FR3014317B1 - Nouveau procede de fabrication de formulations pharmaceutiques transmuqueuses et formations ainsi obtenues - Google Patents

Nouveau procede de fabrication de formulations pharmaceutiques transmuqueuses et formations ainsi obtenues

Info

Publication number
FR3014317B1
FR3014317B1 FR1302904A FR1302904A FR3014317B1 FR 3014317 B1 FR3014317 B1 FR 3014317B1 FR 1302904 A FR1302904 A FR 1302904A FR 1302904 A FR1302904 A FR 1302904A FR 3014317 B1 FR3014317 B1 FR 3014317B1
Authority
FR
France
Prior art keywords
production
pharmaceutical formulations
substance
transmucal
formations
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.)
Expired - Fee Related
Application number
FR1302904A
Other languages
English (en)
Other versions
FR3014317A1 (fr
Inventor
Patrice Binay
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.)
Clemann Group Fr
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to FR1302904A priority Critical patent/FR3014317B1/fr
Priority to PCT/FR2014/000265 priority patent/WO2015086918A1/fr
Priority to EP14824036.9A priority patent/EP3079662A1/fr
Priority to US15/104,028 priority patent/US20160361251A1/en
Publication of FR3014317A1 publication Critical patent/FR3014317A1/fr
Application granted granted Critical
Publication of FR3014317B1 publication Critical patent/FR3014317B1/fr
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical 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
    • A61K9/0012Galenical 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/35Allergens
    • A61K39/36Allergens from pollen
    • 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
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne un nouveau procédé de fabrication de formulations pharmaceutiques transmuqueuses et formulations ainsi obtenues. Le procédé concerne la préparation de grains comportant comme principe actif une substance thermolabile et consiste à dissoudre ladite substance dans un mélange ternaire composé de deux liants amphiphiles dont la température de fusion est comprise entre 40 et 60°C et d'un solvant aqueux tel que, notamment, l'eau, une solution hydroalcoolique ou un solvant hydrosoluble. Les grains ainsi obtenus comprennent une substance active thermolabile, deux liants amphiphiles et un support inerte. Application à l'obtention de comprimés translinguaux où la substance active thermolabile est l'adrénaline.
FR1302904A 2013-12-11 2013-12-11 Nouveau procede de fabrication de formulations pharmaceutiques transmuqueuses et formations ainsi obtenues Expired - Fee Related FR3014317B1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
FR1302904A FR3014317B1 (fr) 2013-12-11 2013-12-11 Nouveau procede de fabrication de formulations pharmaceutiques transmuqueuses et formations ainsi obtenues
PCT/FR2014/000265 WO2015086918A1 (fr) 2013-12-11 2014-12-10 Nouveau procédé de fabrication de formulations pharmaceutiques transmuqueuses et formulations ainsi obtenues
EP14824036.9A EP3079662A1 (fr) 2013-12-11 2014-12-10 Nouveau procédé de fabrication de formulations pharmaceutiques transmuqueuses et formulations ainsi obtenues
US15/104,028 US20160361251A1 (en) 2013-12-11 2014-12-10 Novel process for producing transmucosal pharmaceutical formulations and formulations thus obtained

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1302904A FR3014317B1 (fr) 2013-12-11 2013-12-11 Nouveau procede de fabrication de formulations pharmaceutiques transmuqueuses et formations ainsi obtenues

Publications (2)

Publication Number Publication Date
FR3014317A1 FR3014317A1 (fr) 2015-06-12
FR3014317B1 true FR3014317B1 (fr) 2016-04-22

Family

ID=50489135

Family Applications (1)

Application Number Title Priority Date Filing Date
FR1302904A Expired - Fee Related FR3014317B1 (fr) 2013-12-11 2013-12-11 Nouveau procede de fabrication de formulations pharmaceutiques transmuqueuses et formations ainsi obtenues

Country Status (4)

Country Link
US (1) US20160361251A1 (fr)
EP (1) EP3079662A1 (fr)
FR (1) FR3014317B1 (fr)
WO (1) WO2015086918A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3095122B1 (fr) * 2019-04-18 2021-04-09 Crossject Solution pharmaceutique d’adrénaline pour dispositif d’injection

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9003296L (sv) 1990-10-16 1992-04-17 Kabi Pharmacia Ab Foerfarande foer att formulera laekemedel
EP2083799A1 (fr) * 2006-10-20 2009-08-05 Solvay Pharmaceuticals B.V. Nanoparticules micellaires de substances chimiques
US20090060993A1 (en) * 2007-09-04 2009-03-05 Joseph Schwarz Solid pharmaceutical composition for enhanced delivery of coenzyme q-10 and ubiquinones
WO2010045292A2 (fr) * 2008-10-15 2010-04-22 The University Of North Carolina At Chapel Hill Compositions de nanoparticules comportant des noyaux d'huiles liquides
WO2011050457A1 (fr) * 2009-10-26 2011-05-05 The University Of British Columbia Formulation stabilisée pour administration orale d'agents thérapeutiques et méthodes afférentes
US9655849B2 (en) * 2011-03-18 2017-05-23 Particle Dynamics International, Llc Solid particulate compositions comprising coenzyme Q10

Also Published As

Publication number Publication date
WO2015086918A1 (fr) 2015-06-18
FR3014317A1 (fr) 2015-06-12
US20160361251A1 (en) 2016-12-15
EP3079662A1 (fr) 2016-10-19
WO2015086918A9 (fr) 2017-02-23

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Year of fee payment: 3

TP Transmission of property

Owner name: CLEMANN GROUP, FR

Effective date: 20160405

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Effective date: 20200910