PL3095441T3 - Szybko rozpuszczająca się w jamie ustnej postać dawkowania szczepionki z wykorzystaniem skrobi - Google Patents

Szybko rozpuszczająca się w jamie ustnej postać dawkowania szczepionki z wykorzystaniem skrobi

Info

Publication number
PL3095441T3
PL3095441T3 PL16178493T PL16178493T PL3095441T3 PL 3095441 T3 PL3095441 T3 PL 3095441T3 PL 16178493 T PL16178493 T PL 16178493T PL 16178493 T PL16178493 T PL 16178493T PL 3095441 T3 PL3095441 T3 PL 3095441T3
Authority
PL
Poland
Prior art keywords
starch
dosage form
oral vaccine
dissolving dosage
fast
Prior art date
Application number
PL16178493T
Other languages
English (en)
Inventor
Wei Tian
Rosie Mclaughlin
Original Assignee
R.P. Scherer Technologies, Llc
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 R.P. Scherer Technologies, Llc filed Critical R.P. Scherer Technologies, Llc
Publication of PL3095441T3 publication Critical patent/PL3095441T3/pl

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
    • A61K39/145—Orthomyxoviridae, e.g. influenza 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
    • A61K47/30—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
    • A61K9/0012—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
    • 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
    • A61K9/14—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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
PL16178493T 2010-10-08 2011-10-11 Szybko rozpuszczająca się w jamie ustnej postać dawkowania szczepionki z wykorzystaniem skrobi PL3095441T3 (pl)

Applications Claiming Priority (4)

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
EP16178493.9A EP3095441B1 (en) 2010-10-08 2011-10-11 Oral vaccine fast-dissolving dosage form using starch
PCT/US2011/055689 WO2012048333A1 (en) 2010-10-08 2011-10-11 Oral vaccine fast-dissolving dosage form using starch

Publications (1)

Publication Number Publication Date
PL3095441T3 true PL3095441T3 (pl) 2021-06-14

Family

ID=44908091

Family Applications (1)

Application Number Title Priority Date Filing Date
PL16178493T PL3095441T3 (pl) 2010-10-08 2011-10-11 Szybko rozpuszczająca się w jamie ustnej postać dawkowania szczepionki z wykorzystaniem skrobi

Country Status (17)

Country Link
US (1) US9956169B2 (pl)
EP (2) EP2624815B8 (pl)
JP (2) JP6061859B2 (pl)
KR (1) KR101751964B1 (pl)
CN (2) CN108434089B (pl)
AR (1) AR083361A1 (pl)
AU (1) AU2011312107B2 (pl)
BR (1) BR112013009255B1 (pl)
CA (1) CA2813146C (pl)
DK (2) DK3095441T3 (pl)
ES (2) ES2842290T3 (pl)
HU (1) HUE052853T2 (pl)
MX (2) MX386380B (pl)
PL (1) PL3095441T3 (pl)
PT (1) PT3095441T (pl)
RU (2) RU2639447C2 (pl)
WO (1) WO2012048333A1 (pl)

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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
US11033493B2 (en) 2013-12-02 2021-06-15 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
DK3791395T3 (da) 2019-07-31 2021-09-13 Catalent Uk Swindon Zydis Ltd Densitetsgennemstrømningsmåler til dosering af farmaceutisk formulering
CN116194085A (zh) 2020-09-17 2023-05-30 康特伦英国斯温顿捷迪斯有限公司 基于表面活性剂与高分子量鱼明胶的剂型用于改善流动特性的用途
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
WO2022103635A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

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Also Published As

Publication number Publication date
CA2813146C (en) 2018-12-18
JP6061859B2 (ja) 2017-01-18
MX347101B (es) 2017-04-12
CN108434089B (zh) 2020-06-16
US20120087944A1 (en) 2012-04-12
CA2813146A1 (en) 2012-04-12
ES2602506T3 (es) 2017-02-21
BR112013009255A2 (pt) 2016-07-26
AR083361A1 (es) 2013-02-21
WO2012048333A1 (en) 2012-04-12
MX2013003875A (es) 2013-06-24
EP2624815B1 (en) 2016-08-10
JP2013539766A (ja) 2013-10-28
ES2842290T3 (es) 2021-07-13
RU2017137357A3 (pl) 2019-04-25
EP3095441B1 (en) 2020-12-02
HK1253541A1 (zh) 2019-06-21
BR112013009255B1 (pt) 2021-02-23
KR101751964B1 (ko) 2017-06-28
AU2011312107B2 (en) 2016-06-23
EP2624815A1 (en) 2013-08-14
DK3095441T3 (da) 2021-01-11
PT3095441T (pt) 2021-01-14
JP6403738B2 (ja) 2018-10-10
EP3095441A1 (en) 2016-11-23
KR20140091461A (ko) 2014-07-21
AU2011312107A1 (en) 2013-05-02
HUE052853T2 (hu) 2021-05-28
CN103347494A (zh) 2013-10-09
RU2017137357A (ru) 2019-04-25
CN108434089A (zh) 2018-08-24
MX386380B (es) 2025-03-18
JP2016199605A (ja) 2016-12-01
DK2624815T3 (en) 2016-11-07
US9956169B2 (en) 2018-05-01
RU2639447C2 (ru) 2017-12-21
RU2013119946A (ru) 2014-11-20
EP2624815B8 (en) 2016-09-21

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