IP Library Granted Patent US 11,534,458
Granted Patent B2
US 11,534,458 · App. 17/142,309 · Granted Dec 27, 2022

Phosphorus-sparing nutritional composition

Inventor: Jonathan David Bortz (St. Louis, MO)
Assignee: ALBION LABORATORIES, INC.
A61K33/42A23L29/06A23L33/16A23L33/165A61K31/194A61K38/465A23V2002/00A23V2200/306A23V2250/1578C12Y301/00
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Quick Facts
Patent No.
US 11,534,458
App. No.
17/142,309
Granted
Dec 27, 2022
Kind
B2
Abstract

A nutritional composition comprises (a) one to a plurality of physiologically acceptable calcium salts and/or chelates and (b) one or more phosphorus-containing components, such as phosphate salts, and/or phosphorus-rescuing components, such as phytase. The composition is useful for phosphorus-sparing calcium supplementation of the diet of a human subject, and for treatment of a low bone density condition in a human subject in need thereof.

Claims (28)

1. A composition comprising

(a) one to a plurality of physiologically acceptable calcium salts and/or chelates, at least about 5% of the molar amount of calcium in the composition being in the form of one or more organic acid salts and/or organic chelates of calcium, and

(b) one or more phosphorus-containing components, wherein the total molar amount of phosphorus delivered by such phosphorus-containing component(s) is calculated to be about 33% to about 300% of the molar amount of calcium in the composition,

wherein the composition delivers phosphorus-sparing functionality whereby a reduction in phosphorus availability associated with calcium supplementation is mitigated or eliminated.

2. The composition of claim 1 , further comprising one or more additional nutritional ingredients independently selected from the group consisting of ascorbic acid and salts and esters thereof, vitamin D, and salts and chelates of mineral nutrients other than calcium.

3. The composition of claim 1 , further comprising at least one salt and/or chelate of a mineral nutrient other than calcium, selected from the group consisting of magnesium aspartate, magnesium creatine chelate, magnesium glycinate chelate, magnesium glycyl glutamine chelate, magnesium lysyl glycinate chelate, iron bisglycinate chelate, ferrous asparto glycinate chelate, zinc arginate chelate, zinc glycinate chelate, zinc histinate chelate, chromium nicotinate glycinate chelate, copper glycinate chelate, manganese glycinate chelate, molybdenum glycinate chelate, vanadium nicotinate glycinate chelate and combinations thereof.

4. The composition of claim 1 , further comprising one or more phosphorus-rescuing component.

5. The composition of claim 1 , comprising dicalcium malate (DCM) as an organic acid salt and/or chelate of calcium.

6. The composition of claim 5 , further comprising tricalcium phosphate (TCP).

7. The composition of claim 6 , in a form of one to a plurality of tablets or capsules each comprising DCM in an amount equivalent to about 40 to about 80 mg elemental calcium, TCP in an amount equivalent to about 75 to about 150 mg elemental calcium, and zero to about 150 mg dibasic sodium phosphate.

8. The composition of claim 7 , wherein each tablet or capsule further comprises one or more of zinc glycinate chelate in an amount equivalent to about 2.5 to about 5 mg elemental zinc, cholecalciferol in an amount of about 250 to about 500 IU, vitamin K2 in an amount of about 60 to about 120 μg, and genistein in an amount of about 20 to about 40 mg.

9. The composition of claim 4 , comprising phytase as a phosphorus-rescuing component, in an amount of about 0.1 to about 10 FTU (phytase units).

10. A composition comprising

(a) one to a plurality of calcium salts and/or chelates independently selected from the group consisting of calcium carbonate, monocalcium phosphate (MCP), dicalcium phosphate (DCP), hydroxyapatite, calcium citrate tetrahydrate, calcium citrate malate (CCM), calcium formate, calcium gluconate, calcium glycerophosphate, calcium bisglycinate, calcium lactate, calcium levulinate, dicalcium malate (DCM), calcium succinate and calcium tartrate; and

(b) one or more phosphorus-containing component, wherein the total molar amount of phosphorus delivered by such phosphorus-containing component(s) is calculated to be about 33% to about 300% of the molar amount of calcium in the composition;

wherein the composition delivers phosphorus-sparing functionality whereby a reduction in phosphorus availability associated with calcium supplementation is mitigated or eliminated.

11. A composition comprising

(a) one to a plurality of physiologically acceptable calcium salts and/or chelates in a total amount equivalent to about 75 to about 750 mg elemental calcium per unit dose; and

(b) at least one phytase in a total amount of about 0.1 to about 10 FTU per mg elemental calcium equivalent.

12. The composition of claim 11 , wherein at least about 5% of the molar amount of calcium in the composition is in the form of one or more organic acid salts and/or chelates of calcium.

13. The composition of claim 11 in a form of one to a plurality of tablets or capsules each comprising about 345 to about 862 mg DCM, greater than zero to about 405 mg TCP and about 100 to about 200 FTU phytase per tablet.

14. The composition of claim 11 , wherein the at least one physiologically acceptable calcium salt and/or chelate is in a total amount equivalent to about 250 to about 750 mg elemental calcium per unit dose.

15. The composition of claim 11 , wherein the at least one salt and/or chelate of calcium is selected from the group consisting of carbonate, phosphate, citrate, malate, citrate malate, gluconate, glycerophosphate, bisglycinate, formate, lactate, levulinate and tartrate salts and chelates and combinations thereof.

16. The composition of claim 11 , wherein the at least one phytase comprises a 3-phytase.

17. The composition of claim 11 , wherein the at least one phytase is present in a total amount of about 0.3 to about 3 FTU per mg elemental calcium equivalent.

18. A composition comprising one to a plurality of dose units, each dose unit comprising (a) about 250 to about 800 mg in total of one or more calcium salts and/or chelates and (b) a phosphorus-containing component that is separate from or partly or wholly provided by said one or more calcium salts and/or chelates; wherein the molar ratio of calcium to phosphorus delivered by each dose unit is about 1:3 to about 3:1, and wherein the composition delivers phosphorus-sparing functionality whereby a reduction in phosphorus availability associated with calcium supplementation is mitigated or eliminated.

19. A method for supplementing mineral nutrition in a human subject, comprising orally administering to the subject one to a plurality of unit doses of the composition of claim 1 daily.

20. A method for treating, retarding or reversing the progress of a low bone density condition in a human subject in need thereof, comprising orally administering to the subject one to a plurality of unit doses of the composition of claim 1 daily.

Assignments (1)
SECURITY INTEREST Recorded Jul 28, 2022
From: ALBION LABORATORIES, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 060656/0226 →
Continuity (3)
Division 14772558
Provisional Application 61785062 · Mar 14, 2013
Related Publication 20210137975A1 · May 13, 2021