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US 8,911,719 B2Granted
Tamper resistant dosage forms
AssigneesPurdue Pharma L.P., Purdue Pharmaceuticals L.P.
InventorsWilliam H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Life of this patent
Estimating the term…
Abstract
The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Claims30
A cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
- (1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000,
- (2) oxycodone or a pharmaceutically acceptable salt, and
- (3) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000;
- wherein said tablet is prepared by a process comprising the steps of:
- (a) combining at least (1), (2), and (3) to form a blend;
- (b) shaping 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 comprises:
- (i) 5, 7.5, 10, 15, 20, or 30mg of said oxycodone or pharmaceutically acceptable salt and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000;
- (ii) 40 mg of said oxycodone or pharmaceutically acceptable salt and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000;
- (iii) 60 mg of said oxycodone or pharmaceutically acceptable salt and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000;
- or
- (iv) 80 mg of said oxycodone or pharmaceutically acceptable salt and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
11 more elements
A cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
- (1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000,
- (2) an opioid analgesic or a pharmaceutically acceptable salt, and
- (3) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000;
- wherein said tablet is prepared by a process comprising the steps of:
- (a) combining at least (1), (2), and (3) to form a blend;
- (b) shaping 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 10hours, wherein said polyethylene oxide in said blend is in an amount of at least 79% by weight, based upon the total weight of said composition.
5 more elements
Dependencies are inferred from the claim text.