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EP3621595A4 - DOSAGE FORM IN FILM FORM WITH SUSTAINED-RELEASE MUCOADHESIVE PARTICLES - Google Patents

DOSAGE FORM IN FILM FORM WITH SUSTAINED-RELEASE MUCOADHESIVE PARTICLES Download PDF

Info

Publication number
EP3621595A4
EP3621595A4 EP18798869.6A EP18798869A EP3621595A4 EP 3621595 A4 EP3621595 A4 EP 3621595A4 EP 18798869 A EP18798869 A EP 18798869A EP 3621595 A4 EP3621595 A4 EP 3621595A4
Authority
EP
European Patent Office
Prior art keywords
sustained
dosage form
mucoadhesive particles
release mucoadhesive
film
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP18798869.6A
Other languages
German (de)
French (fr)
Other versions
EP3621595A1 (en
Inventor
Rodolphe Obeid
Nadine Paiement
Erick Gonzalez
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
IntelGenx Corp
Original Assignee
IntelGenx Corp
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
Priority claimed from US15/588,897 external-priority patent/US10272038B2/en
Application filed by IntelGenx Corp filed Critical IntelGenx Corp
Publication of EP3621595A1 publication Critical patent/EP3621595A1/en
Publication of EP3621595A4 publication Critical patent/EP3621595A4/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/348Cannabaceae
    • A61K36/3482Cannabis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Physiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Inorganic Chemistry (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
EP18798869.6A 2017-05-08 2018-05-08 DOSAGE FORM IN FILM FORM WITH SUSTAINED-RELEASE MUCOADHESIVE PARTICLES Pending EP3621595A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15/588,897 US10272038B2 (en) 2013-12-02 2017-05-08 Film dosage form with extended release mucoadhesive particles
PCT/CA2018/050542 WO2018205017A1 (en) 2017-05-08 2018-05-08 Film dosage form with extended release mucoadhesive particles

Publications (2)

Publication Number Publication Date
EP3621595A1 EP3621595A1 (en) 2020-03-18
EP3621595A4 true EP3621595A4 (en) 2021-04-07

Family

ID=64104064

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18798869.6A Pending EP3621595A4 (en) 2017-05-08 2018-05-08 DOSAGE FORM IN FILM FORM WITH SUSTAINED-RELEASE MUCOADHESIVE PARTICLES

Country Status (3)

Country Link
EP (1) EP3621595A4 (en)
CA (1) CA3062704A1 (en)
WO (1) WO2018205017A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11273105B2 (en) * 2017-06-16 2022-03-15 Sorse Technology Corporation Method for preparing solid forms of plant extract
US10828254B2 (en) 2018-09-28 2020-11-10 Intelgenx Corp. Oral film formulation for modulating absorption profile
US12303501B2 (en) 2018-11-05 2025-05-20 Intelgenx Corp. Lipophilic active oral film formulation and method of making the same
BR112022002479A2 (en) * 2019-08-12 2022-04-26 Tenshi Kaizen Private Ltd Pharmaceutical composition and process for preparing solid oral cannabinoid composition into rapidly disintegrating lyophilized tablets
KR102044515B1 (en) * 2019-08-20 2019-11-14 이영환 Sustained release type orally disintegrating film with excellant oral mucoadhesion and the manufacturing method thereof
US12440472B2 (en) 2021-06-16 2025-10-14 Intelgenx Corp. Stable tryptamine oral films

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002051382A2 (en) * 2000-12-27 2002-07-04 University Of Kentucky Research Foundation Ph-sensitive mucoadhesive film-forming gels and wax-film composites
WO2005009386A2 (en) * 2003-07-24 2005-02-03 Smithkline Beecham Corporation Orally dissolving films
WO2010104464A1 (en) * 2009-03-13 2010-09-16 Excellens Tech. Products Aps Oral delivery product
US20110305768A1 (en) * 2008-07-01 2011-12-15 The Johns Hopkins University Quick-dissolving oral thin film for targeted delivery of therapeutic agents
US20160051510A1 (en) * 2014-07-28 2016-02-25 Eric Allen Oral dissolvable film that includes plant extract

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9668970B2 (en) * 2013-12-02 2017-06-06 Intelgenx Corp. Film dosage form with extended release mucoadhesive particles

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002051382A2 (en) * 2000-12-27 2002-07-04 University Of Kentucky Research Foundation Ph-sensitive mucoadhesive film-forming gels and wax-film composites
WO2005009386A2 (en) * 2003-07-24 2005-02-03 Smithkline Beecham Corporation Orally dissolving films
US20110305768A1 (en) * 2008-07-01 2011-12-15 The Johns Hopkins University Quick-dissolving oral thin film for targeted delivery of therapeutic agents
WO2010104464A1 (en) * 2009-03-13 2010-09-16 Excellens Tech. Products Aps Oral delivery product
US20160051510A1 (en) * 2014-07-28 2016-02-25 Eric Allen Oral dissolvable film that includes plant extract

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
SALAMAT-MILLER N ET AL: "The use of mucoadhesive polymers in buccal drug delivery", ADVANCED DRUG DELIVERY REVIEWS, ELSEVIER, AMSTERDAM , NL, vol. 57, no. 11, 3 November 2005 (2005-11-03), pages 1666 - 1691, XP027771408, ISSN: 0169-409X, [retrieved on 20051103] *
See also references of WO2018205017A1 *

Also Published As

Publication number Publication date
EP3621595A1 (en) 2020-03-18
WO2018205017A1 (en) 2018-11-15
CA3062704A1 (en) 2018-11-15

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