IP Library Granted Patent US 10,912,796
Granted Patent B2
US 10,912,796 · App. 14/772,558 · Granted Feb 9, 2021

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
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,912,796
App. No.
14/772,558
Granted
Feb 9, 2021
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 (32)

1. A single dosage form 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 chelates of calcium, and

(b) one or more phosphorus-containing component(s) that provide, in total, up to about 250 mg elemental phosphorus and one or more phosphorus-rescuing component(s), wherein each phosphorus-rescuing component is a phosphohydrolase, a phytase or any other component that can break down phytic acid or phytate to release phosphorus in the body, wherein the total molar amount of phosphorus delivered by such phosphorus-containing component(s) and rescued by such phosphorus-rescuing component(s) is calculated to be about 33% to about 300% of the molar amount of calcium in the single dosage form;

wherein the molar ratio of calcium to phosphorus provides phosphorus-sparing calcium supplementation.

2. The single dosage form 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 single dosage form 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 single dosage form of claim 1 , comprising dicalcium malate (DCM) as an organic acid salt and/or chelate of calcium.

5. The single dosage form of claim 4 , further comprising tricalcium phosphate (TCP).

6. The single dosage form of claim 5 , in a form of a tablet or a capsule 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 greater than zero to about 150 mg dibasic sodium phosphate.

7. The single dosage form of claim 6 , 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.

8. The single dosage form of claim 1 , comprising phytase as a phosphorus-rescuing component, in an amount of about 0.1 to about 10 FTU (phytase units).

9. A single dosage form comprising

(a) one to a plurality of physiologically acceptable 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(s) and one or more phosphorus-rescuing component(s), wherein each phosphorus-rescuing component is a phosphohydrolase, a phytase or any other component that can break down phytic acid or phytate to release phosphorus in the body, wherein the phosphorus—containing component(s) contain up to about 250 mg elemental phosphorus, and wherein the total molar amount of phosphorus delivered by such phosphorus-containing component(s) and rescued by such phosphorus-rescuing component(s) is calculated to be about 33% to about 300% of the molar amount of calcium in the single dosage form;

wherein the molar ratio of calcium to phosphorus provides phosphorus-sparing calcium supplementation.

10. A single dosage form comprising

(a) about 250 to about 800 mg in total of one or more physiologically acceptable 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 physiologically acceptable calcium salts and/or chelates, wherein the phosphorus-containing component contains up to about 250 mg elemental phosphorus; and

(c) a phosphorus-rescuing component is a phosphohydrolase, a phytase or any other component that can break down phytic acid or phytate to release phosphorus in the body;

wherein the molar ratio of calcium to phosphorus delivered by each dosage form is about 1:3 to about 3:1; and

the molar ratio of calcium to phosphorus provides phosphorus-sparing calcium supplementation.

11. A method for supplementing mineral nutrition in a human subject, comprising orally administering to the subject one to a plurality of the single dosage form of claim 1 daily.

12. The method of claim 11 , wherein a total daily dose of about 100 to about 1500 mg elemental calcium equivalent is administered.

13. 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 single dosage form of claim 1 daily.

14. The method of claim 13 , wherein the low bone density condition is manifested as osteomalacia, osteopenia or osteoporosis.

15. The method of claim 13 , wherein a total daily dose of about 250 to about 1500 mg elemental calcium equivalent is administered.

16. The single dosage form of claim 1 , wherein the phosphorus-containing component is separate from said one or more physiologically acceptable calcium salts and/or chelates.

17. The single dosage form of claim 1 , wherein the phosphorus-containing component is partly provided by said one or more physiologically acceptable calcium salts and/or chelates.

18. The single dosage form of claim 9 , wherein the phosphorus-containing component is separate said one or more physiologically acceptable calcium salts and/or chelates.

19. The single dosage form of claim 10 , wherein the phosphorus-containing component is separate from said one or more physiologically acceptable calcium salts and/or chelates.

20. The single dosage form of claim 10 , wherein the phosphorus-containing component is partly provided by said one or more physiologically acceptable calcium salts and/or chelates.

21. The single dosage form of claim 9 , wherein the phosphorus-containing component is partly provided by said one or more physiologically acceptable calcium salts and/or chelates.

Assignments (6)
SECURITY INTEREST Recorded Jul 28, 2022
From: ALBION LABORATORIES, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 060656/0226 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Jun 29, 2018
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: ALBION LABORATORIES, INC. (FORMERLY AMIP, LLC)
Reel/Frame 046464/0731 →
SECURITY INTEREST Recorded Jun 27, 2018
From: ALBION LABORATORIES, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 046221/0237 →
MERGER Recorded Nov 9, 2017
From: AMIP, LLC
To: ALBION LABORATORIES, INC.
Reel/Frame 044082/0796 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded May 4, 2016
From: AMIP, LLC
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 038606/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 26, 2016
From: BORTZ, JONATHAN DAVID
To: AMIP, LLC
Reel/Frame 037586/0839 →
Continuity (2)
Provisional Application 61785062 · Mar 14, 2013
Related Publication 20160015746A1 · Jan 21, 2016