Rasagiline formulations of improved content uniformity

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form

Reexamination Certificate

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C424S464000, C514S467000, C514S554000, C514S657000, C564S429000

Reexamination Certificate

active

07815942

ABSTRACT:
Disclosed are pharmaceutical preparations of R(+)-N-propargyl-1-aminoindan salts having enhanced content uniformity, processes for preparation of the compositions, and their uses.

REFERENCES:
patent: 3513249 (1970-05-01), Gittos et al.
patent: 5387612 (1995-02-01), Youdim et al.
patent: 5444095 (1995-08-01), Tatton et al.
patent: 5453446 (1995-09-01), Youdim et al.
patent: 5457133 (1995-10-01), Youdim et al.
patent: 5486541 (1996-01-01), Sterling et al.
patent: 5519061 (1996-05-01), Youdim et al.
patent: 5532415 (1996-07-01), Youdim et al.
patent: 5576353 (1996-11-01), Youdim et al.
patent: 5599991 (1997-02-01), Youdim et al.
patent: 5668181 (1997-09-01), Youdim et al.
patent: 5744500 (1998-04-01), Youdim et al.
patent: 5767164 (1998-06-01), Tatton et al.
patent: 5786390 (1998-07-01), Youdim et al.
patent: 5844003 (1998-12-01), Tatton et al.
patent: 5891923 (1999-04-01), Youdim et al.
patent: 6126968 (2000-10-01), Peskin et al.
patent: 6277886 (2001-08-01), Levy et al.
patent: 6316504 (2001-11-01), Youdim et al.
patent: 6462222 (2002-10-01), Chorev et al.
patent: 6630514 (2003-10-01), Youdim et al.
patent: 6635667 (2003-10-01), Thomas
patent: 6682716 (2004-01-01), Hodges et al.
patent: 6956060 (2005-10-01), Youdim et al.
patent: 7396860 (2008-07-01), Blaugrund et al.
patent: 7491847 (2009-02-01), Frenkel
patent: 7547806 (2009-06-01), Frenkel et al.
patent: 7572834 (2009-08-01), Sterling et al.
patent: 2003/0212145 (2003-11-01), Youdim et al.
patent: 2004/0010038 (2004-01-01), Blaugrund et al.
patent: 2004/0052843 (2004-03-01), Lerner et al.
patent: 2004/0127577 (2004-07-01), Blaugrund et al.
patent: 2004/0180088 (2004-09-01), Dudhara et al.
patent: 2005/0026979 (2005-02-01), Ghazzi et al.
patent: 2006/0018957 (2006-01-01), Lerner et al.
patent: 2006/0094783 (2006-05-01), Youdim et al.
patent: 2007/0100001 (2007-05-01), Youdim et al.
patent: 2007/0112217 (2007-05-01), Frenkel et al.
patent: 2007/0232700 (2007-10-01), Blaugrund et al.
patent: 2008/0146676 (2008-06-01), Frenkel et al.
patent: 2008/0161408 (2008-07-01), Frenkel et al.
patent: 2009/0111892 (2009-04-01), Patashnik et al.
patent: 2009/0181086 (2009-07-01), Safadi et al.
patent: 0538134 (1993-04-01), None
patent: 0436492 (1994-06-01), None
patent: 9511016 (1995-04-01), None
patent: 9518617 (1995-07-01), None
patent: 9637199 (1996-11-01), None
patent: 9712583 (1997-04-01), None
patent: 9802152 (1998-01-01), None
patent: 2003072055 (2003-09-01), None
patent: 2004045515 (2004-06-01), None
patent: WO 2004/112799 (2004-12-01), None
patent: 2006057912 (2006-01-01), None
patent: 06091657 (2006-08-01), None
patent: 2007098264 (2007-08-01), None
patent: 2008019871 (2008-02-01), None
patent: 2008131961 (2008-06-01), None
Burgess et al.(The AAPS Journal 2004; 6(3) Article 20 (http://www.aapsj.org).
Scientific discussion for the approval of Azilect by FDA, 2005.
Draft guidance of industry on powder blends and finished dosage units-stratified in-process dosage unit sampling and assessment by FDA, Jan. 21, 2004.
FDA submission date azilect.
Finberg and Youdim, (1985) “Modification of Blood Pressure and Nictitating Membrane Response to Sympathetic Amines by Selective Monoamime Oxidase Inhibitors,”Brit. J. Pharmac. 85(2):541-546.
