Nutraceutical composition

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical

Reexamination Certificate

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C424S400000, C424S702000

Reexamination Certificate

active

06585998

ABSTRACT:

The present invention relates to a nutraceutical composition and a method for maintaining normal levels of blood sugar and normal levels of non-enzymatic protein glycosylation.
BACKGROUND OF THE INVENTION
U.S. Pat. No. 5,156,852 teaches that a composition containing both selenium and vitamin E is useful in treating macular degeneration. U.S. Pat. No. 5,405,613 teaches vitamin and mineral compositions that include bioflavonoids for restoring energetic balance or intensity. Administration of glutathione in combination with vitamin E and selenium has been taught to reduce hematological toxicities in patients undergoing radiation therapy. See U.S. Pat. No. 5,639,482.
U.S. Pat. No. 5,976,568 teaches that the bioflavonoid quercetin can inhibit the enzyme cyclooxygenase and U.S. Pat. No. 6,190,678 teaches a personal care product (skin cleaner) containing, inter alia, brazilin, rutin, glutathione, and &agr;-lipoic acid. Vitamin E and &agr;-lipoic acid are taught as components of a multi-component supplement, that also includes aspirin and magnesium salts, for the treatment and control of diabetes. See U.S. Pat. No. 5,976,568. Applicant is the first to recognize that a bioflavonoid such as quercetin or rutin can be combined with brazilin, &agr;-lipoic acid, and other substances to produce a composition that, when administered to a mammal, is effective to promote normal levels of non-enzymatic protein glycosylation in that mammal.
SUMMARY OF THE INVENTION
In one aspect, the present invention is directed to a nutraceutical composition having a tripeptide component, especially glutathione; a brazilin component, especially brazilin; an amino acid component, especially L-lysine; a flavonoid component, especially one including quercetin, rutin, and silymarin; guanidine hydrochloride; &agr;-lipoic acid; catalase; and, optionally, vitamin E and selenium. In a particular aspect, the invention relates to a nutraceutical composition having between about 190 and about 225 parts by weight (pbw) tripeptide component, between about 5 and about 20 pbw guanidine hydrochloride, between about 10 and about 20 pbw &agr;-lipoic acid, between about 40 and about 60 pbw brazilin component, between about 20 and about 30 pbw amino acid component, between about 100 and about 150 pbw flavonoid component, and between about 10 and about 20 pbw catalase.
The nutraceutical composition can be administered as an oral liquid or solid dosage form. In one aspect, the present invention is directed to an oral liquid dosage form including the nutraceutical composition and one or more vehicles and optional ingredients such as emulsifiers, colorants, and flavorings. In another aspect, the invention is directed to an oral solid dosage form that can be a tablet, a caplet, a gelcap, or a capsule that includes the nutraceutical composition and, optionally, one or more pharmaceutically acceptable excipients as is known in the art. In yet another aspect, the invention is directed to an oral solid dosage form including the nutraceutical composition that can be in the form of at least a first and a second oral solid dosage form whereby the components and constituents of the nutraceutical composition are distributed equally or unequally between the at least first and second dosage forms.
In another aspect, the invention is directed to a method of maintaining healthy normal blood sugar levels and healthy normal levels of non-enzymatic protein glycosylation in a mammal, especially a human, by administering to the mammal a blood sugar and glycosylation maintaining effective amount of a nutraceutical composition of the present invention.


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Bosisio, Enrica et al., “Effect of the Flavanolignans ofSilybum marianum L. on Lipid Peroxidation in Rat Liver Microsomes and Freshly Isolated Hepatocytes”, Pharmacological Research, vol. 25, No. 2, 1992, pp. 147-154.
Morazzoni, P. et al., “Comparative pharmacokinetics of silipide and silymarin in rats”, European Journal of Drug Metabolism and Pharmacokinetics, vol. 18, No. 3, 1993, pp. 289-297.

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