Processes for preparing amorphous atorvastatin hemi-calcium

Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

Reexamination Certificate

active

11193112

ABSTRACT:
The present invention provides novel forms of atorvastatin designated Forms VI, VIII, IX, X, XI and XII and novel processes for their preparation as well as processes for preparing atorvastatin Forms I, II, IV, V and amorphous atorvastatin.

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: 2002/0115709 (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: 2004/0242670 (2004-12-01), Sebastian et al.
patent: 2004/0242899 (2004-12-01), Reddy et al.
patent: 2005/0209306 (2005-09-01), Jegorov et al.
patent: WO 97/03960 (1996-07-01), 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
U.S. Appl. No. 60/312,144, filed Aug. 13, 2001.
U.S. Appl. No. 60/326,529, filed Oct. 1, 2001.
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.*
Bang-Chi Chen et al., “Synthesis of Deuterium-Labeled Atorvastatin and its Metabolites for Use as Internal Standards in a LC/MS/MS Method Developed for Quantitation of the Drug and its Metabolites in Human Serum,” Journal of Labelled Compounds and Radiopharmaceuticals 43 (2000) pp. 261-270*.
K.L. Baumann et al., “The Convergent Synthesis of CI-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.
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. Byrn, dated Nov. 25, 1998, filed in U.S. Appl. No. 08/945,812; 3 pages.
Rouhi, Chem. & Eng. News, Feb. 24, 2003, pp. 32-35.
Cheronis, Semimicro Experimental Organic Chemistry, pp. 31-49, 1958.
Haleblian & Crone, 1969. J. Pharm. Sci.58:911-929.
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).
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.
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.

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Processes for preparing amorphous atorvastatin hemi-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 Processes for preparing amorphous atorvastatin hemi-calcium, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Processes for preparing amorphous atorvastatin hemi-calcium will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-3745435

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.