Osmotically driven syringe

• US 4,969,884 A
• Filed: 12/28/1988
• Issued: 11/13/1990
• Est. Priority Date: 12/28/1988
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Yum, Su I.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US07/290,971
• Time in Patent Office: 685 Days
• Field of Search: 604/892.1, 604/131, 604/140, 604/141, 604/150, 604/151, 604/156, 604/218, 604/235
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An improved osmotic engine is disclosed. The osmotic engine is adapted to be used with an osmotically driven syringe which can be used to deliver a beneficial agent, such as a drug, at a pre-determined rate over an extended period of time. The osmotic engine has an exterior wall defining a compartment which contains an osmotic solute. The wall comprises a thin permeable and/or microporous material which is permeable to an external fluid such as water but is impermeable to the solute. The wall also has a delivery orifice drilled therethrough. A rigid non-dissolving ring-shaped wall support is provided for maintaining the shape of the engine during use. The wall support also provides a fluid flow path extending from the semipermeable wall portion toward the delivery orifice.

Claims

1. An osmotic engine comprising:

(a) a shaped wall defining a compartment, the compartment containing an osmotically effective solute, at least a portion of the wall being comprised of a material that is permeable to and hydrated by an external fluid and having a sufficient degree of impermeability to the solute to generate an osmotic pressure differential across the wall when the wall is exposed to an external fluid, the wall also having a passageway therethrough connecting the compartment with an exterior environment; and

(b) a rigid non-dissolving wall support for supporting the wall and maintaining the wall shape, the rigid support having at least one open fluid flow path extending from the semipermeable wall portion toward the passageway through the wall,

wherein in operation, a solution of the solute is delivered from the engine by the external fluid being imbibed through the semipermeable wall portion into the osmotic solute-containing compartment to form a solution containing the osmotic solute, the solution being pumped along the open fluid flow path and through the wall passageway to the exterior environment.

2. The osmotic engine of claim 1, wherein the wall support comprises a ring-shaped member.

3. The osmotic engine of claim 2, wherein the ring-shaped member surrounds the osmotic solute-containing compartment.

4. The osmotic engine of claim 2, wherein the fluid flow path comprises a longitudinally extending groove in the ring-shaped member.

5. The osmotic engine of claim 4, wherein the ring-shaped member contains a plurality of longitudinally extending grooves.

6. The osmotic engine of claim 1, wherein the non-dissolving wall support is comprised of a material selected from the group consisting of rigid plastics, metals, ceramics and glasses.

7. The osmotic engine of claim 6, wherein the wall support material has a Youngs modulus of at least about 50,000 psi.

8. The osmotic engine of claim 6, wherein the wall support material has a compressive strength at 10% compression of at least about 20,000 psi.

9. The osmotic engine of claim 1, wherein the wall is comprised entirely of a material that is permeable to and hydrated by the external fluid.

10. The osmotic engine of claim 1, wherein the semipermeable wall portion comprises a membrane selected from the group consisting of semipermeable and microporous membranes.

11. The osmotic engine of claim 10, wherein the semipermeable membrane is comprised of a cellulose ester and a permeability enhancer.

12. The osmotic engine of claim 1, wherein the external fluid comprises water.

13. The osmotic of claim 1, wherein the osmotically effective solute is selected from the group consisting of sodium chloride, potassium chloride, glucose and lactose.

14. The osmotic engine of claim 13, wherein the solute is in the form of a tablet.

15. The osmotic engine of claim 13, wherein the wall support is a ring-shaped member and the solute comprises a tablet which fits within the ring-shaped member.

16. An osmotically driven dispensing device for delivering a beneficial agent to an environment of use, the device comprising:

(a) a syringe having a movable piston, the piston dividing the syringe into a beneficial agent compartment and a driving compartment;

(b) a fluid reservoir; and

(c) an osmotic engine intermediate said reservoir and said driving compartment, said osmotic engine including;

(i) a shaped wall defining a compartment, the compartment containing an osmotically effective solute, at least a portion of the wall being comprised of a material that is permeable to and hydrated by an external fluid and having a sufficient degree of impermeability to the solute to generate an osmotic pressure differential across the wall when the wall is exposed to the fluid reservoir, the wall also having a passageway therethrough connecting the osmotic solute-containing compartment with the driving compartment;

(ii) a rigid non-dissolving wall support for supporting the wall and maintaining the wall shape, the rigid support having at least one open fluid flow path extending from the semipermeable wall portion toward the passageway through the wall;

wherein in operation, a beneficial agent is delivered from the device by fluid from the reservoir being imbibed through the semipermeable wall portion into the osmotic solute-containing compartment to form a solution containing the osmotic solute, the solution being pumped along the open fluid flow path and through the wall passageway into the driving compartment, thereby exerting pressure on the piston to deliver the beneficial agent from the beneficial agent compartment to the environment of use.

17. The device of claim 16, wherein the wall support comprises a ring-shaped member.

18. The device of claim 17, wherein the ring-shaped member surrounds the osmotic solute-containing compartment.

19. The device of claim 17, wherein the fluid flow path comprises a longitudinally extending groove in the ring-shaped member.

20. The device of claim 19, wherein the ring-shaped member contains a plurality of longitudinally extending grooves.

21. The device of claim 16, wherein the non-dissolving wall support is comprised of a material selected from the group consisting of rigid plastics, metals, ceramics and glasses.

22. The device of claim 21, wherein the wall support material has a Youngs modulus of at least about 50,000 psi.

23. The device of claim 21, wherein the wall support material has a compressive strength at 10% compression of at least about 20,000 psi.

24. The device of claim 16, wherein the wall is comprised entirely of a material that is permeable to and hydrated by the external fluid.

25. The device of claim 16, wherein the semipermeable wall material is comprised of a cellulose ester and a permeability enhancer.

26. The device of claim 16, wherein the external fluid comprises water.

27. The device of claim 16, wherein the osmotically effective solute is selected from the group consisting of sodium chloride, potassium chloride, glucose and lactose.

28. The device of claim 27, wherein the solute is in the form of a tablet.

29. The device of claim 27, wherein the wall support is a ring-shaped member and the solute comprises a tablet which fits within the ring-shaped member.

30. The device of claim 16, wherein the osmotic engine provides a fluid-tight seal between the driving compartment and the fluid reservoir.

31. The device of claim 30, wherein the wall support is a ring-shaped member and said member provides a rigid support for maintaining the fluid-tight seal between the driving compartment and the reservoir.