AR078169A1 - Formulaciones de vacunas que comprenden adyuvantes con saponina - Google Patents

Formulaciones de vacunas que comprenden adyuvantes con saponina

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Publication number
AR078169A1
AR078169A1 ARP100103323A ARP100103323A AR078169A1 AR 078169 A1 AR078169 A1 AR 078169A1 AR P100103323 A ARP100103323 A AR P100103323A AR P100103323 A ARP100103323 A AR P100103323A AR 078169 A1 AR078169 A1 AR 078169A1
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AR
Argentina
Prior art keywords
ethoxylated
sorbitan
ionic surfactant
hydrophilic
composition
Prior art date
Application number
ARP100103323A
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English (en)
Inventor
Guillaume Rigaut
Noel Joseph Francois Detraz
Original Assignee
Merial Ltd
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Filing date
Publication date
Application filed by Merial Ltd filed Critical Merial Ltd
Publication of AR078169A1 publication Critical patent/AR078169A1/es

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    • A61K39/02Bacterial antigens
    • A61K39/0241Mollicutes, e.g. Mycoplasma, Erysipelothrix
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    • A61K39/135Foot- and mouth-disease virus
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    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, 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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    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
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    • A61K2039/55577Saponins; Quil A; QS21; ISCOMS
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Abstract

Una emulsion de aceite en agua (Ac/Ag), con mayor estabilidad en la presencia de suspensiones bacterianas o virales, en especial las que son concentradas y no purificadas (extractos crudos) o mínimamente purificadas. La emulsion de la presente puede actuar como vehículo para la administracion de una composicion farmacéutica que comprende al menos un inmunogeno y, en particular, un inmunogeno seleccionado del grupo que consiste de un patogeno inactivado, un patogeno atenuado, una subunidad, un vector de expresion recombinante y un plásmido o combinaciones de los mismos. Reivindicacion 1: Una composicion de vacuna que comprende una emulsion de aceite en agua (Ac/Ag) inyectable, caracterizada porque comprende: (i) una solucion acuosa que comprende al menos un inmunogeno; (ii) una solucion acuosa que comprende un agente tensioactivo ionico hidrofílico; (iii) una solucion acuosa opcional que comprende hidroxido de aluminio; (iv) un aceite mineral; (v) un agente tensioactivo no ionico lipofílico; (vi) un agente tensioactivo no ionico hidrofílico que tiene un valor alto de equilibrio hidrofilico-lipofílico (HLB) de entre 13 y 40; y (vii) un agente tensioactivo no ionico hidrofílico que tiene un valor bajo de equilibrio hidrofílico-lipofílico (HLB) de entre 9 y 13. Reivindicacion 2: La composicion de la reivindicacion 1, caracterizada porque el agente tensioactivo ionico hidrofílico es sapona y en donde la concentracion de la saponina es de entre aproximadamente 0,35 mg/dosis y aproximadamente 3,0 mg/dosis y en donde la concentracion de hidroxido de aluminio es de entre aproximadamente 0% y aproximadamente 1,0% (p/v). Reivindicacion 7: La composicion de la reivindicacion 2, caracterizada porque el agente tensioactivo no ionico hidrofílico con un valor bajo de HLB se selecciona del grupo que consiste de triésteres de ácidos grasos y sorbitán etoxilados, diésteres de ácidos grasos y sorbitán etoxilados, monoésteres de ácidos grasos y sorbitán etoxilados, alcoholes grasos etoxilados, ácido grasos etoxilados, aceite de ricino etoxilado y combinaciones de los mismos, y en donde el éster de dicho éster de ácido graso etoxilado se selecciona del grupo que consiste de oleato, palmitato, estearato, isoestearato, laurato y combinaciones de los mismos. Reivindicacion 8: La composicion de la reivindicacion 2, caracterizada porque el agente tensioactivo no ionico lipofílico se selecciona del grupo que consiste de ésteres de ácidos grasos y sorbitán, ésteres de ácidos grasos y manida, ésteres de ácidos grasos y manida dietoxilados, ésteres de ácidos grasos y manida trietoxilados, ésteres de ácidos grasos y manida tetraetoxilados y combinaciones de los mismos, y en donde el éster de los ésteres de ácidos grasos se seleccionan del grupo que consiste de oleato, palmitato, estearato, isoestearato, laurato y combinaciones de los mismos. Reivindicacion 9: La composicion de la reivindicacion 2, caracterizada porque el agente tensioactivo no ionico hidrofílico con valor alto de HLB se selecciona del grupo que consiste de monoésteres de ácidos grasos y sorbitán etoxilados, alcoholes grasos etoxilados, ácido grasos etoxilados, copolímeros de bloques no ionicos y combinaciones de los mismos, y en donde el monoéster de sorbitán etoxilado se selecciona del grupo que consiste de monolaurato de sorbitán etoxilado, monopalmitato de sorbitán etoxilado, monoestearato de sorbitán etoxilado, monooleato de sorbitán etoxilado y combinaciones de los mismos. Reivindicacion 11: La composicion de la reivindicacion 2, caracterizada porque comprende un aceite de parafina, un monoéster de ácido graso y sorbitán como un agente tensioactivo no ionico lipofílico, un triéster de ácido graso y sorbitán etoxilado como agente tensioactivo no ionico hidrofílico con un valor bajo de HLB y un copolímero de bloques no ionicos como agente tensioactivo no ionico hidrofílico con un valor alto de HLB. Reivindicacion 16: La composicion de la reivindicacion 15, caracterizada porque el inmunogeno es un virus de la enfermedad de fiebre aftosa (FMD) inactivado, un virus de circovirus tipo 2 porcino (PCV-2) inactivado o una bacteria Mycoplasma hyopneumoniae inactivada.
ARP100103323A 2009-09-10 2010-09-10 Formulaciones de vacunas que comprenden adyuvantes con saponina AR078169A1 (es)

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EP (1) EP2475384B1 (es)
JP (1) JP5759463B2 (es)
KR (1) KR101746880B1 (es)
CN (2) CN102573900B (es)
AR (2) AR078169A1 (es)
AU (1) AU2010292233B2 (es)
BR (1) BR112012005518B1 (es)
CA (1) CA2773486C (es)
CO (1) CO6531435A2 (es)
CY (1) CY1119052T1 (es)
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PT (1) PT2475384T (es)
RU (1) RU2555342C2 (es)
SG (1) SG179037A1 (es)
SI (1) SI2475384T1 (es)
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