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 PDFInfo
- 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
- Authority
- DK
- Denmark
- Prior art keywords
- starch
- dosage form
- oral vaccine
- dissolving dosage
- quick dissolving
- Prior art date
Links
Classifications
-
- 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
- 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
- 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
- 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)
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) | EP3095441B1 (da) |
JP (2) | JP6061859B2 (da) |
KR (1) | KR101751964B1 (da) |
CN (2) | CN103347494A (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 (2) | MX386380B (da) |
PL (1) | PL3095441T3 (da) |
PT (1) | PT3095441T (da) |
RU (2) | RU2639447C2 (da) |
WO (1) | WO2012048333A1 (da) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MX386380B (es) * | 2010-10-08 | 2025-03-18 | Scherer Technologies Llc R P | Forma de dosis de disolución rápida de vacuna oral que usa almidón. |
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 |
PL3791395T3 (pl) | 2019-07-31 | 2022-01-24 | Catalent U.K. Swindon Zydis Limited | Gęstościomierz przepływowy do dozowania formulacji farmaceutycznej |
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 |
GB2615464B (en) | 2020-10-08 | 2025-01-01 | Catalent Uk Swindon Zydis Ltd | Stable oral dispersible formulation for epinephrine and salts or solvates thereof |
US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
Family Cites Families (38)
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GB1548022A (en) | 1976-10-06 | 1979-07-04 | Wyeth John & Brother Ltd | Pharmaceutial dosage forms |
US5079018A (en) * | 1989-08-14 | 1992-01-07 | Neophore Technologies, Inc. | Freeze dry composition and method for oral administration of drugs, biologicals, nutrients and foodstuffs |
IT1250421B (it) | 1991-05-30 | 1995-04-07 | Recordati Chem Pharm | Composizione farmaceutica a rilascio controllato con proprieta' bio-adesive. |
BR9405996A (pt) * | 1993-03-11 | 1995-12-19 | Secretech Inc | Mucoadesivos poliméricos na distribuição de imunógenos em superfícies mucosais |
GB9517062D0 (en) * | 1995-08-18 | 1995-10-25 | Scherer Ltd R P | Pharmaceutical compositions |
AU7682896A (en) * | 1995-10-13 | 1997-04-30 | Zynaxis, Inc. | Solid, orally administrable viral vaccines and methods of preparation |
GB9700878D0 (en) * | 1997-01-17 | 1997-03-05 | Scherer Ltd R P | Dosage forms and method for ameliorating male erectile dysfunction |
US5976577A (en) * | 1997-07-11 | 1999-11-02 | Rp Scherer Corporation | Process for preparing fast dispersing solid oral dosage form |
EP1579851A3 (en) * | 1997-08-29 | 2009-09-02 | Corixa Corporation | Rapid release encapsulated bioactive agents for inducing or potentiating an immune response and methods of use thereof |
GB9722682D0 (en) * | 1997-10-27 | 1997-12-24 | Scherer Ltd R P | Pharmaceutical products |
US20040265377A1 (en) | 1997-10-27 | 2004-12-30 | Harry Seager | Solid dispersing vaccine composition for oral delivery |
GB9901819D0 (en) * | 1999-01-27 | 1999-03-17 | Scherer Corp R P | Pharmaceutical compositions |
GB9908014D0 (en) * | 1999-04-08 | 1999-06-02 | Scherer Corp R P | Pharmaceutical compositions |
WO2001034801A2 (en) | 1999-11-12 | 2001-05-17 | Fibrogen, Inc. | Recombinant gelatin in vaccines |
EP1120109A3 (en) * | 2000-01-24 | 2002-07-10 | Pfizer Products Inc. | Rapidly disintegrating and fast dissolving solid dosage form |
GB0020089D0 (en) | 2000-08-15 | 2000-10-04 | Smithkline Beecham Biolog | Vaccine Composition |
US6509040B1 (en) | 2001-06-22 | 2003-01-21 | R.P. Scherer Corporation | Fast dispersing dosage forms essentially free of mammalian gelatin |
GB0210397D0 (en) * | 2002-05-07 | 2002-06-12 | Ferring Bv | Pharmaceutical formulations |
DE60307082T4 (de) * | 2002-05-07 | 2015-04-30 | Ferring B.V. | In der mundhöhle dispergierbare phamarzeutische zusammensetzung mit desmopressin |
KR20050052467A (ko) * | 2002-08-12 | 2005-06-02 | 다이나박스 테크놀로지 코퍼레이션 | 면역조절 조성물, 이의 제조방법 및 이의 이용방법 |
