ES2487221T3 - Formas cristalinas de 5-amino-2,3-dihidroftalazina-1,4-diona sal sódica (sal sódica 5-amino-2,3-dihidroftalazina-1,4-diona), preparados farmacéuticos que la contienen y método de producción - Google Patents

Formas cristalinas de 5-amino-2,3-dihidroftalazina-1,4-diona sal sódica (sal sódica 5-amino-2,3-dihidroftalazina-1,4-diona), preparados farmacéuticos que la contienen y método de producción Download PDF

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Publication number
ES2487221T3
ES2487221T3 ES11710423.2T ES11710423T ES2487221T3 ES 2487221 T3 ES2487221 T3 ES 2487221T3 ES 11710423 T ES11710423 T ES 11710423T ES 2487221 T3 ES2487221 T3 ES 2487221T3
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Prior art keywords
dihydroftalazine
amino
sodium salt
dione sodium
production method
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Inventor
Josef Breu
Wolfgang Brysch
Astrid Kaiser
Beate Ludescher
Gerrit Maass
Thomas Martin
Wolfgang Milius
Michael Niedermaier
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Metriopharm AG
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Metriopharm AG
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D237/00—Heterocyclic compounds containing 1,2-diazine or hydrogenated 1,2-diazine rings
    • C07D237/26—Heterocyclic compounds containing 1,2-diazine or hydrogenated 1,2-diazine rings condensed with carbocyclic rings or ring systems
    • C07D237/30—Phthalazines
    • C07D237/32—Phthalazines with oxygen atoms directly attached to carbon atoms of the nitrogen-containing ring
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • A61K31/502—Pyridazines; Hydrogenated pyridazines ortho- or peri-condensed with carbocyclic ring systems, e.g. cinnoline, phthalazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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Abstract

Forma I o II de 5-amino-2,3-dihidroftalazina-1,4-diona sal sódica, caracterizada por los valores cristalográficos registrados por medio de diagramas de rayos X de polvo: valores d: 13,5; 6,9; 5,2; 4,6; 3,9; 3,5; 3,4; 3,3; 3,1; 3,0 y valores 2-theta: 6,5; 12,7; 16,9; 19,3; 22,8; 25,8; 26,6; 27,2; 28,7; 30,3 relativos a la forma I así como valores d: 12,9; 7,9; 7,1; 6,5; 5,3; 4,0; 3,7; 3,6; 3,3; 3,2 y valores 2-theta: 6,8; 11,2; 12,5; 13,7; 16,7; 22,4; 24,3; 24,9; 27,2; 27,8 relativos a la forma II, por lo demás caracterizada por una temperatura de descomposición >= 335°C ± 10°C.

Description

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E11710423
29-07-2014
± 5°C). Tras la filtración del agente disolvente restante la torta de filtrado se depura con 2-propanol (2x 10 mL) y se seca en el evaporador rotativo a 90°C/20 mbar hasta alcanzar la constancia de masa.
Índice de abreviaturas:
µg
Microgramo
aaO.
en el lugar indicado
ALT
Alanina aminotransferasa
AST
Aspartato aminotransferasa
ca.
circa, aproximadamente
DMSG
Deutsche Multiple Sklerose Gesellschaft (Sociedad Alemana de Esclerosis Múltiple)
EMEA
European Medicines Agency
g
Gramo
GOT
Glutamato-oxalacetato-transaminasa
GPT
Glutamato-piruvato-transaminasa
IL
Interleucina
KBE
Unidades formadoras de colonias
l
Litro
LPS
Lipopolisacárido
µg
Microgramo
mL
Mililitro
MW
Valor medio
ng
Nanogramo
pg
Picogramo
REM
Microscopio electrónico de barrido
STD
Divergencia estándar
TNF
Factor de necrosis tumoral
U
Unidades internacionales
vol/m
Unidad de volumen por unidad de masa
z.B.
por ejemplo
19

Claims (1)

  1. imagen1
    imagen2
ES11710423.2T 2010-03-01 2011-03-01 Formas cristalinas de 5-amino-2,3-dihidroftalazina-1,4-diona sal sódica (sal sódica 5-amino-2,3-dihidroftalazina-1,4-diona), preparados farmacéuticos que la contienen y método de producción Active ES2487221T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP10002067 2010-03-01
EP10002067 2010-03-01
EP10075744 2010-11-25
EP10075744 2010-11-25
PCT/EP2011/001124 WO2011107295A1 (de) 2010-03-01 2011-03-01 Kristalline formen zu 5-amino-2,3-dihydrophthalazin-1,4-dion natriumsalz, diese enthaltende pharmazeutische zubereitungen und verfahren zu ihrer herstellung

Publications (1)

Publication Number Publication Date
ES2487221T3 true ES2487221T3 (es) 2014-08-20

Family

ID=43828190

Family Applications (1)

Application Number Title Priority Date Filing Date
ES11710423.2T Active ES2487221T3 (es) 2010-03-01 2011-03-01 Formas cristalinas de 5-amino-2,3-dihidroftalazina-1,4-diona sal sódica (sal sódica 5-amino-2,3-dihidroftalazina-1,4-diona), preparados farmacéuticos que la contienen y método de producción

Country Status (23)

Country Link
US (2) US8772294B2 (es)
EP (2) EP2774920A1 (es)
JP (2) JP6061081B2 (es)
KR (1) KR101770011B1 (es)
CN (3) CN102971300B (es)
AU (1) AU2011223226B2 (es)
BR (1) BR112012021857B1 (es)
CA (1) CA2791327C (es)
CH (1) CH704794B1 (es)
CY (1) CY1115585T1 (es)
DK (1) DK2542535T3 (es)
ES (1) ES2487221T3 (es)
HK (1) HK1223836A1 (es)
HR (1) HRP20140752T1 (es)
IL (1) IL221680A (es)
NZ (1) NZ601689A (es)
PL (1) PL2542535T3 (es)
PT (1) PT2542535E (es)
RS (1) RS53492B1 (es)
RU (1) RU2585677C2 (es)
SI (1) SI2542535T1 (es)
WO (1) WO2011107295A1 (es)
ZA (1) ZA201206264B (es)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2542535E (pt) * 2010-03-01 2014-08-25 Metriopharm Ag Formas cristalinas para sal de sódio de 5-amino-2,3-di hidroftalazino-1,4-diona, preparações farmacêuticas contendo o mesmo e processo para a produção das ditas formas
WO2016096143A1 (de) 2014-12-18 2016-06-23 Metriopharm Ag Kristalline form von 5-amino-2,3-dihydrophthalazin-1,4-dion natriumsalz, diese enthaltende pharmazeutische zubereitungen und verfahren zu ihrer herstellung
CA3011766C (en) * 2016-02-16 2023-08-01 Metriopharm Ag Method for producing a crystalline form of 5-amino-2,3-dihydrophthalazine-1,4-dione
EP3416951B1 (en) * 2016-02-16 2020-04-08 MetrioPharm AG Crystalline form of 5-amino-2,3-dihydrophthalazine-1,4-dione
EP3248602A1 (en) 2016-05-26 2017-11-29 MetrioPharm AG Use of 5-amino-2,3-dihydro-1,4-phthalazinedione in the treatment of inflammatory and/or degenerative disorders of the tendons, ligaments of the joints, articular capsules and bursae
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