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Title (de)
(Z)-2-CYANO-3-HYDROXY-BUT-2-ENOLSÄURE-(4'- TRIFLUORMETHYLPHENYL)-AMIDTABLETTENFORMULIERUNGEN MIT
VERBESSERTER STABILITÄT
Title (fr)
FORMULATIONS DE COMPRIMÉS D'ACIDE (Z)-2-CYANO-3-HYDROXY-BUT-2-ÉNOÏQUE-(4'-TRIFLUORMÉTHYLPHÉNYL)-AMIDE À STABILITÉ
AMÉLIORÉE
Publication
EP 2477611 B1 20170405 (EN)
Application
EP 10752585 A 20100914
Priority
• EP 09290716 A 20090918
• US 36338210 P 20100712
• EP 2010063439 W 20100914
• EP 10752585 A 20100914
Abstract (en)
[origin: WO2011032929A1] The invention relates to solid pharmaceutical compositions comprising (Z)-2- cyano-3-hydroxy-but-2-enoic acid-(4'-
trifluoromethylphenyl)-amide, as well as a process for the preparation of the same, methods of using such compositions to treat subjects suffering
from autoimmune diseases in particular systemic lupus erythematosus or chronic graft-versus-host disease, multiple sclerosis or rheumatoid arthritis.
Citation (examination)
AULTON M E (ED) ED - AULTON M E (ED) 2: "PHARMACEUTICS - THE SCIENCE OF DOSAGE FORM DESIGN , PASSAGE",
1 January 2002, PHARMACEUTICS : THE SCIENCE OF DOSAGE FORM DESIGN, LONDON : CHURCHILL LIVINGSTONE, GB,
PAGE(S) 404 - 410, ISBN: 978-0-443-05517-1, XP002396921
Citation (opposition)
Opponent : Wuesthoff & Wuesthoff Patentanwälte PartG mbB
• US 2006024376 A1 20060202 - AVENTIS PHARMA LTD [JP]
• EP 0787491 B1 20000726 - AVENTIS PHARMA INC [US]
• EP 1381356 B1 20080528 - WILLIAMS JAMES W [US]
• EP 1810676 B1 20081112 - AVENTIS PHARMA INC [US]
• GB 2394660 A 20040505 - TIEFENBACHER PHARMACHEMIKALIEN [DE], et al
• AUGSBURGER L.L. ET AL.: "Encyclopedia of Pharmaceutical Technology", 2007, article "Tablet formulation",
pages: 3641 - 3652, XP055449019
• ARMSTRONG N.A.: "Encyclopedia of Pharmaceutical Technology", 2007, article "Tablet manufacture", pages:
3653 - 3672, XP055449024
Opponent : Dr Richard Cooke
• US 2006024376 A1 20060202 - BARTLETT ROBERT R [DE], et al
• EP 1381356 B1 20080528 - WILLIAMS JAMES W [US]
• WO 2007118684 A1 20071025 - WIEBELITZ ULRIKE [DE]
• US 4965276 A 19901023 - BARTLETT ROBERT R [DE], et al
• ROWE ET AL.: "HANDBOOK OF PHARMACEUTICAL EXCIPIENTS", ISBN: 9781582120584, article
"COLLOIDAL SILICON DIOXIDE", pages: 188 - 190, XP003016902
• FUJITA ET AL.: "Generation of formaldehyde by pharmaceutical excipients and its absorption by meglumine",
CHEMICAL & PHARMACEUTICAL BULLETIN, vol. 57, no. 10, 28 July 2009 (2009-07-28), pages 1096 - 1099,
XP002566576
• "PHARMACEUTICS - THE SCIENCE OF DOSAGE FORM DESIGN - Tablet Excipients", 2002, ISBN:
978-0-443-05517-1, pages: 404 - 410, XP002396921
• AINLEY WADE ET AL: "The Handbook of Pharmaceutical Excipients", 1994, London, ISBN: 0853693056,
article "Starch", pages: 483 - 487, XP055452123
• ALFONSO R GENNARO: "Remington: The Science and Practice of Pharmacy", 2000, ISBN: 0683306472,
article "Oral Solid Dosage Forms", pages: 861, 1047 - 1048, XP055452127
• HERBERT A. LIEBERMANN ET AL: "Pharmaceutical Dosage Forms: Tablets", vol. 1, 1989, ISBN:
0824780442, article "Tablet Formulation and Design", pages: 105 - 109, XP055452132
• WALTER LUND ET AL: "The Pharmaceutical Codex", 1994, ISBN: 0853692904, article "Oral Solids", pages: 6
- 9, XP055318927
• PATRICK CRAWLEY: "Drug-excipient interactions", PHARMACEUTICAL TECHNOLOGY, March 2001
(2001-03-01), XP055452143
Opponent : Pentafarma, Sociedade Tecnico Medicinal S.A.
• US 2006024376 A1 20060202 - WILLIAMS JAMES W [US]
• EP 1990048 A2 20081112 - WIEBELITZ ULRIKE [DE]
• WO 0160363 A1 20010823 - TEVA PHARMA [IL], et al
• US 6221891 B1 20010424 - FAASCH HOLGER [DE], et al
• O'CONNOR ET AL.: "A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with
relapses.", NEUROLOGY, vol. 66, 2006, pages 894 - 900, XP002556504
• KIBBE: "Handbook of pharmaceutical excipients", 2000