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Claims for Patent: 5,160,744

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Claims for Patent: 5,160,744

Title: Verapmil therapy
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.
Inventor(s): Jao; Frank (San Jose, CA), Wong; Patrick S. (Palo Alto, CA), Huynh; Hoa T. (Fremont, CA), McChesney; Kathy (Cupertino, CA), Wat; Pamela K. (Santa Clara, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:07/722,622
Patent Claims: 1. A dosage form for the delayed-delivery of a drug, wherein the dosage form comprises:

(a) a first composition comprising 0.05 nanograms to 1.5 grams of the drug verapamil and 20 wt % to 50 wt % of a poly(ethylene oxide) present in the first composition, said poly(ethylene oxide) comprising means for changing from a nondispensable viscosity to a dispensable viscosity when contacted by fluid that enters the dosage form;

(B) a second composition comprising a polymeric composition that imbibes fluid and expands, whereby the second composition pushes the first composition from the dosage form;

(C) a wall that surrounds the first and second compositions, said wall permeable to the passage of fluid present in the environment of use and comprises 35 wt % to 55 wt % of a polymeric composition that hydrates slowly when contacted by fluid that enters the wall;

(D) at least one exit means in the wall for delivering the drug from the dosage form; and, wherein the dosage form is characterized by:

(E) a delayed-drug interval for delivering verapamil up to 4.5 hours provided by (A), (B) and (C) operating in combination as a unit to provide the delayed-drug interval.

2. The dosage form for the delayed-delivery of a drug according to claim 1, wherein the drug verapamil is replaced by a different drug selected from the group consisting of a calcium channel blocker and its pharmaceutically acceptable derivatives.

3. The dosage form for the delayed-delivery of a drug according to claim 1, wherein the drug verapamil is replaced by a member selected from the group consisting of nifedipine, nilvadipine, flunarizine, nimodipine, diltiazem, nicardipine, nitredipine, nisoldipine, felodipine, amlodipine, cinnarizine, and fendiline.

4. The dosage form for the delayed-delivery of a drug according to claim 1, wherein the drug verapamil is a member selected from the group consisting of verapamil and its pharmaceutically acceptable salts.

5. The dosage form for the delayed-delivery of a drug according to claim 1, wherein the drug verapamil is replaced by a member selected from the group consisting of ramipril, fosinopril, altiopril, benazepril, libenzapril, alacepril, cialzapril, cilazaprilat, perindopril, zofenopril, enalapril, lisinopril, imidapril, spriapril, rentiapril, captopril, delapril, olindapril, indalapril and quinapril.

6. The dosage form for administering the drug according to claim 1, wherein the orifice is a pore-orifice.

7. A method for administering the drug verapamil to the gastrointestinal tract of a patient in need of verapamil therapy, which method comprises:

(A) admitting a dosage form into the gastrointestinal tract of the patient, said dosage form comprising:

(1) a wall that surrounds and defines the compartment, said wall comprising 35 wt % to 55 wt % of a hydroxypropylcellulose and a member selected from the group consisting of cellulose acetate, cellulose diacetate, and cellulose triacetate;

(2) a drug composition in the compartment, said compartment comprising a therapeutically effective dose of 0.05 nanograms to 1.5 grams of the verapamil drug and 20 wt % to 50 wt % of a poly(ethylene oxide);

(3) a push composition in the compartment that imbibes fluid into the compartment, expands and pushes the drug composition from the dosage form, said push composition comprising a poly(ethylene oxide) which is different than the poly(ethylene oxide) in the drug composition; and

(4) a passageway in the dosage form for delivering the drug composition from the dosage form; and, wherein the dosage form in the gastrointestinal tract;

(B) changes from a delayed drug-free state over 30 minutes to 4.5 hours to a dispensable drug-delivery state; and,

(C) administering the drug verapamil to the gastrointestinal tract of the patient by the push composition displacing the drug from the dosage form.

8. The method for administering the drug verapamil to the gastrointestinal tract of a patient according to claim 7, wherein an instant dose of verapamil is administered from an external coat in contact with the wall.

9. The method for administering the drug verapamil to the gastrointestinal tract of a patient according to claim 7, wherein the dosage form delivers verapamil after a 2 hour drug-free interval.

10. The method for administering the drug verapamil to the gastrointestinal tract of a patient according to claim 7, wherein the dosage form is administered at bedtime.

11. The method for administering the drug verapamil to the gastrointestinal tract of a patient according to claim 7, wherein the dosage form administers verapamil during the night hours.
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