Long-term delivery device with early startup

• US 5,223,266 A
• Filed: 04/27/1992
• Issued: 06/29/1993
• Est. Priority Date: 01/24/1990
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Burkoth, Terry L., Eckenhoff, James B., Wright, Jeremy C., Carr, John P.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US07/876,734
• Time in Patent Office: 428 Days
• Field of Search: 424/473
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0068 Rumen, e.g. rumen bolus

Abstract

The present invention is directed to an improvement in a delivery device, the device comprising a wall that surrounds an internal lumen or compartment which contains a beneficial agent or medicament formulation, an expandable driving member and an optional density member, and having an a exit means, and wherein the improvement comprises prehydrating the delivery device as a means for advancing the beginning or startup of agent delivery from the delivery system to give earlier release of beneficial agent to the environment of use. An embodiment of the invention concerns a fluid reservoir in contact with the expandable driving member to provide prehydration of the device.

Claims

1. An improved delivery device for delivering a beneficial agent to an environment of use over a prolonged period of time of 23 days or longer, the delivery device comprising:

i) a wall that surrounds an internal compartment;

ii) a beneficial agent formulation in the compartment;

iii) an expandable fluid-activated driving member in the compartment, and

iv) exit means in the wall;

wherein the improvement comprises a prehydration permeant in the delivery device in contact with the expandable driving member, the prehydration permeant being in an amount of from about 0.025 g to 10 g, the amount being greater than 1% of the weight of the expandable driving member, the prehydration permeant being selected from the group consisting of water, distilled water, purified water, a biologically acceptable fluid and a buffer.

2. An improved delivery device according to claim 1, wherein the prehydration permeant is added during manufacture of the delivery device.

3. An improved delivery device according to claim 1, wherein the delivery device comprises from 0.1 g to 3 g of the prehydration permeant.

4. An improved delivery device according to claim 1, wherein the amount of prehydration permeant is about 5% to 40% by weight of the expandable driving member.

5. An improved delivery device according to claim 1, wherein the prehydration permeant is activated between room temperature and 50°

C.

6. An improved delivery device according to claim 1 which further comprises a density element.

7. An improved delivery device according to claim 1, wherein the environment of use is a human.

8. An improved delivery device according to claim 1, wherein the environment of use is an animal.

9. An improved delivery device according to claim 6, wherein the environment of use is a ruminant animal.

10. An improved delivery device according to claim 1 which further comprises a partition layer between the beneficial agent formulation and the expandable driving member.

11. An improved delivery device according to claim 1, wherein the beneficial agent formulation comprises a drug in a thermo-responsive composition.

12. An improved delivery device according to claim 1, wherein the expandable driving member is selected from an osmopolymer, an osmagent, or a mixture of an osmagent in an osmopolymer.

13. An improved delivery device according to claim 11, wherein the drug is ivermectin;

the expandable driving member is selected from an osmopolymer, an osmagent, or a mixture of an osmagent in an osmopolymer; and

the delivery device further comprises a partition layer between the beneficial agent formulation and the expandable driving member and also further comprises a density element.

14. An improved delivery device according to claim 1 which exhibits substantially immediate delivery of the beneficial agent to the environment of use.

15. An improved delivery device for delivering a beneficial agent to an environment of use over a prolonged period of time of 23 days or longer, the delivery device comprising:

i) a wall that surrounds an internal compartment,

ii) a beneficial agent formulation in the compartment,

iii) an expandable fluid-activated driving member in the compartment, and

iv) exit means in the wall;

wherein the improvement comprises a permeant reservoir containing a prehydration permeant in the compartment, the prehydration being in an amount of from about 0.25 g to 10 g, the amount being greater than 1% of the weight of the expandable driving member, the prehydration permeant being selected from the group consisting of water, distilled water, purified water, a biologically acceptable fluid and a buffer.

16. An improved delivery device according to claim 15 wherein the permeant reservoir is comprised of a porous material.

17. An improved delivery device according to claim 15 wherein the device further comprises a partition layer between the beneficial agent formulation and the expandable driving member.

18. An improved delivery device according to claim 15 which further comprises a density element.

19. An improved delivery device according to claim 15 wherein the permeant reservoir is in contacting relation with the expandable driving member.

20. A process for shortening the time to startup of release of a beneficial agent from a long-term delivery device into an environment of use, the delivery device comprising:

i) a wall that surrounds an internal compartment,

ii) a beneficial agent formulation in the compartment,

iii) an expandable fluid-activated driving member in the compartment, and

iv) exit means in the wall;

wherein the process comprises the step of prehydrating the device with a prehydration permeant, where the amount of prehydration permeant is from about 0.025 g to 10 g, the amount being greater than 1% of the weight of the expandable driving member, for providing early beneficial agent release from the device, the prehydration permeant being selected from the group consisting of water, distilled water, purified water, a biologically acceptable fluid and a buffer.

21. A process according to claim 20 wherein the process comprises prehydrating the delivery device with up to 3 g of the prehydration permeant that enters the device.

22. A process according to claim 20 wherein the delivery device is prehydrated by spraying the device with the prehydration permeant, by dipping the device in the prehydration permeant, or by immersing the device in the prehydration permeant.

23. A process according to claim 20 wherein the delivery device is prehydrated by placing the device and the prehydration permeant together in an impermeable package.

24. A process according to claim 20 wherein the delivery device is prehydrated by placing the prehydration permeant into the device and in contact with the expandable driving member at the time of manufacture of the device.

25. A process according to claim 20 the delivery device is prehydrated by placing a permeant reservoir containing the prehydration permeant into the device at the time of manufacture of the device.

26. A process according to claim 20 wherein the prehydration permeant is selected from water, distilled water, purified water, a biologically acceptable fluid, and a buffer.

27. A process according to claim 20 wherein the expandable driving member is selected from an osmopolymer, an osmagent or a mixture of an osmagent in an osmopolymer, and the process comprises internally prehydrating the delivery device with from 0.1 g to 3 g of the prehydration permeant.

28. A process according to claim 20 wherein the expandable driving member is selected from an osmopolymer, an osmagent or a mixture of an osmagent in an osmopolymer, and the process comprises prehydrating the delivery device with the prehydration permeant in an amount of up to 40% of the weight of the expandable driving member.

29. A process according to claim 20 wherein prehydrating the device provides substantially immediate beneficial agent release from the device after the device is placed in the environment of use.

30. A process according to claim 20 wherein the device further comprises a density element.

31. A process according to claim 20 wherein the device further comprises a partition layer between the beneficial agent formulation and the expandable driving member.