Osmotic delivery system with early zero order push power engine

• US 7,074,423 B2
• Filed: 06/17/2003
• Issued: 07/11/2006
• Est. Priority Date: 06/17/2002
• Status: Expired due to Fees

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Fereira, Pamela J., Berry, Stephen A.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/463,300
• Publication Number:
  US 20040097906A1
• Time in Patent Office: 1,120 Days
• Field of Search: 604/890.1, 604/892.1, 424422-425
• US Class Current: 424/423
• 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: 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 an osmotic engine useful in an osmotic delivery system for delivery of a beneficial agent in a controlled manner over a preselected administration period. By including a flowable engine comprising at least one osmotic agent and at least one fluid vehicle, the resulting osmotic engine reaches a zero order push power or push rate quickly and provides steady delivery of the beneficial agent.

Claims

1. An osmotic engine useful in an osmotic device for delivering a beneficial agent formulation, comprising:

a flowable composition that increases in size upon imbibing fluid from a fluid environment through a semipermeable membrane in the osmotic device, the flowable composition comprising a viscous, fluid suspension vehicle with limited osmotic power and at least one particulate osmotic agent suspended in the viscous, fluid suspension vehicle.

2. The osmotic engine of claim 1 wherein the vehicle has low infiltration activity in the semipermeable membrane.

3. The osmotic engine of claim 1, wherein the vehicle is polysorbate or soybean oil.

4. The osmotic engine of claim 1, wherein the at least one osmotic agent is sodium chloride.

5. The osmotic engine of claim 1, further comprising a thickening agent.

6. The osmotic engine of claim 5, wherein the thickening agent is a polymer.

7. The osmotic engine of claim 6, wherein the polymer is present as 1 to 2% W/W.

8. An osmotic device for delivering a beneficial agent formulation, comprising:

(a) a wall comprising in part a semipermeable membrane that allows fluid to pass through the membrane from a fluid environment;

(b) a reservoir to store the beneficial agent formulation, the reservoir being inside the wall and having a passageway connecting the fluid environment with an interior of the reservoir; and

(c) a viscous osmotic engine inside the wall and in contact with the semipermeable membrane, the engine being a flowable composition of at least one particulate osmotic agent suspended in a fluid suspension vehicle that has limited osmotic power;

wherein the engine increases in size upon imbibing fluid from the fluid environment through the semipermeable membrane, and the increase in size creates a pressure on the reservoir containing the beneficial agent formulation so as to force the beneficial agent formulation to pass through the passageway outward to the fluid environment.

9. The osmotic device of claim 8, wherein the vehicle has low infiltration activity in the semipermeable membrane.

10. The osmotic device of claim 8, wherein the vehicle is polysorbate or soybean oil.

11. The osmotic device of claim 8, wherein the at least one osmotic agent is sodium chloride.

12. The osmotic device of claim 8, wherein the viscous osmotic engine further comprises a thickening agent.

13. The osmotic device of claim 12, wherein the thickening agent is a polymer.

14. A method for delivering a beneficial agent formulation into a fluid environment of use, comprising:

(a) placing in the fluid environment an osmotic device, the osmotic device comprising;

(1) a wall comprising at least in part a semipermeable membrane that allows water to pass through the membrane from the fluid environment;

(2) a reservoir to store the beneficial agent formulation, the reservoir being inside the wall and having a passageway connecting the fluid environment with an interior of the reservoir; and

(3) an osmotic engine, the engine being a flowable composition prepared by mixing at least one particulate osmotic agent and a fluid suspension vehicle with limited osmotic power to form a viscous flowable compositon and packed into a compartment inside the wall; and

(b) allowing the osomotic engine to imbibe from the fluid environment through the semipermeable membrane and create a pressure on the reservoir containing the beneficial agent formulation so as to force the beneficial agent formulation to pass through the passageway outward to the fluid environment.

15. The method of claim 14, wherein the vehicle has low infiltration activity in the semipermeable membrane.

16. The method of claim 14, wherein the vehicle is polysorbate or soybean oil.

17. The method of claim 14, wherein the at least one osmotic agent is sodium chloride.

18. The methof of claim 14, wherein the engine further comprises a thickening agent.

19. The method of claim 18, wherein the thickening agent is a polymer.