Abuse-resistant opioid dosage form
First Claim
1. An abuse resistant oral pharmaceutical dosage form comprising:
- a first matrix including a first opioid antagonist;
a second matrix including an opioid agonist; and
a coating including a second opioid antagonist;
wherein said tablet, when intact, is adapted to release at least about 30% of the total opioid antagonist in the first hour based on dissolution according to USP XXIV Apparatus I, basket method at 100 rpm using 0.1 N HCl as dissolution medium at 37.5°
C.
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Accused Products
Abstract
The present invention pertains to a pharmaceutical dosage form comprising an opioid agonist and one or more opioid antagonists contained in a matrix separate from the opioid agonist. The separate matrix for the opioid antagonist allows independent release rates to be achieved for the opioid and opioid antagonist(s). The antagonist(s) can be released slowly or fully contained when the tablet is taken orally. Crushing the tablet allows full release of the antagonist(s), deterring abuse. The abuse deterring antagonist(s) may be an opioid antagonist, an irritant, another appropriate antagonist(s), or a combination thereof. The invention also allows variable release of the opioid and antagonist(s).
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Citations
57 Claims
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1. An abuse resistant oral pharmaceutical dosage form comprising:
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a first matrix including a first opioid antagonist;
a second matrix including an opioid agonist; and
a coating including a second opioid antagonist;
wherein said tablet, when intact, is adapted to release at least about 30% of the total opioid antagonist in the first hour based on dissolution according to USP XXIV Apparatus I, basket method at 100 rpm using 0.1 N HCl as dissolution medium at 37.5°
C. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 16, 17, 18, 19, 20, 21, 22, 23, 25, 26, 27, 28, 29, 30)
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14. An abuse resistant oral pharmaceutical dosage form comprising:
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a first matrix including a first opioid antagonist;
a second matrix including an opioid agonist; and
a third matrix including a second opioid antagonist;
wherein said tablet, when intact, is adapted to release at least about 30% of the total opioid antagonist in the first hour based on dissolution according to USP XXIV Apparatus I, Basket method at 100 rpm using 0.1 N HCl as dissolution medium at 37.5°
C.
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24. An abuse resistant oral pharmaceutical dosage form comprising:
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a first matrix including a first opioid antagonist;
a second matrix including an opioid agonist; and
a coating including a second opioid antagonist;
wherein said tablet, when intact, is adapted to release at least about 0.3 mg of said second opioid antagonist in the first hour based on dissolution according to USP XXIV Apparatus I, Basket method at 100 rpm using 0.1 N HCl as dissolution medium at 37.5°
C.
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31. An abuse resistant oral pharmaceutical dosage form comprising:
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a first matrix including a first opioid antagonist; and
a second matrix including an opioid agonist; and
a third matrix including a second opioid antagonist;
wherein said tablet, when intact, is adapted to release at least about 0.3 mg of said second opioid antagonist in the first hour based on dissolution according to USP XXIV Apparatus I, Basket method at 100 rpm using 0.1 N HCl as dissolution medium at 37.5°
C. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39)
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- 40. An abuse resistant oral pharmaceutical dosage form comprising an opioid agonist and an opioid antagonist, wherein said tablet, when intact, is adapted to release at least about 30% of the total opioid antagonist in the first hour, and not more than about 75% in 12 hours, based on dissolution according to USP XXIV Apparatus I, basket method at 100 rpm using 0.1 N HCl as dissolution medium at 37.5°
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46. An abuse resistant oral pharmaceutical dosage form comprising a first matrix including a first opioid antagonist, a second matrix including an opioid agonist, and a coating including a second opioid antagonist.
- 52. An abuse resistant oral pharmaceutical dosage form comprising a first matrix including a first opioid antagonist, a second matrix including an opioid agonist, and a third matrix including a second opioid antagonist.
Specification