Osmotic delivery system, osmotic delivery system semipermeable body assembly, and method for controlling delivery rate of beneficial agents from osmotic delivery systems

• US 6,923,800 B2
• Filed: 05/18/2001
• Issued: 08/02/2005
• Est. Priority Date: 07/25/1997
• Status: Expired due to Term

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Berry, Steve A., Rodenberger, Craig I., Jordan, Scott D., Chen, Guohua, Lautenbach, Scott D., Dionne, Keith E., Ayer, Rupal
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/859,428
• Publication Number:
  US 20010027311A1
• Time in Patent Office: 1,537 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 424/422, 424/423, 424/424, 424/425
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

Osmotic delivery system semipermeable body assemblies that control the delivery rate of a beneficial agent from an osmotic delivery system incorporating one of the semipermeable body assemblies are provided. A semipermeable body assembly or plug includes a semipermeable body which is positionable in an opening of an osmotic delivery system. The semipermeable body has a hollow interior portion having a size selected to obtain a predetermined liquid permeation rate through the semipermeable body. Because the beneficial agent in the osmotic delivery system is delivered at substantially the same rate, the osmotic agent imbibes liquid which has permeated through the plug from a surrounding environment, and the liquid permeation rate through the plug controls the delivery rate of the beneficial agent from the osmotic delivery system. The liquid permeation rate through a semipermeable body may be varied to control the delivery rate of beneficial agent from an osmotic delivery system by changing the thickness of the semipermeable body or by changing an amount of surface area of the semipermeable body that is exposed to liquid when the osmotic delivery system is located in a liquid environment of use.

Claims

1. An osmotic delivery system plug for controlling a delivery rate of a beneficial agent in an osmotic delivery system comprising:

a semipermeable body at least partially positionable in an opening in an enclosure of an osmotic delivery system, the semipermeable body including

a cone-shaped, liquid contact surface for contacting a liquid outside of the osmotic delivery system; and

a hollow interior portion having a size selected to obtain a predetermined liquid permeation rate through the semipermeable body, the liquid permeation rate for controlling a delivery rate of a beneficial agent in the osmotic delivery system.

2. The osmotic delivery system plug according to claim 1, wherein the hollow interior portion is conical.

3. The osmotic delivery system plug according to claim 1, wherein the hollow interior portion is cylindrical.

4. The osmotic delivery system plug according to claim 3, wherein the liquid contact surface is located at an end of the body opposite the hollow interior portion.

5. The osmotic delivery system plug according to claim 4, wherein the hollow interior portion includes a depth surface defining a plug thickness of the semipermeable body between the liquid contact surface and the depth surface.

6. The osmotic delivery system plug according to claim 1, including an insert located within the hollow interior portion.

7. The osmotic delivery system plug according to claim 6, wherein the hollow interior portion and the insert are cylindrical, the cylindrical hollow interior portion matingly receiving the cylindrical insert.

8. The osmotic delivery system plug according to claim 6, wherein the insert is pervious to liquids.

9. The osmotic delivery system plug according to claim 6, wherein the insert is a semipermeable material having a different permeability than that of the semipermeable body.

10. The osmotic delivery system plug according to claim 6, wherein the insert includes an osmotic agent.

11. The osmotic delivery system plug according to claim 6, wherein the insert has a longitudinal length substantially equal to a depth of the hollow interior portion.

12. The osmotic delivery system plug according to claim 6, wherein the insert has a size and shape which substantially matches a size and shape of the hollow interior portion of the semipermeable body.

13. The osmotic delivery system plug according to claim 1, wherein the semipermeable body includes an outer sealing surface for effecting a seal with the enclosure when the body is at least partially positioned in the enclosure.

14. The osmotic delivery system plug according to claim 13, wherein the hollow interior portion includes an interior surface defining a wall width between the outer sealing surface and the interior surface.

15. The osmotic delivery system plug according to claim 13, including a liquid pervious member located within the hollow interior portion for assisting in effecting the seal.

16. The osmotic delivery system plug according to claim 13, wherein the outer sealing surface includes at least one rib.

17. The osmotic delivery system plug according to claim 1, wherein the semipermeable body is a unitary, one piece member.

18. An osmotic delivery system comprising:

an enclosure having an opening and a delivery port, the enclosure having an interior holding a liquid swellable osmotic agent and a beneficial agent, the liquid swellable osmotic agent for imbibing liquid from a surrounding environment and causing a delivery rate of said beneficial agent from the enclosure;

a plug having a semipermeable body at least partially positioned in the opening, the semipermeable body including

a cone-shaped, liquid contact surface for contacting a liquid outside of the osmotic delivery system; and

a hollow interior portion having a size selected to obtain a predetermined liquid permeation rate through the semipermeable body, the liquid permeation rate for controlling a delivery rate of a beneficial agent in the osmotic delivery system.

19. The osmotic delivery system according to claim 18, further comprising a separating member positioned in the enclosure between the osmotic agent and the beneficial agent.

20. The osmotic delivery system according to claim 19, wherein the separating member is a movable piston.

21. The osmotic delivery system according to claim 18, wherein the osmotic agent is a tablet.

22. The osmotic delivery system according to claim 18, wherein the plug includes an insert located in the hollow interior portion of the semipermeable body.

23. The osmotic delivery system according to claim 18, wherein the enclosure is substantially impermeable to liquids.

24. The osmotic delivery system according to claim 18, wherein the semipermeable body includes a cone-shaped surface.

25. A method of controlling a delivery rate of a beneficial agent from an osmotic drug delivery system that includes an enclosure having an interior holding a liquid swellable osmotic agent and a beneficial agent, the osmotic drug delivery system also including a plug having a semipermeable body at least partially positioned in an opening of the enclosure, the semipermeable body including a hollow interior portion, the method comprising:

determining a desired delivery rate of the beneficial agent;

selecting a plug having a cone-shaped, liquid contact surface for contacting a liquid outside of the osmotic delivery system and having a hollow interior portion sized to obtain a predetermined liquid permeation rate through the semipermeable body corresponding to the desired delivery rate of the beneficial agent;

positioning the plug at least partially within the opening of the enclosure; and

locating the osmotic drug delivery system in an environment of use.

26. The method according to claim 25, further including:

locating an insert within the hollow interior portion.

27. An osmotic delivery system comprising:

an enclosure having an opening and a delivery port, the enclosure having an interior holding a liquid swellable osmotic agent and a beneficial agent, the liquid swellable osmotic agent for imbibing liquid from a surrounding environment and causing a delivery rate of the beneficial agent from the enclosure; and

a plug having a semipermeable body, the plug being at least partially positioned in the opening, the semipermeable body having an exposure surface that is immediately exposed to liquids when the osmotic delivery system is located in a liquid environment of use, the exposure surface including a conical surface.

28. The osmotic delivery system according to claim 27, wherein the semipermeable body includes a cylindrical portion.

29. The osmotic delivery system according to claim 27, wherein a vertex of the conical surface faces away from the osmotic agent.

30. The osmotic delivery system according to claim 27, wherein the semipermeable body includes ribs for effecting a seal between the enclosure and the semipermeable body.

31. The osmotic delivery system according to claim 27, wherein the semipermeable body includes a hollow interior portion having a size selected to obtain a predetermined liquid permeation rate through the semipermeable body, the liquid permeation rate for controlling the delivery rate of the beneficial agent in the osmotic delivery system.

32. The osmotic delivery system according to claim 31, further comprising:

a porous insert located in the hollow interior portion.