AR078558A1 - Excipiente estabilizante para una vacuna de virus completo inactivado - Google Patents

Excipiente estabilizante para una vacuna de virus completo inactivado

Info

Publication number
AR078558A1
AR078558A1 ARP100103658A AR078558A1 AR 078558 A1 AR078558 A1 AR 078558A1 AR P100103658 A ARP100103658 A AR P100103658A AR 078558 A1 AR078558 A1 AR 078558A1
Authority
AR
Argentina
Prior art keywords
composition
free
vaccine composition
vaccine
virus
Prior art date
Application number
Other languages
English (en)
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
Application filed by Sanofi Pasteur filed Critical Sanofi Pasteur
Publication of AR078558A1 publication Critical patent/AR078558A1/es

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Classifications

    • 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
    • A61K39/205—Rhabdoviridae, e.g. rabies virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/26—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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61P31/14—Antivirals for RNA viruses
    • 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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5252—Virus inactivated (killed)
    • 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
    • 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
    • C12N2760/20011—Rhabdoviridae
    • C12N2760/20111—Lyssavirus, e.g. rabies virus
    • C12N2760/20134—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

La presente se refiere a una composicion de vacuna que comprende: a) virus entero inactivado, y b) un excipiente estabilizante que comprende: i) una solucion amortiguadora, ii) una mezcla de aminoácidos esenciales y no esenciales, iii) un disacárido, iv) un poliol, v) un agente quelante, vi) urea o un derivado de la urea, y vii) un tensioactivo no ionico. Reivindicacion 2: La composicion que se reivindica en la reivindicacion 1, donde el virus entero inactivado es el virus de la rabia. Reivindicacion 3: La composicion que se reivindica en la reivindicacion 1 o 2, donde la composicion de vacuna está libre de cualquier proteína sérica. Reivindicacion 4: La composicion que se reivindica en una de las reivindicaciones 1 a 3, donde la composicion de vacuna está libre de cualquier proteína exogena de origen animal y, con preferencia, libre de cualquier producto de origen animal. Reivindicacion 5: La composicion que se reivindica en una de las reivindicaciones 1 a 4, donde las proteínas de los virus están presentes al menos en un nivel del 70% de las proteínas totales que se encuentran en la composicion de vacuna. Reivindicacion 9: La composicion que se reivindica en una de las reivindicaciones 1 a 8, donde, el excipiente estabilizante está libre de proteínas, o de cualquier proteína y cualquier péptido o, con preferencia, libre de cualquier proteína, cualquier péptido y cualquier oligopéptido. Reivindicacion 10: La composicion que se reivindica en una de las reivindicaciones 1 a 9, donde la mezcla de aminoácidos esenciales y no esenciales comprende, al menos, arginina o una sal de arginina y ácido glutámico o una sal de ácido glutámico. Reivindicacion 12: La composicion que se reivindica en una de las reivindicaciones 1 a 11, donde el disacárido es maltosa. Reivindicacion 13: La composicion que se reivindica en una de las reivindicaciones 1 a 12, donde el poliol es sorbitol. Reivindicacion 14: La composicion que se reivindica en una de las reivindicaciones 1 a 13, donde la cantidad total de disacáridos y de poliol contenida en una dosis eficaz de la composicion de vacuna se encuentra en el rango de entre 10 mg y 50 mg. Reivindicacion 15: La composicion que se reivindica en una de las reivindicaciones 1 a 15, donde el agente quelante es EDTA o una sal de EDTA. Reivindicacion 17: La composicion que se reivindica en una de las reivindicaciones 1 a 16, donde la cantidad de urea o de derivado de urea contenida en una dosis eficaz de la composicion de vacuna se encuentra en el rango de entre 0,3 mg y 1,5 mg. Reivindicacion 19: La composicion que se reivindica en una de las reivindicaciones 1 a 18, donde el poloxámero es poloxámero 188. Reivindicacion 21: La composicion que se reivindica en una de las reivindicaciones 1 a 20, donde el pH de la composicion de vacuna es de entre 7 y 10 y, con preferencia, entre 7 y 9. Reivindicacion 28: Una composicion de vacuna liofilizada que contiene una preparacion de virus entero inactivado y purificado que se obtiene conforme al proceso de la reivindicacion 27.
ARP100103658 2009-10-07 2010-10-07 Excipiente estabilizante para una vacuna de virus completo inactivado AR078558A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR0904795 2009-10-07

Publications (1)

Publication Number Publication Date
AR078558A1 true AR078558A1 (es) 2011-11-16

Family

ID=42123015

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP100103658 AR078558A1 (es) 2009-10-07 2010-10-07 Excipiente estabilizante para una vacuna de virus completo inactivado
ARP200100627A AR118273A2 (es) 2009-10-07 2020-03-06 Excipiente estabilizante para una vacuna de virus completo inactivado

Family Applications After (1)

Application Number Title Priority Date Filing Date
ARP200100627A AR118273A2 (es) 2009-10-07 2020-03-06 Excipiente estabilizante para una vacuna de virus completo inactivado

Country Status (15)

