Osmotic device with high drug loading and delayed activation of drug delivery

• US 5,817,335 A
• Filed: 05/26/1995
• Issued: 10/06/1998
• Est. Priority Date: 05/26/1995
• Status: Expired due to Term

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wright, Jeri D., Ferrari, Vincent J., Wong, Patrick S.-L., Dong, Liang C., Larsen, Steven D.
• Primary Examiner(s): Clardy, S. Mark
• Assistant Examiner(s): Harrison, Robert H.
• Application Number:
  US08/451,647
• Time in Patent Office: 1,229 Days
• Field of Search: 424/453, 424/473, 424/451, 514/962, 604/892.1
• 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 being of a predetermined length of time. The dispensing device is formed of a first and second housing that are in reversibly sliding telescoping arrangement with each other. The first housing contains the active agent formulation and has an aspect ratio less than 1. The housings are preferably. ovoloid in shape.

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 and a second housing, the first and second housings having an open end and a closed end, the first and second housings being releasably joined adjacent their open ends, the second housing being semipermeable;

(b) an active agent formulation comprising at least one active agent within said first housing; and

(c) means associated with said first and second housings for separating said first and second housings after an initial time period;

wherein the device is dimensioned such that the ratio of the height to the long axis is less than one.

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

3. The device of claim 1 wherein said separating means comprises an expansion agent selected from the group consisting of osmagents, osmopolymers and mixtures thereof within the second housing.

4. The device of claim 3, further comprising a piston disposed between said expansion agent and said active agent formulation.

5. The delivery device of claim 1, wherein the housings are ovoloid in shape.

6. The delivery 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.

7. The delivery device of claim 1, wherein at least a portion of the external wall of the first housing is ridged.

8. The delivery device of claim 4, wherein the second housing further comprises two posts and wherein the piston comprises a push plate with two holes for receiving the posts therethrough.

9. The delivery device of claim 8, wherein the first housing further comprises two receptacles, each of said receptacles designed to concentrically surround each of said second housing posts.

10. The delivery device of claim 2, wherein the first housing further comprises an impermeable wall that separates the first housing into two sections.

11. The delivery device of claim 10, wherein the impermeable wall bisects the long axis of the first housing.

12. The delivery device of claim 10, wherein each of the two sections of the first housing contains a different active agent formulation.

13. The device of claim 10 wherein each of the two sections of the first housing contains the same active agent.

14. The device of claim 1 which is further dimensioned such that the ratio of the length of the short axis to the length of the long axis is less than one.

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

16. The device of claim 1 wherein the first housing is semipermeable.

17. The device of claim 16 wherein the active agent formulation comprises a soluble osmotic agent.

18. The device of claim 16 wherein the active agent formulation comprises a hydrophilic disintegrating agent.

19. A method for delivering essentially all of an active agent formulation contained in a delivery device to a fluid environment after an initial preset delay of startup of delivery, said method comprising:

(a) placing a fluid-imbibing delivery device into the fluid environment, said device comprising;

(i) a first housing and a second housing, the first and second housings having an open end and a closed end, the first and second housings being releasably joined adjacent their open ends, the second housing being semipermeable;

(ii) an active agent formulation comprising at least one active agent within said first housing;

(iii) means associated with said first and second housings for separating said first and second housings after an initial time period;

wherein the device is dimensioned such that the ratio of the height to the long axis is less than one;

(b) allowing fluid to be imbibed through at least a portion of the second housing thereby separating said first and second housings to expose the active agent formulation to the fluid environment; and

(c) allowing for delivery of essentially all of the active agent formulation to the fluid environment of use.