Tamper resistant dosage forms
DCFirst Claim
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1. 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.
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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.
243 Citations
30 Claims
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1. A pharmaceutical composition comprising:
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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 (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A pharmaceutical composition comprising:
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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 (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification