Phenytoin therapy

• US 6,110,499 A
• Filed: 07/20/1998
• Issued: 08/29/2000
• Est. Priority Date: 07/24/1997
• Status: Expired due to Fees

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Ayer, Atul D., Shivanand, Padmaja, Laidlaw, Barbara F., Hatamkhany, Zahedeh
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): MCQUEENEY, PATRICIA E
• Application Number:
  US09/119,382
• Time in Patent Office: 771 Days
• Field of Search: 424/473
• US Class Current: 424/473
• CPC Class Codes: A61K 31/4166 having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A therapeutic composition, a dosage form and a method are disclosed for administering phenytoin indicated for the management of epilepsy.

Claims

1. A bilayer for treating the symptoms of epilepsy, wherein the bilayer comprises a drug layer comprising 40% sodium phenytoin, 43% polyethylene oxide, 5% sorbitol, 6% tromethamine, 5% polyvinylpyrrolidone, and 1% magnesium stearate, a displacement layer comprising 73.7% polyethylene oxide, 20% sodium chloride, 5% polyvinylpyrrolidone, 1% ferric oxide, 0.25% magnesium stearate, and 0.05% butylated hydroxytoluene.

2. The bilayer for treating the symptoms of epilepsy according to claim 1, where a coat comprising hydroxypropylcellulose and hydroxypropylmethylcellulose surrounds the bilayer.

3. The bilayer for treating the symptoms of epilepsy according to claim 1, wherein a wall comprising a semipermeable composition surrounds the bilayer, and the wall comprises a passageway.

4. A dosage form for treating epilepsy, wherein the dosage form comprises:

(a) a drug layer comprising 83 mg to 405 mg of polyethylene oxide, 6 mg to 50 mg of polyvinylpyrrolidone, 3.75 mg to 75 mg of tromethamine, 3 mg to 50 mg of sorbitol, 0.5 mg to 15 mg of magnesium stearate, and 1 mg to 750 mg of sodium phenytoin;

(b) a displacement layer comprising 38 mg to 280 mg of polyethylene oxide, 9 mg to 120 mg of sodium chloride, 2.25 to 20 mg of hydroxypropylmethylcellulose; and

0.015 mg to 3 mg of butylated hydroxy toluene;

(c) a wall that surrounds the drug and the displacement layers, the wall comprising 60 to 140 mg of cellulose acetate comprising an 32% acetyl content, 19 mg to 32 mg cellulose acetate comprising an 39.8% acetyl content, and 6.75 mg to 15 mg of polyethylene glycol; and

(d) an exit passageway in the wall that connects the drug composition with the exterior of the dosage form for delivering the phenytoin from the dosage form.

5. A dosage form for treating epilepsy, wherein the dosage form comprises:

(a) a drug layer comprising 83 mg to 405 mg of polyethylene oxide, 6 mg to 50 mg of polyvinylpyrrolidone, 3.75 mg to 75 mg of tromethamine, 3 mg to 50 mg of sorbitol, 0.5 mg to 15 mg of magnesium stearate, and 30 mg of sodium phenytoin;

(b) a displacement layer comprising 38 mg to 280 mg of polyethylene oxide, 9 mg to 120 mg of sodium chloride, 2.25 to 20 mg of hydroxypropylmethylcellulose, and, 0.015 mg to 3 mg of butylated hydroxytoluene;

(c) a wall that surrounds the drugs and the displacement layers, the wall comprising 60 mg to 140 mg of cellulose acetate comprising a 32% acetyl content, 19 mg to 32 mg cellulose acetate comprising a 39.8% acetyl content, and 6.75 mg to 15 mg of polyethylene glycol; and

(d) an exit passageway in the wall that connects the drug layer with the exterior of the dosage form for delivering the phenytoin from the dosage form.

6. A dosage form for treating epilepsy, wherein the dosage form comprises:

(a) a drug layer comprising 83 mg to 405 mg of polyethylene oxide, 6 mg to 50 mg of polyvinylpyrrolidone, 3.75 mg to 75 mg of tromethamine, 3 mg to 50 mg of sorbitol, 0.5 mg to 15 mg of magnesium stearate, and 100 mg of sodium phenytoin;

(b) a displacement layer comprising 38 mg to 280 mg of polyethylene oxide, 9 mg to 120 mg of sodium chloride. 2.25 to 20 mg of hydroxypropylmethylcellulose, and 0.015 mg to 3 mg of butylated hydroxytoluene;

(c) a wall that surrounds the drug and the displacement layers, the wall comprising 60 mg to 140 mg of cellulose acetate comprising a 32% acetyl content, 19 mg to 32 mg cellulose acetate comprising a 39.8% acetyl content, and 6.75 mg to 15 mg of polyethylene glycol; and

(d) an exit passageway in the wall that connects the drug layer with the exterior of the dosage form for delivering the phenytoin from the dosage form.

