DK3095441T3 - Hurtigt opløsende doseringsform af en oral vaccine under anvendelse af stivelse - Google Patents

Hurtigt opløsende doseringsform af en oral vaccine under anvendelse af stivelse Download PDF

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Publication number
DK3095441T3
DK3095441T3 DK16178493.9T DK16178493T DK3095441T3 DK 3095441 T3 DK3095441 T3 DK 3095441T3 DK 16178493 T DK16178493 T DK 16178493T DK 3095441 T3 DK3095441 T3 DK 3095441T3
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DK
Denmark
Prior art keywords
starch
dosage form
oral vaccine
dissolving dosage
quick dissolving
Prior art date
Application number
DK16178493.9T
Other languages
English (en)
Inventor
Rosie Mclaughlin
Wei Tian
Original Assignee
Scherer Technologies Llc R P
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
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Application filed by Scherer Technologies Llc R P filed Critical Scherer Technologies Llc R P
Application granted granted Critical
Publication of DK3095441T3 publication Critical patent/DK3095441T3/da

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    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • A61K2039/542—Mucosal route oral/gastrointestinal
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55583—Polysaccharides
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • 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
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6087—Polysaccharides; Lipopolysaccharides [LPS]
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16151—Methods of production or purification of viral material

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
DK16178493.9T 2010-10-08 2011-10-11 Hurtigt opløsende doseringsform af en oral vaccine under anvendelse af stivelse DK3095441T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US39123810P 2010-10-08 2010-10-08
EP11779263.0A EP2624815B8 (en) 2010-10-08 2011-10-11 Oral vaccine fast-dissolving dosage form using starch

Publications (1)

Publication Number Publication Date
DK3095441T3 true DK3095441T3 (da) 2021-01-11

Family

ID=44908091

Family Applications (2)

Application Number Title Priority Date Filing Date
DK11779263.0T DK2624815T3 (da) 2010-10-08 2011-10-11 Oral vaccine i hurtigt opløsende doseringsform under anvendelse af stivelse
DK16178493.9T DK3095441T3 (da) 2010-10-08 2011-10-11 Hurtigt opløsende doseringsform af en oral vaccine under anvendelse af stivelse

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK11779263.0T DK2624815T3 (da) 2010-10-08 2011-10-11 Oral vaccine i hurtigt opløsende doseringsform under anvendelse af stivelse

Country Status (18)

Country Link
US (1) US9956169B2 (da)
EP (2) EP2624815B8 (da)
JP (2) JP6061859B2 (da)
KR (1) KR101751964B1 (da)
CN (2) CN108434089B (da)
AR (1) AR083361A1 (da)
AU (1) AU2011312107B2 (da)
BR (1) BR112013009255B1 (da)
CA (1) CA2813146C (da)
DK (2) DK2624815T3 (da)
ES (2) ES2602506T3 (da)
HK (1) HK1253541A1 (da)
HU (1) HUE052853T2 (da)
MX (1) MX347101B (da)
PL (1) PL3095441T3 (da)
PT (1) PT3095441T (da)
RU (2) RU2639447C2 (da)
WO (1) WO2012048333A1 (da)

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EP2624815B8 (en) * 2010-10-08 2016-09-21 R.P. Scherer Technologies, LLC Oral vaccine fast-dissolving dosage form using starch
US11033493B2 (en) 2013-12-02 2021-06-15 Intelgenx Corp. Film dosage form with extended release mucoadhesive particles
US9668970B2 (en) * 2013-12-02 2017-06-06 Intelgenx Corp. Film dosage form with extended release mucoadhesive particles
US10272038B2 (en) 2013-12-02 2019-04-30 Intelgenx Corp. Film dosage form with extended release mucoadhesive particles
TWI745278B (zh) * 2014-10-10 2021-11-11 以色列商艾畢克生物實驗有限公司 發泡性降低之疫苗組合物
CN104530489B (zh) * 2015-02-05 2017-07-07 湖南尔康制药股份有限公司 一种速溶于水的淀粉成膜组合物
CN109224191A (zh) * 2018-07-23 2019-01-18 西安交通大学医学院第附属医院 一种用于静脉输液用的无菌输液港辅助植入装置
US11523988B2 (en) * 2018-11-29 2022-12-13 Catalent U.K. Swindon Zydis Limited Oral dispersible vaccine comprising virosomes
EP3791395B1 (en) 2019-07-31 2021-08-11 Catalent U.K. Swindon Zydis Limited Density flow meter for pharmaceutical formulation dosing
BR112023003769A2 (pt) 2020-09-17 2023-03-28 Catalent Uk Swindon Zydis Ltd Uso de tensoativo com formulações de dosagem a base de gelatina de peixe de alto peso molecular para melhorar as características de fluxo
US20230364013A1 (en) 2020-10-08 2023-11-16 Catalent U.K. Swindon Zydis Limited Stable oral dispersible formulation for epinephrine
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

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Also Published As

Publication number Publication date
ES2602506T3 (es) 2017-02-21
CA2813146A1 (en) 2012-04-12
RU2013119946A (ru) 2014-11-20
MX347101B (es) 2017-04-12
JP6403738B2 (ja) 2018-10-10
BR112013009255B1 (pt) 2021-02-23
EP2624815A1 (en) 2013-08-14
HK1253541A1 (zh) 2019-06-21
KR20140091461A (ko) 2014-07-21
CN103347494A (zh) 2013-10-09
EP2624815B1 (en) 2016-08-10
US20120087944A1 (en) 2012-04-12
PL3095441T3 (pl) 2021-06-14
AU2011312107B2 (en) 2016-06-23
EP3095441A1 (en) 2016-11-23
EP2624815B8 (en) 2016-09-21
AR083361A1 (es) 2013-02-21
RU2639447C2 (ru) 2017-12-21
JP2013539766A (ja) 2013-10-28
AU2011312107A1 (en) 2013-05-02
MX2013003875A (es) 2013-06-24
KR101751964B1 (ko) 2017-06-28
US9956169B2 (en) 2018-05-01
BR112013009255A2 (pt) 2016-07-26
DK2624815T3 (da) 2016-11-07
CN108434089A (zh) 2018-08-24
JP2016199605A (ja) 2016-12-01
WO2012048333A1 (en) 2012-04-12
PT3095441T (pt) 2021-01-14
CN108434089B (zh) 2020-06-16
ES2842290T3 (es) 2021-07-13
JP6061859B2 (ja) 2017-01-18
HUE052853T2 (hu) 2021-05-28
RU2017137357A (ru) 2019-04-25
RU2017137357A3 (da) 2019-04-25
CA2813146C (en) 2018-12-18
EP3095441B1 (en) 2020-12-02

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