PHARMACEUTICAL COMPOSITION
First Claim
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1. A method of treating pain in a human, the method comprising:
- the human orally taking an intact multi-layer composition in an amount sufficient to treat the pain,wherein the multi-layer composition comprises;
a. a water-soluble core;
b. an antagonist containing layer comprising naltrexone or a pharmaceutically acceptable salt of naltrexone coating the core;
c. a sequestering polymer layer coating the antagonist containing layer;
d. an agonist layer comprising morphine or a pharmaceutically acceptable salt of morphine coating the sequestering polymer layer; and
,e. a controlled release layer coating the agonist layer;
wherein the multi-layer composition sequesters at least 80% of the naltrexone or the pharmaceutically acceptable salt of naltrexone as determined at 73 hours by first placing the multi-layer 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 multi-layer 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 or the pharmaceutically acceptable salt thereof sequestered; and
wherein one of the following conditions are met;
i) the agonist layer comprises sodium chloride;
orii) the multilayer composition further comprises, immediately beneath the agonist layer, an osmotic pressure regulating agent layer comprising sodium chloride.
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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.
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Citations
16 Claims
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1. A method of treating pain in a human, the method comprising:
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the human orally taking an intact multi-layer composition in an amount sufficient to treat the pain, wherein the multi-layer composition comprises; a. a water-soluble core; b. an antagonist containing layer comprising naltrexone or a pharmaceutically acceptable salt of naltrexone coating the core; c. a sequestering polymer layer coating the antagonist containing layer; d. an agonist layer comprising morphine or a pharmaceutically acceptable salt of morphine coating the sequestering polymer layer; and
,e. a controlled release layer coating the agonist layer; wherein the multi-layer composition sequesters at least 80% of the naltrexone or the pharmaceutically acceptable salt of naltrexone as determined at 73 hours by first placing the multi-layer 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 multi-layer 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 or the pharmaceutically acceptable salt thereof sequestered; andwherein one of the following conditions are met; i) the agonist layer comprises sodium chloride;
orii) the multilayer composition further comprises, immediately beneath the agonist layer, an osmotic pressure regulating agent layer comprising sodium chloride. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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Specification