WO2014013090A3 - Formulation comprenant du fingolimod amorphe - Google Patents

Formulation comprenant du fingolimod amorphe Download PDF

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Publication number
WO2014013090A3
WO2014013090A3 PCT/EP2013/073902 EP2013073902W WO2014013090A3 WO 2014013090 A3 WO2014013090 A3 WO 2014013090A3 EP 2013073902 W EP2013073902 W EP 2013073902W WO 2014013090 A3 WO2014013090 A3 WO 2014013090A3
Authority
WO
WIPO (PCT)
Prior art keywords
fingolimod
formulation
amorphous
pharmaceutical formulation
composite
Prior art date
Application number
PCT/EP2013/073902
Other languages
English (en)
Other versions
WO2014013090A2 (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

    • 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
    • A61K9/141Intimate 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
    • A61K9/146Intimate 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
    • 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
    • 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
    • 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
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs 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 WO2014013090A2 (fr) 2014-01-23
WO2014013090A3 true 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)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2015131034A (ru) * 2013-01-15 2017-02-01 Сан Фармасьютикал Индастрис Лтд. Устойчивая композиция, содержащая финголимод
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

Also Published As

Publication number Publication date
WO2014013090A2 (fr) 2014-01-23

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