Controlled release compositions containing zolpidem

摘要

The present invention relates to controlled release compositions of Zolpidem or pharmaceutically acceptable salts thereof adapted to release Zolpidem over a predetermined time period, according to a monophasic and/or a biphasic profile of dissolution. The present invention also relates to monolithic matrix based formulations of Zolpidem or pharmaceutically acceptable salts thereof.

主权项

1. A dry granulated pharmaceutical dosage form comprising a polymer matrix, wherein said polymer matrix comprises zolpidem or a pharmaceutically acceptable salt thereof, one or more rate controlling polymers, and one or more pharmaceutically acceptable excipients, wherein the dosage form is adapted to release zolpidem or a salt thereof on a continuous basis over a predetermined time period, according to an in vitro profile of dissolution when measured in a type II dissolution apparatus according to U.S. Pharmacopoeia in 0.01 M hydrochloric acid buffer at 37° C. , wherein less than 40% of the total amount of zolpidem is released between 15 to 30 minutes and the time for release of 90% of the total amount of zolpidem is between 2 to 6 hours; and wherein the dosages form is a controlled release pharmaceutical composition.