Pharmaceutical compositions for the coordinated delivery of NSAIDs
AssigneePozen Inc.
InventorJohn R. Plachetka
Life of this patent
Estimating the term…
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.
Claims55
A pharmaceutical composition in unit dose form suitable for oral administration to a patient, comprising:
- (a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5 upon the administration of one or more of said unit dosage forms;
- (b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effective to reduce or eliminate pain or inflammation in said patient upon administration of one or more of said unit dosage forms;
- and wherein said unit dosage form provides for coordinated release such that:
- i) said NSAID is surrounded by a coating that, upon ingestion of said unit dosage form by said patient, prevents the release of essentially any NSAID from said dosage form unless the pH of the surrounding medium is 3.5 or higher;
- ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and, upon ingestion of said unit dosage form by said patient, is released regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5.
A method of treating a patient for pain or inflammation, comprising:
- (a) orally administering to said patient an acid inhibitor at a dose effective to raise the gastric pH of said patient to at least 3.5;
- and
- (b) orally administering to said patient an NSAID that is coated in a polymer that only dissolves at a pH of 3.5 or greater.
A method of treating a patient for pain or inflammation, comprising:
- (a) orally administering to said patient an acid inhibitor at a dose effective to raise the gastric pH of said patient to at least 3.5;
- and
- (b) concurrently administering to said patient an NSAID that is coated in a polymer that dissolves at a rate such that said NSAID is not released until said gastric pH is at 3.5 or higher.
Dependencies are inferred from the claim text.