Composition of solifenacin or salt thereof for use in solid...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C546S135000

Reexamination Certificate

active

08039482

ABSTRACT:
A solid pharmaceutical preparation of solifenacin or a salt thereof, the preparation being stable and inhibited from decomposing with time when supplied to clinical fields. In a pharmaceutical preparation containing solifenacin or a salt thereof, the compound in an amorphous form was revealed to be causative of cardinal-drug decomposition with time. The composition for a solid pharmaceutical preparation of solifenacin or a salt thereof contains solifenacin or its salt each in a crystalline from, and the content provided are: a process for producing the composition; and a medicinal composition for solid pharmaceutical preparations which contains solifenacin and an amorphization inhibitor.

REFERENCES:
patent: 4870059 (1989-09-01), Mitsuhashi et al.
patent: 5075114 (1991-12-01), Roche
patent: 5082669 (1992-01-01), Shirai et al.
patent: 5260072 (1993-11-01), Roche et al.
patent: 5534534 (1996-07-01), Makino et al.
patent: 5607697 (1997-03-01), Alkire et al.
patent: 5997903 (1999-12-01), Dietrich et al.
patent: 6011062 (2000-01-01), Schneider
patent: 6017927 (2000-01-01), Takeuchi et al.
patent: 6221402 (2001-04-01), Itoh et al.
patent: 2002/0119196 (2002-08-01), Parikh et al.
patent: 2002/0155156 (2002-10-01), Mulye
patent: 2003/0096791 (2003-05-01), Gupte et al.
patent: 2004/0136915 (2004-07-01), Dugger, III et al.
patent: 2004/0138253 (2004-07-01), Slatter
patent: 2004/0198822 (2004-10-01), Fraser et al.
patent: 2005/0175689 (2005-08-01), Kurimoto et al.
patent: 2005/0181031 (2005-08-01), Saito et al.
patent: 2005/0239890 (2005-10-01), Fraser et al.
patent: 2006/0035923 (2006-02-01), Van Meeteren et al.
patent: 2006/0147531 (2006-07-01), Segula et al.
patent: 2007/0231399 (2007-10-01), Kasashima et al.
patent: 2007/0270459 (2007-11-01), Van Meeteren et al.
patent: 2008/0103171 (2008-05-01), Umejima et al.
patent: 1171109 (1998-01-01), None
patent: 0121291 (1984-10-01), None
patent: 0 459 695 (1991-12-01), None
patent: 0459695 (1991-12-01), None
patent: 0 473 431 (1992-03-01), None
patent: 0473431 (1992-03-01), None
patent: 0801067 (1997-10-01), None
patent: 1219291 (2002-07-01), None
patent: 1552825 (2005-07-01), None
patent: 1 714 965 (2006-10-01), None
patent: 1 726 304 (2006-11-01), None
patent: 1728791 (2006-12-01), None
patent: 1832288 (2007-09-01), None
patent: 62-136240 (1987-06-01), None
patent: 5-194218 (1993-08-01), None
patent: 06-219939 (1994-08-01), None
patent: 06-316536 (1994-11-01), None
patent: 9-71764 (1997-03-01), None
patent: 9-110698 (1997-04-01), None
patent: 10-7547 (1998-01-01), None
patent: 2000-514830 (2000-11-01), None
patent: 2002-272817 (2002-09-01), None
patent: 2003-261439 (2003-09-01), None
patent: 2004026675 (2004-01-01), None
patent: 2004-175796 (2004-06-01), None
patent: 2 090 567 (1997-09-01), None
patent: 2 136 685 (1999-09-01), None
patent: WO 96/20194 (1996-07-01), None
patent: 98/30209 (1998-07-01), None
patent: 02/096392 (2002-12-01), None
patent: 03/006019 (2003-01-01), None
patent: 03/099268 (2003-12-01), None
patent: WO 03/103659 (2003-12-01), None
patent: 2005-039542 (2005-05-01), None
patent: 2005-092889 (2005-10-01), None
patent: 2006/070735 (2006-07-01), None
Yasushi et al., “Effects of Compression Pressure on Physical and Chemical Stability of Tablets Containing an Anticancer Drug TAT-591-3)” (1994), Chem. Pharm. Bull., vol. 42, No. 12, pp. 2582-2587.
Owen C. Chidavaenzi et al., “The effect of co-spray drying with polyethylene glycol 4000 on the crystallinity and physical form of lactose” (2001), International Journal of Pharmaceutics, vol. 216, pp. 43-49.
Ching-Wei et al., “Effect of particle size on the available surface area of nifedipine from nifedipine-polyethylene glycol 6000 solid dispersions” (1996), International Journal of Pharmaceutics, vol. 127, pp. 261-272.
