Controlled release of N-acetylcysteine (NAC) for reduction of systemic and/or vascular inflammation
First Claim
1. A composition in an oral dosage form comprising a sustained release (SR) component, wherein the SR component comprises ethyl ester of N-acetylcysteine, or a salt or solvate thereof;
- further comprising an immediate release (IR) component, wherein the IR component comprises an ethyl ester of N-acetylclysteine or a salt or solvate thereof; and
wherein the composition, upon oral administration, provides a therapeutically effective plasma concentration of N-acetylcysteine over more than about 2 hours following the administration.
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Abstract
The present invention provides a controlled-release composition which provides a therapeutically effective plasma concentration of N-acetylcysteine over prolonged period of time. The present invention also includes the use of the controlled-release composition, either alone or in combination with at least one additional active agent, for reduction of vascular inflammation marker and treatment of diseases, conditions, and/or symptoms associated with systemic and/or vascular inflammation in a patient. Furthermore, the present invention provides a process of making granules comprising N-acetylcysteine, or a salt, solvate, prodrug, and/or analog thereof.
39 Citations
43 Claims
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1. A composition in an oral dosage form comprising a sustained release (SR) component, wherein the SR component comprises ethyl ester of N-acetylcysteine, or a salt or solvate thereof;
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further comprising an immediate release (IR) component, wherein the IR component comprises an ethyl ester of N-acetylclysteine or a salt or solvate thereof; and wherein the composition, upon oral administration, provides a therapeutically effective plasma concentration of N-acetylcysteine over more than about 2 hours following the administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
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29. A composition in an oral dosage form comprising a sustained release (SR) component, wherein the SR component comprises
ethyl ester of N-acetylcysteine, or a salt or solvate thereof; - and
a release rate controlling polymer.
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Specification