Verapmil therapy
First Claim
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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.
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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.
58 Citations
11 Claims
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1. A dosage form for the delayed-delivery of a drug, wherein the dosage form comprises:
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(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. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for administering the drug verapamil to the gastrointestinal tract of a patient in need of verapamil therapy, which method comprises:
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(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. - View Dependent Claims (8, 9, 10, 11)
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Specification