Dosage form and method for treating incontinence

• US 5,912,268 A
• Filed: 02/26/1997
• Issued: 06/15/1999
• Est. Priority Date: 05/22/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Gumucio, Fernando E., Kidney, David J., Jao, Francisco, Guittard, George V., Marks, Susan M.
• Primary Examiner(s): Dees, Jose G.
• Assistant Examiner(s): Williamson, Michael A.
• Application Number:
  US08/806,773
• Time in Patent Office: 839 Days
• Field of Search: 514/534, 514/579, 514/646, 514/663, 514/727, 514/729, 514/730, 424/464, 424/468, 424/474, 424/475, 424/479, 424/480, 424/484, 424/486, 424/488
• 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

Abstract

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

Claims

1. A dosage form for delivering oxybutynin to a patient, wherein the dosage form comprises:

a drug core comprising 240 ng to 650 mg of oxybutynin, 20 mg to 250 mg of polyalkylene oxide, and 1 mg to 50 mg of hydroxypropylalkylcellulose;

a wall that surrounds the drug core permeable to fluid and impermeable to oxybutynin; and

an exit in the wall for delivering the oxybutynin from the dosage form to the patient.

2. A dosage form for delivering oxybutynin to a patient, wherein the dosage form comprises:

a therapeutic composition comprising 5 mg of oxybutynin hydrochloride, 111.6 mg of polyethylene oxide, 7.35 mg of hydroxypropylmethylcellulose, 0.88 mg of magnesium stearate, 22.05 mg of sodium chloride and 0.12 mg of butylated hydroxytoluene;

a wall that surrounds the therapeutic composition and is permeable to fluid and impermeable to oxybutynin; and

an exit in the wall for delivering the oxybutynin from the dosage form to the patient.

3. A dosage form for delivering oxybutynin to a patient, wherein the dosage form comprises:

a therapeutic composition comprising 10 mg of oxybutynin hydrochloride, 74.8 mg of polyethylene oxide, 1.88 mg of hydroxypropylmethylcellulose, 0.24 mg of magnesium stearate, 7.05 mg of sodium chloride, and 0.07 mg of butylated hydroxytoluene;

a wall that surrounds the therapeutic composition and is permeable to fluid and impermeable to oxybutynin; and

an exit in the wall for delivering the oxybutynin from the dosage form to the patient.

4. A dosage form for delivering oxybutynin to a patient, wherein the dosage form comprises:

a therapeutic drug core comprising 15 mg of oxybutynin hydrochloride, 72.07 mg of polyethylene oxide, 1.88 mg of hydroxypropylmethylcellulose, 0.23 mg of magnesium stearate, 4.7 mg of sodium chloride, and 0.08 mg of butylated hydroxytoluene;

a wall that surrounds the therapeutic drug core and is permeable to fluid and impermeable to oxybutynin; and

an exit in the wall for delivering the oxybutynin to the patient.

5. A dosage form for delivering oxybutynin to a patient, wherein the dosage form comprises:

a drug layer comprising 5 mg of oxybutynin hydrochloride, 111.6 mg of a polyethylene oxide, 7.35 mg of a hydroxypropylmethylcellulose, 0.88 mg of magnesium stearate, 22.05 mg of sodium chloride and 0.12 mg of butylated hydroxytoluene;

a displacement layer comprising 6.24 mg of polyethylene oxide possessing a greater molecular weight than the polyethylene oxide in the drug layer, 29.4 mg of sodium chloride, 4.9 mg of hydroxypropylmethylcellulose;

0.08 mg of butylated hydroxytoluene, 0.98 mg red ferric oxide and 0.25 mg of magnesium stearate;

a wall that surrounds the drug layer and displacement layer permeable to fluid and impermeable to oxybutynin; and

an exit in the wall for delivering the oxybutynin to the patient.

6. A dosage form for delivering oxybutynin to a patient, wherein the dosage form comprises:

a drug layer comprising 5 mg of oxybutynin pharmaceutically acceptable salt, 77.42 mg of polyalkylene oxide, 1.88 mg of hydroxypropylalkylcellulose, 2.4 mg of magnesium stearate, 9.4 mg of sodium chloride, 0.08 mg of butylated hydroxytoluene;

a displacement layer comprising 38.2 mg of polyalkylene oxide possessing a larger molecular weight than the polyalkylene oxide in the drug layer, 18 mg of sodium chloride, 3 mg of hydroxypropylalkylcellulose, 0.05 mg of butylated hydroxytoluene, and 0.6 mg of ferric oxide;

a wall that surrounds the layers and is permeable to fluid and impermeable to oxybutynin; and

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

7. A dosage form comprising:

a drug layer 3.4 wt % oxybutynin pharmaceutically acceptable salt, 76 wt % polyalkylene oxide, 5 wt % hydroxypropylalkylcellulose, 0.6 wt % magnesium stearate, 15 wt % sodium chloride;

a displacement layer comprising 58.75 mg hydroxyalkylcellulose, 30 mg of sodium chloride, 10 mg of polyvinylpyrrolidone, 1 mg of a ferric oxide, and 0.25 mg of magnesium stearate;

a wall comprising a semipermeable composition permeable to fluid and impermeable to oxybutynin; and

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

8. A dosage form comprising:

a drug layer comprising;

3.4 wt % oxybutynin pharmaceutically acceptable salt, 76 wt % polyalkylene oxide, 5 wt % hydroxypropylalkylcellulose, 0.6 wt % magnesium stearate, and 15 wt % sodium chloride;

a displacement layer comprising 63.67 wt % of polyalkylene oxide, 30 wt % sodium chloride, 1 wt % ferric oxide, 5 wt % hydroxypropylalkylcellulose, 0.08 wt % butylated hydroxytoluene, and 0.25 wt % magnesium stearate;

a subcoat that surrounds the layers comprising 95 wt % hydroxyalkylcellulose and 5 wt % polyethylene glycol;

a wall that surrounds the subcoat comprising 95 wt % cellulose acetate and 5 wt % polyethylene glycol; and

an exit through the wall and subcoat for delivering the oxybutynin from the dosage form.