Polymorphic form of atorvastatin calcium

Details Polymorphic form of atorvastatin calcium Polymorphic form of atorvastatin calcium

2000-11-16

2008-08-12

Stockton, Laura L. (Department: 1626)

Organic compounds -- part of the class 532-570 series

Organic compounds

Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

active

07411075

ABSTRACT:
The present invention relates to atorvastatin calcium, a useful agent for lowering serum cholesterol levels. New atorvastatin calcium Form V, processes for preparing the new form, and pharmaceutical compositions and dosage forms containing the new form are disclosed.

REFERENCES:
patent: 4137322 (1979-01-01), Endo et al.
patent: 4681893 (1987-07-01), Roth
patent: 5003080 (1991-03-01), Butler et al.
patent: 5273995 (1993-12-01), Roth
patent: 5298627 (1994-03-01), Butler et al.
patent: 5686104 (1997-11-01), Mills et al.
patent: 5969156 (1999-10-01), Briggs et al.
patent: 6087511 (2000-07-01), Lin et al.
patent: 6121461 (2000-09-01), McKenzie
patent: 6476235 (2002-11-01), Butler et al.
patent: 6528661 (2003-03-01), Niddam et al.
patent: 6600051 (2003-07-01), Tully
patent: 6605636 (2003-08-01), Aronhime et al.
patent: 6605728 (2003-08-01), O'Connell et al.
patent: 6605729 (2003-08-01), Byrn et al.
patent: 2002/0099224 (2002-07-01), Niddam et al.
patent: 2002/0155709 (2002-08-01), Aronhime et al.
patent: 2003/0114686 (2003-06-01), Van der Schaaf et al.
patent: 2003/0212279 (2003-11-01), Tessler et al.
patent: 2003/0216584 (2003-11-01), Aronhime et al.
patent: 2004/0054193 (2004-03-01), Byrn et al.
patent: 2004/0077708 (2004-04-01), Grahek et al.
patent: 2004/0106670 (2004-06-01), Blatter et al.
patent: 2004/0220255 (2004-11-01), Van Der Schaaf et al.
patent: 2004/0242899 (2004-12-01), Reddy et al.
patent: 2005/0209306 (2005-09-01), Jegorov et al.
patent: 0 247 633 (1987-12-01), None
patent: 0 409 281 (1991-01-01), None
patent: WO 94 16693 (1994-08-01), None
patent: WO 97/03960 (1996-07-01), None
patent: WO 97/03958 (1997-02-01), None
patent: WO 97 03958 (1997-02-01), None
patent: WO 97/03959 (1997-02-01), None
patent: WO 00/71116 (2000-11-01), None
patent: WO 02/057228 (2001-01-01), None
patent: WO 01/28999 (2001-04-01), None
patent: WO 01/36384 (2001-05-01), None
patent: WO 01/42209 (2001-06-01), None
patent: WO 01/44180 (2001-06-01), None
patent: WO 01/44181 (2001-06-01), None
patent: WO 02/41834 (2002-05-01), None
patent: WO 02/43732 (2002-06-01), None
patent: WO 02/051804 (2002-07-01), None
patent: WO 02/057229 (2002-07-01), None
patent: WO 02/059087 (2002-08-01), None
patent: WO 02/083637 (2002-10-01), None
patent: WO 02/083638 (2002-10-01), None
patent: WO 03/004470 (2003-01-01), None
patent: WO 03/011826 (2003-02-01), None
patent: WO 03/016317 (2003-02-01), None
patent: WO 03/018547 (2003-03-01), None
patent: WO 03/050085 (2003-06-01), None
patent: WO 03/070702 (2003-08-01), None
patent: WO 2004/022053 (2004-03-01), None
patent: WO 2004/050618 (2004-06-01), None
Rouhi, Chemical and Engineering News, Feb. 24, 2003, pp. 32-35.
Concise Encyclopedia Chemistry (1993), Walter de Gruyter Berlin-New York, pp. 872-873.
US Pharmacopia #23, National Formulary #18 (1995), pp. 1843-1844.
Haleblian et al., Journal of Pharmaceutical-Sciences, Aug. 1969, vol. 58, No. 8, pp. 911-929.
Seddon, Crystal Growth & Design, 4(6), (2004), p. 1087.
Bernstein, “Polymorphism in Molecular Crystals”, Clarendon Press, Oxford (2002), pp. 117, 118 and 272.
Davidovich et al., American Pharmaceutical Review, 7(1), (2004), pp. 10, 12, 14, 16 and 100.
Byrn et al., Solid-State Chemistry of Drugs (1999), SSCI, Inc., Indiana, pp. 62-63.
Patent Abstract of Hungarian Patent Application No. HU P9900678, 1999.
Thomas M.A. Bocan et al. “Antiatherosclerotic activity of inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase in cholesterol-fed rabbits: a biochemical and morphological evaluation”, Atheroselerosis 111 (1994) pp. 127-142.
Declaration Under Rule 132 by Thomas M.A. Bocan dated Dec. 2, 1998, filed in U.S. Appl. No. 08/945,812; 2 pages.
Declaration Under Rule 132 by Stephen R. Bym, dated Nov. 25, 1998, filed U.S. Appl. No. 08/945,812; 3 pages.
David J. W. Grant, Theory and Origin of Polymorphism, in Drugs of the Pharmaceutical Sciences, vol. 95, Polymorphism in Pharmaceutical Solids, Chapter 1, (Harry G. Brittain ed., 1999), pp. 1-31.
McCrone W.C., “Polymorphism”, Physics and Chemistry of the Organic Solid State, vol. 2, 1965, pp. 725-767.
Caira M.R., “Crystalline Polymorphism of Organic Compounds” Topics in Current Chemistry, Springer, Berlin, DE, vol. 198, 1998, pp. 163-208.
Graul A., et al., “Atorvastatin Calcium” Drugs of the Future, Barcelona, ES, vol. 22, No. 9, 1997, pp. 956-968.
Guillory, J.K.: “in Polymorphism in Pharmaceutical Solids (Brittain, H.G., ed.)”, 1999, Marcel Dekker, Inc., New York, Basel, pp. 183-226.
Hancock B.C., et al., “Characteristics and Significance of the Amorphous State in Pharmaceutical Systems”, Journal of Pharmaceutical Sciences, American Pharmaceutical Association, Washington, U.S., vol. 86, No. 1, Jan. 1997, pp. 1-12.
Concise Encyclopedia Chem. (1993), Walter deGruyter, Berlin, NY, Title Page and Copyright Page Only.
K.L. Baumann et al., “The Convergent Synthesis of Cl-981, an Optically Active, Highly Potent, Tissue Selective Inhibitor of HMG-CoA Reductase,” Tetrahedron Letters, vol. 33, No. 17 (1992) pp. 2283-2284.
Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th Ed. (1996) pp. 879-881.
Cheronis, Semimicro Experimental Organic Chemistry, pp. 31-49, Year Not Available.
Haleblian & Crone, 1969, J. Pharm. Sci.58:911-929.
G. Michael Wall, “Pharmaceutical Applications of Drug Crystal Studies”, Pharmaceutical Manufacturing (Feb. 1986) pp. 33-42.
U.S. Pharmacopia #23, p. 1843, 941 X-Ray Diffraction, 1995.
Pending U.S. Appl. No. 10/994,142, filed Nov. 19, 2004, Aronhime et al.

Affiliated with

Also associated with

Rating

Polymorphic form of atorvastatin calcium does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Polymorphic form of atorvastatin calcium, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Polymorphic form of atorvastatin calcium will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-4009486