IP Library › Granted Patent US 9,504,678
Granted Patent B2
US 9,504,678 · App. 11/696,554 · Granted Nov 29, 2016

Oral dosage forms including an antiplatelet agent and an acid inhibitor

Inventors: Mark A. Goldsmith (Menlo Park, CA); Elizabeth Vadas (Dorval, CA)
Assignee: KG ACQUISITION LLC
A61K31/4439A61K9/006A61K9/0056A61K9/1623A61K9/1652A61K9/2077A61K9/2081A61K9/2086A61K9/284A61K9/2846A61K9/4866A61K9/4891A61K9/5042A61K9/5084A61K31/4743A61K31/616
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Quick Facts
Patent No.
US 9,504,678
App. No.
11/696,554
Granted
Nov 29, 2016
Kind
B2
Abstract

The present disclosure provides oral dosage forms comprising an antiplatelet agent and an acid inhibitor, as well as methods of treating subjects with an antiplatelet agent and an acid inhibitor.

Claims (16)

1. A single unit oral dosage form comprising: a) an adenosine diphosphate (ADP) or P 2 Y 12 antagonist or a pharmaceutically acceptable salt or enantiomer thereof, in a therapeutically effective amount to provide antiplatelet activity; and b) a proton pump inhibitor (PPI) or a pharmaceutically acceptable salt or enantiomer thereof, in a therapeutically effective amount to prevent or reduce a gastrointestinal disorder associated with use of said ADP or P 2 Y 12 antagonist or said ADP or P 2 Y 12 antagonist and aspirin, wherein said PPI, is enterically coated.

2. The single unit oral dosage form of claim 1 , wherein said ADP or P 2 Y 12 antagonist or pharmaceutically acceptable salt or enantiomer thereof is clopidogrel and said PPI or pharmaceutically acceptable salt or enantiomer thereof is omeprazole.

3. The single unit oral dosage form of claim 2 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof is a powder and the omeprazole or pharmaceutically acceptable salt or enantiomer thereof is enterically coated.

4. The single unit oral dosage form of claim 3 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof and omeprazole or pharmaceutically acceptable salt or enantiomer thereof are disposed within a capsule.

5. The single unit oral dosage form of claim 2 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 20-200 mg and the omeprazole or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of about 10-100 mg.

6. The single unit oral dosage form of claim 2 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 20-200 mg and the omeprazole or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of about 10-100 mg.

7. The single unit oral dosage form of claim 4 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 20-200 mg and the omeprazole or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of about 10-100 mg.

8. The single unit oral dosage form of claim 5 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 75 mg and the omeprazole or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 20 mg.

9. The single unit oral dosage form of claim 6 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 75 mg and the omeprazole or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 20 mg.

10. The single unit oral dosage form of claim 7 , wherein the clopidogrel or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 75 mg and the omeprazole or pharmaceutically acceptable salt or enantiomer thereof is present in an amount of 20 mg.

11. A combination of the single unit oral dosage form of any one of claims 1 , 2 , 3 , 4 , or 5 - 10 , together with an oral dosage form comprising aspirin.

12. The single unit oral dosage form of any one of claims 1 , 2 , 3 , 4 , or 5 - 10 , further comprising aspirin.

13. The single unit oral dosage form of any one of claims 1 , 2 , 3 , 4 , or 5 - 10 , wherein said single unit oral dosage form excludes a non-aspirin non-steroidal anti-inflammatory drug (NSAID).

14. A method of treating a patient who is in need of antiplatelet therapy and does not have symptoms of gastrointestinal bleeding or a gastrointestinal ulcer, comprising orally administering to said patient the single unit oral dosage form of any one of claims 5 - 10 .

15. A method of treating a patient who is in need of antiplatelet therapy and does not have symptoms of gastrointestinal bleeding or a gastrointestinal ulcer, comprising orally administering to said patient the combination of oral dosage forms recited in claim 11 .

16. A method of treating a patient who is in need of antiplatelet therapy and does not have symptoms of gastrointestinal bleeding or a gastrointestinal ulcer, comprising orally administering to said patient the single unit oral dosage form recited in claim 12 .

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 25, 2010
From: CHAPTER 7 ESTATE OF COGENTUS PHARMACEUTICALS, INC. C/O MARK BOSTICK
To: KG ACQUISITION LLC
Reel/Frame 023841/0347 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 26, 2007
From: GOLDSMITH, MARK A.; ELIZABETH VADAS
To: COGENTUS PHARMACEUTICALS, INC.
Reel/Frame 019481/0975 →
Continuity (3)
Provisional Application 60789543 · Apr 4, 2006
Provisional Application 60812326 · Jun 9, 2006
Related Publication 20070243243A1 · Oct 18, 2007