Therapy delayed

• US 5,252,338 A
• Filed: 11/02/1992
• Issued: 10/12/1993
• Est. Priority Date: 06/27/1991
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wat, Pamela K., Jao, Frank, Huynh, Hoa T., Wong, Patrick S. L., McChesney, Kathy
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Phelan, D. Gabrielle
• Application Number:
  US07/971,011
• Time in Patent Office: 344 Days
• Field of Search: 424/473
• US Class Current: 424/473
• CPC Class Codes: A61K 31/275 Nitriles; Isonitriles
• CPC Class Codes: A61K 31/277 having a ring, e.g. verapamil
• CPC Class Codes: A61K 31/401 Proline; Derivatives thereof, e.g. captopril
• CPC Class Codes: A61K 31/4422 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
• CPC Class Codes: A61K 31/554 having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
• CPC Class Codes: A61K 38/556 Angiotensin converting enzyme inhibitors
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A dosage form is disclosed comprising means for delaying the delivery of drug from the dosage form following the administration of the dosage form to a patient in need of drug therapy.

Claims

1. A method for producing a delayed therapeutic effect of thirty minutes to seven hours in a patient in need of therapy, wherein the method comprises:

(a) admitting into the gastrointestinal tract of a patient a dosage form comprising;

(1) a drug composition comprising 0.05 mg to 1.5 g of a drug, and a pharmaceutically acceptable polymer comprising a molecular weight up to 1,000,000;

(2) a push composition that imbibes fluid and expands, whereby the push composition pushes the drug composition from the dosage form;

(3) a wall that surrounds the drug and push compositions, said wall comprising a semipermeable polymer permeable to the passage of fluid and up to 85 wt. % of a different polymer comprising a molecular weight up to 4,000,000 molecular weight for slowing the rate of fluid passage through the semipermeable wall;

(4) at least one exit means in the semipermeable wall for delivering the drug from the dosage form; and

wherein the dosage form is characterized by;

(5) a subcoat for the delayed-delivery of the drug, which subcoat comprises a hydroxyalkylcellulose polymer comprising a molecular weight up to 4,000,000 that surrounds the drug and the composition on the inside surface of the semipermeable wall;

(b) imbibing fluid into the dosage form to provide a delayed drug delivery of thirty minutes up to seven hours b the polymer in the drug composition, the polymer in the semipermeable wall and the polymer in the subcoat operation operating together for delaying the drug delivery; and

,

(c) administering the drug at a delayed time to the patient in need of drug therapy.