Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2008-04-04
2010-06-29
Kosack, Joseph R (Department: 1626)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C548S537000
Reexamination Certificate
active
07745480
ABSTRACT:
The present application describes deuterium-enriched atorvastatin, pharmaceutically acceptable salt forms thereof, and methods of treating using the same.
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Woo et al., Atorvastatin, an HMG-CoA Reductase Inhibitor and Effective Lipid-Regulating Agent. Part III. “Synthesis of [2H5]-, [13C8], and [13C7, 15N] Artorvastatin and Their Application in Metabolic and Pharmacokinetic Studies.” J. Labelled Cpd. Radiopharm. 42, 135-145 (1999).
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.” J. Labelled Cpd. Radiopharm. 43(3), 135-145 (2000).
Whitfield et al., “A Study Utilizing Stable Isotope Technique to Provide Information for the Design of Pivotal Atorvastatin Tablet Bioequivalence Studies.” Pharm. Res. 14, No. 11, Suppl., S250 (1997). (Abstract only).
Valesky, R.J., Automated enzyme inhibition assay method for the determination of atorvastatin-derived HMG-CoA reductase inhibitors in human plasma using radioactivity detection, J. Pharmacol. & Toxicol. 2008, 57, 61-69.
Kosack Joseph R
Protia, LLC
Vance Intellectual Property, PC
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