Combined calcium, magnesium and vitamin D supplements
Inventors
Nelson, Deanna Jean • Holberg, III, Walter C.
Assignees
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Publication Number
US-8324191-B2
Publication Date
2012-12-04
Expiration Date
Abstract
The present invention relates to oral nutritional and therapeutic products which are useful for providing vitamins and minerals required for bone health. The present invention is an oral nutritional and therapeutic composition of calcium succinate, magnesium R-(+)-alpha-lipoate, and Vitamin D for use in the maintenance of bone health, the optimization of bone growth, reducing the risk of bone fracture, and the prevention and treatment of osteoporosis. The pharmaceutical products and methods of the present invention are particularly useful in building bone mass, quality, and density during growth, maintaining bone mass, quality, and density over time, reducing bone fracture risk, and treating osteoporosis in men and women.
Core Innovation
The invention relates to an oral nutritional/therapeutic composition and related methods for bone health and osteoporosis in a human. The composition comprises calcium succinate, magnesium R-(+)-alpha-lipoate, and a vitamin D material, and the method administers a safe and effective amount sufficient to achieve building bone mass, strength, microarchitecture, and density during growth, maintaining bone mass, strength, microarchitecture, and density over time, reducing bone fracture risk, and treating osteoporosis in a human.
The approach emphasizes magnesium R-(+)-alpha-lipoate having greater than 95% purity and greater than 95% chiral purity. The vitamin D material is selected from vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2, 1alpha,25(OH)2D3, 1alpha,25(OH)2D2, and mixtures thereof, and the calcium component is provided as calcium succinate.
The composition is positioned as achieving unexpectedly high bioavailability despite water insolubility of magnesium R-(+)-alpha-lipoate. The claimed overall effect is linked to synergistic outcomes on bone mass, bone strength, bone microarchitecture, bone density, and fracture risk, supported by example outcomes for calcium absorption and bone-density outcomes in rats and post-menopausal women.
Claims Coverage
The independent claims define two related inventive feature groups: administration of calcium succinate, magnesium R-(+)-alpha-lipoate, and an enumerated vitamin D material to build and maintain bone properties and treat osteoporosis, and a unit dosage or serving mixture with specified elemental amounts and vitamin D3-equivalent range. Both groups require magnesium R-(+)-alpha-lipoate with greater than 95% purity and greater than 95% chiral purity.
Bone mass and fracture risk reduction using calcium succinate, magnesium R-(+)-alpha-lipoate, and a selected vitamin D material
Administering to a human a safe and effective amount of a composition comprising calcium succinate, magnesium R-(+)-alpha-lipoate, and a vitamin D material selected from vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2, 1alpha,25(OH)2D3, 1alpha,25(OH)2D2, and mixtures thereof, where the amount is sufficient to achieve building bone mass, strength, microarchitecture, and density during growth, maintaining these properties over time, reducing bone fracture risk, and treating osteoporosis in a human.
High-purity magnesium R-(+)-alpha-lipoate for the bone health method
Magnesium R-(+)-alpha-lipoate has greater than 95% purity and greater than 95% chiral purity.
Serving mixture with specified elemental amounts and vitamin D3-equivalent range
A unit dosage or serving mixture comprising about 25 milligrams to about 250 milligrams of calcium, on an elemental basis, as calcium succinate; about 5 milligrams to about 100 milligrams magnesium, on an elemental basis; about 400 milligrams to about 4,000 milligrams R-(+)-alpha-lipoate in the form of magnesium R-(+)-alpha-lipoate; and vitamin D material equivalent to about 5 to about 50 micrograms of vitamin D3.
High-purity and chiral-purity constraint for magnesium R-(+)-alpha-lipoate in the serving mixture
Magnesium R-(+)-alpha-lipoate has greater than 95% purity and greater than 95% chiral purity.
The claims focus on a calcium succinate, magnesium R-(+)-alpha-lipoate, and vitamin D material composition for bone health and osteoporosis, with the additional requirement that magnesium R-(+)-alpha-lipoate have greater than 95% purity and greater than 95% chiral purity. The serving-mixture claim further narrows the composition by specifying elemental calcium and magnesium ranges, an R-(+)-alpha-lipoate mass range, and a vitamin D3-equivalent range.
Stated Advantages
Enhanced absorption/utilization despite water insolubility of magnesium R-(+)-alpha-lipoate.
Improved organoleptics/compliance compared with conventional calcium/magnesium/vitamin D supplements.
Ability to reduce bone fracture risk and treat osteoporosis in a human.
Documented Applications
Building bone mass, strength, microarchitecture, and density during growth in a human.
Maintaining bone mass, strength, microarchitecture, and density over time in a human.
Reducing bone fracture risk in a human.
Treating osteoporosis in a human.
Calcium absorption outcomes in the described examples.
Bone-density outcomes in the described examples, including post-menopausal women.
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