Pharmaceutical compositions for the coordinated delivery of NSAIDs

摘要

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.

主权项

1. A pharmaceutical composition in unit dose form suitable for oral administration to a patient, comprising:
(a) esomeprazole 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) naproxen present 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:
i) said unit dosage form is a tablet in which said naproxen is present in a core;ii) said tablet comprises a coating, wherein said coating surrounds said core and does not release said naproxen until the pH of the surrounding medium is 3.5 or higher; andiii) said esomeprazole is in one or more layers outside said core, wherein said one or more layers:
A) do not include an naproxen;B) are not surrounded by an enteric coating; andC) upon ingestion of said tablet by a patient, release said esomeprazole into said patient's stomach.