Tamper-resistant oral opioid agonist formulations
0 Assignments
0 Petitions
Accused Products
Abstract
Disclosed is an oral dosage form comprising (i) an opioid agonist in releasable form and (ii) a sequestered opioid antagonist which is substantially not released when the dosage form is administered intact, such that the ratio of the amount of antagonist released from said dosage form after tampering to the amount of said antagonist released from said intact dosage form is about 4:1 or greater, based on the in-vitro dissolution at 1 hour of said dosage form in 900 ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37 degrees C. wherein said agonist and antagonist are interdispersed and are not isolated from each other in two distinct layers.
239 Citations
74 Claims
-
1-61. -61. (canceled)
- 62. A composition comprising an inert core, a first layer and a second layer, the first layer being between the core and the second layer, the first layer consisting essentially of an opioid antagonist and the second layer comprising a hydrophobic material.
-
63. A composition comprising an inert core, a first layer and a second layer, the first layer being between the core and the second layer, the first layer comprising naltrexone, nalmefene, or pharmaceutically acceptable salts thereof and the second layer comprising a hydrophobic material.
-
68. The oral dosage form of claim 76, wherein the opioid agonist is hydrocodone or a pharmaceutically acceptable salt thereof.
Specification