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DE13169139T1 - Zusammensetzungen und deren Verwendung zur Behandlung von Multipler Sklerose - Google Patents

Zusammensetzungen und deren Verwendung zur Behandlung von Multipler Sklerose Download PDF

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Publication number
DE13169139T1
DE13169139T1 DE13169139.6T DE13169139T DE13169139T1 DE 13169139 T1 DE13169139 T1 DE 13169139T1 DE 13169139 T DE13169139 T DE 13169139T DE 13169139 T1 DE13169139 T1 DE 13169139T1
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fumarate
administered
monomethyl
dimethyl fumarate
dimethyl
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Matvey E. Lukashev
Gilmore O'neill
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Biogen MA Inc
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    • GPHYSICS
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    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
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    • G01N33/502Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects
    • AHUMAN NECESSITIES
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    • 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
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
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    • 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
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    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/194Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
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    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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    • A61K31/47Quinolines; Isoquinolines
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Abstract

Pharmazeutische Zusammensetzung zur Verwendung bei der Behandlung Multipler Sklerose, wobei die Zusammensetzung Folgendes umfasst:(a) Fumarsäuredimethylester oder Fumarsäuremonomethylester und(b) einen oder mehrere pharmazeutisch unbedenkliche Arzneimittelträger, wobei die Zusammensetzung einem Patienten mit Behandlungsbedarf bei Multipler Sklerose oral zu verabreichen ist und wobei die zu verabreichende Dosis Fumarsäuredimethylester oder Fumarsäuremonomethylester etwa 480 mg bis etwa 720 mg pro Tag beträgt.

Claims (21)

  1. Pharmazeutische Zusammensetzung zur Verwendung bei der Behandlung Multipler Sklerose, wobei die Zusammensetzung Folgendes umfasst: (a) Fumarsäuredimethylester oder Fumarsäuremonomethylester und (b) einen oder mehrere pharmazeutisch unbedenkliche Arzneimittelträger, wobei die Zusammensetzung einem Patienten mit Behandlungsbedarf bei Multipler Sklerose oral zu verabreichen ist und wobei die zu verabreichende Dosis Fumarsäuredimethylester oder Fumarsäuremonomethylester etwa 480 mg bis etwa 720 mg pro Tag beträgt.
  2. Pharmazeutische Zusammensetzung zur Verwendung nach Anspruch 1, wobei die Zusammensetzung Fumarsäuredimethylester und einen oder mehrere pharmazeutisch unbedenkliche Arzneimittelträger umfasst.
  3. Pharmazeutische Zusammensetzung zur Verwendung nach Anspruch 1, wobei die Zusammensetzung Fumarsäuremonomethylester und einen oder mehrere pharmazeutisch unbedenkliche Arzneimittelträger umfasst.
  4. Pharmazeutische Zusammensetzung zur Verwendung nach irgendeinem der Ansprüche 1 bis 3, wobei die zu verabreichende Dosis Fumarsäuredimethylester oder Fumarsäuremonomethylester etwa 480 mg pro Tag beträgt.
  5. Pharmazeutische Zusammensetzung zur Verwendung nach irgendeinem der Ansprüche 1 bis 4, wobei die Zusammensetzung in Form einer Tablette, einer Suspension oder einer Kapsel zu verabreichen ist.
  6. Pharmazeutische Zusammensetzung zur Verwendung nach irgendeinem der Ansprüche 1 bis 5, wobei der Fumarsäuredimethylester und/oder Fumarsäuremonomethylester in getrennten Verabreichungen von 2, 3, 4 oder 6 gleichen Dosen zu verabreichen ist.
  7. Pharmazeutische Zusammensetzung zur Verwendung nach Anspruch 6, wobei die Dosis von Fumarsäuredimethylester oder Fumarsäuremonomethylester in getrennten Verabreichungen von 2 gleichen Dosen zu verabreichen ist.
  8. Pharmazeutische Zusammensetzung zur Verwendung nach Anspruch 6, wobei die Dosis von Fumarsäuredimethylester oder Fumarsäuremonomethylester in getrennten Verabreichungen von 3 gleichen Dosen zu verabreichen ist.
  9. Pharmazeutische Zusammensetzung zur Verwendung nach irgendeinem der Ansprüche 1 bis 8, wobei die Zusammensetzung dem Patienten 5, 10, 12, 20, 40, 52, 100 oder 200 Wochen lang oder länger zu verabreichen ist.
  10. Pharmazeutische Zusammensetzung zur Verwendung nach irgendeinem der Ansprüche 1 bis 9, wobei die Zusammensetzung dem Patienten für mindestens 12 Wochen zu verabreichen ist.
  11. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung bei der Behandlung Multipler Sklerose, wobei der Fumarsäuredimethylester oder Fumarsäuremonomethylester einem Patienten mit Behandlungsbedarf bei Multipler Sklerose mit einer Dosis von etwa 480 mg bis etwa 720 mg pro Tag oral zu verabreichen ist.
  12. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach Anspruch 11, wobei der Fumarsäuredimethylester oder Fumarsäuremonomethylester das einzige zu verabreichende Neuroprotektivum ist.
  13. Fumarsäuredimethylester zur Verwendung nach Anspruch 12, wobei der Fumarsäuredimethylester das einzige zu verabreichende Neuroprotektivum ist.
  14. Fumarsäuremonomethylester zur Verwendung nach Anspruch 12, wobei der Fumarsäuremonomethylester das einzige zu verabreichende Neuroprotektivum ist.
  15. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach irgendeinem der Ansprüche 11 bis 14, wobei die Dosis etwa 480 mg pro Tag beträgt.
  16. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach irgendeinem der Ansprüche 11 bis 15, wobei der Fumarsäuredimethylester oder Fumarsäuremonomethylester in Form einer Tablette, einer Suspension oder einer Kapsel zu verabreichen ist.
  17. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach irgendeinem der Ansprüche 11 bis 16, wobei die Dosis in getrennten Verabreichungen von 2, 3, 4 oder 6 gleichen Dosen zu verabreichen ist.
  18. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach Anspruch 17, wobei die Dosis in getrennten Verabreichungen von 2 gleichen Dosen zu verabreichen ist.
  19. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach Anspruch 17, wobei die Dosis in getrennten Verabreichungen von 3 gleichen Dosen zu verabreichen ist.
  20. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach irgendeinem der Ansprüche 11 bis 19, wobei der Fumarsäuredimethylester oder Fumarsäuremonomethylester dem Patienten 5, 10, 12, 20, 40, 52, 100 oder 200 Wochen lang oder länger zu verabreichen ist.
  21. Fumarsäuredimethylester oder Fumarsäuremonomethylester zur Verwendung nach irgendeinem der Ansprüche 11 bis 20, wobei der Fumarsäuredimethylester oder Fumarsäuremonomethylester dem Patienten mindestens 12 Wochen lang zu verabreichen ist.
DE13169139.6T 2007-02-08 2008-02-07 Zusammensetzungen und deren Verwendung zur Behandlung von Multipler Sklerose Pending DE13169139T1 (de)

