TAMPER RESISTANT DOSAGE FORMS
2 Assignments
0 Petitions
Accused Products
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.
19 Citations
199 Claims
-
1-169. -169. (canceled)
-
170. A pharmaceutical composition comprising:
-
at least one active agent comprising hydrocodone or a pharmaceutically acceptable salt thereof; at least one high molecular weight polyethylene oxide (PEO), having an approximate molecular weight of from 1 million to 15 million; at least one of an additive and a film coating; and optionally at least one low molecular weight PEO having an approximate molecular weight of less than 1,000,000;
wherein(a) the active agent and high molecular weight PEO are combined in a solid oral extended release dosage form that is (i) compression shaped, (ii) air cured by heated air, without compression, for at least about 5 minutes at a temperature above the softening temperature of the high molecular weight PEO, (iii) cooled, and (iv) hardened; (b) the high molecular weight PEO comprises at least about 30% (by weight) of the dosage form; (c) the molecular weight of each PEO is based on rheological measurements; and (d) the total weight of the dosage form is calculated by excluding the combined weight of said film coatings. - View Dependent Claims (171, 172, 173, 174, 175, 176, 177, 178, 179)
-
-
180. A pharmaceutical composition comprising:
-
at least one active agent comprising a pharmaceutically acceptable salt of hydrocodone; at least one high molecular weight polyethylene oxide (PEO) having an approximate molecular weight of from 1 million to 8 million; at least one additive comprising an anti-tacking agent, an antioxidant, an immediate release component, or a retardant; optionally a film coating; and at least one low molecular weight PEO having an approximate molecular weight of less than 1,000,000;
wherein(a) the active agent, high molecular weight PEO, and low molecular weight PEO, are combined in a solid oral extended release dosage form that is (i) compression shaped, (ii) air cured by heated air, without compression, for a curing time of at least about 10 minutes at a curing temperature of at least about 60°
C., (iii) cooled, and (iv) hardened;(b) the high molecular weight PEO comprises at least about 50% (by weight), and the low molecular weight PEO comprises at least about 10% (by weight), of the dosage form; (c) the active agent comprises at least about 2.4% (by weight) of the dosage form; (d) the molecular weight of each PEO is based on rheological measurements; and (e) the total weight of the dosage form is calculated by excluding the combined weight of said film coatings. - View Dependent Claims (181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199)
-
Specification