Three-Phase System for Modified Release of a Non-Steroidal Antiinflammatory

摘要

A novel pharmaceutical composition in solid form of a nonsteroidal anti-inflammatory and/or pharmaceutically acceptable salts thereof. The composition includes a tablet having a modified delivery system in three phases, which are: a) a delayed-release core being localized at the center of the composition; b) an immediate-release underlayer fully and/or partially covering the core; and, c) an extended-release top layer fully and/or partially covering the core. Said composition is orally administered and is used to treat mild to moderate pain caused by headache, myalgia, altralgia, eye pain, photophobia, burning feeling secondary to eye surgery, postoperative pain, neuropathic pain, swelling, among others.

主权项

1. A solid pharmaceutical composition comprising as an active ingredient a nonsteroidal anti-inflammatory, which is ketorolac and/or its pharmaceutically acceptable salts; the composition comprises a triple release system that consists of three phases, which are: a) at least one delayed-release central core comprising ketorolac and/or pharmaceutically acceptable salts thereof, and one or more pharmaceutically acceptable excipients; b) an immediate-release underlayer comprising ketorolac and/or pharmaceutically acceptable salts thereof, and one or more pharmaceutically acceptable excipients; c) at least one extended-release top layer comprising ketorolac and/or pharmaceutically acceptable salts thereof, and one or more pharmaceutically acceptable excipients.