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Claims for Patent: 4,327,725

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Claims for Patent: 4,327,725

Title: Osmotic device with hydrogel driving member
Abstract:An osmotic device is disclosed comprising a semipermeable wall surrounding a compartment housing an agent that is insoluble to very soluble in aqueous and biological fluids, and a layer of a fluid swellable, hydrogel. A passageway in the wall connects the agent with the exterior of the device.
Inventor(s): Cortese; Richard (San Jose, CA), Theeuwes; Felix (Los Altos, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Application Number:06/210,176
Patent Claims: 1. An osmotic device for the controlled delivery of a beneficial agent to a fluid environment of use, comprising:

a. a wall formed of a semipermeable material permeable to the passage of an exterior aqueous fluid present in environment of use and substantially impermeable to the passage of beneficial agent, the semipermeable wall surrounding and forming;

b. a compartment containing a layer of beneficial agent, that is insoluble to very soluble in the aqueous fluid and a layer of an expandable hydrogel; and,

c. a passageway in the semipermeable wall communicating with the layer of beneficial agent in the compartment and with the exterior of the device.

2. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the layer of beneficial agent contains an osmagent.

3. The osmotic device for the controlled delivery of the benficial agent according to claim 1 wherein the wall is formed of a member selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate and cellulose triacetate.

4. The osmotic device for the controlled delivery of the benificial agent according to claim 1 wherein the agent is a member selected from the group consisting of pesticides, herbicides, germicides, fungicides, insecticides and algicides.

5. The osmotic device for the controlled delivery of agent according to claim 1 wherein the hydrogel is cross-linked.

6. The osmotic device for the controlled delivery of agent according to claim 1 wherein layer of agent contains osmagent and suspending agent.

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

a. a shaped wall formed of a semipermeable material permeable to the passage of an exterior fluid present in the environment of use, and substanitially impermeable to the passage of drug, the wall surrounding and forming:

b. a compartment comprising a drug that is soluble to very soluble in the biological fluid and exhibits an osmotic pressure gradient across the wall against the exterior fluid, and a layer of an expandable hydrogel in contact with the drug formation, which hydrogel can expand from a rested to an expanded state in the presence of exterior fluid imbibed into the compartment; and,

c. a passageway in the wall communicating with the exterior of the device and the drug for delivering the drug formulation from the device at a controlled rate over a prolonged period of time.

8. The osmotic device for the controlled delivery of the beneficial drug according to claim 7, wherein the device when in operation in the environment of use, imbides fluid through the wall into the compartment, thereby (1) producing a solution of drug, and (2) causing the hydrogel to expand, whereby through the combined operation of (1) and (2) the solution is delivered through the passageway from the compartment to the exterior of the device over time

9. The osmotic device for the controlled delivery of the drug according to claim 7 wherein drug is mixed with an osmagent that is soluble in the biological fluid and exhibits an osmotic pressure gradient across the semipermeable wall against the exterior fluid.

10. The osmotic device for the controlled delivery of the drug formulation according to claim 7 wherein the drug is present in the compartment as a layer thereof.

11. The osmotic device for the controlled delivery of the drug according to claim 7 wherein the biological environment of use is the gastrointestinal tract.

12. The osmotic device for the controlled delivery of the drug according to claim 7 wherein the biological environment of use is the vaginal channel.

13. The osmotic device for delivering the drug according to claim 7 wherein the hydrogel is cross-linked.

14. The osmotic device for delivering the drug according to claim 7 wherein the drug is mixed with a suspending agent.

15. The osmotic device for the controlled delivery of the drug according to claim 7 wherein the biological environment of use is the ano-rectal canal.

16. The osmotic device for the controlled delivery of the drug according to claim 7 wherein the drug is a member selected from the group consisting essentially of metoprolol, diclofenac, oxprenolol, hydralazine, aspirin, levodopa, valproate, and theophylline.

17. The osmotic device for the controlled delivery of the drug according to claim 7 wherein the environment of use is a human.

18. The osmotic device for the controlled delivery of the drug according to claim 7 wherein the drug is a member selected from the group consisting essentially of central nervous system, depressant, hypnotic, sedative, psychic energizer, tranquilizer, anticonvulsant, muscle relaxant, antiparkinson, analgesic, antiinflammatory, anesthetic, muscle contractant, hormonal, contraceptive, sympathomimetic, diuretic, cardiovascular, hypoglycemic, and ophthalmic drugs.

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

a. a shaped semipermeable wall permeable to the passage of an exterior biological fluid and substantially impermeable to the passage of drug formulation, the wall surrounding and forming;

b. a compartment comprising a drug formulation, which formulation comprises a drug that is insoluble to poorly soluble in the biological fluid and an osmotically effective solute that is soluble in the exterior fluid and exhibits an osmotic pressure gradient across the wall against the fluid, and a layer of a hydrogel in contact with the drug formulation, which hydrogel can absorb fluid that enters the compartment and swell; and,

c. a passageway in the semipermeable wall connecting the exterior of the device and drug formulation for delivering the drug formulation from the device to the environment at a controlled rate over a prolonged period of time.

20. The osmotic device for the controlled delivery of the beneficial drug formulation according to claim 17 wherein the environment of use is a human.

21. The osmotic device for the controlled delivery of the beneficial drug formulation according to claim 17 wherein the environment of use is the gastrointestinal tract and the device is sized and shaped for oral admittance therein.

22. The osmotic device for the controlled delivery of the beneficial drug formulation according to claim 17 wherein the environment of use is the vagina and the device is adapted for placement and retention therein.

23. The osmotic device for the controlled delivery of the beneficial drug formulation according to claim 17 wherein the environment of use is the ano-rectal canal and the device is adapted for insertion therein.

24. The osmotic device for the controlled delivery of the beneficial drug formulation according to claim 17, wherein when fluid is imbibed into the compartment, the hydrogel interacts with the fluid and retains the fluid within its hydrogel structure without dissolution, and exhibits a 2 to 50 fold increase in volume.

25. The osmotic device for the controlled delivery of the beneficial drug formulation according to claim 17, wherein when fluid is imbibed into the compartment, a precipitate is formed in the surface of the hydrogel at the interface defined by the hydrogel and the drug formulation.

26. The osmotic device for the controlled delivery of the drug according to claim 17 wherein the drug is mixed with a suspending agent.

27. The osmotic device for the controlled delivery of the beneficial drug formulation according to claim 19, wherein when fluid is imbibed into the compartment, a precipitate is formed in the surface of the hydrogel at the interface defined by the hydrogel and the drug formulation.

28. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug phenoxybenzamine.

29. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug norgestrel.

30. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug norethindone.

31. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug norethynodrel.

32. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug norgesterone.

33. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug norethisterone.

34. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug progesterone.

35. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug metaprolol.

36. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug diclofenac.

37. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug indomethacin.

38. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug oxprenolol.

39. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug l-dopa.

40. The osmotic device for the controlled delivery of the beneficial agent according to claim 1 wherein the agent is the drug valporate.
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