BR112013009524A2 - método de armazenamento de uma vacina contendo um adjuvante de alumínio - Google Patents

método de armazenamento de uma vacina contendo um adjuvante de alumínio

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Publication number
BR112013009524A2
BR112013009524A2 BR112013009524A BR112013009524A BR112013009524A2 BR 112013009524 A2 BR112013009524 A2 BR 112013009524A2 BR 112013009524 A BR112013009524 A BR 112013009524A BR 112013009524 A BR112013009524 A BR 112013009524A BR 112013009524 A2 BR112013009524 A2 BR 112013009524A2
Authority
BR
Brazil
Prior art keywords
storing
aluminum adjuvant
antigen
composition
loading
Prior art date
Application number
BR112013009524A
Other languages
English (en)
Other versions
BR112013009524B1 (pt
Inventor
Ronzon Frédéric
Chacornac Isabelle
Tirefort Julien
Ikhelef-Gribi Nabila
Lentsch Graf Sandrine
Original Assignee
Sanofi Pasteur
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44059027&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112013009524(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Pasteur filed Critical Sanofi Pasteur
Publication of BR112013009524A2 publication Critical patent/BR112013009524A2/pt
Publication of BR112013009524B1 publication Critical patent/BR112013009524B1/pt

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    • 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
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/005—Closures provided with linings or internal coatings so as to avoid contact of the closure with the contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • 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
    • 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
    • A61K39/099—Bordetella
    • 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
    • A61K39/29—Hepatitis virus
    • A61K39/292—Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2539/00—Details relating to closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D2539/001—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2730/00—Reverse transcribing DNA viruses
    • C12N2730/00011—Details
    • C12N2730/10011—Hepadnaviridae
    • C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

método de armazenamento de uma vacina contendo um adjuvante de alumínio a presente invenção refere-se a um método para o carregamento e o armazenamento de uma composição de vacina, que contém o antígeno adsorvido no adjuvante de alumínio, que (a) compreende (i) o carrega-mento da composição em um recipiente, e (ii) o fechamento do recipiente com um dispositivo de atuação especial como uma tampa, a superfície do dispositivo ficando em contato com a composição a ser revestida com um. polímero fluorado, como teflon®, e/ou (b) o carregamento da composição dentro de um recipiente em que a superfície interior a qual é revestida com silicone polimerizado. o uso de polímero fluorado ou silicone polimerizado optimiza a estabilidade do antígeno adsorvido durante a armazenagem. em uma modalidade particular, o antígeno é o antígeno de superfície da hepatite b e o adjuvante de alumínio é hidróxido de óxi alumínio.
BR112013009524-5A 2010-10-18 2011-10-17 recipiente de armazenamento e/ou administração de uma composição de vacina contendo um adjuvante de óxi hidróxi de alumínio e uso do mesmo BR112013009524B1 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
FR1058464A FR2966044B1 (fr) 2010-10-18 2010-10-18 Procede de conditionnement d'un vaccin contenant un adjuvant d'aluminium
FR1058464 2010-10-18
US201161454248P 2011-03-18 2011-03-18
US61/454,248 2011-03-18
PCT/EP2011/068090 WO2012052394A1 (en) 2010-10-18 2011-10-17 Method of storing a vaccine containing an aluminum adjuvant

Publications (2)

Publication Number Publication Date
BR112013009524A2 true BR112013009524A2 (pt) 2018-12-11
BR112013009524B1 BR112013009524B1 (pt) 2021-01-26

Family

ID=44059027

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BR112013009524-5A BR112013009524B1 (pt) 2010-10-18 2011-10-17 recipiente de armazenamento e/ou administração de uma composição de vacina contendo um adjuvante de óxi hidróxi de alumínio e uso do mesmo

Country Status (33)

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US (2) US9066895B2 (pt)
EP (1) EP2629792B1 (pt)
JP (2) JP5890837B2 (pt)
KR (1) KR101875828B1 (pt)
CN (2) CN107753944A (pt)
AP (1) AP2013006876A0 (pt)
AR (2) AR084491A1 (pt)
AU (1) AU2011317649B2 (pt)
BR (1) BR112013009524B1 (pt)
CA (1) CA2811075C (pt)
CR (1) CR20130223A (pt)
CY (1) CY1118557T1 (pt)
DK (1) DK2629792T3 (pt)
EA (1) EA026876B1 (pt)
ES (1) ES2606545T3 (pt)
FR (1) FR2966044B1 (pt)
GE (1) GEP20156238B (pt)
GT (1) GT201300094A (pt)
HR (1) HRP20161637T1 (pt)
HU (1) HUE031210T2 (pt)
IL (1) IL225431A (pt)
LT (1) LT2629792T (pt)
ME (1) ME02614B (pt)
MX (1) MX342345B (pt)
NZ (1) NZ609973A (pt)
PE (1) PE20140850A1 (pt)
PL (1) PL2629792T3 (pt)
PT (1) PT2629792T (pt)
RS (1) RS55520B1 (pt)
SI (1) SI2629792T1 (pt)
UA (1) UA113049C2 (pt)
WO (1) WO2012052394A1 (pt)
ZA (1) ZA201303164B (pt)

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WO2012052394A1 (en) 2012-04-26
US9066895B2 (en) 2015-06-30
FR2966044B1 (fr) 2012-11-02
HRP20161637T1 (hr) 2017-03-10
LT2629792T (lt) 2017-01-10
CN103140239A (zh) 2013-06-05
GEP20156238B (en) 2015-01-26
PL2629792T3 (pl) 2017-07-31
ES2606545T3 (es) 2017-03-24
RS55520B1 (sr) 2017-05-31
EP2629792A1 (en) 2013-08-28
UA113049C2 (xx) 2016-12-12
EA201390585A1 (ru) 2014-03-31
CR20130223A (es) 2013-06-27
ZA201303164B (en) 2014-06-25
SI2629792T1 (sl) 2017-04-26
KR101875828B1 (ko) 2018-07-06
CY1118557T1 (el) 2017-07-12
US9938055B2 (en) 2018-04-10
CN107753944A (zh) 2018-03-06
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AU2011317649B2 (en) 2014-09-18
PE20140850A1 (es) 2014-08-01
CA2811075C (en) 2020-01-14
KR20130126615A (ko) 2013-11-20
IL225431A (en) 2017-07-31
JP2013541380A (ja) 2013-11-14
BR112013009524B1 (pt) 2021-01-26
MX342345B (es) 2016-09-26
FR2966044A1 (fr) 2012-04-20
ME02614B (me) 2017-06-20
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EA026876B1 (ru) 2017-05-31
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CA2811075A1 (en) 2012-04-26
AR120025A2 (es) 2022-01-26
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AR084491A1 (es) 2013-05-22
MX2013003735A (es) 2013-07-29
JP6577369B2 (ja) 2019-09-18
IL225431A0 (en) 2013-06-27
PT2629792T (pt) 2016-12-16
JP2016093534A (ja) 2016-05-26
AP2013006876A0 (en) 2013-05-31
AU2011317649A1 (en) 2013-03-28
US20150259111A1 (en) 2015-09-17

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