Patent ID: 8158156

Claim:
A method of treating moderate to severe pain in a human, the method comprising: orally administering to said human an intact composition in an amount sufficient to treat the moderate to severe pain; wherein the composition comprises 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 selected from the group consisting of naltrexone, naloxone, nalmefene, cyclazacine, levallorphan, salts of these molecules, and combinations thereof; c. a sequestering polymer layer coating the opioid antagonist comprising layer; d. an osmotic pressure regulating agent comprising layer coating the sequestering polymer layer, wherein the osmotic pressure regulating agent is selected from the group consisting of sodium chloride, sodium bromide, sodium iodide, hydroxypropyl methyl cellulose, and combinations thereof; e. an opioid agonist comprising layer coating the osmotic pressure regulating agent comprising layer, 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 f. a controlled release layer coating the opioid agonist comprising layer; 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; 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 sodiumsulfosuceinate, sodiumdodecylbenzene sulfonate, and combinations thereof; and 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 comprises first placing the composition in 500 mL of a 0.1 N HCl solution for 1 hour at 37° 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° C. using USP paddle method, 100 rotations per minute, and then determining the amount of the opioid antagonist sequestered.