Dosage forms of risedronate

Abstract

Oral dosage forms of a risedronate comprised of a safe and effective amount of a pharmaceutical composition comprising risedronate, a chelating agent, and, means for effecting delayed release of the risedronate and the chelating agent in the small intestine provide immediate release of the pharmaceutical composition to the small intestine of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between risedronate and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of risedronate and the chelating agent to the small intestine, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.

1 . An oral dosage form comprising:
 (a) about 35 mg of a risedronate salt;   (b) about 100 mg of EDTA or a pharmaceutically acceptable salt thereof; and   (c) a delayed release mechanism to immediately release the risedronate salt and EDTA or pharmaceutically acceptable salt thereof to the lower gastrointestinal tract.