SUSTAINED RELEASE COMPOSITION COMPRISING AN AMINE AS ACTIVE AGENT AND A SALT OF A CYCLIC ORGANIC ACID
First Claim
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1. A sustained-release oral pharmaceutical composition comprising within a single dosage form:
- a hydrophilic matrix;
a pharmacologically active amine-containing compound; and
a pharmaceutically acceptable salt of a non-NSAID cyclic organic acid compound;
wherein the amine-containing compound and the salt of the cyclic organic acid are within the hydrophilic matrix; and
wherein the composition exhibits a release profile of the amine-containing compound comprising a substantial portion that is representative of zero-order release kinetics under in vitro conditions.
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Abstract
The present invention provides sustained-release oral pharmaceutical compositions and methods of use. The sustained-release oral pharmaceutical compositions include an amine-containing compound (e.g., an opioid) (including salts thereof) and a pharmaceutically acceptable salt of a non-NSAID cyclic organic acid compound.
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Citations
30 Claims
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1. A sustained-release oral pharmaceutical composition comprising within a single dosage form:
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a hydrophilic matrix; a pharmacologically active amine-containing compound; and a pharmaceutically acceptable salt of a non-NSAID cyclic organic acid compound; wherein the amine-containing compound and the salt of the cyclic organic acid are within the hydrophilic matrix; and wherein the composition exhibits a release profile of the amine-containing compound comprising a substantial portion that is representative of zero-order release kinetics under in vitro conditions. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17)
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2. A sustained-release oral pharmaceutical composition comprising within a single dosage form:
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a hydrophilic matrix; a pharmacologically active amine-containing compound; a pharmaceutically acceptable salt of a non-NSAID cyclic organic acid compound; and a pharmaceutically acceptable anionic surfactant; wherein the amine-containing compound, the salt of the cyclic organic acid, and the anionic surfactant are within the hydrophilic matrix. - View Dependent Claims (3, 13, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification