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US 2017/0246116 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 solid, oral, extended release pharmaceutical tablet comprising:
- (A) a core comprising:
- a therapeutically effective amount of a hydrochloride salt of an opioid analgesic;
- an antioxidant;
- hydroxypropyl methylcellulose;
- polyethylene glycol;
- at least one hardened high molecular weight polyethylene oxide (PEO), wherein said high molecular weight PEO has an approximate molecular weight of from 4 million to 8 million, based upon rheological measurements, and is present in an amount of at least about 30% (by weight) of the core;
- (B) a coating on said core, said coating comprising:
- a. polyethylene glycol;
- b. talc;
- and
- c. titanium dioxide;
- wherein said tablet
- is crush resistant and has a breaking strength of at least about 439 N;
- is resistant to alcohol extraction and has an in vitro dissolution rate of said opioid hydrochloride salt, at 0.5 hours in simulated gastric fluid with 40% ethanol, that differs by no more than about 20% points from a corresponding in vitro dissolution rate without ethanol;
- and
- provides a mean tmax of said opioid hydrochloride salt at about 2 to about 6 hours after administration of a single tablet in a human subject.
13 more elements
A solid, oral, extended release pharmaceutical tablet comprising:
- (A) a core consisting of:
- a. a therapeutically effective amount of a hydrochloride salt of an opioid analgesic;
- b. vitamin E;
- c. hydroxypropyl methylcellulose;
- d. polyethylene glycol;
- e. at least one high molecular weight polyethylene oxide (PEO) that is hardened by exposure to a temperature of at least 60° C., wherein said high molecular weight PEO
- has an approximate molecular weight of from 4 million to 8 million, based upon rheological measurements, and is present in an amount of at least about 30% (by weight) of the core;
- (B) a coating on said core, said coating comprising:
- a. polyethylene glycol;
- b. talc;
- and
- c. titanium dioxide;
- wherein said tablet
- is crush resistant and has a breaking strength of at least about 439 N;
- is resistant to alcohol extraction and has an in vitro dissolution rate of said opioid hydrochloride salt, at 0.5 hours in simulated gastric fluid with 40% ethanol, that differs by no more than about 20% points from a corresponding in vitro dissolution rate without ethanol;
- and
- provides a mean tmax of said opioid hydrochloride salt at about 2 to about 6 hours after administration of a single tablet in a human subject.
14 more elements
Dependencies are inferred from the claim text.