AU2003280324A1 (en) * | 2002-11-26 | 2004-06-18 | Alk-Abello A/S | Pharmaceutical allergen product |
US8012505B2 (en) * | 2003-02-28 | 2011-09-06 | Alk-Abello A/S | Dosage form having a saccharide matrix |
JP2006525308A (ja) * | 2003-05-02 | 2006-11-09 | ワーナー−ランバート カンパニー リミティド ライアビリティー カンパニー | 耐熱性および耐湿性が改善された変性デンプンを含有する速溶性の経口消耗フィルム |
AU2004281634B2 (en) | 2003-09-03 | 2011-01-27 | Dendritherapeutics, Inc. | Multiplex vaccines |
US7972621B2 (en) * | 2004-06-03 | 2011-07-05 | R.P. Scherer Technologies, Llc | Process for formulating fast dispersing dosage forms comprising at least one fish gelatin selected on the basis of molecular weight |
US20090155351A1 (en) | 2005-10-04 | 2009-06-18 | Alk-Abello A/S | Solid Vaccine Formulation |
US20070166239A1 (en) * | 2006-01-13 | 2007-07-19 | Haixiang Lin | Mucosal immunogenic substances comprising a polyinosinic acid - polycytidilic acid based adjuvant |
WO2008002663A2 (en) * | 2006-06-28 | 2008-01-03 | The Board Of Trustees Of The Leland Stanford Junior University | Immunogenic protein constructs |
US20110059130A1 (en) * | 2007-08-20 | 2011-03-10 | Fraunhofer Usa, Inc. | Prophylactic and therapeutic influenza vaccines, antigens, compositions and methods |
EP2247284B1 (en) * | 2008-02-28 | 2017-04-19 | R.P. Scherer Technologies, LLC | Process to minimize polymorphism |
JP2011526888A (ja) * | 2008-07-01 | 2011-10-20 | ザ・ジョンズ・ホプキンス・ユニバーシティ | 治療薬を標的送達するための経口速溶性薄膜 |
WO2010036970A2 (en) * | 2008-09-25 | 2010-04-01 | Fraunhofer Usa, Inc. | Influenza vaccines, antigens, compositions, and methods |
KR101074271B1 (ko) * | 2009-06-25 | 2011-10-17 | (주)차바이오앤디오스텍 | 불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름 |
US8545879B2 (en) * | 2009-08-31 | 2013-10-01 | Wilmington Pharmaceuticals, Llc | Fast disintegrating compositions of meloxicam |
KR101612073B1 (ko) * | 2009-10-30 | 2016-04-14 | 아이엑스 바이오파마 리미티드 | 신속 용해 고체 투약 제형 |
GB201009273D0 (en) | 2010-06-03 | 2010-07-21 | Glaxosmithkline Biolog Sa | Novel vaccine |
RU2539209C2 (ru) * | 2010-07-08 | 2015-01-20 | Вм. Ригли Дж. Компани | Кондитерское изделие и способ его изготовления |
MX386380B (es) * | 2010-10-08 | 2025-03-18 | Scherer Technologies Llc R P | Forma de dosis de disolución rápida de vacuna oral que usa almidón. |
-
2011
- 2011-10-11 MX MX2017004866A patent/MX386380B/es unknown
- 2011-10-11 JP JP2013533011A patent/JP6061859B2/ja active Active
- 2011-10-11 AR ARP110103727A patent/AR083361A1/es not_active Application Discontinuation
- 2011-10-11 US US13/270,411 patent/US9956169B2/en active Active
- 2011-10-11 WO PCT/US2011/055689 patent/WO2012048333A1/en active Application Filing
- 2011-10-11 EP EP16178493.9A patent/EP3095441B1/en active Active
- 2011-10-11 CN CN2011800590592A patent/CN103347494A/zh active Pending
- 2011-10-11 RU RU2013119946A patent/RU2639447C2/ru not_active Application Discontinuation
- 2011-10-11 KR KR1020137011905A patent/KR101751964B1/ko active Active
- 2011-10-11 DK DK11779263.0T patent/DK2624815T3/da active
- 2011-10-11 CN CN201810325584.8A patent/CN108434089B/zh active Active
- 2011-10-11 EP EP11779263.0A patent/EP2624815B8/en active Active
- 2011-10-11 HU HUE16178493A patent/HUE052853T2/hu unknown
- 2011-10-11 MX MX2013003875A patent/MX347101B/es active IP Right Grant
- 2011-10-11 ES ES11779263.0T patent/ES2602506T3/es active Active
- 2011-10-11 BR BR112013009255-6A patent/BR112013009255B1/pt active IP Right Grant
- 2011-10-11 DK DK16178493.9T patent/DK3095441T3/da active
- 2011-10-11 PL PL16178493T patent/PL3095441T3/pl unknown
- 2011-10-11 AU AU2011312107A patent/AU2011312107B2/en active Active
- 2011-10-11 PT PT161784939T patent/PT3095441T/pt unknown
- 2011-10-11 ES ES16178493T patent/ES2842290T3/es active Active
- 2011-10-11 CA CA2813146A patent/CA2813146C/en active Active
-
2016
- 2016-09-09 JP JP2016176393A patent/JP6403738B2/ja active Active
-
2017
- 2017-10-25 RU RU2017137357A patent/RU2017137357A/ru unknown
-
2018
- 2018-10-08 HK HK18112743.5A patent/HK1253541A1/zh unknown
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