AR070800A1 - Proceso para estabilizar una composicion para vacuna que contiene adyuvantes. kit - Google Patents

Proceso para estabilizar una composicion para vacuna que contiene adyuvantes. kit

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Publication number
AR070800A1
AR070800A1 ARP090100787A ARP090100787A AR070800A1 AR 070800 A1 AR070800 A1 AR 070800A1 AR P090100787 A ARP090100787 A AR P090100787A AR P090100787 A ARP090100787 A AR P090100787A AR 070800 A1 AR070800 A1 AR 070800A1
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AR
Argentina
Prior art keywords
composition
influenza virus
antigens
process according
microgranules
Prior art date
Application number
ARP090100787A
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English (en)
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Sanofi Pasteur
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Publication date
Application filed by Sanofi Pasteur filed Critical Sanofi Pasteur
Publication of AR070800A1 publication Critical patent/AR070800A1/es

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/0208—Specific bacteria not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/102—Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
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    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/285—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Pasteurellaceae (F), e.g. Haemophilus influenza
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    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16151—Methods of production or purification of viral material
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    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16211—Influenzavirus B, i.e. influenza B virus
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
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Abstract

Reivindicacion 1: Un proceso para estabilizar una composicion para vacuna contra la gripe que comprende los pasos de diluir una composicion líquida a granel que comprende un antígeno de la gripe o una preparacion antigénica de una cepa del virus de la gripe estacional, prepandémica o pandémica mediante una solucion acuosa que comprende un carbohidrato y/o un alcohol de azucar o una mezcla de estos para obtener un contenido entre el 2% (p/v) y el limite de solubilidad de los carbohidratos y/o alcoholes de azucar de la composicion diluida obtenida, someter la composicion diluida a un proceso para formar gotitas regulares con un diámetro de entre aproximadamente 200 micrometros y aproximadamente 1500 micrometros, someter las gotitas regulares a congelamiento en un medio congelante para formar microgránulos o partículas esféricos regulares congelados y deshidratar los microgránulos o partículas esféricos regulares congelados para formar microgránulos o partículas esféricos regulares deshidratados con un diámetro de aproximadamente 200 micrometros a aproximadamente 1500 micrometros. Reivindicacion 6: El proceso de acuerdo con cualquiera de las reivindicaciones 1 a 5, en donde la composicion líquida a granel comprende además uno o más antígenos de gripe o preparaciones antigénicas adicionales, cada uno proveniente de una cepa diferente del virus de la gripe estacional, prepandémica o pandémica, para obtener microgránulos o partículas esféricos regulares deshidratados, cada uno comprende dos o más antígenos de gripe o preparaciones antigénicas de dos o más cepas diferentes del virus de la gripe estacional, prepandémica o pandémica. Reivindicacion 10: El proceso de acuerdo con cualquiera de las reivindicaciones 1 a 9, que además comprende la adicion de una solucion acuosa que comprende uno o más adyuvantes y, como opcion, un estabilizador para la composicion de antígenos líquida a granel. Reivindicacion 12: El proceso de acuerdo con las reivindicaciones 10 u 11, en donde el adyuvante pertenece al grupo integrado por liposomas, micelios de lípidos o detergentes u otras partículas lipídicas, nanopartículas o micropartículas poliméricas, polímeros solubles, partículas de proteínas, geles minerales, nanopartículas o micropartículas minerales, nanohíbridos de polímero/aluminio, emulsiones aceite en agua o agua en aceite, extractos de saponina, extractos de la pared celular bacteriana, estimuladores de los receptores de la inmunidad innata, en particular agonistas naturales o sintéticos de TLR, agonistas naturales o sintéticos de NOD y agonistas naturales o sintéticos de RIG. Reivindicacion 13: El proceso de acuerdo con cualquiera de las reivindicaciones 1 a 12, en donde las cepas del virus de la gripe pertenecen al grupo integrado por H5N1, H9N2, H7N7, H2N2, H7N1 y H1N1. Reivindicacion 15: El proceso de acuerdo con cualquiera de las reivindicaciones 1 a 14, en donde el antígeno de la gripe está en una forma perteneciente al grupo integrado por virus entero purificado de la gripe, virus de la gripe o componentes subunitarios del virus de la gripe inactivados. Reivindicacion 16: El proceso de acuerdo con la reivindicacion 15, en donde el virus inactivado de la gripe es un virus ôsplitö (fraccionado) de la gripe. Reivindicacion 33: Una composicion para vacuna, deshidratada, estabilizada que comprende uno o más antígenos cuya composicion es en forma de microgránulos o partículas esféricos regulares deshidratados con un diámetro de aproximadamente 200 ?m a aproximadamente 1500 ?m que se pueden obtener por el proceso de acuerdo con una o más de las reivindicaciones 24 a 32. Reivindicacion 35: La composicion de acuerdo con la reivindicacion 33 en donde cada perla o partícula regular comprende uno o más tipos diferentes de antígenos. Reivindicacion 38: La composicion de acuerdo con cualquiera de las reivindicaciones 33 a 37 en donde el antígeno o los antígenos pertenecen al grupo integrado por virus enteros o componentes antigénicos de virus, vivos, atenuados e inactivados, tales como Polio, Gripe, Rotavirus, citomegalovirus y Hepatitis A y B, y bacterias enteras o antígenos (conjugados o no conjugados) de proteínas o polisacáridos de bacterias, tales como polisacáridos meningococidos, tétanos, difteria, pertussis celular y acelular, botulismo y ántrax.
ARP090100787A 2008-03-05 2009-03-05 Proceso para estabilizar una composicion para vacuna que contiene adyuvantes. kit AR070800A1 (es)

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EP08290216 2008-03-05

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US (3) US8551527B2 (es)
EP (2) EP2254594B1 (es)
JP (1) JP5689687B2 (es)
KR (1) KR101695800B1 (es)
CN (2) CN101959527B (es)
AR (1) AR070800A1 (es)
AU (1) AU2009221180B2 (es)
BR (1) BRPI0909820A2 (es)
CA (1) CA2716399C (es)
ES (1) ES2615390T3 (es)
IL (1) IL207308A (es)
MX (1) MX2010008799A (es)
WO (1) WO2009109550A1 (es)
ZA (1) ZA201006225B (es)

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