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Details for Patent: 7,736,668

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Details for Patent: 7,736,668

Title:System for delaying drug delivery up to seven hours
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.-L. (Palo Alto, CA), Huynh; Hoa T. (Fremont, CA), Mc Chesney; Kathy (Cupertino, CA), Wat; Pamela K. (Santa Clara, CA)
Assignee: Janssen Pharmaceutica NV (Beerse, BE)
Filing Date:Jan 28, 2003
Application Number:10/352,625
Claims:1. A method for providing a therapeutic program that delays the delivery of verapamil followed by delivering verapamil to a patient, wherein the method comprises: administering orally to the patient a dosage form comprising (i) a drug composition comprising 0.05 ng to 1.0 g of verapamil and polyethylene oxide having a molecular weight of between 250,000 and 350,000; (ii) a push composition comprising 60 wt. % to 85 wt. % polymer comprising 2.0 wt. % to 15 wt. % hydroxypropylalkylcellulose having a molecular weight of between 9,000 and 25,000, and 15 wt. % to 30 wt. % of an osmagent capable of expanding and pushing the drug composition from the dosage form; (iii) a non-erodible and fluid-insoluble wall surrounding the drug and push compositions, the wall having a thickness of between 2 mils to 20 mils and comprising between 15 wt. % to 85 wt. % of a cellulose polymer; and (iv) an exit in the wall for delivery of verapamil from the dosage form, said exit having a diameter up to 30 mil, wherein the dosage form delays the delivery of verapamil up to 7 hours followed by delivery of verapamil over a prolonged period of time to provide the therapeutic program.

2. The method for providing the therapeutic program according to claim 1, wherein the delay is 30 minutes to 4.5 hours.

3. The method for providing a therapeutic program according to claim 1, wherein the delay is 15 minutes to 3 hours.

4. The method for providing a therapeutic program according to claim 1, wherein the delivery of the drug is up to 8 hours.

5. The method for providing a therapeutic program according to claim 1, wherein the delivery of the drug is up to 16.6 hours.

6. A method for making available at a later time a drug selected from the group consisting of verapamil and diltiazem, wherein the method comprises administering orally to a patient a dosage form comprising (i) a drug composition comprising a therapeutic amount of the drug and polyethylene oxide having a molecular weight of between 250,000 and 350,000; (ii) a push composition comprising 60 wt. % to 85 wt. % polymer comprising 2.0 wt. % to 15 wt. % hydroxypropylalkylcellulose having a molecular weight of between 9,000 and 25,000, and 15 wt. % to 30 wt. % of an osmagent capable of expanding and pushing the drug composition from the dosage form; (iii) a non-erodible and fluid-insoluble wall surrounding the drug and push compositions, the wall having a thickness of between 2 mils to 20 mils and comprising between 15 wt. % to 85 wt. % of a cellulose polymer; and (iv) an exit in the wall for delivery of the drug from the dosage form, said exit having a diameter up to 30 mil, wherein the dosage form provides a drug-free interval and, at a later time, a drug-delivery interval that delivers the drug over a prolonged time.

7. A method of administering verapamil for antihypertensive therapy, wherein the method comprises administering orally to a patient a dosage form that comprises (i) a drug composition comprising verapamil and polyethylene oxide having a molecular weight of between 250,000 and 350,000; (ii) a push composition comprising 60 wt. % to 85 wt. % polymer comprising 2.0 wt. % to 15 wt. % hydroxypropylalkylcellulose having a molecular weight of between 9,000 and 25,000, and 15 wt. % to 30 wt. % of an osmagent capable of expanding and pushing the drug composition from the dosage form; (iii) a non-erodible and fluid-insoluble wall surrounding the drug and push compositions, the wall having a thickness of between 2 mils to 20 mils and comprising between 15 wt. % to 85 wt. % of a cellulose polymer; and (iv) an exit in the wall for delivery of the drug from the dosage form, said exit having a diameter up to 30 mil, wherein the dosage form delays the administration of verapamil up to 7 hours then administers verapamil at a controlled rate up to 40 mg per hour up to 20 hours for antihypertensive therapy.

8. A method of delivering diltiazem to a patient, wherein the method comprises admitting orally into the patient a dosage form comprising (i) a drug composition comprising diltiazem and polyethylene oxide having a molecular weight of between 250,000 and 350,000; (ii) a push composition comprising 60 wt. % to 85 wt. % polymer comprising 2.0 wt. % to 15 wt. % hydroxypropylalkylcellulose having a molecular weight of between 9,000 and 25,000 and 15 wt. % to 30 wt. % of an osmagent capable of expanding and pushing the drug composition from the dosage form; (iii) a non-erodible and fluid-insoluble wall surrounding the drug and push compositions, the wall having a thickness of between 2 mils to 20 mils and comprising between 15 wt. % to 85 wt. % of a cellulose polymer; and (iv) an exit in the wall for delivery of diltiazem from the dosage form, said exit having a diameter up to 30 mil, wherein said dosage form delivers diltiazem followed by a diltiazem-free period.

9. The method of delivering diltiazem to the patient according to claim 8, wherein the diltiazem is delivered for its antihypertensive effect.

10. The method of claim 1, wherein the polymeric material for slowing the rate of fluid imbibition through the wall comprises a polymer having a molecular weight of 8,500 to 4,000,000.

11. The method of claim 6, wherein the polymeric material for slowing the rate of fluid imbibition through the wall comprises a polymer having a molecular weight of 8,500 to 4,000,000.

12. The method of claim 7, wherein the polymeric material for slowing the rate of fluid imbibition through the wall comprises a polymer having a molecular weight of 8,500 to 4,000,000.

13. The method of claim 8, wherein the polymeric material for slowing the rate of fluid imbibition through the wall comprises a polymer having a molecular weight of 8,500 to 4,000,000.
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