Hydrocodone therapy

• US 20030077320A1
• Filed: 12/18/2002
• Published: 04/24/2003
• Est. Priority Date: 09/16/1994
• Status: Abandoned Application

• Current Assignee: Anthony L. Kuczynski, George V. Guittard, Glen E. Barclay, Jerry D. Childers, Patrick S.-L. Wong
• Original Assignee: Anthony L. Kuczynski, George V. Guittard, Glen E. Barclay, Jerry D. Childers, Patrick S.-L. Wong
• Inventors: Barclay, Glen E., Childers, Jerry D., Wong, Patrick S.-L., Kuczynski, Anthony L., Guittard, George V.
• Application Number:
  US10/267,500
• Publication Number:
  US 20030077320A1
• Time in Patent Office: Days
• US Class Current: 424/465
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

A hydrocodone composition, a hydrocodone dosage form, and a method of administering hydrocodone are disclosed and indicated for hydrocodone therapy.

Claims

1. A therapeutic composition comprising 0.5 to 1250 mg of hydrocodone, 10 mg to 350 mg of a poly(alkylene oxide) possessing a 75,000 to 400,000 molecular weight, 5 mg to 50 of hydroxyalkylcellulose possessing a 9,000 to 150,000 molecular weight, and 0.01 mg to 5 mg of a lubricant.

2. The therapeutic composition according to claim 1, wherein the hydrocodone is selected from the group consisting of hydrocodone pharmaceutically acceptable salt, hydrocodone bitartrate hemipentahydrate, hydrocodone bitartrate, hydrocodone bitartrate hydrate, hydrocodone hydrochloride, hydrocodone phosphate, hydrocodone sulfate, hydrocodone mucate, hydrocodone sulfate pentahydrate and hydrocodone oleate.

3. The therapeutic composition according to claim 1, wherein the composition is compressed under 1⅛

to 10-ton force compression, and a semipermeable wall with an exit passageway encased the therapeutic composition.

4. A therapeutic composition comprising 0.5 to 1250 mg of hydrocodone, 10 to 50 mg of alkali carboxymethylcellulose of 70,000 to 400,000 molecular weight, 5 to 50 mg of hydroxypropylalkylcellulose of 9,000 to 150,000 molecular weight, and 0.01 to 5 mg of a lubricant.

5. The therapeutic composition according to claim 4, wherein the therapeutic composition comprises poly(vinylpyrrolidone).

6. The therapeutic composition according to claim 4, wherein the therapeutic composition comprises sorbitol.

7. The therapeutic composition according to claim 4, wherein the hydrocodone is selected from the group consisting of hydrocodone bitartrate hemipentahydrate, hydrocodone bitartrate, hydrocodone hydrochloride, hydrocodone phosphate and hydrocodone sulfate.

8. The therapeutic composition according to claim 4, wherein a semipermeable wall with an exit passageway surrounds the therapeutic composition.

10. The bilayer composition according to claim 4, wherein the push composition comprises an antioxidant.

11. The bilayer composition according to claim 4, wherein the push composition comprises a lubricant.

12. The bilayer composition according to claim 4, wherein a semipermeable wall with an exit passageway surrounds the bilayer composition.

9. A bilayer composition comprising a hydrocodone layer comprising 0.5 to 1250 mg of hydrocodone, 10 mg to 350 mg of a poly(alkylene oxide) of 75,000 to 400,000 molecular weight, 5 to 50 mg of a hydroxyalkylcellulose of 9,000 to 450,000 molecular weight and 0.01 to 5 mg of a lubricant;

and a push layer comprising 25 to 300 mg of a poly(alkylene oxide) of 3,000,000 to 7,500,000 molecular weight, 5 to 150 mg of an osmagent, and 1 to 30 mg of a hydroxypropylalkylcellulose of 9,200 to 175,000 molecular weight.

13. A bilayer composition comprising a hydrocodone layer comprising 0.5 to 1250 mg of hydrocodone, 10 to 50 mg of alkli carboxymethylcellulose comprising a 70,000 to 400,000 molecular weight, 5 to 50 mg of hydroxypropylalkylcellulose of 9,000 to 150,000 molecular weight;

and a push layer comprising 10 to 60 mg of an alkali carboxymethylcellulose of 650,000 to 1,200,000 molecular weight, 5 to 75 mg of an osmagent, and 1 to 30 mg of a hydroxypropylalkylcellulose of 9,000 to 150,000 molecular weight.

14. The bilayer composition according to claim 13 wherein the hydrocodone layer comprises a poly(vinylpyrrolidone).

15. The bilayer composition according to claim 13, wherein a semipermeable wall comprising a passageway surrounds the bilayer composition.

16. A method for administering 0.5 to 1250 mg of hydrocodone to a patient in need of hydrocodone therapy, which method comprises admitting orally into the gastrointestinal tract of the patient a sustained delivery composition comprising the hydrocodone, and a polymer carrier for the hydrocodone comprising a 75,000 to 400,000 molecular weight that is delivered at a rate of release of 0.5 mg to 10 mg per hour over a sustained period of 20 hours.

17. The method for administering the hydrocodone according to claim 16, wherein the hydrocodone composition is surrounded by a semipermeable wall permeable to the passage fluid in the gastrointestinal tract and impermeable to the passage of hydrocodone, with a passageway in the semipermeable wall for delivering the hydrocodone to the patient.

18. A method for administering 0.5 to 1250 mg of hydrocodone to a patient in need of hydrocodone therapy, which method comprises orally administering the hydrocodone at a rate of 0.5 mg to 10 mg per hour over 20 hours, for hydrocodone therapy.

19. A method for administering 0.5 to 1250 mg of hydrocodone to a patient in need of hydrocodone therapy, which method comprises orally admitting into the gastrointestinal tract of the patient a bilayer comprising a hydrocodone layer comprising 0.5 to 1250 mg of hydrocodone, 10 mg to 350 mg of poly(alkylene oxide) possessing a 75,000 to 400,000 molecular weight, 5 to 50 mg of a hydroxyalkylcellulose of 9,000 to 450,000 molecular weight and 0.01 to 5 mg of a lubricant;

and a push layer comprising 25 mg to 300 mg of a poly(alkylene oxide) of 3,000 to 7,500,000 molecular weight 5 to 150 mg an osmagent, and 1 to 30 mg of a hydroxypropylalkylcellulose of 9,200 to 175,000 molecular weight, which bilayer delivers the hydrocodone over a period of 30 hours to the gastrointestinal tract of the patient.