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US 2010/0143483 A1Published application
Pharmaceutical compositions
AssigneeAlpharma Pharmaceuticals, LLC
InventorsFrank MATTHEWS, Garth Boehm, Lijuan Tang, Alfred Liang
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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.
Claims16
A multi-layer composition comprising:
- 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;
- or
- ii) the multilayer composition further comprises, immediately beneath the agonist layer, an osmotic pressure regulating agent layer comprising sodium chloride.
9 more elements
Dependencies are inferred from the claim text.