Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
The present disclosure is directed to a method for delivering a pharmaceutical composition to a patient in need thereof, comprising: administering to said patient a pharmaceutical composition in unit dose form comprising acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and omeprazole, or pharmaceutically acceptable salt thereof.
1. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising:
administering to said patient a pharmaceutical composition in unit dose form comprising:
about 325 mg acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and
about 40 mg omeprazole, or pharmaceutically acceptable salt thereof,
wherein said omeprazole, or pharmaceutically acceptable salt thereof:
is an immediate release omeprazole, or pharmaceutically acceptable salt thereof,
is released from said unit dose form at a pH of from about 0 or greater, and
achieves a mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period after reaching steady state of at least about 50%, and
wherein said unit dose form achieves a pharmacokinetic (pk) profile for omeprazole comprising C max under 1200 ng/mL.
2. The method according to claim 1 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 4.5 hours.
3. The method according to claim 1 wherein said pharmaceutical composition in unit dose form has an omeprazole t max ranging from about 20 minutes to about 1.5 hours.
4. The method according to claim 1 , wherein said unit dose form is administered for a period of at least about 7 days.
5. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising:
administering to said patient a pharmaceutical composition in unit dose form comprising:
about 325 mg acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and
about 40 mg omeprazole, or pharmaceutically acceptable salt thereof,
wherein said omeprazole, or pharmaceutically acceptable salt thereof:
is an immediate release omeprazole, or pharmaceutically acceptable salt thereof,
is released from said unit dose form at a pH of from about 0 or greater,
achieves a mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period after reaching steady state of at least about 50%, and
wherein said unit dose form achieves a pharmacokinetic (pk) profile for omeprazole comprising AUC 0-12 ranging from about 0.8 hr*μg/mL to about 2.5 hr*μg/m L.
6. The method according to claim 5 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 4.5 hours.
7. The method according to claim 5 , wherein said pharmaceutical composition in unit dose form has an omeprazole t max ranging from about 20 minutes to about 1.5 hours.
8. The method according to claim 5 , wherein said unit dose form is administered for a period of at least about 7 days.
9. The method according to claim 5 , wherein said patient in need thereof is being treated for cardiovascular disease, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or a combination thereof.
10. A pharmaceutical composition in unit dose form comprising:
a core comprising about 325 mg acetylsalicylic acid, or pharmaceutically acceptable salt thereof;
an enteric coating over said core that at least begins to dissolve when the pH of the surrounding medium is about 3.5 or greater; and
a second layer comprising about 40 mg immediate release omeprazole, or pharmaceutically acceptable salt thereof, wherein said omeprazole, or pharmaceutically acceptable salt thereof is released at a pH of from about 0 or greater;
wherein said unit dose form is administered and achieves a pharmacokinetic (pk) profile for omeprazole comprising a C max under 1200 ng/mL, and
wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 4.5 hours.
11. The pharmaceutical composition in unit dose form according to claim 10 , wherein said pharmaceutical composition in unit dose form has an omeprazole, or pharmaceutically acceptable salt thereof, t max ranging from about 20 minutes to about 1.5 hours.
12. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising:
administering to said patient a pharmaceutical composition in unit dose form comprising:
about 81 mg acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and
about 40 mg omeprazole, or pharmaceutically acceptable salt thereof,
wherein said omeprazole, or pharmaceutically acceptable salt thereof:
is an immediate release omeprazole, or pharmaceutically acceptable salt thereof,
is released from said unit dose form at a pH of from about 0 or greater, and
achieves a mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period after reaching steady state of at least about 50%, and
wherein said unit dose form achieves a pharmacokinetic (pk) profile for omeprazole comprising C max under 1200 ng/mL.
13. The method according to claim 12 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 4.5 hours.
14. The method according to claim 12 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 3.5 hours.
15. The method according to claim 12 wherein said pharmaceutical composition in unit dose form has an omeprazole t max ranging from about 20 minutes to about 1.5 hours.
16. The method according to claim 12 , wherein said unit dose form is administered for a period of at least about 7 days.
17. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising:
administering to said patient a pharmaceutical composition in unit dose form comprising:
about 81 mg acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and
about 40 mg omeprazole, or pharmaceutically acceptable salt thereof,
wherein said omeprazole, or pharmaceutically acceptable salt thereof:
is an immediate release omeprazole, or pharmaceutically acceptable salt thereof,
is released from said unit dose form at a pH of from about 0 or greater,
achieves a mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period after reaching steady state of at least about 50%, and
wherein said unit dose form achieves a pharmacokinetic (pk) profile for omeprazole comprising AUC 0-12 ranging from about 0.8 hr*μg/mL to about 2.5 hr*μg/m L.
18. The method according to claim 17 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 4.5 hours.
19. The method according to claim 17 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 3.5 hours.
20. The method according to claim 17 wherein said pharmaceutical composition in unit dose form has an omeprazole t max ranging from about 20 minutes to about 1.5 hours.
21. The method according to claim 17 , wherein said unit dose form is administered for a period of at least about 7 days.
22. A pharmaceutical composition in unit dose form comprising:
a core comprising about 81 mg acetylsalicylic acid, or pharmaceutically acceptable salt thereof;
an enteric coating over said core that at least begins to dissolve when the pH of the surrounding medium is about 3.5 or greater; and
a second layer comprising about 40 mg immediate release omeprazole, or pharmaceutically acceptable salt thereof, wherein said omeprazole, or pharmaceutically acceptable salt thereof is released at a pH of from about 0 or greater;
wherein said unit dose form is administered and achieves a pharmacokinetic (pk) profile for omeprazole comprising a C max under 1200 ng/mL, and
wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 4.5 hours.
23. The pharmaceutical composition according to claim 22 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 3.5 hours.
24. The pharmaceutical composition according to claim 22 wherein said pharmaceutical composition in unit dose form has an omeprazole t max ranging from about 20 minutes to about 1.5 hours.
25. The method according to claim 1 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 3.5 hours.
26. The method according to claim 5 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 3.5 hours.
27. The pharmaceutical composition according to claim 10 wherein said pharmaceutical composition in unit dose form has an acetylsalicylic acid t max ranging from about 3 hours to about 3.5 hours.