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1. WO2018152237 - HEAT STABLE LIQUID ROTAVIRUS VACCINE

Publication Number WO/2018/152237
Publication Date 23.08.2018
International Application No. PCT/US2018/018226
International Filing Date 14.02.2018
IPC
A61K 39/15 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
12Viral antigens
15Reoviridae, e.g. calf diarrhea virus
A61K 9/16 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
C12N 7/00 2006.1
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
7Viruses, e.g. bacteriophages; Compositions thereof; Preparation or purification thereof
CPC
A61K 2039/525
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
51comprising whole cells, viruses or DNA/RNA
525Virus
A61K 2039/5254
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
51comprising whole cells, viruses or DNA/RNA
525Virus
5254avirulent or attenuated
A61K 2039/542
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
54characterised by the route of administration
541Mucosal route
542oral/gastrointestinal
A61K 39/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
12Viral antigens
A61K 39/15
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
12Viral antigens
15Reoviridae, e.g. calf diarrhea virus
A61K 47/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
Applicants
  • INVENTPRISE, LLC [US]/[US]
Inventors
  • KAPRE, Subhash V.
  • OLAVE, Ivan A.
Agents
  • REMENICK, James
  • SMITH, Matthew
Priority Data
62/458,90414.02.2017US
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) HEAT STABLE LIQUID ROTAVIRUS VACCINE
(FR) VACCIN À ROTAVIRUS LIQUIDE STABLE À LA CHALEUR
Abstract
(EN) The invention is directed to an oral vaccine composed of a micronized freeze-dried rotavirus particle emulsion with buffering excipients in a non-aqueous liquid. This IVT-06 formulation has imparted heat stability by protecting the virus at temperatures of 30°C and 40°C for at least twelve months. Extrapolations from the 12-month stability data indicate a shelf life of more than two years at 30°C, and six months at 50°C. In addition, for ease of administration, the formulated dose has a volume of 0.5 mL.
(FR) La présente invention concerne un vaccin oral composé d'une émulsion de particules de rotavirus lyophilisées micronisées avec des excipients tampons dans un liquide non aqueux. Cette formulation IVT -06 présente une stabilité thermique conférée en protégeant le virus à des températures de 30 °C et 40 °C pendant au moins douze mois. Des extrapolations à partir des données de stabilité à 12 mois indiquent une durée de conservation de plus de deux ans à 30 °C, et six mois à 50 °C. De plus, afin de faciliter l'administration, la dose formulée a un volume de 0,5 ml.
Latest bibliographic data on file with the International Bureau