SLOW RELEASE MAGNESIUM COMPOSITION AND USES THEREOF
First Claim
1. An oral dosage form comprising magnesium (Mg) and threonate (T), wherein said threonate comprises one or more of a threonate salt or a threonate precursor, wherein said oral dosage form has an in vitro dissolution profile in a dissolution medium, and wherein said dissolution profile ranges between less than or equal to 5% in about 2 hours, less than 10% in about 4 hours, less than 40% in about 6 hours, greater than or equal to 60% in about 10 hours, and greater than or equal to 80% in about 12 hours as measured using a USP type II (paddle) dissolution system at 75 rpm, at a temperature of 37°
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2 Assignments
0 Petitions
Accused Products
Abstract
The present invention provides compositions that contain magnesium and threonate, or a threonate precursor molecule, formulated for extended or modified release to provide physiological concentrations over a desired time period. The extended release or modified release form is particularly useful in providing Mg to a subject while avoiding adverse side effects such as diarrhea.
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Citations
40 Claims
- 1. An oral dosage form comprising magnesium (Mg) and threonate (T), wherein said threonate comprises one or more of a threonate salt or a threonate precursor, wherein said oral dosage form has an in vitro dissolution profile in a dissolution medium, and wherein said dissolution profile ranges between less than or equal to 5% in about 2 hours, less than 10% in about 4 hours, less than 40% in about 6 hours, greater than or equal to 60% in about 10 hours, and greater than or equal to 80% in about 12 hours as measured using a USP type II (paddle) dissolution system at 75 rpm, at a temperature of 37°
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5. (canceled)
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8. (canceled)
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9. (canceled)
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15-22. -22. (canceled)
- 23. An oral dosage form comprising between about 10 mg to 500 mg elemental magnesium (Mg), wherein said oral dosage form is a controlled release formulation, and wherein upon administering said oral dosage form to a Sprague-Dawley rat at a dosage of equal to or less than 75 mg/kg/day yields an incidence of diarrhea of less than 20%.
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25. (canceled)
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28-30. -30. (canceled)
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33. An oral dosage form comprising magnesium (Mg) and threonate (T), wherein said threonate comprises one or more of a threonate salt or a threonate precursor, wherein said oral dosage form is readily absorbed or retained upon administering said oral dosage form to a subject at least about 50% of said administered magnesium is absorbed in said subject, or that at least 30% of the magnesium administered to the subject is retained over a period of at least two days when said oral dosage form is administered at a dose of 20 mg/kg/day or higher.
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34-38. -38. (canceled)
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40-46. -46. (canceled)
Specification