Controlled release formulations containing an active ingredient, preferably melatonin and the method of preparation
AssigneeAmbros Pharma S.R.L.
InventorBojidar M. Stankov
Life of this patent
Estimating the term…
Abstract
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.
Claims7
1-15. (canceled)
A controlled release melatonin tablet which consists of:
- (a) a slow release nucleus consisting 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 which consist 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.
A controlled release melatonin tablet which consists of:
- (a) a slow release nucleus consisting of melatonin, hydroxypropyl methylcellulose, a volume excipient and a glidant which releases the melatonin over a 5 to 7 hour period in vivo;
- (b) a fast release cortex coating on said nucleus consisting of melatonin, hydroxypropyl methylcellulose, a volume excipient and a glidant which releases the melatonin in 5-10 minutes in vivo.
(canceled)
Dependencies are inferred from the claim text.