Modified release formulations of tramadol and uses thereof
First Claim
1. A first once daily controlled-release dosage form comprising tramadol comprising at least one means for controllably releasing the tramadol such that said first once daily controlled-release dosage form exhibits an in-vitro release rate such that after about 2 hours from about 0 to about 22% by weight of tramadol is released, after about 4 hours from about 5 to about 30% by weight of tramadol is released, after about 6 hours, from about 15 to about 38% by weight of tramadol is released, and after about 8 hours, more than about 40% by weight of tramadol is released, and when said first once daily controlled-release dosage form is administered to a patient in need of such administration under fed or fasted conditions and is bioequivalent according to FDA guidelines to a second orally administrable dosage form comprising the same dose of tramadol also suitable for once daily administration in the fed or fasted state.
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Abstract
The present invention relates to specific types of controlled and modified release dosage forms containing tramadol or at least one pharmaceutically acceptable salt, enantiomer, or metabolite thereof that possess specific pharmacokinetic properties and which desirably are not subject to dose dumping, e.g., induced by food or alcohol. The invention also relates to methods of making and using these controlled and modified release dosage forms in therapeutic regimens wherein tramadol is therapeutically effective.
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Citations
52 Claims
- 1. A first once daily controlled-release dosage form comprising tramadol comprising at least one means for controllably releasing the tramadol such that said first once daily controlled-release dosage form exhibits an in-vitro release rate such that after about 2 hours from about 0 to about 22% by weight of tramadol is released, after about 4 hours from about 5 to about 30% by weight of tramadol is released, after about 6 hours, from about 15 to about 38% by weight of tramadol is released, and after about 8 hours, more than about 40% by weight of tramadol is released, and when said first once daily controlled-release dosage form is administered to a patient in need of such administration under fed or fasted conditions and is bioequivalent according to FDA guidelines to a second orally administrable dosage form comprising the same dose of tramadol also suitable for once daily administration in the fed or fasted state.
Specification