7. A dosage form for treating epilepsy, wherein the dosage form comprises:

(a) a drug composition that comprises 83 mg to 405 mg of polyethylene oxide. 6 mg to 50 mg of polyvinylpyrrolidone, 3.75 mg to 75 mg of tromethamine, 3 mg to 50 mg of sorbitol, 0.5 mg to 15 mg of magnesium stearate, and 300 mg of sodium phenytoin;

(b) a displacement layer comprising 38 mg to 280 mg of polyethylene oxide, 9 mg to 120 mg of sodium chloride, 2.25 to 20 mg of hydroxypropylmethylcellulose, and 0.015 mg to 3 mg of butylated hydroxytoluene;

(c) a wall that surrounds the drug composition and the displacement layer, the wall comprising 60 mg to 140 mg of cellulose acetate comprising a 32% acetyl content, 19 mg to 32 mg cellulose acetate comprising a 39.8% acetyl content; and

(d) an exit passageway in the wall that connects the drug layer with the exterior of the dosage form for delivering the phenytoin from the dosage form.

8. A dosage form for treating epilepsy wherein the dosage form comprises:

(a) a drug composition comprising 83 mg to 405 mg of polyethylene oxide, 6 mg to 50 mg of polyvinvlpyrrolidone, 3.75 mg to 75 mg of tromethamine, 3 mg to 50 mg of sorbitol, 0.5 mg to 15 mg of magnesium stearate, and 1 mg to 750 mg of sodium phenytoin;

(b) a displacement composition comprising 38 mg to 280 mg of polyethylene oxide, 9 mg to 120 mg of sodium chloride, 2.25 mg to 20 mg of hydroxypropylmethylcellulose; and

0.015 mg to 3 mg of butylated hydroxytoluene;

(c) a coat comprising 6 mg to 45 mg of hydroxypropylcellulose and 2.25 mg to 18 mg of hydroxypropylmethylcellulose positional between a wall and the compositions;

(d) a wall that surrounds the drug and displacement composition and the coat, the wall comprising 60 to 140 mg of cellulose acetate comprising a 32% acetyl content, 19 mg to 32 mg cellulose acetate comprising a 39.8% acetyl content, and 6.75 mg to 15 mg of polyethylene glycol; and

(e) an exterior passageway in the wall that connects the drug composition with the exterior of the dosage form for delivering the phenytoin from the dosage form.

9. A dosage form for treating epilepsy, wherein the dosage form comprises:

(a) a drug layer comprising 83 mg to 405 mg of polyethylene oxide, 6 mg to 50 mg of polyvinylpyrrolidone, 3.75 mg to 75 mg of tromethamine, 3 mg to 50 mg of sorbitol, 0.5 mg to 15 mg of magnesium stearate, and 1 mg to 750 mg of sodium phenytoin;

(b) a displacement layer comprising 38 mg to 280 mg of polyethylene oxide, 9 mg to 120 mg of sodium chloride, 2.25 to 20 mg of polyvinylpyrrolidone, 0.5 to 15 mg of magnesium stearate, 0.015 mg to 3 mg of butylated hydroxytoluene, and 0.1 to 3% colorant;

(c) a wall that surrounds the drug and the displacement layers, the wall comprising 60 to 140 mg of cellulose acetate comprising an 32% acetyl content, 19 mg to 32 mg cellulose acetate comprising an 39.8% acetyl content, and 6.75 mg to 15 mg of polyethylene glycol; and

(d) an exit passageway in the wall that connects the drug composition with the exterior of the dosage form for delivering the phenytoin from the dosage form.

10. A dosage form for treating epilepsy, wherein the dosage form comprises:

(a) a drug layer comprising 83 mg to 405 mg of polyethylene oxide, 6 mg to 50 mg of polyvinylpyrrolidone, 3.75 mg to 75 mg of tromethamine, 3 mg to 50 mg of sorbitol, 0.5 mg to 15 mg of magnesium stearate, and 1 to 750 mg of sodium phenytoin;

(b) a displacement layer comprising 38 mg to 280 mg of polyethylene oxide, 9 mg to 120 mg of sodium chloride, 2.25 to 20 mg of hydroxypropylmethylcellulose, 0.5 mg to 15 mg of magnesium stearate, 0.05 mg to 3 mg of butylated hydroxytoluene, and 0.1 to 3% colorant, (c) a wall that surrounds the drug and the displacement layers, the wall comprising 60 to 140 mg of cellulose acetate comprising an 32% acetyl content, 19 mg to 32 mg cellulose acetate comprising an 39.8% acetyl content, and 6.75 mg to 15 mg of polyethylene glycol; and

(d) an exit passageway in the wall that connects the drug composition with the exterior of the dosage form for delivering the phenytoin from the dosage form.