Hydromorphone therapy

• US 5,702,725 A
• Filed: 03/05/1996
• Issued: 12/30/1997
• Est. Priority Date: 07/07/1994
• Status: Expired due to Term

• Current Assignee: Mallinckrodt LLC (Mallinckrodt plc)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Chadha, Navjot, Kuczynski, Anthony L., Merrill, Sonya, Ayer, Atul Devdatt
• Primary Examiner(s): Kulkosky, Peter F.
• Application Number:
  US08/611,294
• Time in Patent Office: 665 Days
• Field of Search: 424/472
• US Class Current: 424/472
• 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: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 23/00 Anaesthetics

Abstract

A hydromorphone composition, a hydromorphone dosage form and a method for administering hydromorphone are disclosed, indicated for the management of pain.

Claims

1. A therapeutic composition indicated for the relief of pain comprising 1 to 1000 mg of hydromorphone, 25 to 500 mg of a poly(alkylene oxide) possessing a 150,000 to 500,000 molecular weight, 1 to 50 mg of a poly(vinylpyrrolidone) having a 10,000 to 300,000 molecular weight, and 0 to 7.5 mg of a lubricant.

2. The therapeutic composition according to claim 1;

wherein the hydromorphone is selected from the group consisting of hydromorphone salt, hydromorphone sulfate, hydromorphone hydrochloride, hydromorphone trifluoracetate, hydromorphone mucate, hydromorphone oleate, hydromorphone acetate, hydromorphone phosphate, and hydromorphone bitartrate.

3. The therapeutic composition according to claim 1, wherein the composition is compressed under 1/8 to 10 ton-force of compression.

4. The therapeutic composition according to claim 1, wherein the therapeutic composition is encased with a semipermeable composition with a passageway through the semipermeable composition.

5. A bilayer comprising a hydromorphone composition that comprises 1 to 1000 mg of hydromorphone, 25 to 500 mg of a poly(alkylene oxide) possessing a 150,000 to 500,000 molecular weight, 1 to 50 mg of a poly(vinyl pyrrolidone) having a 10,000 to 300,000 molecular weight, and 0 to 7.5 mg of a lubricant;

and an expandable composition comprising 15 to 250 mg of a poly(alkylene oxide) of 3,000,000 to 7,500,000 molecular weight, 0 to 75 mg of an osmagent, 1 to 50 mg of a hydroxyalkylcellulose, 0 to 10 mg of a tableting lubricant, 0 to 10 mg of an antioxidant, and 0 to 10 mg of a colorant.

6. The bilayer according to claim 5, wherein the hydromorphone composition and the expandable composition are in bilayered arrangement, and the tableting lubricant is selected from magnesium stearate, calcium stearate, starch, and citric acid.

7. The bilayer according to claim 5, wherein the bilayer is encased with a semipermeable composition with a passageway in the semipermeable composition.

8. A method for administering 1 to 1000 mg of hydromorphone to a patient in need of pain relief, which method comprises admitting orally into the gastrointestinal tract a composition comprising 1 to 1000 mg of hydromorphone, 25 to 500 mg of a poly(alkylene oxide) possessing a 150,000 to 500,000 molecular weight, 1 to 50 mg of poly(vinyl pyrrolidone) possessing a 10,000 to 300,000 molecular weight, and 0 to 7.5 mg of a lubricant, which composition delivers the hydromorphone at a sustained rate over time for pain relief.

9. The method for administering the hydromorphone composition according to claim 8, wherein an expandable composition is in layered contact with the hydromorphone composition.

10. The method for administering the hydromorphone composition according to claim 9, wherein the expandable composition comprises a poly(alkylene oxide) possessing a 3,000,000 to 7,500,000 molecular weight, and a semipermeable wall permeable to the passage of fluid in the patient, surrounds the hydromorphone composition with a passageway in the semipermeable wall for delivering the hydromorphone to the patient.

11. A dosage form comprising:

a therapeutic composition comprising;

1 mg to 1000 mg of hydromorphone, 25 mg to 500 mg of a polyalkylene oxide, 1 mg to 50 mg of a polyvinylpyrrolidone, and 0 to 7.5 mg of a lubricant;

a push composition comprising 15 mg to 250 mg of a polyalkylene oxide, 0 to 75 mg of an osmagent, 1 mg to 50 mg of a hydroxyalkylcellulose, 0 to 10 mg of a colorant, 0 to 10 mg of a lubricant, 0 to 10 mg of an antioxidant;

a semipermeable wall that surrounds the therapeutic and push composition; and

an exit in the wall for delivering the hydromorphone from the dosage form.

12. The dosage form according to claim 11 wherein the hydroxyalkylcellulose is hydroxypropylmethylcellulose.

13. The dosage form according to claim 11, wherein the semipermeable wall comprises polyethylene glycol.

14. The dosage form according to claim 11 wherein the wall comprises a member selected from the group consisting of cellulose acylate, cellulose diacylate and cellulose triacylate.