale ileum.
8. Kapsel i en oral vaccineformulering i kapselform ifølge krav 7, hvor antigenet er et svækket levende virus.
9. Oral vaccineformulering ifølge krav 1, hvor antigenet er blandet med et næringsstof udvalgt fra gruppen bestående af sukre, frie fedtsyrer, polypeptider, aminosyrer og sammensætninger, der frigør sukre, frie fedtsyrer, polypeptider eller aminosyrer ved fordøjelse, og det blandede antigen og næringsstof er indkapslet af den første enteriske coating.
10. Oral vaccineformulering ifølge krav 1, hvor kernerne er mikropartikler med en gennemsnitlig diameter på mellem ca. 1 nanometer til ca. 100 mikrometer i diameter.
11. Oral vaccineformulering ifølge krav 10, hvor kernerne af den første kernepopulation og den anden kernepopulation er mikropartikler, den gennemsnitlige diameter af kernerne af den første kernepopulation er større end den gennemsnitlige diameter af kernerne af den anden kernepopulation, kernerne af den anden kernepopulation har en gennemsnitlig diameter på mellem ca. 1 nanometer til ca. 99 mikrometer i diameter, og kernerne af den første kernepopulation har en gennemsnitlig diameter på mellem ca. 2 nanometer til ca. 100 mikrometer.
12. Kapsel i en oral vaccineformulering i kapselform ifølge krav 7, hvor antigenet er blandet med et næringsstof udvalgt fra gruppen bestående af sukre, frie fedtsyrer, polypeptider, aminosyrer og sammensætninger, der frigør sukre, frie fedtsyrer, polypeptider eller aminosyrer ved fordøjelse, og hvor det blandede antigen og næringsstof er indkapslet af den første enteriske coating.
13. Kapsel i en oral vaccineformulering i kapselform ifølge krav 7, hvor antigenet er et virus udvalgt fra gruppen bestående af adenovirus, herpes simplex, varicella zoster, cytomegalovirus, Epstein Barr-virus, hepatitis A-virus, hepatitis B-virus, hepatitis C-virus, influenzavirus, humane papillomavira, parainflu-enzavirus, mæslingevirus, respiratorisk syncytialvirus, poliovirus, Coxsackie-virus, rhinovirus, vacciniavirus, variolavirus, rotavirus, human T-lymfotrofisk vi-rus-1, human immundefektvirus (HIV), rabiesvirus, rubellavirus, arbovirus, en-terovira, såsom polio-, cocksackie- og Norwalk-virus.
14. Kapsel i en oral vaccineformulering i kapselform ifølge krav 7, hvor antigenet er et antigen til tarmbakterier udvalgt fra gruppen bestående af kolera, salmonella, Shigella, Campylobacter, Leptospirosis, Helicobacter pylori og enter-otoksigen e-coli, herunder E. Coli 0157, og L/ster/a-bakterier, Staphylococcus aureus og Streptococcus pneumoniae.
15. Kapsel i en oral vaccineformulering i kapselform ifølge krav 7, hvor antigenet er et virus udvalgt fra gruppen bestående af Adenoviridae, Flaviviridae, Herpesviridae, Herpadnaviridae, Orthomyxoviridae, Papovaviridae, Paramyx-oviridae, Picornaviridae, Poxviridae, Reoviridae, Retroviridae, Rhabdoviridae og Togaviridae.
16. Kapsel i en oral vaccineformulering i kapselform ifølge krav 7, hvor antigenet er et intracellulært patogen eller parasit udvalgt fra gruppen bestående af Afipia spp, Brucella spp, Burkholderia pseudomallei, Chlamydia, Coxiella bur-netii, Francisella tularensis, Legionella pneumophila, Listeria monocytogenes, Mycobacterium avium, Mycobacterium leprae, Mycobacterium tuberculosis, Neisseria gonorrhoeae, Rickettsiae, Salmonella typhi, Shigella dysenteriae, Yersinia pestis, Plasmodium spp, Theileria parva, Toxoplasma gondii, Crypto-sporidium parvum, Leishmania, Trypanosoma cruzi og Cryptococcus neofor-mans, Giardia og Cryptosporidia.
17. Kapsel i en oral vaccineformulering i kapselform ifølge krav 7, hvor antigenet er et antigen til tarmbakterier, herunder kolera, salmonella, Shigella, Cam-pylobacter, Leptospirosis, Helicobacter pylori og enterotoksigen e-coli, herunder E. Coli 0157, og L/ster/a-bakterier, herunder Staphylococcus aureus og Streptococcus pneumoniae.
18. Farmaceutisk virksom mængde af en oral vaccineformulering ifølge et hvilket som helst af kravene 1-6 til anvendelse ved behandling eller forebyggelse af opståen af en virussygdom.
DK13769010.3T 2012-03-29 2013-03-14 Site-specifikke gastrointestinale orale vaccineformuleringer med virkning på ileum og appendix DK2830599T3 (da)

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