Dosage forms of bisphosphonates

Abstract

Provided is an oral dosage form comprising a bisphosphonate selected from the group consisting of a risedronate and salts thereof; an ethylenediaminetetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof; and a delayed release mechanism to deliver the risedronate and the EDTA in the lower gastrointestinal tract, wherein the oral dosage form is administered according to a scheduled dosing interval. The present invention substantially alleviates the interaction between bisphosphonates 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 the bisphosphonate and the chelating agent to the lower GI tract, 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.

What is claimed is: 
     
         1 . An oral dosage form comprising:
 (a) about 150 mg of a bisphosphonate selected from the group consisting of a risedronate and salts thereof;   (b) from about 55 mg to about 500 mg of an ethylenediaminetetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof; and   (c) a delayed release mechanism to deliver the risedronate and the EDTA in the lower gastrointestinal tract,   wherein the oral dosage form is administered according to a continuous schedule having a once monthly dosing interval.