BR112017000515A2 - formulação de vacina contra rotavírus termoestável seca por liofilização e processo para preparação da mesma - Google Patents

formulação de vacina contra rotavírus termoestável seca por liofilização e processo para preparação da mesma

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Publication number
BR112017000515A2
BR112017000515A2 BR112017000515A BR112017000515A BR112017000515A2 BR 112017000515 A2 BR112017000515 A2 BR 112017000515A2 BR 112017000515 A BR112017000515 A BR 112017000515A BR 112017000515 A BR112017000515 A BR 112017000515A BR 112017000515 A2 BR112017000515 A2 BR 112017000515A2
Authority
BR
Brazil
Prior art keywords
vaccine formulation
preparing
rotavirus vaccine
rotavirus
lyophilization
Prior art date
Application number
BR112017000515A
Other languages
English (en)
Inventor
Gill Davinder
Sikriwal Deepa
Madan Madhu
Shukla Nidhi
Evans Robert
Kale Sachin
Sharma Tarun
Original Assignee
Msd Wellcome Trust Hilleman Laboratories Pvt 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 Msd Wellcome Trust Hilleman Laboratories Pvt Ltd filed Critical Msd Wellcome Trust Hilleman Laboratories Pvt Ltd
Publication of BR112017000515A2 publication Critical patent/BR112017000515A2/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
    • A61K39/15—Reoviridae, e.g. calf diarrhea 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
    • A61K39/12—Viral antigens
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/19—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
    • A61P31/12—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
    • 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
    • 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
    • C12N2720/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011—Details
    • C12N2720/12011—Reoviridae
    • C12N2720/12311—Rotavirus, e.g. rotavirus A
    • C12N2720/12321—Viruses as such, e.g. new isolates, mutants or their genomic sequences
    • 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
    • C12N2720/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsRNA viruses
    • C12N2720/00011—Details
    • C12N2720/12011—Reoviridae
    • C12N2720/12311—Rotavirus, e.g. rotavirus A
    • C12N2720/12334—Use 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)

Abstract

a presente invenção se refere a uma formulação de vacina contra rotavírus liofilizada termoestável e a um processo de preparação da mesma. mais especificamente, a presente invenção divulga uma formulação de vacina contra rotavírus multivalente termoestável líquida, em pó ou uma formulação de vacina contra rotavírus com base em bolo preparado utilizando o processo de liofilização, de tal modo que a referida formulação da vacina possua estabilidade térmica melhorada, seja de fácil uso e de fácil transporte e altamente acessível, satisfazendo assim os requisitos de desenvolvimento e um programa de vacinação de um país de baixa renda. a referida formulação de vacina liofilizada contra rotavírus é apresentada juntamente com um tampão de reconstituição que é concebida para ser adequada para enchimento em recipientes apropriados para empacotamento / recipientes fechados concebidos de modo tal que eles reduzem o requisito de logística para armazenamento.
BR112017000515A 2014-07-18 2015-07-16 formulação de vacina contra rotavírus termoestável seca por liofilização e processo para preparação da mesma BR112017000515A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2037DE2014 2014-07-18
PCT/IB2015/055383 WO2016009381A2 (en) 2014-07-18 2015-07-16 A thermostable freeze dried rotavirus vaccine formulation and process to prepare thereof

Publications (1)

Publication Number Publication Date
BR112017000515A2 true BR112017000515A2 (pt) 2017-11-14

Family

ID=55079131

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017000515A BR112017000515A2 (pt) 2014-07-18 2015-07-16 formulação de vacina contra rotavírus termoestável seca por liofilização e processo para preparação da mesma

Country Status (9)

