Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1996-08-02
1998-08-18
Scheiner, Laurie
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514249, 514345, 514814, A01N 4304, A01N 4358, A01N 4340
Patent
active
057958734
ABSTRACT:
A method for orally administering vitamin preparations is described which combine vitamin B.sub.12 (B.sub.12, cobalamin) and folic acid (folate), with and without pyridoxine (B.sub.6), for preventing and treating elevated serum homocysteine (HC), cystathionine (CT), methylmalonic acid (MMA), or 2-methylcitric acid (2-MCA) levels. These metabolites have been shown to be indicative of B.sub.12 and/or folic acid deficiencies. Further, it is likely that a B.sub.6 deficiency may be present with a B.sub.12 or folate deficiency. The method of the invention is also for use in lowering serum HC, CT, MMA, or 2-MCA in patients with or at risk for neuropsychiatric, vascular, renal or hematologic diseases. One embodiment of the invention is the use of a non-prescription formulation containing 2.0 mg B.sub.12 and 0.4 mg folic acid, with and without 25 mg B.sub.6. Another embodiment uses a prescription strength formulation containing 2.0 mg B.sub.12 and 1.0 mg folic acid, with and without 25 mg B.sub.6. The method of the present invention eliminate the costly and time consuming steps of distinguishing between vitamin deficiencies once a deficiency is found by measurement of serum metabolite levels. The present invention is of particular benefit to the populations at risk for elevated serum metabolite levels, such as the people over the age of 65, and populations that have or are at risk for neuropsychiatric, vascular, renal and hematologic diseases.
REFERENCES:
Rosenblatt et al., 1987, Amer. J. Med. Gen. 26:377-383.
Brattstrom et al., 1990, Atheroscler. 81:51-60.
Stabler et al., 1990, Blood 76:871-881.
Lee, Richard G., et al., "Disorders of Red Blood Cells", Wintrobe's Clinical Hematology, 1993, pp. 745-790, vol. 1, Ninth Ed., Lea & Febiger, Philadelphia, PA.
Pechet, Liberto, "Anemias and Other Red Cell Disorders", Textbook of Primary Care Medicine, 1996, pp. 722-734, 2nd Ed., Mosby-YearBook, Inc. St. Souis, Missouri.
Ueland, Per Magne et al., "Plasma Homocysteine and Cardiovascular Disease", Artherosclerotic Cardiovascular Disease, Hemostasis, and Endothelial Function, 1992, pp. 183-236, Marcel Decker, New York, New York.
Ueland, Per Magne et al., "Review Article: Plasma homocysteine, a risk factor for vascular disease: Plasma levels in health, disease, and drug therapy" The Clinical Pharmacology Unit, Department of Pharmacology and Toxicology, 1989, pp. 473-501, University of Bergen, Bergen Norway.
Graham, Ian, FRCPI, et al. "Plasma Homocysteine as Risk Factor for Vascular Disease", JAMA, 1997, pp. 1775-1781, vol. 277, No. 22, The Adelaide Hospital Peter STreet, Dublin 8, Ireland.
Brattstrom, L.E. et al., "Folic acid--an innocuous means to reduce plasma homocysteine", Scand J. Clin Lab Invest, 1988; pp. 215-221, University Hospital, Lund, Sweden.
Stabler, Sally P. et al, "Elevation of Total Homocysteine in the Serum of Patients with Cobalamin or Folate Deficiency Detected by Capillary Gas Chromatography-Mass Spectrometry", The American Society for Clinical Investigation, Inc., 1988, pp. 466-474, vol. 81,J. Clin. Invest. 0021-9738/88/02/0466/09.
Wilcken, D.E.L., "Homocysteine in the plasma of renal transplant recipients: effects of cofactors for methionine metabolism", Clinical Science, 1981, pp. 743-479, vol. 61., Sydney New South Wales, Australia.
Wilcken, David E.L. et al., "Homocystinuria Due to Cystathionine B-Synthase Deficiency--The Effects of Betaine Treatment in Pyridoxine-Responsive Patients", Metabolism, 1985, pp. 1115-1121, vol. 34, No. 12, Sydney, N.S.W., Australia.
Brattstrom, Lars E., et al., "Folic Acid Responsive Postmenopausal Homocysteinemia", Metabolism, 1985, pp. 1073-1077, vol. 34, No. 11, Lund, Sweden.
Olszewski, Andrzej. J. et al., "Reduction of plasma lipid and homocysteine levels by pyridoxine, folate, cobalamin, choline, roboflavin, and troxerutin in atherosclerosis", Athersclerosis, 1989, pp. 1-6, vol. 75, Elsevier Scientific Publishers, Ireland, Ltd. 0021-9150/89.
Arnesen, Egil et al., "Serum Total Homocysteine and Coronary Heart Disease", International Journal of Epidemiology, 1995, pp. 704-709, vol. 24, No. 4, Great Brittan.
Mason, Joel B., et al., "The Effects of Vitamins.sub.a B.sub.12, B.sub.6, and Folate on Blood Homocysteine Levels" Annals of the New YOrk Academy of Sciences, pp. 197-204, vol. 669, New York, New York.
Franken, Diana G., et al., "Treatment of Mild Hyperhomocysteinemia in Vascular Disease Patients" Arteriosclerosis and Thrombosis, pp. 465-470, vol. 14, No. 3, (1994).
Van Den Berg, Michaiel, et al., "Combined vitamin B.sub.6 plus folic acid therapy in young patients with arteriosclerosis and hyperhomocysteinemia", Journal of Vascular Surgery, 1994, vol. 20, No. 6, pp. 933-940.
"Homocysteine, Folic Acid, and the Prevention of Vascular Disease", Nutrition Reviews pp. 247-249, vol. 47, No. 8.
Kang, Soo-Sang et al., "Hyperhomocyst(e)inemia as a Risk Factor for Occlusive Vascular Disease", Annu. Rev. Nutr, 1992, pp. 279-298, vol. 12:279-98.
Stampfer, Meir J., et al., "A Prospective Study of Plasma Homocyst(e)ine and Risk of Myocardial Infarction in US Physcicians", JAMA, 1992, pp. 877-881, vol. 268, No. 7.
Stampfer, Meir J., et al., "Homocysteine and Marginal Vitamin Deficiency The Importance of Adequate Vitamin Intake", JAMA, 1993, pp. 2726-2727 vol. 270, No. 22.
Chasan-Taber, Lisa, et al., "A Prospective Study of Folate and Vitamin B.sub.6 and Risk of Myocardial Infarction in US Physicians", Journal of the American College of Nutrition, pp. 136-143, vol. 15, No. 2.
Harpey, Jean-Paul, "Hemocystinuira caused by 5, 10 methylenetetrahydrofolate reductase deficiency: A case in an infant responding to methionine, folinic acid, pyridoxine, and vitamin B.sub.12 therapy", The Journal of Pediatrics,1981, pp. 275-278, vol. 98 No. 2 (The C.V. Mosby Co.).
Wilcken, David, "Folic Acid Lowers Elevated Plasma Homocysteine in Chronic Renal Insufficiency: Possible Implications for Prevention of Vascular Disease", Metabolism, 1988, pp. 697-701, vol. 37, No. 7 (Jul.) Sydney N.S.W., Australia.
Metabolite Laboratories, Inc.
Parkin Jeffrey S.
Scheiner Laurie
LandOfFree
Method for treatment and prevention of deficiencies of vitamins does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for treatment and prevention of deficiencies of vitamins , we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for treatment and prevention of deficiencies of vitamins will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1114835