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Claims for Patent: 8,846,104

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Claims for Patent: 8,846,104

Title:Pharmaceutical compositions for the deterrence and/or prevention of abuse
Abstract: Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
Inventor(s): Matthews; Frank (Edison, NJ), Boehm; Garth (Westfield, NJ), Tang; Lijuan (Flemington, NJ), Liang; Alfred (Edison, NJ)
Assignee: Alpharma Pharmaceuticals LLC (Bridgewater, NJ)
Application Number:13/371,760
Patent Claims: 1. A composition comprising a plurality of multi-layer pellets comprising: a. a water-soluble core; b. an opioid antagonist comprising layer coating the core, wherein the opioid antagonist is naltrexone or a pharmaceutically acceptable salt thereof; c. a sequestering polymer layer coating the opioid antagonist comprising layer; d. an opioid agonist wherein the opioid agonist is selected from the group consisting of morphine, oxycodone, hydrocodone, hydromorphone dihydrocodeine, codeine, dihydromorphine, buprenorphine, salts of these molecules, and combinations thereof; and e. a controlled release layer coating the opioid agonist; wherein the sequestering polymer layer comprises copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, a surfactant in an amount from 1.6% to 6.3% of the copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups on a weight-to-weight basis, and talc in an amount of from 75% to 125% of the copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups on a weight-to-weight basis; and wherein the surfactant is selected from the group consisting of sodium lauryl sulfate, sodium docusate, dioctyl sodium sulphosuccinate, sodium lauryl sarcosinate, sodium methyl cocyl taurate, magnesium lauryl sulfate, dioctyl sodium sulfosuceinate, sodium dodecylbenzene sulfonate, and combinations thereof.

2. The composition of claim 1, wherein when tested by a testing method, the composition sequesters at least 80% of the opioid antagonist as determined at 73 hours from the start of the testing method, wherein the testing method consists of first placing the composition in 500 mL of a 0.1 N HCl solution for 1 hour at 37.degree. C. using USP paddle method, 100 rotations per minute, and then placing the composition in 500 mL of a pH 7.5, 0.05 M phosphate buffer, for 72 hours at 37.degree. C. using USP paddle method, 100 rotations per minute.

3. The composition of claim 1, wherein the surfactant is sodium lauryl sulfate.

4. The composition of claim 1, wherein the opioid agonist is morphine sulfate.

5. The composition of claim 1, wherein the opioid agonist comprising is oxycodone hydrochloride.

6. The composition of claim 1, wherein when tested by a testing method, the composition sequesters at least 90% of the opioid antagonist as determined at 73 hours from the start of the testing method, wherein the testing method consists of first placing the composition in 500 mL of a 0.1 N HCl solution for 1 hour at 37.degree. C. using USP paddle method, 100 rotations per minute, and then placing the composition in 500 mL of a pH 7.5, 0.05 M phosphate buffer, for 72 hours at 37.degree. C. using USP paddle method, 100 rotations per minute.

7. The composition of claim 1, wherein when tested by a testing method, the composition sequesters at least 95% of the opioid antagonist as determined at 73 hours from the start of the testing method, wherein the testing method consists of first placing the composition in 500 mL of a 0.1 N HCl solution for 1 hour at 37.degree. C. using USP paddle method, 100 rotations per minute, and then placing the composition in 500 mL of a pH 7.5, 0.05 M phosphate buffer, for 72 hours at 37.degree. C. using USP paddle method, 100 rotations per minute.

8. The composition of claim 1, wherein when tested by a testing method, the composition sequesters at least 98% of the opioid antagonist as determined at 73 hours from the start of the testing method, wherein the testing method consists of first placing the composition in 500 mL of a 0.1 N ICl solution for 1 hour at 37.degree. C. using USP paddle method, 100 rotations per minute, and then placing the composition in 500 mL of a pH 7.5, 0.05 M phosphate buffer, for 72 hours at 37.degree. C. using USP paddle method, 100 rotations per minute.
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