Osmotic device with delayed activation of drug delivery and complete drug release

• US 5,800,422 A
• Filed: 08/08/1996
• Issued: 09/01/1998
• Est. Priority Date: 06/02/1995
• Status: Expired due to Term

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Dealey, Michael H., Yum, Si-Hong A., Wong, Patrick S.-L., Hamel, Lawrence G., Dong, Liang C.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/700,323
• Time in Patent Office: 754 Days
• Field of Search: 604/891.1, 604/892.1, 424/422-424, 424/473, 424/430, 424/451, 424/453, 424/462, 424/463
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084

Abstract

The present invention is directed to a fluid-imbibing drug delivery device which is useful for the initial delayed delivery of an active agent formulation to a fluid environment of use, the initial delay period to startup or activation of the device being of a predetermined length of time. The delivery of the agent formulation from the dispensing device is continued until essentially all of the active agent formulation is delivered as a result of the expansion of an expansion agent in the active agent delivery chamber.

Claims

1. A fluid-imbibing delivery device for dispensing essentially all of an active agent formulation to a fluid environment of use after an initial, preset delay of startup of delivery, the device comprising:

(a) a first housing and a second housing, the first and second housings being in reversibly sliding telescoping arrangement with each other, the second housing having an open end and a closed end and being semipermeable;

(b) said first housing having an open end and a closed end, said open end of said first housing being slidably received in said open end of said second housing, and said first housing containing an active agent formulation located adjacent its open end and a biologically inert first expansion agent devoid of active agent formulation located adjacent its closed end, said active agent formulation and said first expansion agent being contained within said first housing; and

(c) said second housing containing a second expansion agent, wherein said second expansion agent upon imbibing fluid operates to separate said first and second housings and said first expansion agent upon imbibing fluid operates to dispense essentially all of said active agent formulation from said first housing.

2. The device of claim 1 wherein the first housing is impermeable.

3. The device of claim 1 wherein the first and second expansion agents are selected from the group consisting of osmagents, osmopolymers and mixtures thereof.

4. The device of claim 1 comprising a piston disposed between said second expansion agent and said active agent formulation.

5. The device of claim 1 wherein the active agent formulation comprises progesterone.

6. The device of claim 1 wherein the active agent formulation comprises human growth hormone.

7. The device of claim 1 wherein the active agent formulation is selected from the group consisting of liquid, solid, semi-solid, thermo-responsive formulations, and mixtures thereof.

8. The device of claim 1 further comprising a third housing surrounding said first and second housings.

9. The device of claim 1 that further comprises an enteric coating.

10. A fluid-imbibing delivery device for dispensing essentially all of an active agent formulation to a fluid environment of use after an initial, preset delay of startup of delivery, the device comprising:

(a) a first housing and a second housing, the first and second housings being in reversibly sliding telescoping arrangement with each other, the second housing having an open end and a closed end and being semipermeable;

(b) said first housing having an open end, and a closed end, said open end of said first housing being slidably received in said open end of said second housing, and said first housing containing an active agent formulation located adjacent its open end and a biologically inert first expansion agent devoid of active agent formulation located adjacent its closed end, said active agent formulation and said first expansion agent being contained within said first housing;

(c) said second housing containing a second expansion agent; and

(d) a third housing containing a second active agent formulation comprising a second active agent, said third housing concentrically surrounding said first and second housings and being adapted to release the active agent formulation when placed in the environment of use and expose the second housing to a fluid environment;

wherein said second expansion agent upon imbibing fluid operates to separate said first and second housings and said first expansion agent upon imbibing fluid operates to dispense essentially all of said active agent formulation from said first housing.

11. The device of claim 10 wherein the first and second active agents are different.

12. The device of claim 10 wherein the first and second active agents are the same.

13. The device of claim 12 wherein the first and second active agents are progesterone.

14. The device of claim 10 wherein the first housing is impermeable.

15. The device of claim 10 that further comprises an enteric coating.

16. The device of claim 10 comprising a piston disposed between said second expansion agent and said active agent formulation.