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US5849338A
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Unit dosage forms for treatment of vasoconstriction and related conditions
Assignee: RICHELL LABORATORIES
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Filing: 1997-03-18
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Granted: 1998-12-15
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Expires: 2017-03-18
Abstract
Abstract Magnesium is formulated in combination with vitamin E, vitamin C, folate, selenium, and optionally melatonin in a unit dosage form for oral administration, for the treatment of vasoconstriction and the physiological and pathological conditions giving rise to vasoconstriction. These active agents complement each other in suppressing these conditions, using a variety of mechanisms operating in conjunction with one another. The inclusion of magnesium in a plurality of forms provides additional advantages in terms of controlling and sustaining the release of magnesium in locations along the digestive tract where the magnesium will have its greatest effectiveness as a therapeutic agent, thus improving control over thge clinical bioavailability of magnesium and in improving the selection of appropriate therapeutic ranges.
Inventors
- 👤 Kenneth T. Richardson
- 👤 Don C. Pearson
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 15:49
CPC Classifications
A; A61; A61K; A61K33/00; A61K33/06; A61K33/24
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
77 words
A unit dosage form for treatment of vasoconstriction and physiological conditions giving rise thereto, said dosage form comprising a combination of the following components in therapeutically effective amounts: (i) magnesium; (ii) a member selected from the group consisting of α-tocopherol, β-tocopherol, and esters thereof; (iii) a member selected from the group consisting of ascorbic acid and ascorbate ion; (iv) a member selected from the group consisting of folic acid and folate ion; (v) selenium; and (vi) melatonin.
Claim 2
Dependent Claim
77 words
A unit dosage form for treatment of vasoconstriction and physiological conditions giving rise thereto, said dosage form comprising a combination of the following components in therapeutically effective amounts: (i) magnesium; (ii) a member selected from the group consisting of α-tocopherol, β-tocopherol, and esters thereof; (iii) a member selected from the group consisting of ascorbic acid and ascorbate ion; (iv) a member selected from the group consisting of folic acid and folate ion; (v) selenium; and (vi) melatonin.
Claim 3
Dependent Claim
70 words
A unit dosage form in accordance with claim 1 in which said components are included in the following ranges of amounts: (i) about 20 mg to about 700 mg; (ii) about 15 IU to about 1,000 IU; (iii) about 30 mg to about 1,000 mg; (iv) about 0.05 mg to about 0.225 mg; (v) about 0.005 mg to about 0.15 mg; and (vi) about 0.10 mg to about 40 mg.
Claim 4
Dependent Claim
69 words
A unit dosage form in accordance with claim 1 in which said components are included in the following ranges of amounts: (i) about 40 mg to about 180 mg; (ii) about 20 IU to about 400 IU; (iii) about 40 mg to about 500 mg; (iv) about 0.10 mg to about 0.20 mg; (v) about 0.005 to about 0.035 mg; and (vi) about 0.5 mg to about 30 mg.
Claim 5
Dependent Claim
48 words
A unit dosage form in accordance with claim 1 in which the weight ratios of components (ii), (iii), and (iv) relative to component (i) are in the following ranges: (ii) about 0.2:1 to about 2:1; (iii) about 0.2:1 to about 2:1; and (iv) about 0.0003:1 to about 0.0030:1.
Claim 6
Dependent Claim
48 words
A unit dosage form in accordance with claim 1 in which the weight ratios of components (ii), (iii), and (iv) relative to component (i) are in the following ranges: (ii) about 0.5:1 to about 1:1; (iii) about 0.5:1 to about 1:1; and (iv) about 0.00075:1 to about 0.0020:1.
Claim 7
Dependent Claim
46 words
A unit dosage form in accordance with claim 1 in which said magnesium is supplied in the form of a member selected from the group consisting of magnesium lactate, magnesium citrate, magnesium stearate, magnesium acetate, magnesium ascorbate, magnesium malate, magnesium orotate, magnesium diglycinate, and magnesium oxide.
Claim 8
Dependent Claim
27 words
A unit dosage form in accordance with claim 1 in which said magnesium is supplied as a combination of magnesium compounds comprising magnesium citrate and magnesium ascorbate.
Claim 9
Dependent Claim
29 words
A unit dosage form in accordance with claim 1 in which said magnesium is supplied as a combination of magnesium compounds comprising magnesium acetate, magnesium citrate, and magnesium oxide.
