Controlled release formulations containing an active ingredient, preferably melatonin and the method of preparation

摘要

A controlled release melatonin tablet having: (a) a slow release nucleus of melatonin, hydroxypropyl methylcellulose, a lubricant, a volume excipient and a glidant, wherein 95% of the melatonin is released within 5 hours in an oscillating tray containing gastric/intestinal juice at 37° C.; (b) a fast release cortex coating on said nucleus of melatonin, hydroxypropyl methylcellulose, a lubricant, a volume excipient and a glidant, wherein at least 95% of the melatonin is released within 10 minutes in an oscillating tray containing gastric/intestinal juice at 37° C.