Tamper resistant dosage forms
AssigneePurdue Pharma 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.
Claims31
1-169. (canceled)
A process of preparing a solid oral extended release pharmaceutical dosage form comprising an extended release matrix comprising a composition, said process comprising the steps of:
- (a) combining (1) an opioid or a pharmaceutically acceptable salt thereof with each of (2) at least one low molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000, and (3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000 to form at least one blend;
- (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 comprises at least 72% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides.
A process of preparing a solid oral extended release pharmaceutical dosage form comprising an extended release matrix comprising a composition, said process comprising the steps of:
- (a) combining (1) hydrocodone or a pharmaceutically acceptable salt thereof with each of (2) at least one low molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000 and (3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000 to form at least one blend;
- (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 comprises at least 72% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides, and wherein said low molecular weight polyethylene oxide comprises at least 20% by weight, based upon the total weight of said composition.
Dependencies are inferred from the claim text.