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Claims for Patent: 5,545,413

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Claims for Patent: 5,545,413

Title: Dosage form for administering oral hypoglycemic glipizide
Abstract:A dosage form is disclosed comprising the antidiabetic drug glipizide for administering to a patient in need of glipizide therapy.
Inventor(s): Kuczynski; Anthony L. (Palo Alto, CA), Ayer; Atul D. (Palo Alto, CA), Wong; Patrick S. (Palo Alto, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:07/650,822
Patent Claims: 1. A method for controlling hyperglycemia and its associated symptomatology in a patient in need of glipizide therapy for controlling same, wherein the method comprises:

(a) admitting orally into the patient a dosage form comprising:

(1) a wall comprising at least at part a composition permeable to the passage of fluid, which wall surrounds;

(2) a compartment;

(3) a lamina in the compartment comprising about 2.0 mg to 50 mg of glipizide and a polyethylene oxide comprising an 80,000 to 350,000 molecular weight;

(4) a displacement lamina in the compartment comprising a polyethylene oxide comprising a 4,000,000 to 8,000,000 molecular weight, which displacement lamina imbides fluid, expands and displaces the lamina comprising the glipizide from the compartment;

(5) at least one exit means in the wall for delivering glipizide from the dosage form;

(b) imbibing fluid into the dosage form for contacting the displacement lamina comprising the polyethylene oxide causing it to expand and displace the lamina comprising the glipizide; thereby,

(c) delivering a therapeutically effective amount of glipizide to the patient to produce the intended effects.

2. A method for controlling hyperglycemia and its associated symptomatology in a patient in need of glipizide therapy for controlling same, wherein the method comprises:

(a) admitting orally into the patient a dosage form comprising:

(1) a wall comprising at least in part a composition permeable to the passage of fluid, which wall surrounds;

(2) a compartment;

(3) a lamina in the compartment comprising about 2.0 mg to 50 mg of glipizide and a polyethylene oxide comprising an 80,000 to 350,000 molecular weight;

(4) a displacement lamina in the compartment comprising sodium carboxymethylcellulose comprising a 200,000 to 1,000,000 molecular weight, which displacement lamina imbibes fluid, sweils and pushes glipizide from the compartment;

(5) at least one exit means in the wall for delivering glipizide from the dosage form;

(b) imbibing fluid by the sodium carboxymethylcellulose causing it to expand and push the glipizide from the dosage form; thereby,

(c) delivering a therapeutically effective amount of glipizide to the patient to produce the intended effects.

3. A dosage form for administering glipizide to a patient, wherein the dosage form comprises:

(a) a wall permeable at least in part to the passage of an exterior fluid, which wall surrounds:

(b) a compartment;

(c) a lamina in the compartment comprising from 2 mg to 50 mg of glipizide and a polyethylene oxide comprising a 80,000 to 350,000 molecular weight;

(d) a displacement lamina in the compartment comprising a polyethylene oxide comprising a 4,000,000 to 8,000,000 molecular weight; and,

(e) at least one exit passageway in the wall for connecting the exterior with the interior of the dosage form for delivering glipizide to the patient.

4. The dosage form for administering glipizide to the patient according to claim 3, wherein the patient is a diabetic and the wall of the dosage form is permeable in at least a part to the passage of fluid and comprises a member selected from the group consisting of a cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, and cellulose triacetate, and wherein the wall comprises at least one exit for delivering the glipizide from the dosage form.

5. A dosage form for delivering an antidiabetic glipizide for lowering blood glucose in a patient in need of lowering blood glucose therapy, wherein the dosage form comprises:

(a) a pharmaceutically acceptable wall comprising a composition permeable in at least a part to the passage of fluid, which wall surrounds:

(b) a compartment;

(c) a first lamina in the compartment comprising from 2 mg to 50 mg of glipizide, a polyethylene oxide and a hydroxypropylmethylcellulose comprising a 9,000 to 25,000 average molecular weight;

(d) a second displacement lamina in the compartment comprising a polyethylene oxide polymer comprising a 4,000,000 to 8,000,000 molecular weight; and

(e) at least one passageway in the wall for connecting the exterior with the interior of the dosage form for delivering glipizide from the dosage form to the patient.

6. The dosage form for delivering the antidiabetic glipizide to the patient according to claim 5, wherein the passageway is formed by leaching to provide a passageway of controlled porosity.

7. A dosage form for delivering an antidiabetic drug glipizide to a patient in need of hypoglycemic action, wherein the dosage form comprises:

(a) a pharmaceutically acceptable wall permeable to the passage of a fluid present in the patient, which wall surrounds;

(b) a compartment;

(c) a first lamina in the compartment comprising from 2 mg to 50 mg of glipizide, a hydroxypropylcellulose polymer and a polyvinylpyrrolidone polymer;

(d) a second displacement lamina in the compartment, the displacement lamina comprising sodium carboxymethylcellulose, and hydroxypropylmethylcellulose; and

(e) at least one passageway in the wall for connecting the exterior with the interior of the dosage form for delivering the glipizide from the dosage form to the patient.
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