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Claims for Patent: 4,576,604

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Claims for Patent: 4,576,604

Title: Osmotic system with instant drug availability
Abstract:An osmotic device is disclosed for delivering a beneficial agent. The device comprises a wall surrounding a compartment containing an agent, a passageway in the wall connecting the exterior of the device with the compartment, and (a) an agent in the wall or (b) an agent carried on the wall in the wall. The device delivers the agent from the compartment and the wall.
Inventor(s): Guittard; George V. (Cupertino, CA), Deters; Joseph C. (Mountain View, CA), Theeuwes; Felix (Los Altos, CA), Cortese; Richard (San Jose, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:06/472,333
Patent Claims: 1. An osmotic device for delivering a beneficial agent to an environment of use, the osmotic device comprising:

(a) a wall at least in part formed of a substantially inert material which surrounds and forms a compartment containing a beneficial agent formulation, said substantially inert material being permeable to the passage of an exterior fluid present in the environment of use and substantially impermeable to the passage of the beneficial agent in the compartment;

(b) a beneficial agent in the wall, said agent being released from the wall when the osmotic device is in operation in a fluid environment of use; and,

(c) an osmotic passageway in the wall communicating with the compartment and the exterior of the device for dispensing the beneficial agent from the compartment when the device is in the environment of use wherein fluid passes through the wall, causes the formation of an osmotic pressure gradient across the wall and dispenses the beneficial agent from the compartment to the environment via the osmotic passageway.

2. The osmotic device for delivering the beneficial agent according to claim 1, wherein the wall is formed of a semipermeable material containing the beneficial agent that is released therefrom in a pulsed amount.

3. The osmotic device for delivering the beneficial agent according to claim 1, wherein the wall is a laminate that surrounds the compartment and comprises a semipermeable lamina adjacent to the compartment, and a microporous lamina in laminar arrangement with the semipermeable lamina and distant from the compartment, which microporous lamina contains a beneficial agent that is released therefrom in pulsed amount.

4. The osmotic device for delivering the beneficial agent according to claim 1, wherein the wall is a laminate that surrounds the compartment and comprises a semipermeable lamina adjacent to the compartment, and a water soluble lamina in laminar arrangement with the semipermeable lamina distant from the compartment, which water soluble lamina contains a beneficial agent that is released therefrom in a pulsed amount.

5. The osmotic device for delivering the beneficial agent according to claim 1, wherein the wall is a laminate that surrounds the compartment and comprises a semipermeable lamina adjacent to the compartment containing a beneficial agent that is released therefrom in a pulsed amount, and a water soluble lamina in laminar arrangement distant from the compartment that contains a beneficial agent that is released therefrom in a pulsed amount.

6. The osmotic device for delivering the beneficial agent according to claim 1, wherein the beneficial agent is released from the wall in a short period of time and from the compartment over a prolonged period of time.

7. The osmotic device for delivering the beneficial agent according to claim 1, wherein the wall is a laminate that surrounds the compartment and comprises an inner semipermeable lamina, a middle microporous lamina, and an outer water soluble lamina containing beneficial agent that is released therefrom in a short period of time.

8. The osmotic device for delivering the beneficial agent according to claim 1, wherein the wall is a laminate that surrounds the compartment and comprises an inner lamina formed of a semipermeable material, a middle lamina formed of a microporous material containing a beneficial agent that is released therefrom in a short period of time, and an outer lamina formed of a water soluble material containing a beneficial agent that is released therefrom in a short period of time.

9. The osmotic device for delivering the beneficial agent according to claim 7, wherein the beneficial agent is released from the outer lamina in a short pulsed period of time followed by the beneficial agent released from the middle lamina.

10. The osmotic device for delivering the beneficial agent according to claim 1, wherein the beneficial agent is released from the wall concomitantly with beneficial agent being delivered through the passageway from the device.

11. The osmotic device for delivering the beneficial agent according to claim 1, wherein the beneficial agent is released from the wall followed by delivery through the osmotic passageway from the device.

