Dosage form comprising oxybutynin

• US 5,674,895 A
• Filed: 05/22/1995
• Issued: 10/07/1997
• Est. Priority Date: 05/22/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Kidney, David J., Jao, Francisco, Gumucio, Fernando, Guittard, George V., Marks, Susan M.
• Primary Examiner(s): Seidleck, James J.
• Assistant Examiner(s): Williamson, Michael A.
• Application Number:
  US08/445,849
• Time in Patent Office: 869 Days
• Field of Search: 424/464, 424/467, 424/468, 424/474, 424/475, 424/479, 424/480, 424/484, 424/486, 424/488, 514/579, 514/646, 514/663, 514/727, 514/729, 514/730, 514/534
• US Class Current: 514/534
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/221 with compounds having an amino group, e.g. acetylcholine, acetylcarnitine
• 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
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives

Abstract

A composition comprising oxybutynin and a device comprising oxybutynin are disclosed for oxybutynin therapy.

Claims

1. A therapeutic composition comprising:

1 ng to 450 mg of oxybutynin, 40 mg to 250 mg of polyalkylene oxide, 1 mg to 25 mg of hydroxypropylalkylcellulose, and 0.01 mg to 5 mg of a lubricant.

2. The therapeutic composition according to claim 1, wherein the oxybutynin is a therapeutically acceptable salt selected from the group consisting of acetate, bitartrate, citrate, edetate, edisylate, estolate, esylate, fumarate, gluceptate, gluconate, glutamate, hydrobromide, hydrochloride, lactate, malate, maleate, mandelate, mesylate, methylnitrate, mucate, napsylate, nitrate, pamoate, pantothenate, phosphate, salicylate, stearate, succinate, sulfate, tannate, and tartrate.

3. A bilayered tablet comprising a therapeutic layer comprising 1 ng to 450 mg of oxybutynin, 40 mg to 450 mg of polyalkylene oxide, 1 mg to 25 mg of hydroxypropylalkylcellulose and 0.01 mg to 5 mg of a lubricant;

in contact with a hydrogel layer comprising 40 mg to 250 mg of polyalkylene oxide, 10 mg to 50 mg of an osmagent, 0.1 mg to 20 mg of hydroxypropylalkylcellulose, 0.0 ng to 1.5 mg of an antioxidant, and 0.2 mg to 7 mg of a lubricant.

4. A bilayered tablet comprising a therapeutic layer comprising a therapeutic layer comprising 1 ng to 450 mg of oxybutynin, 40 mg to 250 mg of polyalkylene oxide, 1 mg to 25 mg of hydroxypropylalkylcellulose, and 0.01 mg to 5 mg of a lubricant;

said layer in contact with a push layer comprising 40 mg to 250 mg of an alkali carboxymethylcellulose, 10 mg to 50 mg of an osmagent, 0.1 mg to 20 mg of hydroxypropylalkylcellulose, 0.1 mg to 30 mg of hydroxyalkylcellulose, 0.0 ng to 1.5 mg of an antioxidant, and 0.2 mg to 7 mg of a lubricant.

5. A delivery device for administering oxybutynin to a patient in need of oxybutynin, wherein the delivery device comprises:

a layer comprising 1 ng to 450 mg of oxybutynin, 40 mg to 250 mg of polyalkylene oxide, 1 mg to 25 mg of hydroxypropylalkylcellulose, and 1 mg to 50 mg of an osmagent; and

contacting layer comprising 40 mg to 250 mg of an osmopolymer and 10 mg to 50 mg of an osmagent;

a semipermeable wall that surrounds the layers, which semipermeable wall is permeable to the passage of fluid, and impermeable to the passage of oxybutynin, and an exit through the semipermeable wall for administering the oxybutynin to the patient at a controlled rate over time.

6. A delivery device for administering oxybutynin to a patient in need of oxybutynin, wherein the delivery device comprises:

a drug layer comprising 1 ng to 450 mg of oxybutynin, 40 mg to 250 mg of polyalkylene oxide, 1 mg to 25 mg of hydroxypropylalkylcellulose, 1 mg to 50 mg of an osmagent; and

a contacting displacement layer comprising 40 mg to 250 mg of carboxymethylcellulose and 10 mg to 50 mg of an osmagent;

a semipermeable wall that surrounds the layers, which semipermeable wall is permeable to the passage of fluid, and impermeable to the passage of oxybutynin, and an exit through the semipermeable wall for administering the oxybutynin to the patient at a controlled rate over time.

7. A delivery device for administering oxybutynin to a patient in need of oxybutynin, wherein the delivery device comprises:

a drug layer comprising 1 ng to 450 mg of oxybutynin, 40 mg to 250 mg of polyalkylene oxide, 1 mg to 25 mg of a hydroxypropylalkylcellulose, 1 mg to 50 mg of an osmagent; and

a contracting displacement layer comprising 40 mg to 250 mg of polyalkylene oxide, and 10 mg to 50 mg of an osmagent;

a semipermeable wall that surrounds the layer, which semipermeable wall is permeable to the passage of fluid, and impermeable to the passage of oxybutynin, and an exit through the semipermeable wall for administering the oxybutynin to the patient at a controlled rate over time.