Finberg et al. (1981) “Selective Irreversible Propargyl Derivative Inhibitors of Monoamine Oxidase (MAO) without the Cheese Effect”Chem. Abstracts94:202499.
Finberg et al. (1985) “Modification of Blood Pressure and Nictitating Membrane Response to Sympathetic Amides by Selective Monoamide Oxidase Inhibitors, Types A and B, in the Cat”Chem. Abstracts103:81618.
J. Mendlewicz and M.B.H. YoudimBrit. J. Psychiat1983 142:508-511.
Youdim et al. in Handbook of Experimental pharmacology vol. 90/I (1988) Chapter 3, Trendlenburg and Weiner, eds.
Youdim et al. “Rasagiline (N-propargy1-1R(+)-aminoindan), a Selective and Potent Inhibitor of Mitochondrial Monoamine Oxidase B”Br. J. Pharmacol. 2001, 132:500-6.
Youdim et al.Progress in Medicinal Chemistry1984, 21:138-167.
International Preliminary Report of PCT International Application No. PCT/US2006/006252, International Filing Date Feb. 22, 2006.
U.S. Appl. No. 11/791,684, filed May, 24, 2007, Patashnik et al.
U.S. Appl. No. 12/223,794, filed Aug, 7, 2008, Poewe et al.
U.S. Appl. No. 12/283,946, filed Sep. 16, 2008, Lendvai et al.
U.S. Appl. No. 12/231,601, filed Sep. 3, 2008, Oron et al.
U.S. Appl. No. 12/456,642, filed Jun. 19, 2009, Frenkel.
U.S. Appl. No. 12/456,643, filed Jun. 19, 2009, Frenkel at al.
U.S. Appl. No. 12/455,969, filed Jun. 10, 2009, Frenkel et al.
U.S. Appl. No. 12/456,029, filed Jun. 9, 2009, Safadi et al.
U.S. Appl. No. 12/456,031, filed Jun. 9, 2009, Safadi et al.
U.S. Appl. No. 12/455,976, filed Jun. 9, 2009, Safadi et al.
U.S. Appl. No. 12/456,001, filed Jun. 9, 2009, Safadi et al.
U.S. Appl. No. 12/283,022, filed Sep. 8, 2008, Sterling et al.
U.S. Appl. No. 12/283,107, filed Sep. 8, 2008, Sterling et al.
U.S. Appl. No. 12/283,105, filed Sep. 8, 2008, Sterling et al.
Official Action issued in counterpart Chinese Patent Application No. 200680005518.8 on Aug. 21, 2009, with English language translation provided by the Chinese associates.
Official Action issued in counterpart New Zealand Patent Application No. 560660 on Jul. 10, 2009.
U.S. Appl. No. 12/456,166, filed Jun. 12, 2009 (including specification and pending claim set).
Jul. 17, 2006 International Search Report for International Application No. PCT/US06/006252.
International Preliminary Report on Patentability and the Written Opinion of the International Searching Authority for International Application No. PCT/US06/006252.
Sun Ling-ling, “The Comparison of Content Uniformity in Ch.P. With Those in BP \Eurp and USP and JP”, Drug Standards of China (2003), vol. 4 (3), p. 13-16.
Feb. 15, 2010 Official Action issued in Russian Patent Application No. 2007135169.
Dec. 31, 2009 Amendment filed in response to the Aug. 21, 2009 Official Action issued in Chinese Patent Application No. 200680005518.8.
Apr. 15, 2010 Communication issued by European Patent Office including a Third Party Observation in connection with European Application No. 06720975.9.
Yalkowsky, S.H., et al. (1990) “Particle Size and Content Uniformity” Pharmaceutical Research. vol. 7 No. 9, pp. 962-966.
European Pharmacopoeia 5.0, Section 2.9.6, “Uniformity of Content of Single-Dose Preparations”, p. 234.
Zhang, Y., et al. (1997) “Effect of drug size particle size on content uniformity of low-dose solid dosage. . . ”, International Journal of Pharmaceutics. vol. 154, pp. 179-183.
Apr. 14, 2010 Official Action issued in the counterpart Chinese Application No. 200680005518.8, with English language translation provided by the Chinese associates.

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