IP Library › Granted Patent US 7,364,755
Granted Patent B2
US 7,364,755 · App. 10/882,669 · Granted Apr 29, 2008

Modified calcium phosphate excipient

Assignee: Synthon IP Inc.
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Quick Facts
Patent No.
US 7,364,755
App. No.
10/882,669
Granted
Apr 29, 2008
Kind
B2
Abstract

Calcium phosphate modified with a fatty acid wax in a weight ratio of 50:50 to 95:5, respectively, is useful as an excipient.

Claims (18)

1. An excipient composition comprising calcium phosphate modified with a fatty acid wax, wherein a weight ratio of said calcium phosphate to said wax is within the range of 50:50 to 95:5.

2. The excipient composition according to claim 1 , wherein said weight ratio of calcium phosphate:wax is within the range of 60:40 to 85:15.

3. The excipient composition according to claim 1 , wherein said wax is selected from the group consisting of palmitic acid, behenic acid, stearic acid, glyceryl behenate, glyceryl palmitostearate, hydrogenated castor oil, and mixtures thereof.

4. The excipient composition according to claim 3 , wherein said wax is glyceryl behenate.

5. The excipient composition according to claim 4 , wherein said weight ratio of calcium phosphate to glyceryl behenate is within the range of 60:40 to 85:15.

6. The excipient composition according to claim 1 , wherein said calcium phosphate is an anhydrous dibasic calcium phosphate.

7. The excipient composition according to claim 1 , wherein said excipient composition is in a particulate form.

8. The excipient composition according to claim 7 , wherein said particles have an average size within the range of 50 to 500 microns.

9. The excipient composition according to claim 8 , wherein the average size of said particles is within the range of 125 to 250 microns.

10. The excipient composition according to claim 8 , wherein said particulate form is substantially monodisperse such that at least 50% of said particles have a size within 20 microns of the average particle size.

11. The excipient composition according to claim 8 , wherein said composition has an angle of repose within the range of 20° to 40°.

12. A solid dosage form comprising an effective amount of an active agent and the excipient composition according to claim 1 .

13. The solid dosage form according to claim 12 , wherein said active agent is a pharmaceutically active agent.

14. The solid dosage form according to claim 13 , wherein said form is a tablet.

15. The solid dosage form according to claim 14 , wherein said excipient composition is contained in said tablet in an amount of at least 40% by weight.

16. The solid dosage form according to claim 15 , wherein said amount of excipient composition is at least 70% by weight.

17. The solid dosage form according to claim 14 , wherein said excipient composition and said pharmaceutically active agent taken together total an amount that is at least 85% of said tablet by weight.

18. A particle, consisting essentially of a calcium phosphate particle having a fatty acid wax at least partially coated thereon, impregnated therein, or both; said particle having a size within the range of 125 to 250 microns and said calcium phosphate and said wax present in a weight ratio of calcium phosphate:wax that is within the range of 50:50 to 95:5.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 20, 2006
From: SYNTHON BV
To: SYNTHON IP INC.
Reel/Frame 017499/0906 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2004
From: CUCALA ESCOI, JOAN; GALLEGO LUENGO, MONTSERRAT; SILES ORTEGA, ARTURO
To: SYNTHON BV
Reel/Frame 015266/0909 →
Continuity (2)
Provisional Application 6048466900 · Jul 7, 2003
Related Publication 20050031682A1 · Feb 10, 2005