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US 2017/0319490 A1Published application
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.
Claims31
1-169. (canceled)
A process of preparing a cured shaped extended release tablet comprising
- (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, and
- (3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000;
- said process comprising the steps of:
- (a) providing a first combination comprising said high molecular weight polyethylene oxide and said opioid or pharmaceutically acceptable salt thereof;
- and
- (b) providing a second combination comprising said low molecular weight polyethylene oxide and optionally comprising said opioid or pharmaceutically acceptable salt thereof;
- and
- (c) forming a shaped tablet comprising the first and second combinations;
- (d) curing said shaped tablet by applying a temperature from about 60° C. to about 90° C. for a time of from about 15 minutes to about 10 hours;
- and
- (e) optionally applying one or more coatings to said shaped tablet;
- wherein the total combined weight of said high and low molecular weight polyethylene oxides is at least 79% by weight, and said percent by weight is based upon the total weight of said shaped tablet, not including the combined weight of said coatings.
10 more elements
A process of preparing a cured shaped extended release tablet comprising
- (1) hydrocodone 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, and
- (3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000;
- said process comprising the steps of:
- (a) providing a first combination comprising said high molecular weight polyethylene oxide and said opioid or pharmaceutically acceptable salt thereof;
- and
- (b) providing a second combination comprising said low molecular weight polyethylene oxide and optionally comprising said opioid or pharmaceutically acceptable salt thereof;
- and
- (c) forming a shaped tablet comprising the first and second combinations;
- (d) curing said shaped tablet by applying a temperature from about 60° C. to about 90° C. for a time of from about 15 minutes to about 10 hours;
- and
- (e) optionally applying one or more coatings to said shaped tablet;
- wherein said low molecular weight polyethylene oxide is at least 20% by weight, and the total combined weight of said high and low molecular weight polyethylene oxides is at least 79% by weight, and said percent by weight is based upon the total weight of said shaped tablet, not including the combined weight of said coatings.
10 more elements
Dependencies are inferred from the claim text.