Calcium glutarate supplement and phosphorus binder

• US 6,887,897 B2
• Filed: 07/31/2001
• Issued: 05/03/2005
• Est. Priority Date: 07/31/2001
• Status: Expired due to Fees

• Current Assignee: Mission Pharmacal Company
• Original Assignee: Mission Pharmacal Company
• Inventors: Alexandrides, George, Walsdorf, Neill B. Sr.
• Primary Examiner(s): Clardy, S. Mark
• Assistant Examiner(s): CHOI, FRANK I
• Application Number:
  US09/919,025
• Publication Number:
  US 20030077331A1
• Time in Patent Office: 1,372 Days
• Field of Search: 424/451, 424/464, 424/43, 424/682, 424/490, 514/492, 514/557, 514/574, 514/578, 514/891, 514/54, 514/60
• US Class Current: 514/492
• CPC Class Codes: A61K 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61P 3/12 for electrolyte homeostasis

Abstract

Methods of controlling calcium intake and phosphate metabolism and metabolic acidosis in patients suffering from renal failure and associated hyperphosphatemia or patients predisposed to development of a hyperphosphatemic condition are provided. The method in accordance with this invention comprises administering to a patient a calcium glutarate compound. Therapeutic benefit can be realized in accordance with such method by administering the compound orally to a patient to increase available calcium and contact and bind with ingested phosphate in the patient'"'"'s digestive tract, and thereby prevent its intestinal absorption.

Claims

1. A method of inhibiting gastrointestinal absorption of phosphorous in a person, comprising:

orally administering to a person in need thereof a quantity of a pharmaceutical composition of calcium glutarate sufficient to bind with phosphorous in the gastrointestinal tract, wherein said pharmaceutical composition inhibits gastrointestinal absorption of phosphorous in the person, and wherein said composition does not contain non-glutarate calcium salts in amounts sufficient to neutralize gastric acidity.

2. The method according to claim 1 wherein the calcium glutarate is present in an amount sufficient to provide between about 400 mg to about 1500 mg of calcium as calcium glutarate.

3. The method according to claim 1 wherein the calcium glutarate is in tablet form.

4. The method according to claim 1 wherein the calcium glutarate is in gelatin capsule form.

5. The method according to claim 1 wherein the calcium glutarate is in liquid form.

6. A method of inhibiting gastrointestinal absorption of phosphorous in an individual, comprising:

orally administering to a person in need thereof a quantity of a pharmaceutical composition of calcium glutarate sufficient to bind with phosphorous in the gastrointestinal tract at a mealtime, wherein said pharmaceutical composition inhibits gastrointestinal absorption of phosphorous in the person, and wherein said composition does not contain non-glutarate calcium salts in amounts sufficient to neutralize gastric acidity.

7. The method according to claim 6 wherein the quantity of calcium glutarate is present in an amount sufficient to provide between about 400 mg to about 1500 mg of calcium as calcium glutarate.

8. The method according to claim 6 wherein the quantity of calcium glutarate is in tablet form.

9. The method according to claim 6 wherein the quantity of calcium glutarate is in gelatin form.

10. The method according to claim 6 wherein the calcium glutarate is in liquid form.

11. A pharmaceutical therapeutic composition in solid or gel oral dosage form for controlling phosphate retention in patients having need for reduced absorption of dietary phosphate, said oral dosage form composition comprising sufficient calcium glutarate to bind with phosphorous in the gastrointestinal tract, and a pharmaceutically acceptable excipient for said oral dosage form, wherein said solid or gel oral dosage form comprises a single dose, and wherein said composition does not contain non-glutarate calcium salts in amounts sufficient to neutralize gastric acidity.

12. The therapeutic composition according to claim 11 wherein the quantity of calcium glutarate is present in an amount sufficient to provide between about 400 mg to about 1500 mg of calcium as calcium glutarate.

13. The therapeutic composition according to claim 11 wherein the quantity of calcium glutarate is in tablet form.

14. The therapeutic composition according to claim 11 wherein the quantity of calcium glutarate is in gelatin form.

15. An orally administerable pharmaceutical composition for use in the treatment of hyperphosphatemia and for reducinig the risk of the formation of phosphate- and oxalate-containing kidney stones in humans which comprises as the principal active ingredient a therapeutically effective amount of calcium glutarate sufficient to bind with phosphorous in the gastrointestinal tract combined with a pharmaceutically acceptable carrier, wherein said pharmaceutical composition comprises, solid or gel oral dosage of a single dose, and wherein said composition does not contain non-ghitarate calcium salts in amounts sufficient to neutralize gastric acidity.

16. A pharmaceutical composition according to claim 15 particularly adapted for treating hyperphosphatemia and for reducing the risk of the formation of phosphate- and oxalate-containing kidney stones in which the calcium glutarate is present in the amount of about 400 mg to about 1500 mg of calcium as calcium glutarate.

17. A method for treating hyperphosphatemia and for reducing the risk of the formation of phosphate- and oxalate-containing kidney stones in humans which comprises orally administering to a person in need thereof a pharmaceutical composition according to claim 16.

18. A method of treating hyperphosphatemia and for reducing the risk of the formation of phosphate-containing kidney stones in humans which comprises orally administering to a person in need thereof a pharmaceutical composition according to claim 16.

19. A method of treating hyperphosphatemia and for reducing the risk of the formation of phosphate- and oxalate-containing kidney stones in humans which comprises orally administering to a person in need thereof a pharmaceutical composition according to claim 15.

20. A method of treating hyperphosphatemia and for reducing the risk of the formation of phosphate-containing kidney stones in humans which comprises orally administering to a person in need thereof a pharmaceutical composition according to claim 15.

21. A pharmaceutical compound for treating hyperphosphatemia and for reducing the risk of the formation of phosphate-containing kidney stones in humans of the formula:

pharmaceutical grade [OOC—

CH₂—

CH₂—

CH₂—

COO]Ca in an amount sufficient to inhibit gastrointestinal absorption of phosphorous in a person, and a pharmaceutically acceptable carrier, wherein said pharmaceutical composition comprises a solid or gel oral dosage of a single dose, and wherein said composition does not contain non-glutarate calcium salts in amounts sufficient to neutralize gastric acidity.

22. A method of treating hyperphosphatemia and for reducing the risk of the formation of phosphate-containing kidney stones in mammals, which comprises administering to a mammal a phosphorous binding amount of the compound of claim 21.

23. A method of treating hyperphosphatemia, which comprises administering to a mammal a hyperphosphatemia treating amount of the compound of claim 21.

24. A therapeutic composition according to claim 21 wherein the quantity of calcium glutarate is present in an amount sufficient to provide between about 400 mg to about 1500 mg of calcium as calcium glutarate.

25. The therapeutic composition according to claim 21 wherein the quantity of calcium glutarate is in tablet form.

26. The therapeutic composition according to claim 21 wherein the quantity of calcium glutarate is in gelatin form.