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Claims for Patent: 4,765,989

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Claims for Patent: 4,765,989

Title: Osmotic device for administering certain drugs
Abstract:An osmotic system is disclosed comprising a wall comprising in at least a part of a semipermeable material that surrounds a compartment. The compartment contains an osmotic composition comprising a beneficial drug selected from the group consisting of nifedipine, prazosin and doxazosin, and a second and different osmotic composition. A passageway in the wall connects the first composition with the exterior of the system.
Inventor(s): Wong; Patrick S. L. (Hayward, CA), Barclay; Brian L. (Sunnyvale, CA), Deters; Joseph C. (Mt. View, CA), Theeuwes; Felix (Los Altos, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:06/902,915
Patent Claims: 1. An osmotic device for the oral administration at a controlled rate the beneficial drug nifedipine to an environment of use, the osmotic device comprising:

(a) a wall comprising in at least a part of a semipermeable material permeable to the passage of an exterior fluid present in the environment of use and substantially impermeable to the passage of the beneficial drug, the wall surrounding and forming:

(b) a compartment;

(c) a first composition in the compartment, said first composition comprising the beneficial drug nifedipine and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid;

(d) a second composition in the compartment, said second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid; and,

(e) at least one passageway in the wall communicating with the first composition and the exterior of the device for delivering the beneficial drug nifedipine through the passageway from the osmotic device.

2. The osmotic device for the oral administration at a controlled rate the beneficial drug nifedipine according to claim 1 wherein the second composition comprises an osmotically effective solute that exhibits an osmotic pressure gradient across the semipermeable wall against an external fluid.

3. A method for administering the beneficial drug nifedipine to a warm blooded animal, which method comprises:

(a) admitting an osmotic device orally into the animal, said osmotic device comprising:

(1) a shaped semipermeable wall comprising a composition permeable to the passage of an exterior fluid and substantially impermeable to the passage of the beneficial drug, the wall surrounding and forming:

(2) a compartment containing a first composition comprising a dosage unit amount of the beneficial drug nifedipine and an osmopolymer that exhibits an osmotic gradient across the semipermeable wall against an external fluid, and a second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the semipermeable wall against an external fluid;

(3) at least one passageway in the wall connecting the exterior of the osmotic device with the first composition; and,

(b) administering the beneficial drug nifedipine to the animal by imbibing fluid through the semipermeable wall into the osmotic device to form a dispensable first composition containing nifedipine, and a second expanding composition, whereby the drug nifedipine is administered by the combined actions of the first and second compositions through the passageway to the animal over time.

4. A method for managing the plasma levels in a patient on nifedipine, which method comprises administering orally nifedipine to said patient a therapeutically effective amount of nifedipine from an osmotic device, which device comprises: a semipermeable wall permeable to the passage of an exterior fluid and substantially impermeable to the passage of nifedipine, the wall surrounding and forming: a compartment containing a first composition comprising a dosage amount of nifedipine and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an exterior fluid, and a second composition comprising a different osmopolymer that exhibits an osmotic pressure gradient across the wall against an exterior fluid; an osmotic passageway in the wall communicating the exterior of the device with the first composition; and, delivering nifedipine through the passageway to the patient for managing the plasma levels.

5. A method of treating a cardiovascular condition in a patient having such condition which method comprises orally administering to the patient a therapeutically effective amount of nifedipine, which nifedipine is administered orally from an osmotic device comprising: a semipermeable wall permeable to the passage of fluid and substantially impermeable to the passage of drug, the wall surrounding and forming: a compartment containing a first composition comprising a dosage amount of nifedipine and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid, and a second composition comprising a different osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid; and, a passageway in the wall connecting the exterior of the device with the first composition; and, administering nifedipine through the passageway to the patient for treating the condition.

6. An osmotic device for orally administering the beneficial drug prazosin to an environment of use, the osmotic device comprising:

(a) a wall permeable to the passage of fluid and substantially impermeable to the passage of drug, which wall surround and forms:

(b) a compartment housing a first composition comprising the beneficial drug prazosin and an osmopolymer that exhibits an osmotic pressure gradient across the wall against a fluid, and a second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the wall against a fluid; and,

(c) a passageway in the wall communicating with the first composition and the exterior of the device for delivering the beneficial drug prazosin through the passageway to the environment of use from the device.

7. The osmotic device for orally administering the beneficial drug prazosin according to claim 6, wherein prazosin is present in the osmotic device as a pharmaceutically acceptable salt.

8. The osmotic device for orally administering the beneficial drug prazosin according to claim 6, wherein the second composition comprises an osmotically effective compound that exhibits an osmotic pressure gradient across the wall against a fluid.

9. A method for managing the plasma levels in a patient on prazosin, which method comprises administering orally prazosin to said patient a therapeutically effective amount of prazosin from an osmotic device, which device comprises:

(a) a semipermeable wall permeable to the passage of an exterior fluid and substantially impermeable to the passage of drug, the wall surrounding and forming:

(b) a compartment containing a first composition comprising a dosage amount of prazosin and an osmopolymer that exhibits an osmotic pressure gradient across the wall against a fluid, and a second composition comprising a different osmopolymer that exhibits an osmotic pressure gradient across the wall against a fluid:

(c) a passageway in the wall communicating the exterior of the device with the first composition; and, administering prazosin through the passageway to the patient for managing the plasma levels.

