WO2012103464A3 - Oral thin film vaccine preparation - Google Patents

Oral thin film vaccine preparation Download PDF

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Publication number
WO2012103464A3
WO2012103464A3 PCT/US2012/022952 US2012022952W WO2012103464A3 WO 2012103464 A3 WO2012103464 A3 WO 2012103464A3 US 2012022952 W US2012022952 W US 2012022952W WO 2012103464 A3 WO2012103464 A3 WO 2012103464A3
Authority
WO
WIPO (PCT)
Prior art keywords
thin film
vaccine preparation
vaccine
rotovirus
oral thin
Prior art date
Application number
PCT/US2012/022952
Other languages
French (fr)
Other versions
WO2012103464A2 (en
Inventor
Brian Pulliam
Original Assignee
Brian Pulliam
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 Brian Pulliam filed Critical Brian Pulliam
Publication of WO2012103464A2 publication Critical patent/WO2012103464A2/en
Publication of WO2012103464A3 publication Critical patent/WO2012103464A3/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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • A61K2039/542—Mucosal route oral/gastrointestinal
    • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Virology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Disclosed herein are methods for thermostable Rotovirus vaccine preparations for oral administration. The preparation of the present invention provides an effective Rotovirus vaccine preparation that has a shelf-life. The thermostable Rotovirus vaccine is prepared on an oral thin film which can be packaged and delivered to remote areas where sources of electricity and refrigeration are cost prohibitive.
PCT/US2012/022952 2011-01-28 2012-01-27 Oral thin film vaccine preparation WO2012103464A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161437463P 2011-01-28 2011-01-28
US61/437,463 2011-01-28

Publications (2)

Publication Number Publication Date
WO2012103464A2 WO2012103464A2 (en) 2012-08-02
WO2012103464A3 true WO2012103464A3 (en) 2012-09-20

Family

ID=46581186

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2012/022952 WO2012103464A2 (en) 2011-01-28 2012-01-27 Oral thin film vaccine preparation
PCT/US2012/022962 WO2012103472A1 (en) 2011-01-28 2012-01-27 Granularized particular thermostable rotovirus vaccine preparation

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/US2012/022962 WO2012103472A1 (en) 2011-01-28 2012-01-27 Granularized particular thermostable rotovirus vaccine preparation

Country Status (1)

Country Link
WO (2) WO2012103464A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2913971C (en) 2013-05-31 2022-08-02 Universal Stabilization Technologies, Inc. Polymeric compositions containing ambient-temperature stable biopharmaceuticals & methods for formulation thereof
US9186386B2 (en) 2014-04-17 2015-11-17 Gary J. Speier Pharmaceutical composition and method of manufacturing
US9044390B1 (en) 2014-04-17 2015-06-02 Gary J. Speier Pharmaceutical composition and method of manufacturing
CN109475508A (en) * 2016-06-07 2019-03-15 阿瑞迪思医药品股份有限责任公司 The preparation method of the instant film containing bioactive materials of thermal stability with enhancing
GB201614799D0 (en) * 2016-09-01 2016-10-19 Glaxosmithkline Biologicals Sa Compositions
WO2020187903A1 (en) * 2019-03-19 2020-09-24 Glaxosmithkline Biologicals Sa Thermostable quick-disolving thin film

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020076440A1 (en) * 1999-06-25 2002-06-20 Thomas Leon Veterinary delivery systems and methods of delivering effective agents to animals
US20030092145A1 (en) * 2000-08-24 2003-05-15 Vic Jira Viral vaccine composition, process, and methods of use
US20040036193A1 (en) * 2002-08-23 2004-02-26 Berry Craig J. Process for manufacturing thin film strips
US20080166372A1 (en) * 2005-02-17 2008-07-10 Glaxosmithkline Biologicals S.A., Live Attenuated Rotavirus Vaccine for Oral Administration
WO2010002418A2 (en) * 2008-07-01 2010-01-07 The Johns Hopkins University Quick-dissolving oral thin film for targeted delivery of therapeutic agents
US20100209455A1 (en) * 2007-09-04 2010-08-19 Baoming Jiang Thermal inactivation of rotavirus

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6616931B1 (en) * 1996-09-26 2003-09-09 Merck & Co., Inc. Rotavirus vaccine formulations
GB0020089D0 (en) * 2000-08-15 2000-10-04 Smithkline Beecham Biolog Vaccine Composition
CA2505521A1 (en) * 2002-11-22 2004-06-10 Meiji Seika Kaisha, Ltd. Granular composition and process for producing the same
GB0414787D0 (en) * 2004-07-01 2004-08-04 Glaxosmithkline Biolog Sa Method
US20090252787A1 (en) * 2006-07-28 2009-10-08 Dr. Reddy's Laboratories Ltd. Granular pharmaceutical compositions
EP3023107A1 (en) * 2008-04-21 2016-05-25 Nanobio Corporation Nanoemulsion influenza vaccine

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020076440A1 (en) * 1999-06-25 2002-06-20 Thomas Leon Veterinary delivery systems and methods of delivering effective agents to animals
US20030092145A1 (en) * 2000-08-24 2003-05-15 Vic Jira Viral vaccine composition, process, and methods of use
US20040036193A1 (en) * 2002-08-23 2004-02-26 Berry Craig J. Process for manufacturing thin film strips
US20080166372A1 (en) * 2005-02-17 2008-07-10 Glaxosmithkline Biologicals S.A., Live Attenuated Rotavirus Vaccine for Oral Administration
US20100209455A1 (en) * 2007-09-04 2010-08-19 Baoming Jiang Thermal inactivation of rotavirus
WO2010002418A2 (en) * 2008-07-01 2010-01-07 The Johns Hopkins University Quick-dissolving oral thin film for targeted delivery of therapeutic agents

Also Published As

Publication number Publication date
WO2012103472A1 (en) 2012-08-02
WO2012103464A2 (en) 2012-08-02

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