Patent ID: 7682633

Claim:
A method of treating moderate to severe pain in a human, the method comprising: the human orally taking 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 antagonist containing layer comprising naltrexone HCl coating the core; c. a sequestering polymer layer coating the antagonist containing layer; d. an agonist layer comprising morphine sulfate coating the sequestering polymer layer; e. a controlled release layer coating the agonist layer; and f. immediately beneath the agonist layer, an osmotic pressure regulating agent layer comprising sodium chloride; wherein the sequestering polymer layer comprises copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, sodium lauryl sulfate 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 agonist layer comprises morphine sulfate and hydroxypropyl cellulose; wherein in the multi-layer pellets, the sodium lauryl sulfate is only contained in the sequestering polymer layer; and wherein the composition sequesters at least 80% of the naltrexone HCl as determined at 73 hours by 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 naltrexone HCl sequestered.