Sustained delivery of an active agent using an implantable system

• US 6,635,268 B2
• Filed: 03/28/2002
• Issued: 10/21/2003
• Est. Priority Date: 02/02/1996
• Status: Expired due to Term

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Lautenbach, Scott D., Landrau, Felix A., Eckenhoff, James B., Wright, Jeremy C., Dionne, Keith E., Magruder, Judy A., Peery, John R.
• Primary Examiner(s): Spear, James M.
• Application Number:
  US10/108,303
• Publication Number:
  US 20030031714A1
• Time in Patent Office: 572 Days
• Field of Search: 424/422, 424/424, 424/473, 424/423
• US Class Current: 424/422
• CPC Class Codes: A61K 38/09 Luteinising hormone-releasing hormone [LHRH] , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2206/10 Flow characteristics
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.

Claims

1. An implantable device for delivering an active agent to a fluid environment of use for a predetermined administration period of at least 2 months, said device comprising a reservoir and a back-diffusion regulating outlet in mating relationship, wherein a flow path for the active agent comprises a pathway formed between the mating surfaces of the reservoir and the back-diffusion regulating outlet.

2. The device of claim 1 wherein a time to start-up is less than 10% of the predetermined administration period.

3. The device of claim 1 wherein the predetermined administration period is at least 3 months.

4. The device of claim 3 wherein a time to start-up is less than 10% of the predetermined administration period.

5. The device of claim 1 wherein the predetermined administration period is at least 12 months.

6. The device of claim 5 wherein a time to start-up is less than 10% of the predetermined administration period.

7. The device of claim 1 wherein the device maintains at least 70% activity for the predetermined administration period.

8. The device of claim 1 wherein the device maintains at least 70% activity for 14 months.

9. The device of claim 1 wherein the device provides a steady state flow rate of at least 70% of an intended flow rate after start-up.

10. An implantable active agent delivery system for delivering an active agent to a fluid environment of use for a predetermined administration period of at least 2 months, said agent being susceptible to degradation if exposed to the fluid environment of use prior to delivery, said system comprising:

(a) a piston that divides the system into a first and second chamber, the first and second chambers each having an open end;

(b) a water-swellable agent formulation in the first chamber;

(c) an active agent formulation in the second chamber;

(d) a semipermeable plug in the open end of the first chamber; and

(e) a back-diffusion regulating outlet in the open end of the second chamber;

wherein said system effectively seals and isolates the active agent chamber from the environment of use.

11. The system of claim 10 wherein said system expels the active agent through the outlet at a rate corresponding to a rate at which water from the environment flows into the water-swellable agent.

12. The system of claim 10 wherein a time to start-up is less than 10% of the predetermined administration period.

13. The system of claim 10 wherein the predetermined administration period is at least 3 months.

14. The system of claim 13 wherein a time to start-up is less than 10% of the predetermined administration period.

15. The system of claim 10 wherein the predetermined administration period is at least 12 months.

16. The system of claim 15 wherein a time to start-up is less than 10% of the predetermined administration period.

17. The system of claim 10 wherein the system maintains at least 70% activity for the predetermined administration period.

18. The system of claim 10 wherein the system maintains at least 70% activity for 14 months.

19. The system of claim 10 wherein the system provides a steady state flow rate of at least 70% of an intended flow rate after start-up.

20. An implantable active agent delivery system for delivering an active agent to a fluid environment of use at a steady state flow rate of at least 70% of an intended flow rate after start-up, said agent being susceptible to degradation if exposed to the fluid environment of use prior to delivery, said system comprising:

(a) a piston that divides the system into a first and second chamber, the first and second chambers each having an open end;

(b) a water-swellable agent formulation in the first chamber;

(c) an active agent formulation in the second chamber;

(d) a semipermeable plug in the open end of the first chamber; and

(e) a back-diffusion regulating outlet in the open end of the second chamber;

wherein said system effectively seals and isolates the active agent chamber from the environment of use.