12. An osmotic device for the controlled delivery of a beneficial drug to a biological environment of use, the osmotic device comprising:

(a) a shaped wall at least in part formed of a substantially inert semipermeable material, which surrounds and forms a compartment containing a drug formulation, said substantially inert material being permeable to the passage of a fluid present in the environment of use, and substantially impermeable to the passage of the drug in the compartment;

(b) a beneficial drug carried by the shaped wall that is released therefrom when the device is in operation in the environment of use,;

(c) the drug formulation in the compartment exhibiting an osmotic pressure gradient across the shaped wall against a fluid present in the environment of use, said drug formulation comprising a dosage amount of drug; and,

(c) a passageway in the wall connecting the compartment with the exterior of the osmotic device for delivering drug formulation from the compartment to the environment of use wherein fluid passes through the wall, causes the formation of an osmotic pressure gradient across the wall and dispenses the drug from the compartment to the environment via the passageway.

13. The osmotic device for delivering the beneficial agent according to claim 12, wherein the compartment contains an osmagent.

14. The osmotic device for the controlled delivery of the beneficial drug according to claim 12, wherein the wall is at least in part formed of a semipermeable material that is a member selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, and cellulose triacetate.

15. The osmotic device for the controlled delivery of the beneficial drug according to claim 12, wherein the beneficial drug is cimetidine.

16. The osmotic device for the controlled delivery of the beneficial drug according to claim 12, wherein the beneficial drug is ranitidine.

17. The osmotic device for the controlled delivery of the beneficial drug according to claim 12, wherein the beneficial drug is phenylpropanolamine.

18. The osmotic device for the controlled delivery of the beneficial drug according to claim 12, wherein the environment of use is the gastrointestional tract.

19. The osmotic device for the controlled delivery of the beneficial drug according to claim 12, wherein the environment of use is a human.

20. The osmotic device for the controlled delivery of the beneficial drug according to claim 12, wherein the device is adapted and sized for oral use in a warm-blooded animal, and when in operation, the device released drug from the wall and imbibed fluid through the wall into the compartment in a tendency towards osmotic equilibrium at a rate controlled by the wall and the osmotic pressure gradient across the wall producing a drug formulation solution that is dispensed from the device at a controlled rate and continuously over a prolonged period of time.

21. The osmotic device for delivering a beneficial drug to the environment of use according to claim 12, wherein the drug is released in a short period of time from the wall for providing beneficial drug instantly to the environment of use.

22. The osmotic device for the controlled delivery of a beneficial drug to the biological environment of use according to claim 12, wherein the drug in the wall is the same as the drug in the compartment.

23. The osmotic device for the controlled delivery of a beneficial drug to the biological environment of use according to claim 12, wherein the drug in the wall is different than the drug in the compartment.

24. The osmotic device for the controlled delivery of a beneficial drug to the biological environment of use according to claim 12, wherein the wall is formed in part of the semipermeable material with the remainder of the wall formed of an impermeable material.

25. The osmotic device for the controlled delivery of a beneficial drug to the biological environment of use according to claim 12, wherein the wall releases the drug in a pulsed therapeutically effective amount.

26. The osmotic device for the controlled delivery of a beneficial drug to the biological environment of use according to claim 12, wherein the device delivers drug from the compartment in a therapeutically effective amount over a prolonged period of time.

27. The osmotic device for the controlled delivery of a beneficial drug to the biological environment of use according to claim 12, wherein the shaped wall is a laminate comprising a semipermeable lamina and a microporous lamina.

28. The osmotic device for the controlled delivery of a beneficial drug to the biological environment of use according to claim 12, wherein the shaped wall comprises a lamina that contains the drug.

29. The osmotic device for delivering the beneficial agent according to claim 1, wherein the beneficial agent in the compartment is the same as the beneficial agent in the wall.

30. The osmotic device for delivering the beneficial agent according to claim 1, wherein the beneficial agent in the compartment is different than the beneficial agent in the wall.

31. The osmotic device for delivering the beneficial agent according to claim 1, wherein the beneficial agent formulation in the compartment exhibits an osmotic pressure gradient across the wall against a fluid present in the environment of use.

32. The osmotic device for delivering a beneficial drug to the environment of use according to claim 12, wherein the beneficial drug carried by the shaped wall is carried by a water soluble lamina.

33. The osmotic device for delivering a beneficial drug to the environment of use according to claim 12, wherein the shaped wall is a laminate and the beneficial drug is carried by a lamina coated onto the shaped wall.

34. The osmotic device for delivering a beneficial drug to the environment of use according to claim 12, wherein the shaped wall is a laminate comprising a semipermeable lamina and a microporous lamina, and the beneficial drug is carried by the microporous lamina.
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