Country Link
US (1) US10532093B2 (pt)
EP (1) EP3169313B1 (pt)
JP (1) JP6674945B2 (pt)
KR (1) KR20170028992A (pt)
CN (1) CN106794145A (pt)
AU (1) AU2015291181A1 (pt)
BR (1) BR112017000515A2 (pt)
SG (1) SG11201610921PA (pt)
WO (1) WO2016009381A2 (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130309273A1 (en) 2012-05-17 2013-11-21 Kimberly Hassett Thermostable Vaccine Compositions and Methods of Preparing Same
US11273127B2 (en) 2014-05-06 2022-03-15 The Regents Of The University Of Colorado, A Body Corporate Compositions, methods and uses for thermally stable multi-targeted antigens
WO2017147318A1 (en) 2016-02-23 2017-08-31 The Regents Of The University Of Colorado, A Body Corporate Compositions and methods for making and using thermostable immunogenic formulations with increased compatibility of use as vaccines against one or more pathogens
US11110163B2 (en) 2017-02-14 2021-09-07 Inventprise, Llc Heat stable vaccines
MY191286A (en) * 2017-02-14 2022-06-14 Inventprise Llc Heat stable liquid rotavirus vaccine
US11523988B2 (en) 2018-11-29 2022-12-13 Catalent U.K. Swindon Zydis Limited Oral dispersible vaccine comprising virosomes
CN111948153A (zh) * 2020-07-16 2020-11-17 深圳市锦瑞生物科技有限公司 一种冻干试剂球、生化分析芯片及血清总钙测定方法
CN112675134A (zh) * 2020-12-29 2021-04-20 深圳康泰生物制品股份有限公司 重组乙型肝炎抗原冻干保护剂、重组乙型肝炎抗原冻干疫苗及其制备方法
CN115197918B (zh) * 2022-07-22 2023-07-18 中国生物技术股份有限公司 一种病毒保护剂及其应用

Family Cites Families (14)

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JPS63307827A (ja) * 1987-06-08 1988-12-15 Kitasato Inst:The 安定化された生ウイルスワクチンおよびその製造法
US5626851A (en) * 1987-11-30 1997-05-06 The Wistar Institute Of Anatomy And Biology Rotavirus reassortant vaccine
US6780630B1 (en) * 1992-07-10 2004-08-24 Baylor College Of Medicine Parenteral immunization against rotavirus
DE69738271T2 (de) * 1996-09-26 2008-08-28 Merck & Co., Inc. Rotavirus-impfstoff
US6403098B1 (en) * 1996-09-26 2002-06-11 Merck & Co., Inc. Rotavirus vaccine formulations
US6616931B1 (en) * 1996-09-26 2003-09-09 Merck & Co., Inc. Rotavirus vaccine formulations
MX2008014391A (es) * 2006-05-12 2009-03-06 Bharat Biotech Int Ltd Una composicion util como vacuna.
JP5373618B2 (ja) * 2006-11-02 2013-12-18 オムリクス バイオファーマシューティカルズ リミテッド 微粒化方法
WO2010146598A2 (en) * 2008-11-07 2010-12-23 Serum Institute Of India Ltd. Stable, dried rotavirus vaccine, compositions and process for preparation thereof
US20110293717A1 (en) * 2008-12-08 2011-12-01 Ratiopharm Gmbh Compacted moxifloxacin
RU2553331C2 (ru) * 2009-07-13 2015-06-10 Бхарат Байотек Интернэшнл Лимитед Композиция, применимая в качестве ротавирусной вакцины, и способ ее получения
US20110243988A1 (en) * 2009-10-01 2011-10-06 Aridis Pharmaceuticals Methods and Compositions for Stabilization of a Virus Vaccine
CN101947321B (zh) * 2010-09-30 2012-01-11 郑州后羿制药有限公司 活疫苗用耐热冻干保护剂及其制备方法及鸡新城疫活疫苗
EP2701735A4 (en) * 2011-04-28 2014-11-26 Internat Medica Foundation LIQUID VACCINE COMPOSITIONS

Also Published As

Publication number Publication date
US10532093B2 (en) 2020-01-14
EP3169313A2 (en) 2017-05-24
WO2016009381A3 (en) 2016-03-17
JP2017522327A (ja) 2017-08-10
JP6674945B2 (ja) 2020-04-01
US20170165354A1 (en) 2017-06-15
WO2016009381A2 (en) 2016-01-21
SG11201610921PA (en) 2017-02-27
EP3169313A4 (en) 2018-02-07
KR20170028992A (ko) 2017-03-14
CN106794145A (zh) 2017-05-31
AU2015291181A1 (en) 2017-02-02
EP3169313B1 (en) 2019-08-28

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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements
B350 Update of information on the portal [chapter 15.35 patent gazette]