IP Library Granted Patent US 9,623,066
Granted Patent B2
US 9,623,066 · App. 15/266,464 · Granted Apr 18, 2017

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 9,623,066
App. No.
15/266,464
Granted
Apr 18, 2017
Kind
B2
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 (112)

1. An oral dosage form or plurality of dosage forms comprising citric acid and three ingredients selected from magnesium citrate, phytin, pyridoxine, and musa where in the dosage form or plurality of dosage forms is selected from:

a. an oral dosage form or plurality of dosage forms wherein citric acid is present in an amount of about 101 mg to about 699 mg, magnesium citrate is present in an amount of about 77 mg to about 227 mg, phytin is present in an amount of about 3.06 mg to about 600 mg, and pyridoxine is present in an amount of about 0.23 mg to about 15.13 mg, wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 89%;

b. an oral dosage form or plurality of dosage forms wherein citric acid is present in an amount of about 102 mg to about 1052 mg, magnesium citrate is present in an amount of about 2.32 mg to about 201 mg, phytin is present in an amount of about 100 mg to about 600 mg, and musa is present in an amount of about 1.51 mg to about 251 mg, wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 92%;

c. an oral dosage form or plurality of dosage forms wherein citric acid is present in an amount of about 101 mg to about 1051 mg, magnesium citrate is present in an amount of about 2.14 mg to about 226 mg, pyridoxine is present in an amount of about 0.25 mg to about 10.23 mg, and musa is present in an amount of about 41 mg to about 252 mg, wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 59%; and

d. an oral dosage form or plurality of dosage forms wherein citric acid is present in an amount of about 101 mg to less than about 700 mg, phytin is present in an amount of about 101 mg to about 600 mg, pyridoxine is present in an amount of about 0.23 mg to about 15.12 mg, and musa is present in an amount of about 1.46 mg to about 252 mg, wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 88%.

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

citric acid is present in an amount of about 101 mg to about 699 mg,

magnesium citrate is present in an amount of about 77 mg to about 227 mg,

phytin is present in an amount of about 3.06 mg to about 600 mg, and

pyridoxine is present in an amount of about 0.23 mg to about 15.13 mg.

3. The oral dosage form or a plurality of dosage forms according to claim 2 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 94%.

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

citric acid is present in an amount of about 102 mg to about 1052 mg,

magnesium citrate is present in an amount of about 2.32 mg to about 201 mg,

phytin is present in an amount of about 100 mg to about 600 mg, and

musa is present in an amount of about 1.51 mg to about 251 mg.

5. The oral dosage form or a plurality of dosage forms according to claim 4 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 97%.

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

citric acid is present in an amount of about 101 mg to about 1051 mg,

magnesium citrate is present in an amount of about 2.14 mg to about 226 mg,

pyridoxine is present in an amount of about 0.25 mg to about 10.23 mg, and

musa is present in an amount of about 41 mg to about 252 mg.

7. The oral dosage form or a plurality of dosage forms according to claim 6 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 63%.

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

citric acid is present in an amount of about 101 mg to less than about 700 mg,

phytin is present in an amount of about 101 mg to about 600 mg,

pyridoxine is present in an amount of about 0.23 mg to about 15.12 mg, and

musa is present in an amount of about 1.46 mg to about 252 mg.

9. The oral dosage form or a plurality of dosage forms according to claim 8 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 101%.

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

citric acid is present in an amount of about 350 mg;

and three ingredients selected from

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

ii. phytin is present in an amount of about 200 mg;

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

iv. musa is present in an amount of about 200 mg.

11. 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,

e. the amount of citric acid is selected from:

i. about 101 mg to about 700 mg,

ii. about 101 mg to about 352 mg,

iii. about 101 mg to about 177 mg,

iv. about 177 mg to about 1052 mg,

v. about 177 mg to about 700 mg,

vi. about 177 mg to about 352 mg,

vii. about 351 mg to about 1052 mg,

viii. about 351 mg to about 700 mg, and

ix. about 700 mg to about 1052 mg.

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

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

14. 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.

15. 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 .

16. The method of claim 15 , wherein the oral dosage form or plurality of dosage forms is administered once daily.

17. The method of claim 15 , wherein the oral dosage form or plurality of dosage forms is administered twice daily.

18. The method of claim 15 , wherein the oral dosage form or plurality of dosage forms comprises

a. citric acid is present in the amount of about 350 mg;

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

c. phytin is present in an amount of about 200 mg;

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

e. musa is present in an amount of about 200 mg.

19. The method according to claim 18 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 89%.

20. The method according to claim 15 wherein the oral dosage form or plurality of dosage forms comprises

citric acid is present in an amount of about 102 mg to about 1052 mg,

magnesium citrate is present in an amount of about 2.32 mg to about 201 mg,

phytin is present in an amount of about 100 mg to about 600 mg, and

musa is present in an amount of about 1.51 mg to about 251 mg.

21. The method according to claim 20 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 92%.

22. The method according to claim 15 , wherein the oral dosage form or plurality of dosage forms comprises

citric acid is present in an amount of about 101 mg to about 1051 mg,

magnesium citrate is present in an amount of about 2.14 mg to about 226 mg,

pyridoxine is present in an amount of about 0.25 mg to about 10.23 mg, and

musa is present in an amount of about 41 mg to about 252 mg.

23. The method according to claim 22 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 59%.

24. The method according to claim 15 wherein the oral dosage form or plurality of dosage forms comprises

citric acid is present in an amount of about 101 mg to less than about 700 mg,

phytin is present in an amount of about 101 mg to about 600 mg,

pyridoxine is present in an amount of about 0.23 mg to about 15.12 mg, and

musa is present in an amount of about 1.46 mg to about 252 mg.

25. The method according to claim 24 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 88%.

26. A method of inhibiting calcium oxalate formation, comprising administering to a subject the oral dosage form or plurality of dosage forms according to claim 1 .

Assignments (2)
CHANGE OF NAME Recorded Apr 13, 2017
From: KIDNEY STONE LABORATORIES, INC.
To: KIDNEY STONE RESEARCH COMPANY, INC.
Reel/Frame 042246/0173 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 16, 2016
From: HAYER, GREGORY K.; MAGRAB, BRENDAN; WOLFE, HENRY R., JR
To: KIDNEY STONE LABORATORIES, INC.
Reel/Frame 039761/0891 →
Continuity (4)
Division 15059644 · Mar 3, 2016
Continuation In Part 14960692 · Dec 7, 2015
Continuation 14845612 · Sep 4, 2015
Related Publication 20170065658A1 · Mar 9, 2017