Deirdre O. Corrigan et al., “The effect of spray drying solutions of bendroflumethiazide/polyethylene glycol. on the physicochemical properties of the resultant materials” (2003), International Journal of Pharmaceutics, vol. 262, pp. 125-137.
Claes Ahlneck et al., “The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state” (1990), International Journal of Pharmaceutics, vol. 62, pp. 87-95.
Russian Office Action dated Mar. 24, 2008.
Mealy N., et al., “Treatment of Urinary Incontinence Muscarinic M3 Antagonist”, Drugs of the Future, Prous Science, vol. 24, No. 8, Jan. 1, 1999, pp. 871-874, XP001061585.
Hedge Sharath S., “Antimuscarinics for the treatment of overactive bladder: Current options and emerging therapies”, Current Opinion in Investigational Drugs, vol. 5, No. 1, Jan. 1, 2004, pp. 40-49, XP008061336.
“VESIcare”, www.rxlist.com/vesicare-drug.htm, p. 1, XP002500528.
“Amorphous Solids: Implications for Solubility and Stability”, www.ssci-inc.com/Information/RecentPublications/ApplicationNotes/AmorphousSolidsImplications/tabid/142/Default.aspx, 2003, pp. 1-3, XP0025005273.
Supplementary European Search Report dated Nov. 10, 2008.
Chinese Office Action, dated May 8, 2009.
European Office Action dated Jun. 22, 2009.
Non-Final Office Action issued Nov. 1, 2007 in U.S. Appl. No. 11/458,582.
Non-Final Office Action issued Jun. 26, 2008, in U.S. Appl. No. 11/458,582.
Final Office Action issued Jan. 30, 2009, in U.S. Appl. No. 11/458,582.
Non-Final Office Action issued Jul. 17, 2009, in U.S. Appl. No. 11/458,582.
Non-Final Office Action issued Dec. 27, 2007 in U.S. Appl. No. 10/975,210.
Final Office Action issued Sep. 11, 2008 in U.S. Appl. No. 10/975,210.
Non-Final Office Action issued May 27, 2009 in U.S. Appl. No. 10/975,210.
Non-Final Office Action issued Jun. 11, 2009 in U.S. Appl. No. 11/721,863.
IPRP (PCT/ISA/237) dated Feb. 21, 2006 filed in U.S. Appl. No. 11/721,863.
Office Action (Interview Summary) issued in U.S. Appl. No. 11/458,582 dated Oct. 31, 2008.
Office Action issued in counterpart Russian Patent Application No. 2007128815/15(031373) dated Nov. 2, 2009.
Extended European Search Report dated Jan. 25, 2010 in European Application No. 05820232.6.
Extended European Search Report dated Jan. 25, 2010 in European Application No. 09014500.4.
Mexican Office Action dated Mar. 19, 2010 in Mexican Application No. MX/E/2009/075271.
Japanese Office Action dated Jan. 5, 2010, in Japanese Application No. 2006-511,497.
Australian Office Action dated Apr. 23, 2010 in Australian Application No. 2005226357.
Indonesian Office Action dated May 18, 2010, in Indonesian Application No. W-00 2006 02634.
Chinese Office Action dated Nov. 11, 2009 in Chinese Application No. 2005800450144.
Japanese Office Action dated Nov. 19, 2009 in Japanese Application No. 2006-550,756.
U. S. Office Action dated Feb. 2, 2010 in U.S. Appl. No. 10/975,210.
Office Action issued on Mar. 17, 2010 in Australian Application No. 2005320672.
Office Action issued on May 4, 2010 in Indonesian Application No. W-00 2007 02057.
Philippine Office Action issued Jun. 23, 2010 in corresponding Philippine Application No. 1-2006-501883.
Korean Office Action issued Jun. 16, 2010 in corresponding Korean Application No. 10-2006-7019783.
Third Party Observation issued Apr. 13, 2010 in corresponding European Application No. 05721391.0.
L. Yu, “Amorphous pharmaceutical solids: preparation, characterization and stabilization,” Advanced Drug Delivery Reviews, vol. 48, pp. 27-42 (2001).
B. Hancock, “Characteristics and Significance of the Amorphous State in Pharmaceutical Systems,” Journal of Pharmaceutical Sciences, vol. 86, No. 1, pp. 1-12 (1997).
Solifenacin Succinate: Crystallization experiments.
E. Shalaev et al., “How Does Residual Water Affect the Solid-State Degradation of Drugs in the Amorphous State,” Journal of Pharmaceutical Sciences, vol. 85, No. 11, pp. 1137-1141 (1996).
International Search Report (ISA) issued Jan. 25, 2005 in PCT/JP2004/016196.
International Preliminary Report on Patentability (IPRP) issued in PCT/JP2004/016196.
International Search Report (ISA) issued Sep. 12, 2006 in PCT/J

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