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US 11,298,322 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 process of preparing a solid oral extended release pharmaceutical dosage form, comprising the steps of:
- (a) combining (1) at least one polyethylene oxide (PEO) having, based on rheological measurements, an approximate molecular weight of at least 800,000, and (2) at least one opioid analgesic, to form a composition;
- (b) shaping the composition to form an extended release matrix formulation;
- (c) subsequently heating said extended release matrix formulation by subjecting the extended release matrix formulation to an elevated temperature that is at least the softening temperature of said PEO for a time period of at least about 1 minute;
- and
- (d) cooling the heated extended release matrix formulation.
2 more elements
A process of preparing a solid oral extended release pharmaceutical dosage form, comprising the steps of:
- (a) combining (1) at least one polyethylene oxide (PEO) having, based on rheological measurements, an approximate molecular weight of at least 800,000, and (2) at least one opioid analgesic, to form a composition, wherein the total PEO content of the composition is at least about 15% (by weight) of the composition;
- (b) shaping the composition to form a plurality of extended release tablets;
- (c) subsequently subjecting the tablets to an elevated temperature of at least about 55° C. for a time period of at least about 15 minutes;
- and
- (d) cooling the tablets at a temperature below 50° C.
2 more elements
Dependencies are inferred from the claim text.