IP Library Granted Patent US 9,492,491
Granted Patent B1
US 9,492,491 · App. 15/059,644 · Granted Nov 15, 2016

Compositions and methods to inhibit kidney stone growth

Inventors: Gregory K. Hayer (Fort Lauderdale, FL); Brendan Magrab (Westfield, NJ); Henry R. Wolfe, Jr. (Glenmoore, PA)
Assignee: KIDNEY STONE LABORATORIES, INC.
A61K36/88A61K9/0053A61K9/48A61K31/194A61K31/4415A61K31/6615A61K33/06
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Quick Facts
Patent No.
US 9,492,491
App. No.
15/059,644
Granted
Nov 15, 2016
Kind
B1
Abstract

An oral dosage form or plurality of oral dosage forms comprising as active ingredients combinations of citric acid, magnesium citrate, phytin, pyridoxine, and musa is disclosed. The oral dosage form(s) is useful for inhibiting calcium oxalate crystal growth and for treating or inhibiting growth of kidney stones. Methods of inhibiting calcium oxalate crystal growth and of treating or preventing kidney stones are also disclosed.

Claims (111)

1. An oral dosage form or plurality of dosage forms comprising ingredients:

magnesium citrate in an amount of about 2.03 mg to about 203 mg,

phytin in an amount of about 100 mg to about 600 mg,

pyridoxine in an amount of about 0.22 mg to about 15.1 mg, and

musa in an amount of about 1.46 mg to about 252 mg,

wherein the percent inhibition of the rate of calcium oxalate crystal formation is greater than about 99%.

2. The oral dosage form or plurality of dosage forms of claim 1 , wherein

magnesium citrate is present in an amount of about 150 mg;

phytin is present in an amount of about 200 mg;

pyridoxine is present in an amount of about 5 mg; and

musa is present in an amount of about 200 mg.

3. The oral dosage form or plurality of dosage forms according to claim 1 where there is one oral dosage form.

4. The oral dosage form or plurality of dosage forms according to claim 1 , which is a plurality of oral dosage forms.

5. The oral dosage form or plurality of dosage forms according to claim 1 , wherein the oral dosage form or plurality of dosage forms is a capsule, an emulsion, or a plurality thereof.

6. The oral dosage form or plurality of dosage forms according to claim 1 wherein

a) the amount of magnesium citrate is selected from:

i) about 2.03 mg to about 151 mg,

ii) about 2.03 mg to about 77 mg,

iii) about 77 mg to about 201 mg,

iv) about 77 mg to about 151 mg, and

v) about 151 mg to about 201 mg;

b) the amount of phytin is selected from:

i) about 100 mg to about 475 mg

ii) about 100 mg to about 400 mg,

iii) about 100 mg to about 202 mg,

iv) about 201 mg to about 475 mg,

v) about 201 to about 400 mg, and

vi) about 400 to about 475 mg;

c) the amount of pyridoxine is selected from:

i) about 0.22 mg to about 10.11 mg,

ii) about 0.22 mg to about 6.01 mg,

iii) about 0.22 mg to about 2.69 mg,

iv) about 2.69 mg to about 15.1 mg,

v) about 2.69 mg to about 10.11 mg,

vi) about 2.69 mg to about 6.01 mg,

vii) about 5.4 mg to about 15.1 mg,

viii) about 5.4 mg to about 10.11 mg, and

ix) about 10.11 mg to about 15.1 mg;

and,

d) the amount of musa is selected from:

i) about 1.46 mg to about 168 mg,

ii) about 1.46 mg to about 85 mg,

iii) about 1.46 mg to about 42 mg,

iv) about 42 mg to about 252 mg,

v) about 42 mg to about 168 mg,

vi) about 42 mg to about 85 mg,

vii) about 85 mg to about 252 mg,

viii) about 85 mg to about 168 mg, and

ix) about 168 mg to about 252 mg.

7. The oral dosage form or plurality of dosage forms according to claim 1 , where the percent inhibition is greater than about 104%.

8. The oral dosage form or plurality of dosage forms according to claim 1 where the percent inhibition is greater than about 106%.

