SG11201610920WA - An improved thermostable spray dried rotavirus vaccine formulation and process thereof - Google Patents

An improved thermostable spray dried rotavirus vaccine formulation and process thereof

Info

Publication number
SG11201610920WA
SG11201610920WA SG11201610920WA SG11201610920WA SG11201610920WA SG 11201610920W A SG11201610920W A SG 11201610920WA SG 11201610920W A SG11201610920W A SG 11201610920WA SG 11201610920W A SG11201610920W A SG 11201610920WA SG 11201610920W A SG11201610920W A SG 11201610920WA
Authority
SG
Singapore
Prior art keywords
spray dried
vaccine formulation
rotavirus vaccine
dried rotavirus
improved thermostable
Prior art date
Application number
SG11201610920WA
Inventor
Dr Davinder Gill
Dr Nitin Saigal
Dr Sachin Kale
Dr Tarun Sharma
Dr Nidhi Shukla
Dr Deepa Sikriwal
Dr Robert Evans
Original Assignee
Msd Wellcome Trust Hilleman Lab 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 Lab Pvt Ltd filed Critical Msd Wellcome Trust Hilleman Lab Pvt Ltd
Publication of SG11201610920WA publication Critical patent/SG11201610920WA/en

Links

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
    • 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
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • 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
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • 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
    • A61K2039/51—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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—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
    • 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
    • C12N2720/12334—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • C12N2720/12351—Methods of production or purification of viral material
SG11201610920WA 2014-07-18 2015-07-17 An improved thermostable spray dried rotavirus vaccine formulation and process thereof SG11201610920WA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2039DE2014 2014-07-18
PCT/IB2015/055427 WO2016009400A2 (en) 2014-07-18 2015-07-17 An improved thermostable spray dried rotavirus vaccine formulation and process thereof

Publications (1)

Publication Number Publication Date
SG11201610920WA true SG11201610920WA (en) 2017-02-27

Family

ID=55079132

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201610920WA SG11201610920WA (en) 2014-07-18 2015-07-17 An improved thermostable spray dried rotavirus vaccine formulation and process thereof

Country Status (8)

Country Link
US (1) US10556000B2 (en)
EP (1) EP3169359A4 (en)
JP (1) JP6674944B2 (en)
KR (1) KR20170029579A (en)
CN (1) CN106687132B (en)
AU (1) AU2015291200A1 (en)
SG (1) SG11201610920WA (en)
WO (1) WO2016009400A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11110163B2 (en) 2017-02-14 2021-09-07 Inventprise, Llc Heat stable vaccines
US10413604B2 (en) 2017-02-14 2019-09-17 Inventprise, Llc Heat stable liquid rotavirus vaccine
EP4058056A1 (en) 2020-10-07 2022-09-21 Valneva Sweden AB Cholera vaccine formulation

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP4809533B2 (en) * 1998-11-20 2011-11-09 オバン・エナジー・リミテッド Dispersible phospholipid stabilized microparticles
JP4792457B2 (en) * 2004-03-26 2011-10-12 ユニヴァーシタ’デグリ ステュディ ディ パルマ Highly breathable insulin microparticles
US8241886B2 (en) * 2007-09-25 2012-08-14 Aridis Pharmaceuticals Formulations for preservation of rotavirus
US8268354B2 (en) * 2007-11-07 2012-09-18 Aridis Pharmaceuticals Sonic low pressure spray drying
BRPI0915696B8 (en) * 2008-11-07 2021-05-25 Serum Institute Of India Ltd lyophilized rotavirus vaccine composition and method of preparing said composition
TR201802619T4 (en) * 2009-05-20 2018-03-21 Aeras Stable, spray-dried, immunogenic, viral compounds.
US20110243988A1 (en) * 2009-10-01 2011-10-06 Aridis Pharmaceuticals Methods and Compositions for Stabilization of a Virus Vaccine
US20110154404A1 (en) 2009-12-17 2011-06-23 At & T Intellectual Property I, L.P. Systems and Methods to Provide Data Services for Concurrent Display with Media Content Items
GB201002419D0 (en) 2010-02-12 2010-03-31 Isis Innovation Stable live vaccine formulations
US20120219590A1 (en) * 2011-02-24 2012-08-30 Paxvax, Inc. Formulations useful for spray drying vaccines
EP2709657B1 (en) * 2011-05-17 2018-10-24 Soligenix, Inc. Thermostable vaccine compositions and methods of preparing same

Also Published As

Publication number Publication date
WO2016009400A3 (en) 2016-03-17
WO2016009400A2 (en) 2016-01-21
KR20170029579A (en) 2017-03-15
US10556000B2 (en) 2020-02-11
AU2015291200A1 (en) 2017-02-02
CN106687132A (en) 2017-05-17
CN106687132B (en) 2021-12-03
US20170173145A1 (en) 2017-06-22
JP2017524695A (en) 2017-08-31
EP3169359A4 (en) 2018-04-18
JP6674944B2 (en) 2020-04-01
EP3169359A2 (en) 2017-05-24

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