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Summary for Patent: 9,707,181
|Title:||Pharmaceutical compositions for the coordinated delivery of NSAIDs|
|Abstract:||The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.|
|Inventor(s):||Plachetka; John R. (Chapel Hill, NC)|
|Assignee:||Pozen Inc. (Chapel Hill, NC)|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for patent 9,707,181|
1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of: (a) esomeprazole, wherein at least a portion of said esomeprazole is not
surrounded by an enteric coating; and (b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; wherein said unit dosage form provides for release of
said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium; and wherein said unit dosage form sequentially releases said esomeprazole
followed by said naproxen.
2. The pharmaceutical composition of claim 1, wherein naproxen is present in said unit dosage form in an amount of 200-600 mg.
3. The pharmaceutical composition of claim 1, wherein esomeprazole is present in said unit dosage form in an amount of from 5 to 100 mg.
4. The pharmaceutical composition of claim 1, wherein naproxen is present in said unit dosage form in an amount of between 200-600 mg and esomeprazole in an amount of from 5 to 100 mg per unit dosage form.
5. The pharmaceutical composition of claim 1, wherein said unit dosage form is a multilayer tablet comprising a core layer and one or more layers outside of said core layer.
6. The pharmaceutical composition of claim 5, wherein said core layer comprises naproxen.
7. The pharmaceutical composition of claim 5, wherein said one or more layers outside of said core layer do not contain naproxen.
8. The pharmaceutical composition of claim 1, further comprising at least one carrier.
9. The pharmaceutical composition of claim 1, further comprising at least one auxiliary agent chosen from the group consisting of lubricants, preservatives, disintegrants, stabilizers, wetting agents, emulsifiers, salts, buffers, coloring agents, flavoring agents, and aromatic substances.
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