Drug delivery device with minimal residual drug retention

• US 5,902,605 A
• Filed: 04/18/1997
• Issued: 05/11/1999
• Est. Priority Date: 04/18/1996
• Status: Expired due to Term

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Yum, Si-Hong, Wong, Patrick S.-L., Dong, Liang C., Pollock, Crystal
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Seidleck, Brian K.
• Application Number:
  US08/851,525
• Time in Patent Office: 753 Days
• Field of Search: 424/451, 424/463, 424/473, 424/438, 424/453, 424/462, 604/892.1, 604/890.1
• US Class Current: 424/453
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

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 fluid inhibition into a fluid flow path in the housing of the device and the expansion of an expansion agent in the active agent delivery chamber.

Claims

1. A fluid-imbibing delivery device for dispensing an active agent formulation to a fluid environment of use after an initial, preset delay of startup of delivery, the device comprising a housing and a closure for the housing, the housing containing an active agent formulation comprising at least one active agent and a first expansion agent, the housing and the active agent formulation being configured to provide a fluid flow path between the interior of the housing and the active agent formulation, and the closure comprising a second expansion agent.

2. The device of claim 1 wherein the housing is an impermeable housing and the closure comprises a semipermeable housing in reversibly sliding telescoping relation with the impermeable housing.

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 partition 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 closure comprises a plug in said housing.

8. The device of claim 1 wherein said housing contains a second active agent formulation.

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

10. The device of claim 1, wherein the first housing has an interior cross-sectional area and the fluid flow path occupies 5-75% of the interior cross-sectional area of the first housing.

11. In a fluid-imbibing delivery device for dispensing an active agent formulation to a fluid environment of use after an initial, preset delay of startup of delivery, the device comprising a housing having a closed end and an open end, the housing containing an active agent formulation comprising at least one active agent and an expansion agent, and a plug sealing the open end of the housing;

the improvement comprising a fluid flow path between the active agent formulation and the interior of the housing.

12. The device of claim 11 that further comprises an enteric coating.

13. The device of claim 11, wherein the housing has an interior cross-sectional area and the fluid flow path occupies 5-75% of the interior cross-sectional area of the housing.

14. The device of claim 11, wherein the plug comprises a second expansion agent.

15. In a fluid-imbibing delivery device for dispensing an active agent formulation to a fluid environment of use after an initial, preset delay of startup of delivery, the device comprising a first impermeable housing and a second semipermeable housing, the first and second housings being in reversibly sliding telescoping arrangement with each other, the first housing containing an active agent formulation comprising at least one active agent and a first expansion agent, and the second housing containing a second expansion agent;

the improvement comprising a fluid flow path between the active agent formulation and the interior of the first housing.

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

17. The device of claim 15, wherein the first housing has an interior cross-sectional area and the fluid flow path occupies 5-75% of the interior cross-sectional area of the first housing.