WO2014013090A2 - Formulation comprenant du fingolimod amorphe - Google Patents

Formulation comprenant du fingolimod amorphe Download PDF

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Publication number
WO2014013090A2
WO2014013090A2 PCT/EP2013/073902 EP2013073902W WO2014013090A2 WO 2014013090 A2 WO2014013090 A2 WO 2014013090A2 EP 2013073902 W EP2013073902 W EP 2013073902W WO 2014013090 A2 WO2014013090 A2 WO 2014013090A2
Authority
WO
WIPO (PCT)
Prior art keywords
fingolimod
copolymer
solid composite
divinylbenzene
formulation
Prior art date
Application number
PCT/EP2013/073902
Other languages
English (en)
Other versions
WO2014013090A3 (fr
Inventor
Deepak Murpani
Reinerus Gerardus Gieling
Lisardo ÁLVAREZ FERNÁNDEZ
Original Assignee
Synthon B.V.
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 Synthon B.V. filed Critical Synthon B.V.
Publication of WO2014013090A2 publication Critical patent/WO2014013090A2/fr
Publication of WO2014013090A3 publication Critical patent/WO2014013090A3/fr

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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system

Abstract

La présente invention concerne un composite solide contenant une base de fingolimod et un copolymère d'acide méthacrylique et de divinylbenzène, une formulation pharmaceutique comprenant ledit composite, et l'utilisation du composite solide ou de la formulation pharmaceutique en tant que médicament, en particulier pour le traitement de la sclérose en plaques.
PCT/EP2013/073902 2013-05-06 2013-11-15 Formulation comprenant du fingolimod amorphe WO2014013090A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EPPCT/EP2013/059370 2013-05-06
EP2013059370 2013-05-06

Publications (2)

Publication Number Publication Date
WO2014013090A2 true WO2014013090A2 (fr) 2014-01-23
WO2014013090A3 WO2014013090A3 (fr) 2014-04-03

Family

ID=49622811

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2013/073902 WO2014013090A2 (fr) 2013-05-06 2013-11-15 Formulation comprenant du fingolimod amorphe

Country Status (1)

Country Link
WO (1) WO2014013090A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150165057A1 (en) * 2013-01-15 2015-06-18 Sun Pharmaceutical Industries Ltd. Fingolimod containing stable composition
WO2016042493A1 (fr) 2014-09-19 2016-03-24 Aizant Drug Research Pvt. Ltd Compositions pharmaceutiques de fingolimod

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008037421A2 (fr) * 2006-09-26 2008-04-03 Novartis Ag Composés organiques
EP2198857A1 (fr) * 2008-12-19 2010-06-23 Ratiopharm GmbH Comprimé dispersible oral
EP2505589A1 (fr) * 2011-04-01 2012-10-03 Johann Wolfgang Goethe-Universität Frankfurt am Main Nouveaux composés hétérocycliques de sphingolipides en tant que modulateurs de la signalisation de sphingolipides et leurs utilisations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008037421A2 (fr) * 2006-09-26 2008-04-03 Novartis Ag Composés organiques
EP2198857A1 (fr) * 2008-12-19 2010-06-23 Ratiopharm GmbH Comprimé dispersible oral
EP2505589A1 (fr) * 2011-04-01 2012-10-03 Johann Wolfgang Goethe-Universität Frankfurt am Main Nouveaux composés hétérocycliques de sphingolipides en tant que modulateurs de la signalisation de sphingolipides et leurs utilisations

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150165057A1 (en) * 2013-01-15 2015-06-18 Sun Pharmaceutical Industries Ltd. Fingolimod containing stable composition
US9173948B2 (en) * 2013-01-15 2015-11-03 Sun Pharamaceutical Industries, Ltd. Fingolimod containing stable composition
US9717800B2 (en) 2013-01-15 2017-08-01 Sun Pharmaceutical Industries Ltd. Fingolimod containing stable composition
WO2016042493A1 (fr) 2014-09-19 2016-03-24 Aizant Drug Research Pvt. Ltd Compositions pharmaceutiques de fingolimod

Also Published As

Publication number Publication date
WO2014013090A3 (fr) 2014-04-03

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