10. A method for administering prazosin to an animal, which method comprises:

(a) admitting an osmotic device orally into the animal, said osmotic device comprising:

(1) a semipermeable wall permeable to the passage of an exterior fluid and substantially impermeable to the passage of a drug, which wall surrounds and forms:

(2) a compartment containing a first composition comprising a dosage amount of prazosin and an osmopolymer that exhibits an osmotic gradient across the semipermeable wall against an external fluid, and a second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the semipermeable wall against an external fluid;

(3) at least one passageway in the wall connecting the exterior of the osmotic device with the first composition; and,

(b) administering prazosin to the animal by imbibing fluid through the semipermeable wall into the osmotic device to form an administrable first composition containing prazosin and to form an expanding second composition that urges the first composition from the device whereby the prazosin is administered by the combined actions of the first and second compositions through the passageway to the animal over time.

11. A method of treating a cardiovascular condition in a patient having such a condition, which method comprises orally administering to the patient a therapeutically effective amount of prazosin, which prazosin is administered orally from an osmotic device comprising:

(a) a wall permeable to the passage of fluid, the wall surrounding and forming:

(b) a compartment containing a first composition comprising a dosage amount of prazosin and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an exterior fluid, and a second composition comprising a different osmopolymer that exhibits an osmotic pressure gradient across the wall against an exterior fluid; and,

(c) an osmotic passageway in the wall connecting the exterior of the device with the first composition, and administering the prazosin through the passageway to the patient for treating said cardiovascular condition.

12. An osmotic device for administering the beneficial drug doxazosin to an environment of use, the osmotic device comprising:

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

(b) a compartment;

(c) a first composition in the compartment, said first composition comprising the beneficial drug doxazosin and an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid;

(d) a second composition in the compartment, said second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid; and,

(e) a passageway in the wall connecting the exterior of the device with the interior of the device for delivering the beneficial drug doxazosin to the environment of use over time.

13. The osmotic device for administering the beneficial drug doxazosin to the environment of use according to claim 12, wherein the passageway comprises at least one pore.

14. The osmotic device for administering the beneficial drug doxazosin to the environment of use according to claim 12, wherein the passageway comprises a pore formed by leaching a leachable material from the wall.

15. A method for administering the beneficial drug doxazosin to a warm blooded animal, which method comprises:

(a) admitting an osmotic device orally into the animal, said osmotic device comprising:

(1) a shaped semipermeable wall comprising a composition permeable to the passage of an exterior fluid and substantially impermeable to the passage of the beneficial drug, the wall surrounding and forming:

(2) a compartment containing a composition comprising a dosage unit amount of the beneficial drug doxazosin and an osmopolymer that exhibits an osmotic gradient across the semipermeable wall against an external fluid, and a composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the semipermeable wall against an external fluid;

(3) at least one passageway in the wall connecting the exterior with the interior of the device; and,

(b) administering the beneficial drug doxazosin to the animal by imbibing fluid through the wall into the compartment to form a dispensable composition comprising doxazosin, and an expanding composition, whereby the drug doxazosin is administered by the combined actions of the compositions through the passageway to the animal over time.

16. A method for managing the plasma levels in a patient on doxazosin, which method comprises administering orally doxazosin to said patient a therapeutically effective amount of doxazosin from an osmotic device, which device comprises: a semipermeable wall permeable to the passage of an exterior fluid and substantially impermeable to the passage of the wall surrounding and forming: a compartment containing a composition comprising a dosage amount of doxazosin and an osmopolymer, and a second composition comprising a osmopolymer that exhibits an osmotic pressure gradient across the wall against an exterior fluid; a passageway in the wall communicating the exterior of the device with the compartment; and, delivering doxazosin through the passageway to the patient for managing the plasma levels.

17. A method of treating a cardiovascular condition in a patient having such condition which method comprises orally administering to the patient a therapeutically effective amount of doxazosin, which doxazosin is administered orally from an osmotic device comprising: a semipermeable wall permeable to the passage of fluid and substantially impermeable to the passage of drug, the wall surrounding and forming: a compartment containing a composition comprising a dosage amount of doxazosin and an osmopolymer and a second composition comprising an osmopolymer that exhibits an osmotic pressure gradient across the wall against an external fluid; and, or at least one passageway in the wall connecting the exterior of the device with the compartment; and, administering doxazosin through the passageway to the patient for treating the condition.

18. The method of treating the cardiovascular condition in the patient according to claim 17, wherein the doxazosin produces an antihypertensive effect, thereby treating the cardiovascular condition.

19. The method of treating the cardiovascular condition in the patient according to claim 17, wherein doxazosin exhibits an alpha-adrenoceptor antagonist effect that lowers blood pressure by reducing peripheral resistance, thereby treating the cardiovascular condition.
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