System for delaying drug delivery up to seven hours

• US 6,146,662 A
• Filed: 03/24/1993
• Issued: 11/14/2000
• Est. Priority Date: 06/27/1991
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.-L., Wat, Pamela K., Jao, Frank, Huynh, Hoa T., Mc Chesney, Kathy
• Primary Examiner(s): Page, Thurman K.
• Application Number:
  US08/036,648
• Time in Patent Office: 2,792 Days
• Field of Search: 424/473, 424/464, 424/465
• 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 dosage form for the delayed-delivery of a drug to a fluid environment of use, wherein the dosage form comprises:

(a) a drug composition comprising a dose of 0.05 ng to 1.5 g of a calcium channel blocker drug, and a polymer comprising a molecular weight up to 1,000,000 and a rate of hydration in the presence of fluid that contacts the dosage form to change from a non-dispensable phase to a dispensable phase; and

,

(b) a drug-delayed delivery composition in the dosage form comprising a polymer possessing a 8,500 to 4,000,000 molecular weight that delays the delivery of the drug from the dosage form up to seven hours.

2. The dosage form for the delayed-delivery of the drug according to claim 1, wherein the drug is a member selected from the group consisting of nifedipine, isradipine, nilvadipine, verapamil, flunarizine, nimodipine, diltiazem, nicardipine, norverapamil, nitredipine, nisolclipine, felodipine, amlodipine, uninarizine and fendiline.

3. A dosage form for the delayed-delivery of a drug to a fluid environment of use, wherein the dosage form comprises:

(a) a drug composition comprising a dose of 0.05 ng to 1.5 g of an angiotensin converting enzyme inhibitor and a polymer comprising a molecular weight up to 1,000,000 and rate of hydration in the presence of fluid that contacts the dosage form to cause the dosage form to change to a dispensable phase; and

,

(b) a drug-delayed delivery composition in the dosage form comprising a polymer possessing a 8,500 to 4,000,000 molecular weight that delays the delivery of the angiotensin converting enzyme inhibitor from the dosage form for up to seven hours.

4. The dosage form that delays the drug delivery according to claim 3, wherein the angiotensin converting enzyme inhibitor is a member selected from the group consisting of an angiotensin converting enzyme inhibitor essentially-free of sulfur, an angiotensin converting enzyme inhibitor comprising a sulfhydryl group, an angiotensin converting enzyme inhibitor comprising a linear sulfide, angiotensin converting enzyme inhibitor containing a cyclic sulfide, and an angiotensin converting enzyme inhibitor containing a methylsulfonyl group.

5. The dosage form that delays the drug delivery according to claim 3, wherein the angiotensin converting enzyme inhibitor is a member selected from the group consisting of ramipril, fosinopril, altropril, benazepril, libenzapril, alacepril, cilazaprit, cilazaprilat, perindopril, zofenopril, enalapril, lisinopril, imidapril, spirapril, rentiapril, captopril, delapril, alindapril, indolapril and quinapril.

6. A dosage form for the delayed-delivery of a drug to a patient fluid environment, wherein the dosage form comprises:

(a) a drug composition comprising a dose of 0.05 ng to 1.5 g of a patient administrable drug and a polymer comprising a molecular weight up to 1,000,000 and a rate of hydration in the presence of fluid that contacts the dosage form to cause the dosage form to change to a dispensable phase; and

,

(b) a drug-delayed delivery composition in the dosage form comprising a polymer possessing a 8,500 to 4,000,000 molecular weight that delays the delivery of the drug from the dosage form for up to seven hours.

7. A method for the delayed-delivery of a drug to a patient in need of delayed therapy, wherein the method comprises:

(A) admitting into the patient a dosage form comprising;

(1) a drug composition comprising a dose of 0.05 ng to 1.5 g of a patient administrable drug and a polymer comprising a molecular weight up to 1,000,000 and a rate of hydration in the presence of fluid that contacts the dosage form to cause the dosage form to change to a dispensable phase; and

,

(2) a drug-delayed delivery composition in the dosage form comprising a polymer possessing a 8,500 to 4,000,000 molecular weight that delays the delivery of drug from the dosage form for up to seven hours; and

(B) delivering the drug from the dosage form to obtain the indicated therapeutic intent.

8. A method for the delayed-delivery of a drug to a patient in need of delayed therapy, wherein the method comprises:

(A) admitting into the patient a delayed-delivery dosage form comprising;

(1) a drug composition comprising a dose of 0.05 ng to 1.5 g of a patient administrable drug and a pharmaceutical carrier comprising a molecular weight up to 1,000,000 for delivering the drug to the patient; and

,

(2) means in the dosage form comprising a molecular weight up to 4,000,000 that delays the delivery of drug from the dosage form to provide a delayed delivery of the drug up to 7 hours; and

(B) delivering the drug after the delay at a delivery rate up to 40 mg/hr over an extended period of 24 hours.