BR112014026407A2 - formulação de vacina líquida - Google Patents

formulação de vacina líquida

Info

Publication number
BR112014026407A2
BR112014026407A2 BR112014026407A BR112014026407A BR112014026407A2 BR 112014026407 A2 BR112014026407 A2 BR 112014026407A2 BR 112014026407 A BR112014026407 A BR 112014026407A BR 112014026407 A BR112014026407 A BR 112014026407A BR 112014026407 A2 BR112014026407 A2 BR 112014026407A2
Authority
BR
Brazil
Prior art keywords
vaccine
rotavirus
vaccine formulation
administration
buffers
Prior art date
Application number
BR112014026407A
Other languages
English (en)
Other versions
BR112014026407B1 (pt
Inventor
Mohan Vadrevu Krishna
Devarajulu Prasad Sai
Original Assignee
Bharat Biotech Int Ltd
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 Bharat Biotech Int Ltd filed Critical Bharat Biotech Int Ltd
Publication of BR112014026407A2 publication Critical patent/BR112014026407A2/pt
Publication of BR112014026407B1 publication Critical patent/BR112014026407B1/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/15Reoviridae, e.g. calf diarrhea virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2720/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011Details
    • C12N2720/12011Reoviridae
    • C12N2720/12311Rotavirus, e.g. rotavirus A
    • C12N2720/12334Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Landscapes

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

Abstract

resumo formulação de vacina líquida a invenção provê composições novas de vacina contra rotavírus compreendendo antígenos do rotavírus, estabilizadores e tampões. os tampões na invenção são pré- misturados nas composições de vacina contra rotavírus para neutralizar o ph altamente acídico do estômago sem a necessidade de administração separada de um antiácido antes da administração da vacina. as composições de vacina com tampões da invenção são formulações de vacina contra rotavírus líquidas estáveis para administração oral. 1/1
BR112014026407-4A 2012-04-23 2013-04-23 formulação de vacina líquida BR112014026407B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN667CH2012 2012-04-23
IN667/CHE/2012 2012-04-23
PCT/IN2013/000272 WO2013160913A1 (en) 2012-04-23 2013-04-23 Rotavirus vaccine compositions and process for preparing the same

Publications (2)

Publication Number Publication Date
BR112014026407A2 true BR112014026407A2 (pt) 2017-06-27
BR112014026407B1 BR112014026407B1 (pt) 2020-12-22

Family

ID=48808420

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014026407-4A BR112014026407B1 (pt) 2012-04-23 2013-04-23 formulação de vacina líquida

Country Status (7)

Country Link
US (1) US10568957B2 (pt)
EP (1) EP2945650B1 (pt)
JP (1) JP6126684B2 (pt)
CN (2) CN110227152A (pt)
BR (1) BR112014026407B1 (pt)
RU (1) RU2643929C2 (pt)
WO (1) WO2013160913A1 (pt)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2018007413A (es) * 2015-12-18 2018-08-15 Merck Sharp & Dohme Formulaciones de vacuna contra rotavirus termicamente estable y metodos de uso de la misma.
MA44557B1 (fr) * 2016-06-16 2021-11-30 Bharat Biotech Int Ltd Vaccin contre le rotavirus sans tampon, stable en milieu acide, et d'un faible volume de dose à administrer
GB201614799D0 (en) * 2016-09-01 2016-10-19 Glaxosmithkline Biologicals Sa Compositions
CN110106291A (zh) * 2019-06-03 2019-08-09 中国食品药品检定研究院 猪圆环病毒1型病毒核酸参考品及其制备方法与应用
EP3980058A1 (en) * 2019-06-10 2022-04-13 Boehringer Ingelheim Animal Health USA Inc. Stabilized liquid live vaccine
CN113994925B (zh) * 2021-12-30 2022-04-26 北京赛尔富森生物科技有限公司 一种轮状病毒攻毒动物模型及其建立方法

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4720460A (en) * 1985-04-04 1988-01-19 Miles Laboratories, Inc. Process for preserving acid producing bacteria and compositions produced thereby
US7150984B2 (en) * 1994-07-11 2006-12-19 The United States Of America As Represented By The Department Of Health And Human Services Attenuated human rotavirus vaccine
US6616931B1 (en) 1996-09-26 2003-09-09 Merck & Co., Inc. Rotavirus vaccine formulations
US6403098B1 (en) 1996-09-26 2002-06-11 Merck & Co., Inc. Rotavirus vaccine formulations
US5914135A (en) * 1997-04-16 1999-06-22 Mcneil-Ppc, Inc. Liquid antacid compositions
ES2260046T3 (es) 1999-08-17 2006-11-01 Glaxosmithkline Biologicals S.A. Procedimiento para separar variantes rotavirus y vacuna de rotavirus vivos atenuados.
EP1391513A1 (en) * 2002-08-08 2004-02-25 Cytheris IL-7 drug substance, IL-7 comprising composition, preparation and uses thereof
JP2006517913A (ja) * 2003-02-13 2006-08-03 ベクトン・ディキンソン・アンド・カンパニー 改良型炭疽ワクチンおよび送達方法
GB0503337D0 (en) * 2005-02-17 2005-03-23 Glaxosmithkline Biolog Sa Compositions
PE20070235A1 (es) * 2005-08-17 2007-04-04 Glaxosmithkline Biolog Sa Vacuna que contiene rotavirus atenuado
DE102006054260A1 (de) * 2006-02-28 2007-09-27 Lohmann Animal Health Gmbh & Co. Kg Wasser stabilisierende Zusammensetzung, Verfahren zu deren Herstellung und deren Verwendung
AU2007251122B2 (en) * 2006-05-12 2013-01-10 Bharat Biotech International Limited A composition useful as a vaccine
CA2681159A1 (en) * 2007-03-13 2008-09-18 Peros Systems Technologies, Inc. Immunoactive compositions for improved oral delivery of vaccines and therapeutic agents
US8241886B2 (en) * 2007-09-25 2012-08-14 Aridis Pharmaceuticals Formulations for preservation of rotavirus
BRPI1012170A2 (pt) * 2009-05-20 2016-03-29 Lingual Consegna Pty Ltd formulação e/ou sublingual e método para reduzir a quantidade de composto ativo usado para alcançar um efeito em um paciente em comparação com um composto típico que é ingerido.
BR112012000588A2 (pt) 2009-07-13 2020-08-11 Bharat Biotech International Limited composição, composição líquida, composição liofilizada e método para produzir um rotavirus atenuado
US20110243988A1 (en) * 2009-10-01 2011-10-06 Aridis Pharmaceuticals Methods and Compositions for Stabilization of a Virus Vaccine
EP3225247B1 (en) * 2010-05-28 2020-09-02 3M Innovative Properties Company Aqueous formulations for coating microneedle arrays

Also Published As

Publication number Publication date
EP2945650B1 (en) 2023-07-05
CN104507495A (zh) 2015-04-08
US10568957B2 (en) 2020-02-25
US20150098967A1 (en) 2015-04-09
WO2013160913A1 (en) 2013-10-31
JP6126684B2 (ja) 2017-05-10
CN110227152A (zh) 2019-09-13
JP2015514750A (ja) 2015-05-21
RU2643929C2 (ru) 2018-02-06
BR112014026407B1 (pt) 2020-12-22
EP2945650A1 (en) 2015-11-25
RU2014146772A (ru) 2016-06-10

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/04/2013, OBSERVADAS AS CONDICOES LEGAIS.