主权项 |
1. A cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
(1) an opioid or a pharmaceutically acceptable salt thereof, (2) at least one low molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000, (3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000; and (4) at least one additive;wherein said tablet is prepared by a process comprising the steps of:
(a) combining said opioid or pharmaceutically acceptable salt thereof with each of said low molecular weight polyethylene oxide and said high molecular weight polyethylene oxide to form at least one blend, wherein said at least one blend further comprises at least one additive; (b) applying each said blend to form a shaped tablet; and (c) curing said shaped tablet by subjecting the shaped tablet to a temperature from about 60 to about 90° C. for a time of from about 15 minutes to about 10 hours,wherein said cured shaped tablet a once-a-day dosage form having at least 79% by weight, based upon the total weight of said composition, of the total combined weight of said high and low molecular weight polyethylene oxide, wherein said low molecular weight polyethylene oxide comprises at least 22% by weight and said high molecular weight polyethylene oxide comprises at least 50% by weight, based upon the total weight of said composition. |