Country Link
US (2) US8557253B2 (es)
EP (2) EP2485766B1 (es)
CN (1) CN102281900B (es)
AR (2) AR078558A1 (es)
AU (1) AU2010304898B2 (es)
BR (1) BR112012008000B1 (es)
ES (1) ES2862910T3 (es)
MA (1) MA33723B1 (es)
MX (1) MX338300B (es)
PE (1) PE20121405A1 (es)
PL (1) PL2485766T3 (es)
PT (1) PT2485766T (es)
RU (1) RU2560675C2 (es)
WO (1) WO2011042663A1 (es)
ZA (1) ZA201202758B (es)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8557253B2 (en) * 2009-10-07 2013-10-15 Sanofi Pasteur Sa Stabilizing excipient for inactivated whole virus vaccine
FR2960781B1 (fr) * 2010-06-07 2013-11-22 Sanofi Pasteur Preparation d'un vaccin oral sec stabilise, compose d'un virus vivant attenue
BR112013005049A2 (pt) * 2010-09-02 2016-05-31 Sanofi Pasteur estabilizador para a preparação de uma composição vacina da pólio seca injetável
AU2012260807B2 (en) * 2011-05-26 2016-05-12 Glaxosmithkline Biologicals Sa Inactivated Dengue virus vaccine
EP3744833A1 (en) 2011-06-28 2020-12-02 Leukocare Ag Stabilisation method for viruses
US9314519B2 (en) 2012-08-21 2016-04-19 Intervet Inc. Liquid stable virus vaccines
TWI690322B (zh) * 2012-10-02 2020-04-11 法商傳斯堅公司 含病毒的調配物及其使用
US9480739B2 (en) * 2013-03-15 2016-11-01 Intervet Inc. Bovine virus vaccines that are liquid stable
US9393298B2 (en) 2013-03-15 2016-07-19 Intervet Inc. Liquid stable bovine virus vaccines
EP3041504B1 (en) 2013-09-03 2021-08-25 Georgia Tech Research Corporation Thermally stable vaccine formulations and microneedles
AR097762A1 (es) 2013-09-27 2016-04-13 Intervet Int Bv Formulaciones secas de vacunas que son estables a temperatura ambiente
US10588957B2 (en) 2013-10-25 2020-03-17 Leukocare Ag Method for the production of stabile vaccines
AR099470A1 (es) 2014-02-17 2016-07-27 Intervet Int Bv Vacunas de virus de aves de corral líquidas
TWI670085B (zh) 2014-02-19 2019-09-01 荷蘭商英特威國際公司 液體穩定之豬病毒疫苗
CN104548085B (zh) * 2014-12-09 2018-01-19 吕宏亮 一种口蹄疫全病毒颗粒疫苗组合物及其制备方法和应用
CN105816879A (zh) * 2016-03-17 2016-08-03 广州市嘉合生物技术有限公司 用于提高冻干病毒疫苗在常温下保存的效力的冻干稳定剂
WO2018050873A1 (en) * 2016-09-16 2018-03-22 Leukocare Ag A novel method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation
JP7051132B2 (ja) 2016-09-16 2022-04-11 ロイコケア・アクチェンゲゼルシャフト ワクチン接種または遺伝子治療のための効率的なウイルスベクターベースの組成物を得るための新規方法
US20190256551A1 (en) * 2016-09-16 2019-08-22 Leukocare Ag A novel method of producing a liquid biopharmaceutical drug product
GB201815011D0 (en) * 2018-09-14 2018-10-31 Adaptimmune Ltd Viral assay method
US20220193222A1 (en) * 2018-11-30 2022-06-23 Vaccine Stabilization Institute Viral formulations containing amino acids
WO2021092392A1 (en) * 2019-11-07 2021-05-14 Cornell University Use of membrane inhibitors to enhance vaccine development against enveloped viruses
CN112245394B (zh) * 2020-10-21 2022-10-11 成都柏奥特克生物科技股份有限公司 一种疫苗保护剂
WO2023023371A1 (en) * 2021-08-20 2023-02-23 Vaccine Stabilization Institute Formulations containing amino acids for stabilizing lipid enveloped viral and non-viral vectors
CN114377127B (zh) * 2022-01-25 2023-10-24 天津市中升挑战生物科技有限公司 一种三联卵黄抗体制剂及其制备方法和应用

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JPS577423B2 (es) 1972-12-29 1982-02-10
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Also Published As

Publication number Publication date
RU2012118386A (ru) 2013-11-20
AU2010304898B2 (en) 2015-03-19
US20110081380A1 (en) 2011-04-07
PL2485766T3 (pl) 2021-09-06
PE20121405A1 (es) 2012-11-02
CN102281900A (zh) 2011-12-14
MX2012003935A (es) 2012-05-08
AU2010304898A1 (en) 2012-05-17
BR112012008000B1 (pt) 2021-07-13
EP3915586A1 (fr) 2021-12-01
EP2485766B1 (fr) 2020-12-30
RU2560675C2 (ru) 2015-08-20
BR112012008000A2 (pt) 2016-03-29
WO2011042663A1 (fr) 2011-04-14
MX338300B (es) 2016-04-11
US8557253B2 (en) 2013-10-15
CN102281900B (zh) 2013-07-03
US20140037684A1 (en) 2014-02-06
PT2485766T (pt) 2021-03-18
MA33723B1 (fr) 2012-11-01
ES2862910T3 (es) 2021-10-08
US9028839B2 (en) 2015-05-12
AR118273A2 (es) 2021-09-22
ZA201202758B (en) 2013-06-26
EP2485766A1 (fr) 2012-08-15

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