Controlled release hydrocodone formulations
DCFirst Claim
Patent Images
1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a bitartrate salt of hydrocodone and a poly(alkylene oxide), the dosage form, after administration to a human subject, providing a C24/Cmax hydrocodone ratio of from about 0.55 to about 1.0, whereinthe dosage form is a tablet,the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, andthe bitartrate salt of hydrocodone is the only active agent in the dosage form.
1 Assignment
Litigations
0 Petitions
Accused Products
Abstract
A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
372 Citations
30 Claims
-
1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a bitartrate salt of hydrocodone and a poly(alkylene oxide), the dosage form, after administration to a human subject, providing a C24/Cmax hydrocodone ratio of from about 0.55 to about 1.0, wherein
the dosage form is a tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the bitartrate salt of hydrocodone is the only active agent in the dosage form.
-
12. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a bitartrate salt of hydrocodone and a poly(alkylene oxide), the dosage form, after administration to human subjects, providing a mean C24/Cmax hydrocodone ratio of from about 0.55 to about 1.0, wherein
the dosage form is a tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the bitartrate salt of hydrocodone is the only active agent in the dosage form.
-
21. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising hydrocodone or a pharmaceutically acceptable salt thereof and a poly(alkylene oxide), wherein
the dosage form, after administration to a human subject, provides a W50 of hydrocodone of between 4 and 22 hours and a therapeutic effect for about 24 hours, the dosage form is a compressed tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form.
-
28. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising hydrocodone or a pharmaceutically acceptable salt thereof and a poly(alkylene oxide), wherein
the dosage form, after administration to human subjects, provides a mean W50 of hydrocodone of between 4 and 22 hours and a therapeutic effect for about 24 hours, wherein the dosage form is a compressed tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form.
Specification