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Claims for Patent: 5,232,705

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Claims for Patent: 5,232,705

Title: Dosage form for time-varying patterns of drug delivery
Abstract:A dosage form is disclosed that comprises means inside the dosage form for providing a substantially drug-free interval before the dosage form delivers a drug from inside the dosage form. The dosage form in an embodiment comprises a drug on the exterior of the dosage form, which drug is available for immediate delivery.
Inventor(s): Wong; Patrick S. (Palo Alto, CA), Theeuwes; Felix (Los Altos, CA), Ayer; Atul D. (Palo Alto, CA), Kuczynski; Anthony L. (Palo Alto, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:07/864,824
Patent Claims: 1. A dosage form for administering a dose of a drug twice a day from a single dosage form, which dosage form comprises:

(1) a compartment;

(2) a wall that surrounds and forms the compartment, said wall comprising a composition that is permeable to the passage of fluid;

(3) a first composition in the compartment, said first composition drug-free for producing a drug-free interval prior to the administration of drug from the compartment;

(4) a second composition in the compartment comprising a dose amount of a drug for producing a therapeutic effect;

(5) a third composition in the compartment that expands in the presence of fluid that enters the device;

(6) exit means in the wall for connecting the exterior of the dosage form with the compartment; and,

(7) a substantially immediate release dose amount of drug on the exterior surface of the wall.

2. A dosage form for administering a first dose and a second dose of drug, said dosage form comprising:

(1) a compartment;

(2) a wall that surrounds and forms the compartment, said wall comprising a composition that is permeable to the passage of fluid;

(3) a first dose of drug for producing a therapeutic effect on the exterior surface of the wall;

(4) a first composition in the compartment, said first composition substantially drug-free for producing a drug-free interval prior to the administration of drug from the compartment;

(5) a second composition in the compartment comprising a second dose amount of a drug for producing a therapeutic effect;

(6) a third composition in the compartment that expands in the presence of fluid that enters the device; and,

(7) exit means in the wall for connecting the exterior of the dosage form with the compartment.

3. The dosage form for administering the drug according to claim 2, wherein the drug is a member selected from the group consisting of verapamil, nimodipine, nitredipine, nisoldipine, nicardipine, felodipine, diltiazem, lidoflazine, tiapamil, guanabenz, isradipine, gallopamil, amlodipine, mioflazine, and caroverene.

4. The dosage form for administering the drug according to claim 2, wherein the drug is a member selected from the group consisting of amyl nitrate, glyceryl trinitrate, octyl nitrite, sodium nitrite, erythrityl tetranitrate, isosorbide dinitrate, mannitol hexanitrate, pentaerythritol tetranitrate, pentritol, triethanolamine trinitrate, and trolnitrate phosphate.

5. The dosage form for administering the drug according to claim 2, wherein the exit means is a pore.

6. A dosage form comprising:

(1) a wall that surrounds:

(2) a first composition, which first composition is a means for delaying the delivery of a drug from the dosage form;

(3) a second composition comprising 25 nanograms to 1.5 grams of the drug verapamil;

(4) a third composition that expands in the presence of fluid that enters the dosage form causing the third composition to increase in physical dimensions and push against the first and second composition, whereby verapamil is delivered from the dosage form; and,

(5) exit means in the wall connecting the exterior with the interior of the dosage form for delivering the verapamil from the dosage form.

7. A therapeutic composition comprising 0.05 ng to 1.5 g of verapamil and a member selected from the group consisting of poly(vinyl pyrrolidone), poly(alkylene oxide) and a poly(cellulose), which therapeutic composition can be delivered from an osmotic dosage form for an antianginal, antiarrhythmic, and antihypertensive therapeutic effect in a patient in need of verapamil therapy.

8. A therapeutic composition according to claim 7, wherein verapamil is in the therapeutic composition as a pharmaceutically acceptable salt.
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