9. An oral dosage form or plurality of dosage forms comprising ingredients:

magnesium citrate in an amount of about 2.03 mg to about 203 mg,

phytin in an amount of about 100 mg to about 600 mg,

pyridoxine in an amount of about 0.22 mg to about 15.1 mg, and

musa in an amount of about 1.46 mg to about 252 mg,

wherein the percent inhibition of the rate of calcium oxalate crystal formation is greater than about 99%, and

wherein the oral dosage form or plurality of dosage forms is a capsule, an emulsion, or a plurality thereof.

10. The oral dosage form or plurality of dosage forms of claim 9 , wherein

a) magnesium citrate is present in an amount of about 150 mg;

b) phytin is present in an amount of about 200 mg;

c) pyridoxine is present in an amount of about 5 mg; and

d) musa is present in an amount of about 200 mg.

11. The oral dosage form or plurality of dosage forms according to claim 9 where there is one oral dosage form.

12. The oral dosage form or plurality of dosage forms according to claim 9 , which is a plurality of oral dosage forms.

13. The oral dosage form or plurality of dosage forms according to claim 9 , wherein the oral dosage form or plurality of dosage forms is an oral capsule or a plurality of oral capsules.

14. The oral dosage form or plurality of dosage forms according to claim 9 wherein

a) the amount of magnesium citrate is selected from:

i) about 2.03 mg to about 151 mg,

ii) about 2.03 mg to about 77 mg,

iii) about 77 mg to about 201 mg,

iv) about 77 mg to about 151 mg, and

v) about 151 mg to about 201 mg;

b) the amount of phytin is selected from:

i) about 100 mg to about 475 mg

ii) about 100 mg to about 400 mg,

iii) about 100 mg to about 202 mg,

iv) about 201 mg to about 475 mg,

v) about 201 to about 400 mg, and

vi) about 400 to about 475 mg;

c) the amount of pyridoxine is selected from:

i) about 0.22 mg to about 10.11 mg,

ii) about 0.22 mg to about 6.01 mg,

iii) about 0.22 mg to about 2.69 mg,

iv) about 2.69 mg to about 15.1 mg,

v) about 2.69 mg to about 10.11 mg,

vi) about 2.69 mg to about 6.01 mg,

vii) about 5.4 mg to about 15.1 mg,

viii) about 5.4 mg to about 10.11 mg, and

ix) about 10.11 mg to about 15.1 mg;

and,

d) the amount of musa is selected from:

i) about 1.46 mg to about 168 mg,

ii) about 1.46 mg to about 85 mg,

iii) about 1.46 mg to about 42 mg,

iv) about 42 mg to about 252 mg,

v) about 42 mg to about 168 mg,

vi) about 42 mg to about 85 mg,

vii) about 85 mg to about 252 mg,

viii) about 85 mg to about 168 mg, and

ix) about 168 mg to about 252 mg.

15. The oral dosage form or plurality of dosage forms according to claim 9 , where the percent inhibition is greater than about 104%.

16. The oral dosage form or plurality of dosage forms according to claim 9 where the percent inhibition is greater than about 106%.

17. A method of promoting kidney health in a subject, comprising

administering to a subject the oral dosage form or plurality of dosage forms according to claim 1 .

18. The method of claim 17 , wherein the oral dosage form or plurality of dosage forms is administered once daily.

19. The method of claim 17 , wherein the oral dosage form or plurality of dosage forms is administered twice daily.

20. The method of claim 17 , wherein the oral dosage form or plurality of dosage forms is an oral capsule or a plurality of oral capsules.

21. The method of claim 17 , wherein the oral dosage form or plurality of dosage forms is one oral capsule.

22. The method of claim 17 , wherein the oral dosage form or plurality of dosage forms is two oral capsules.

23. The method of claim 17 , wherein the administered oral dosage form or plurality of dosage forms inhibits calcium oxalate crystal formation.

Assignments (2)
CHANGE OF NAME Recorded Apr 13, 2017
From: KIDNEY STONE LABORATORIES
To: KIDNEY STONE RESEARCH COMPANY, INC.
Reel/Frame 042246/0114 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 3, 2016
From: HAYER, GREGORY K.; MAGRAB, BRENDAN; WOLFE, HENRY R., JR.
To: KIDNEY STONE LABORATORIES, INC.
Reel/Frame 037885/0157 →
Continuity (2)
Continuation In Part 14960692 · Dec 7, 2015
Continuation 14845612 · Sep 4, 2015