Hydromorphone therapy

• US 5,529,787 A
• Filed: 07/07/1994
• Issued: 06/25/1996
• Est. Priority Date: 07/07/1994
• Status: Expired due to Term

• Current Assignee: Mallinckrodt LLC (Mallinckrodt plc)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Ayer, Atul D., Kuczynski, Anthony L., Merrill, Sonya, Chadha, Navjot
• Primary Examiner(s): Dees, Jose G.
• Assistant Examiner(s): KEYS, ROSALYND ANN
• Application Number:
  US08/271,593
• Time in Patent Office: 719 Days
• Field of Search: 424/465, 424/468, 424/470, 424/472, 424/475, 514/468
• 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 9/2027 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 for the relief of pain comprising 1 to 1000 mg of hydromorphone, 25 to 500 mg of a carboxymethylcellulose possessing a 10,000 to 300,000 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, which therapeutic composition is encased with a semipermeable wall with a passageway through the semipermeable composition.

2. A bilayer comprising a hydromorphone composition that comprises 1 to 1000 mg of hydromorphone. 25 to 500 mg of a carboxymethylcellulose possessing a 10,000 to 300,000 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;

and an push 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.

3. A method for administering hydromorphone, to a patient in need of pain relief which method comprises admitting orally into the patient 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, an push composition comprising a carboxymethylcellulose having a 450,000 to 2,500,000 molecular weight, and wherein the method administers the hydromorphone at a sustained rate over time for the relief of pain.

4. The method for administering the hydromorphone according to claim 3, wherein the hydromorphone composition and the push composition are surrounded by a semipermeable wall permeable to aqueous biological fluid. and impermeable to the passage of hydromorphone, with a passageway in the semipermeable wall, the poly(alkylene) is replaced by carboxymethylcellulose possessing a 10,000 to 300,000 molecular weight for administering the hydromorphone to the patient for the relief of pain.