Osmotic pump with means for dissipating internal pressure

• US 7,207,982 B2
• Filed: 03/31/2004
• Issued: 04/24/2007
• Est. Priority Date: 03/31/2003
• Status: Active Grant

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Peery, John R., Davis, Craig R., Dionne, Keith E., Mosbauer, Robert
• Primary Examiner(s): Kennedy; Sharon E.
• Application Number:
  US10/814,801
• Publication Number:
  US 20050070884A1
• Time in Patent Office: 1,119 Days
• Field of Search: 424/473, 424/422, 424/423, 424/438, 604/890.1, 604/892.1
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

The present invention includes an osmotic pump that includes a means for venting an osmotic composition included in the pump before the internal pressure of the pump has the opportunity to build to such an extent that the pump is structurally compromised, such as when one or more components of the pump are physically separated. The means for venting osmotic material included in an osmotic pump according to the present invention includes a vent that allows the material included in the osmotic composition of the pump to dissipate into an environment of operation at a rate that results in dissipation of the pressure created within the osmotic pump and a reduced potential for subject discomfort or irritation.

Claims

1. An osmotic pump for providing sustained delivery of a beneficial agent, comprising:

a reservoir for holding the beneficial agent and an osmotic agent;

at least one wall defining a boundary of the reservoir;

at least one vent formed through the at least one wall; and

a semipermeable membrane positioned to seal the at least one vent, the semipermeable membrane being capable of displacement relative to the reservoir when a threshold pressure in the osmotic pump is reached, wherein the at least one vent is exposed to the osmotic agent and at least a portion of the osmotic agent is released from the reservoir when the semipermeable membrane is displaced relative to the reservoir.

2. The osmotic pump of claim 1, wherein the at least one vent is sized to increase an exposed surface area of the semipermeable membrane by less than 1%.

3. The osmotic pump of claim 1, wherein the at least one vent comprises an annular orifice having a diameter of less than 0.01 inches.

4. The osmotic pump of claim 1, wherein the at least one vent is sealed from an environment of operation by a water impermeable material that is readily expelled as the at least one vent is exposed to the osmotic agent.

5. The osmotic pump of claim 4, wherein the water impermeable material comprises a wax or an oil.

6. The osmotic pump of claim 1, wherein the semipermeable membrane is friction fit within the reservoir.

7. The osmotic pump of claim 1, wherein the semipermeable membrane is configured for progressive displacement relative to the reservoir when a threshold pressure in the osmotic pump is reached.

8. The osmotic pump of claim 1, wherein the semipermeable membrane is configured as a plug with multiple retaining rings.

9. The osmotic pump of claim 1, wherein the reservoir is made of a non-bioerodible material.

10. The osmotic pump of claim 1, wherein the osmotic agent comprises an osmotic tablet.

11. The osmotic pump of claim 1, wherein the osmotic agent comprises an osmagent, an osmopolymer, or mixtures thereof.

12. The osmotic pump of claim 1, further comprising a filler distributed within the reservoir and around the osmotic agent.

13. The osmotic pump of claim 1, further comprising a movable piston located in the reservoir and between the beneficial agent and the osmotic agent.

14. The osmotic pump of claim 13, wherein the movable piston is formed of a noncompressible material.

15. The osmotic pump of claim 1, wherein the beneficial agent is selected from the group consisting of medicaments, vitamins, nutrients, biocides, sterilization agents, food supplements, sex sterilants, fertility inhibitors, fertility promoters, and combinations thereof.

16. The osmotic pump of claim 1, wherein the beneficial agent is formulated as a slurry, a suspension, or a solution.

17. An implantable osmotic pump for providing sustained delivery of a beneficial agent, comprising:

a reservoir for holding the beneficial agent and an osmotic agent;

a semipermeable membrane formulated to be permeable to passage of external liquids and being capable of displacement relative to the reservoir when a threshold pressure in the osmotic pump is reached; and

a means for venting the osmotic agent out of the reservoir upon displacement of the semipermeable membrane.

18. The implantable osmotic pump of claim 17, wherein the means for venting the osmotic agent comprises a vent formed through a wall that defines a boundary of the reservoir.

19. The implantable osmotic pump of claim 17, wherein the means for venting the osmotic agent comprises a plurality of vents formed through one or more walls that define boundaries of the reservoir.

20. An osmotic pump for providing sustained delivery of a beneficial agent, comprising:

a reservoir for holding the beneficial agent and an osmotic agent;

at least one wall defining a boundary of the reservoir;

at least one vent formed through the at least one wall; and

a means for removably sealing the at least one vent, the sealing means being capable of displacement relative to the reservoir when a threshold pressure in the osmotic pump is reached to expose the osmotic agent and release at least a portion of the osmotic agent from the reservoir.

21. The osmotic pump of claim 20, wherein the sealing means comprises a semipermeable membrane.

22. The osmotic pump of claim 20, wherein the sealing means comprises a semipermeable membrane that is friction fit within the reservoir.

23. The osmotic pump of claim 20, wherein the sealing means comprises a semipermeable membrane that is configured for progressive displacement relative to the reservoir when a threshold pressure in the osmotic pump is reached.

24. The osmotic pump of claim 20, wherein the sealing means comprises a semipermeable membrane that is configured as a plug with multiple retaining rings.