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Claims for Patent: 4,946,687

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Claims for Patent: 4,946,687

Title: Dosage form for treating cardiovascular diseases
Abstract:An osmotic device is disclosed comprising a first composition, and a second composition with the beneficial drug isradipine in the first composition.
Inventor(s): Ayer; Atul D. (Palo Alto, CA), Swanson; David R. (Palo Alto, CA), Kuczynski; Anthony L. (Palo Alto, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:07/267,894
Patent Claims: 1. An osmotic dosage form for the administration of isradipine to a biological environment of use, wherein the dosage form comprises:

(A) a first composition comprising a dosage amount of isradipine, and a polyethylene oxide comprising a molecular weight of about 200,000;

(B) a second composition comprising a polyethylene oxide comprising a molecular weight of about 5,000,000 to 7,800,000;

(C) a wall comprising at least in part a composition permeable to the passage of an exterior fluid present in the environment of use, which wall surrounds the first and second compositions; and,

(D) at least one passageway in the wall connecting the exterior of the dosage form with the interior of the dosage form for delivering isradipine to the environment of use.

2. The osmotic dosage form for the administration of isradipine to the biological environment of use according to claim 1, wherein the first composition comprises a hydroxypropylmethylcellulose comprising a number average molecular weight of 9,000 to 15,000.

3. The osmotic dosage form for the administration of isradipine to the biological environment of use according to claim 1, wherein the second composition comprises a hydroxypropylmethylcellulose comprising a number average molecular weight of 9,000 to 15,000.

4. The osmotic dosage form for the administration of isradipine to the biological environment of use according to claim 1, wherein the second composition comprises an osmagent.

5. An osmotic dosage form for the administration of isradipine to a biological environment of use, wherein the dosage form comprises:

(A) a first composition comprising a dosage amount of isradipine and a polyethylene oxide comprising a molecular weight of about 300,000;

(B) a second composition comprising a polyethylene oxide comprising a molecular weight of about 5,000,000 to 7,800,000;

(C) a wall comprising at least in part a composition permeable to the passage of an exterior fluid present in the environment of use, which wall surrounds the first and second compositions; and,

(D) at least one passageway in the wall connecting the exterior of the dosage form with the interior of the dosage form for delivering isradipine to the environment of use.

6. The osmotic dosage form for the administration of isradipine to a biological environment of use, according to claim 5 , wherein the first composition comprises a hydroxypropylmethylcellulose comprising a number average molecular weight of 9,000 to 15,000.

7. The osmotic dosage form for the administration of isradipine to a biological environment of use, according to claim 5, wherein the second composition comprises a hydroxypropylmethylcellulose comprising a number average molecular weight of 9,000 to 15,000.

8. The osmotic dosage form for the administration of isradipine to a biological environment of use, according to claim 5, wherein the second composition comprises an osmotically effective solute.

9. An osmotic dosage form for the administration of isradipine to a warm-blooded animal, wherein the dosage form comprises:

(A) a first lamina comprising isradipine, a polyethylene oxide comprising a molecular weight of about 200,000 and a polyethylene oxide comprising a molecular weight of about 300,000;

(B) a second lamina comprising a polyethylene oxide comprising a molecular weight of about 5,000,000 to 7,800,000;

(C) a wall surrounding the first composition and the second composition, said wall comprising at least in part a composition permeable to the passage of fluid; and,

(D) at least one exit means in the wall for delivering the isradipine to the arm-blooded animal.

10. The osmotic dosage form for the administration of isradipine to the warm-blooded animal according to claim 9, wherein the first lamina comprises a hydroxypropylmethylcellulose.

11. The osmotic dosage form for the administration of isradipine to the warm-blooded animal according to claim 9, wherein the second lamina comprises a hydroxypropylmethylcellulose.

12. The osmotic dosage form for the administration of isradipine to the warm-blooded animal according to claim 9, wherein the second lamina comprises an osmotically effective compound.

13. An improvement in an osmotic device for the administration of a drug at a metered release rate per unit time, wherein the osmotic device comprises:

(A) a all comprising at least in part a composition permeable to the passage of lfuid, which wall surrounds and forms;

(B) a compartment;

(C) exit means in the wall for connecting the exterior of the osmotic device with the compartment for delivering the drug from the osmotic device; and wherein the improvement comprises;

(D) a polyethylene oxide comprising a molecular weight of about 5,000,000 to 7,800,000 which is means for cooperating with the osmotic device for administering the drug at a metered release rate per unit time.
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