Morphine therapy

• US 5,667,805 A
• Filed: 10/04/1996
• Issued: 09/16/1997
• Est. Priority Date: 06/27/1994
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Hwang, Paul, Kuczynski, Anthony L., Merrill, Sonya, Ayer, Atul Devdatt
• Primary Examiner(s): Kishore, Gollamudi S.
• Application Number:
  US08/726,107
• Time in Patent Office: 347 Days
• Field of Search: 424/473, 424/464, 424/465, 424/468, 424/474, 424/475, 424/479, 424/472, 424/480-482
• US Class Current: 424/473
• 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 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• 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: A61P 25/04 Centrally acting analgesics, e.g. opioids

Abstract

A composition comprising morphine; and a dosage form comprising morphine are disclosed for morphine therapy. A method of using the composition and the dosage form are disclosed and indicated for morphine therapy.

Claims

1. A dosage in the form of a tablet comprising:

a drug layer comprising 35 wt % morphine sulfate, 58.5 wt % polyethylene oxide possessing a 200,000 molecular weight, 6 wt % polyvinylpyrrolidone, 0.45 wt % magnesium stearate, and 0.05 wt % butylated hydroxytoluene which drug layer weighs 86 mg;

a displacement-push layer comprising 93.67 wt % polyethylene oxide of 7,000,000 molecular weight, 5 wt % hydroxypropylmethylcellulose, 1 wt % ferric oxide, 0.25 wt % magnesium stearate, and 0.083 wt % butylated hydroxytoluene which displacement push layer weighs 55 mg;

a semipermeable wall surrounding the layer; and

a passageway on the semipermeable wall.

2. The dosage in the form of a tablet according to claim 1, wherein the drug layer weighs 172 mg and the displacement-push layer weighs 91 mg.

3. The dosage in the form of a tablet according to claim 1, wherein the drug layer weighs 287 mg and the displacement-push layer weighs 151 mg.

4. The dosage in the form of a tablet according to claim 1 wherein the polyethylene oxide in the drug layer possesses a 300,000 molecular weight.

5. A dosage in the form of a tablet comprising:

a drug composition comprising 35 wt % morphine sulfate, 58.5 wt % polyethylene oxide possessing a 200,000 molecular weight, 6 wt % polyvinylpyrrolidone, 0.45 wt % magnesium stearate and 0.05 wt % butylated hydroxytoluene;

a push composition comprising 63.675 wt % polyethylene oxide comprising a 7,000,000 molecular weight, 30 wt % sodium chloride, 5 wt % hydroxypropylcellulose, 1 wt % ferric oxide and 0.075 wt % butylated hydroxytoluene;

a semipermeable wall that surrounds the compositions; and

, a passageway in the wall.

6. The dosage in the form of a tablet according to claim 5, wherein the drug composition weighs at least one of 86 mg, 172 mg, and 287 mg.

7. The dosage in the form of a tablet according to claim 5, wherein the push composition weighs at least one of 55 mg, 91 mg, and 151 mg.

8. The dosage in the form of a tablet according to claim 5, wherein the polyethylene oxide in the drug composition comprises a 300,000 molecular weight.