Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2010-04-26
2011-12-13
Chang, Celia (Department: 1625)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C548S255000
Reexamination Certificate
active
08076362
ABSTRACT:
The invention relates to dosage forms and formulations comprising the novel crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide, wherein crystal modification A is characterized by characteristic lines with interplanar spacings (d values) of 10.5 Å, 5.14 Å, 4.84 Å, 4.55 Å, 4.34 Å, 4.07 Å, 3.51 Å, 3.48 Å, 3.25 Å, 3.19 Å, 3.15 Å, 3.07 Å, and 2.81 Å, determined by means of an X-ray powder pattern. Dosage forms of crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide may be for oral or parenteral administration, in the form of a solid or liquid, and in a dosage range of 20 mg to less than 500 mg. Solid dosage forms comprise a tablet or capsule, and further comprise a pharmaceutically-acceptable carrier and film-coat.
REFERENCES:
patent: 4156734 (1979-05-01), Stone
patent: 4536518 (1985-08-01), Welch
patent: 4789680 (1988-12-01), Meier
patent: 5248699 (1993-09-01), Sysko
patent: 6156907 (2000-12-01), Portmann
patent: 6455556 (2002-09-01), Portmann
patent: 6740669 (2004-05-01), Portmann et al.
patent: 0114347 (1983-12-01), None
patent: 0371564 (1989-11-01), None
patent: 812320 (1996-08-01), None
patent: 1511195 (1978-05-01), None
patent: A-02/214504 (1990-08-01), None
patent: A-05/155822 (1993-06-01), None
patent: 91/01724 (1991-02-01), None
patent: 95/12417 (1995-05-01), None
patent: 96/08485 (1996-03-01), None
patent: 96/09295 (1996-03-01), None
patent: 98/56773 (1998-12-01), None
Material record “amorphous” internet (2010).
Rouhi, A. Maureen. “The Right Stuff.” Chem. & Engineering News, p. 32, (2003).
Concise Encyclopedia Chemistry, Walter de Gruyter, Berlin, New York, p. 82-83, (1993).
US Pharmacopia #23, National Formulary #18, p. 1843-1844, (1995).
Munzel, Prog Drug Res, 10: 227-230, (1966).
Munzel, Prog Drug Res, 14: 309-321, (1970).
Chemical Abstracts 105:48847, 1986.
Chemical Abstracts 106:182481, 1987.
Chemical Abstracts 108:118769, 1988.
Chemical Abstracts 90:192418, (1979).
Chemical Abstracts 77:168514, (1972).
Chemical Abstracts 80:100132, (1974).
Chemical Abstracts 80:6799, (1974).
Chemical Abstracts 94:180542, (1981).
Cheung, “Intra- and Inter-subject Variabilities of CGP 33101 After Replicate Single Oral Doses of Two 200-mg Tablets and 400-mg Suspension.” Pharm. Res. 12(12): 1878-1882 (1995).
Chemical Abstracts 104:24095, (1986).
Ulicky, Comp Dic Phys Chem, 21, (1992).
Wyngaarden et al., Cecil Textbook Medicine. p. 48-55 (1983).
Full Development proposal CGP33101, (2009).
Meier, Characteristics of CGP33101 Kenndaten Fuer, (2009).
Energy Temperature Diagram, (2009).
Dissolution profiles, (2009).
Merck Index, 13th Ed. Monograph No. 8373, (2001).
Presentation on patenting polymorphs by EPO examiner, (2006).
Kostic et al, Dopaminergic Ligands, Drugs Res, 44(1): 697-702, (1994).
EP431943 (Jun. 1991).
US3992378, (Nov. 1976).
DE4217952, (Dec. 1993).
WO9207847, (May 1992).
Chemical Abstracts, 95:50317r, (1981).
Cheung, “Intra- and Inter-Subject Variabilities of CGP33101 after Replicate Single Oral Doses of Two 200-mg Tablets and 400-mg Suspension,” Pharmaceutical Research, 12(12):1878-79, (1995).
Rouan, “Automated analysis of a novel and-epileptic compound, CGP 33 101, and its metabolite, CGP 47 292, in body fluids by high-performance liquid chromatography and liquid-solid extraction,” J. Chromatography B., 667:307-313, (1995).
Haleblian, “Pharmaceutical Applications of Polymorphism,” J. Pharm. Sci., 58(8):911-929, (1969).
Leusen, “Ab initio prediction of polymorphs,” J. Crystal Growth, 166:900-903, (1996).
Burkhard Andreas
Hofmeier Urs Christoph
Portmann Robert
Scherrer Walter
Szelagiewicz Martin
Chang Celia
Montgomery, McCracken, Walker & Rhoads LLP
Nevins Kristin M.
Novartis AG
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