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US88892107P 2007-02-08 2007-02-08
US888921P 2007-02-08
EP13169139.6A EP2653873B8 (de) 2007-02-08 2008-02-07 Zusammensetzungen und deren Verwendung zur Behandlung von Multipler Sklerose

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US20180263906A1 (en) 2018-09-20
FR23C1003I1 (fr) 2023-03-10
RS63489B1 (sr) 2022-09-30
CY2023004I1 (el) 2023-06-09
EP2653873A1 (de) 2013-10-23
NO2014015I1 (no) 2014-06-26
US20200016072A1 (en) 2020-01-16
SI2137537T1 (sl) 2013-10-30
US20110112196A1 (en) 2011-05-12
EP2653873B8 (de) 2022-08-24
EP2518511A1 (de) 2012-10-31
US8399514B2 (en) 2013-03-19
FR23C1003I2 (fr) 2024-01-12
CY2023002I1 (el) 2023-06-09
EP2653873B1 (de) 2022-07-20
ES2424022T3 (es) 2013-09-26
PT2137537E (pt) 2013-08-22
EP2680010A1 (de) 2014-01-01
PL2137537T3 (pl) 2013-10-31
CY1114340T1 (el) 2016-08-31
ES2916649T3 (es) 2022-09-21
PL2653873T1 (pl) 2022-07-04
PT2653873T (pt) 2022-07-26
EP2680007A1 (de) 2014-01-01
SI2653873T1 (sl) 2022-09-30
HUS2300001I1 (hu) 2023-02-28
US20120259012A1 (en) 2012-10-11
CY2014026I1 (el) 2016-10-05
EP2680008A1 (de) 2014-01-01
EP2137537B1 (de) 2013-05-29
DK2629097T1 (da) 2022-05-30
EP2137537B8 (de) 2016-06-01
FR14C0050I1 (fr) 2014-08-08
RS52922B (en) 2014-02-28
CY2023004I2 (el) 2023-06-09
EP2680006A1 (de) 2014-01-01
DK2137537T3 (da) 2013-07-29
HRP20220902T3 (hr) 2022-10-14
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EP4137819A1 (de) 2023-02-22
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