Claim 10
Dependent Claim
33 words
A unit dosage form in accordance with claim 1 in which said magnesium is supplied as a combination of magnesium compounds comprising magnesium lactate, magnesium acetate, magnesium citrate, magnesium ascorbate, and magnesium oxide.
Claim 11
Dependent Claim
29 words
A unit dosage form in accordance with claim 1 in which component (ii) is a member selected from the group consisting of a-tocopherol, a-tocopherol acid succinate, and α-tocopherol acetate.
Claim 12
Dependent Claim
36 words
A unit dosage form in accordance with claim 1 in which said components are formulated as a member selected from the group consisting of a tablet, a gelatin capsule, a solution, a suspension, and a powder.
Claim 13
Dependent Claim
36 words
A unit dosage form in accordance with claim 1 in which said components are formulated as a substantially homogeneous tablet that releases all of said components into the stomach upon ingestion for contact with gastric fluid.
Claim 14
Dependent Claim
34 words
A unit dosage form in accordance with claim 12 in which said components comprise: (a) magnesium oxide, (b) magnesium acetate, (c) magnesium ascorbate, (d) α-tocopherol succinate, (e) folic acids (f) selenium, and (g) melatonin.
Claim 15
Dependent Claim
17 words
A unit dosage form in accordance with claim 13 in which said components further comprise magnesium citrate.
Claim 16
Dependent Claim
79 words
A unit dosage form in accordance with claim 13 in which components (a) through (g) are present in the following ranges of amounts: (a) about 50 mg to about 100 mg, (b) about 40 mg to about 100 mg, (c) about 150 mg to about 250 mg, (d) about 50 IU to about 100 IU, (e) about 0.03 mg to about 0.3 mg, (f) about 0.007 mg to about 0.02 mg, and (g) about 0.5 to about 30 mg.
Claim 17
Dependent Claim
17 words
A unit dosage form in accordance with claim 13 in which said components further comprise: magnesium citrate.
Claim 18
Dependent Claim
26 words
A unit dosage form in accordance with claim 16 in which component (h) is present in the amount of about 50 mg to about 100 mg.
Claim 19
Dependent Claim
61 words
A unit dosage form in accordance with claim 1 in which said components are formulated as a combination tablet in which said components are present as first and second portions separately formulated such that said first portion is released into the stomach upon ingestion for contact with gastric fluid, and said second portion is protected from release until reaching the intestine.
Claim 20
Dependent Claim
38 words
A unit dosage form in accordance with claim 18 in which the components of said second portion are coated with an acid-resistant protective coating that substantially prevents penetration thereof by gastric fluid but is penetrable by intestinal fluid.
Claim 21
Dependent Claim
63 words
A unit dosage form in accordance with claim 18 in which said components of said first portion comprise: (a) a member selected from the group consisting of α-tocopherol, β-tocopherol, and esters thereof, (b) a member selected from the group consisting of folic acid and folate ion, (c) selenium, and (d) magnesium compounds; and said components of said second portion comprise further magnesium compounds.
Claim 22
Dependent Claim
53 words
A unit dosage form in accordance with claim 18 in which said components of said first portion comprise: (a) α-tocopherol succinate, (b) folic acid, (c) selenium, (d) magnesium oxide, (e) magnesium diglycinate, and (f) magnesium ascorbate, and said components of said second portion comprise: (g) magnesium citrate, (h) magnesium acetate, and (i) melatonin.
Claim 23
Dependent Claim
95 words
A unit dosage form in accordance with claim 21 in which components (a) through (i) are present in the following ranges of amounts: (a) about 50 IU to about 100 IU, (b) about 0.03 mg to about 0.3 mg, (c) about 0.007 mg to about 0.20 mg, (d) about 50 mg to about 100 mg, (e) about 50 mg to about 200 mg, (f) about 150 mg to about 250 mg, (g) about 50 mg to about 100 mg, (h) about 40 mg to about 100 mg, (i) about 0.5 mg to about 30 mg.
References Cited (Backward Citations)
CA2057463A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-12-14 | 2002-06-15 | 2002-12-15 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-12-14 | 2006-06-15 | 2006-12-15 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-12-14 | 2010-06-15 | 2010-12-15 | $7700.00 | Window Closed / Lapsed |