Pharmaceutical compositions and method for alleviating side-effects of estrogen replacement therapy

• US 20040253319A1
• Filed: 06/11/2003
• Published: 12/16/2004
• Est. Priority Date: 06/11/2003
• Status: Abandoned Application

• Current Assignee: Matthias Rath
• Original Assignee: Matthias Rath
• Inventors: Rath, Matthias, Niedzwiecki, Aleksandra, Netke, Shrirang, Ivanov, Vadim
• Application Number:
  US10/460,023
• Publication Number:
  US 20040253319A1
• Time in Patent Office: Days
• US Class Current: 424/630
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/05 Phenols cannabinoids A61K31/658
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/32 Tin compounds
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 33/04 Sulfur, selenium or tellurium; Compounds thereof
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/32 Manganese; Compounds thereof
• CPC Class Codes: A61K 33/34 Copper; Compounds thereof
• CPC Class Codes: A61K 36/82 Theaceae (Tea family), e.g. camellia
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 : Antihypertensives

Abstract

The present invention provides pharmaceutical compositions for alleviating pathological conditions in a post-menopausal woman, comprising lysine, proline, arginine, ascorbic acid, magnesium, green tea extract, N-acetyl-cysteine, selenium, copper, manganese and one pharmaceutical acceptable component selected from the group consisting of a carrier, a diluent, and an excipient, wherein the compositions contain 24-25 wt % lysine, 16-25 wt % ascorbic acid and 22-25 wt % green tea extract. A method of treatment using the pharmaceutical compositions are also disclosed.

Claims

1. A pharmaceutical composition for alleviating pathological conditions in a post-menopausal woman, comprising lysine, proline, arginine, ascorbic acid, magnesium, green tea extract, N-acetyl-cysteine, selenium, copper, manganese and one pharmaceutical acceptable component selected from the group consisting of a carrier, a diluent, and an excipient, wherein the composition contains 24-25 wt % lysine, 16-25 wt % ascorbic acid and 22-25 wt % green tea extract.

2. The pharmaceutical composition of claim 1, further comprising an estrogen compound selected from the group consisting of ethynyl estrogen, mestranol, estradiol, ethinyl estradiol, estriol, norethisterone, lynestrenol, ethynodiol, dienoestrol, biperazine estrone sulfate, and phytoestrogen.

3. The pharmaceutical compound of claim 2, further comprising a progestin compound selected from the group consisting of medroxyprogesterone, norethylnodrel, and nonethindrone.

4. The pharmaceutical composition of claim 1, wherein lysine is present at 750 mg-15 gram, proline is present at 500 mg-10 gram, arginine is present at 400 mg-8 gram, ascorbic acid is present at 500 mg-10 gram, magnesium is present at 40 mg-750 mg, green tea extract is present at 750 mg-15 gram, N-acetyl-cysteine is present at 150 mg-2 gram, selenium is present at 20-700 mcg, copper is present at 1.5 mg-20 mg, and manganese is present at 0.8 mg-15 mg.

5. The composition of claim 1, wherein lysine is present at 1 gram-5.5 gram, proline is present at 750 mg-4 gram , arginine is present at 500 mg-3 gram, ascorbic acid is present at 710 mg-4 gram, magnesium is present at 50 mg-300 mg, green tea extract is present at 1 gram-5 gram, N-acetyl-cysteine is present at 200 mg-1 gram, selenium is present at 30-400 mcg, copper is present at 2 mg-10 mg, and manganese is present at 1 mg-8 mg.

6. The composition of claim 1, wherein lysine is present at 1 gram, proline is present at 750 mg, arginine is present at 500 mg, ascorbic acid is present at 710 mg, magnesium is present at 50 mg, green tea extract is present at 1 gram, N-acetyl-cysteine is present at 200 mg, selenium is present at 30 mcg, copper is present at 2 mg, and manganese is present at 1 mg.

7. The pharmaceutical composition of claim 1, wherein the pathological condition is at least one disease selected from the group consisting of hypertension, atherosclerosis and breast cancer.

8. The pharmaceutical composition of claim 1, wherein the composition is in a oral form or a parenteral form.

9. The pharmaceutical composition of claim 8, wherein the oral form is a tablet, a pill or a capsule.

10. A method for alleviating pathological conditions in a post-menopausal woman, comprising the step of administering to the woman in need of treatment an effective amount of the pharmaceutical composition of claim 1, 2 or 3.

11. The method of claim 10, wherein the effective amount of the composition is a daily dosage of 10-208 mg/kg lysine, 7-139 mg/kg proline, 5-111 mg/kg arginine, 7-139 mg/kg ascorbic acid, 0.5-10 mg/kg magnesium, 10-208 mg/kg green tea extract, 2-28 mg/kg N-acetyl-cysteine, 0.0003-0.01 mg/kg selenium, 0.02-0.3 mg/kg copper, 0.01-0.2 mg/kg manganese.

12. The method of claim 10, wherein the effective amount of the composition is a daily dosage of 13-70 mg/kg lysine, 10-56 mg/kg proline, 7-42 mg/kg arginine, 9.8-4 mg/kg ascorbic acid, 0.7-4.2 mg/kg magnesium, 13-70 mg/kg green tea extract, 3-14 mg/kg N-acetyl-cysteine, 0.0004-0.006 mg/kg selenium, 0.03-0.15 mg/kg copper, 0.01-0.1 mg/kg manganese.

13. The method of claim 10, wherein the effective amount of the composition is a daily dosage of 13 mg/kg lysine, 10 mg/kg proline, 7 mg/kg arginine, 56 mg/kg ascorbic acid, 0.7 mg/kg magnesium, 13 mg/kg green tea extract, 3 mg/kg N-acetyl-cysteine, 0.0004 mg/kg selenium, 0.03 mg/kg copper, 0.01 mg/kg manganese.

14. The method of claim 10, wherein the pharmaceutical composition is administered orally, intravenously, or parenterally.