Hydrocodone therapy
First Claim
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1. A method for administering hydrocodone to a patient in need of hydrocodone therapy, which method comprises orally admitting into the gastrointestinal tract of the patient a sustained delivery bilayer comprising a hydrocodone layer comprising up to 1250 mg of hydrocodone, 10 mg to 350 mg of poly(alkylene oxide), 5 to 50 mg of a hydroxyalkylcellulose, and 0.01 to 5 mg of a lubricant;
- and a push layer comprising 25 mg to 300 mg of a poly(alkylene oxide), 5 to 150 mg of an osmagent, and 1 to 30 mg of a hydroxypropylalkylcellulose, which bilayer through the combined operation of the bilayer imbibes fluid and releases hydrocodone, thereby delivers the hydrocodone at a controlled rate of 0.5 mg to 10 mg per hour over a period of 30 hours to the gastrointestinal tract of the patient in need of hydrocodone therapy.
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Abstract
A hydrocodone composition, a hydrocodone dosage form, and a method of administering hydrocodone are disclosed and indicated for hydrocodone therapy.
184 Citations
1 Claim
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1. A method for administering hydrocodone to a patient in need of hydrocodone therapy, which method comprises orally admitting into the gastrointestinal tract of the patient a sustained delivery bilayer comprising a hydrocodone layer comprising up to 1250 mg of hydrocodone, 10 mg to 350 mg of poly(alkylene oxide), 5 to 50 mg of a hydroxyalkylcellulose, and 0.01 to 5 mg of a lubricant;
- and a push layer comprising 25 mg to 300 mg of a poly(alkylene oxide), 5 to 150 mg of an osmagent, and 1 to 30 mg of a hydroxypropylalkylcellulose, which bilayer through the combined operation of the bilayer imbibes fluid and releases hydrocodone, thereby delivers the hydrocodone at a controlled rate of 0.5 mg to 10 mg per hour over a period of 30 hours to the gastrointestinal tract of the patient in need of hydrocodone therapy.
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Current AssigneeALZA Corporation (Johnson & Johnson)
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Original AssigneeALZA Corporation (Johnson & Johnson)
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InventorsWong, Patrick S.-L., Kuczynski, Anthony L., Guittard, George V., Barclay, Glen E., Childers, Jerry D.
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Primary Examiner(s)Mullis, Jeffrey C.
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Application NumberUS08/680,399Time in Patent Office932 DaysField of Search424/464, 424/465, 424/468, 424/471, 424/472, 424/473, 424/474, 424/486, 424/488US Class Current424/465CPC Class CodesA61K 31/485 Morphinan derivatives, e.g....A61K 9/0004 Osmotic delivery systems; S...A61K 9/2031 obtained otherwise than by ...A61K 9/2054 Cellulose; Cellulose deriva...
