Osmotically driven syringe

• US 5,030,216 A
• Filed: 12/15/1989
• Issued: 07/09/1991
• Est. Priority Date: 12/15/1989
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Theeuwes, Felix, Wong, Patrick S. L.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US07/451,476
• Time in Patent Office: 571 Days
• Field of Search: 604/140, 604/141, 604/150, 604/131, 604/151, 604/218, 604/235, 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: 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 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons

Abstract

An implantable osmotically driven syringe is disclosed which can be used to deliver a beneficial agent, such as a drug, at a predetermined rate over an extended period of time. A movable piston divides the syringe into a beneficial agent-containing compartment and a driving compartment. The piston is movable into a position wherein the driving compartment has a volume of essentially zero. The syringe is driven by an osmotic engine which has a shaped wall surrounding, and in contact with, an osmotic solute. The wall is comprised of a semipermeable and/or microporous material which is permeable to the external fluid (e.g., water) but is impermeable to the solute. The engine also has a passageway forming a fluid flow path between the osmotic solute and the driving compartment. A portion of the wall is exposed to a fluid-containing external environment. At least about 30% of the wall which contacts the solute also is exposed to the fluid in the external environment. In operation, water from the external environment is imbided through the semipermeable wall forming a solution of the solvent in the osmotic engine. As fresh incoming fluid from the external environment is imbided by the engine, the solution is pumped through the passageway into the driving compartment. The pumping action drives the piston which causes the beneficial agent to be delivered by the syringe.

Claims

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

a) a syringe having a chamber with a movable piston therein, the piston dividing the chamber into a beneficial agent-containing compartment and a driving compartment, the piston being movable into a position wherein the piston occupies substantially all of the drive compartment;

b) an osmotic engine attached to the syringe adjacent the driving compartment, the engine comprising a shaped wall surrounding, and in contact with, an osmotic solute, the wall having an external surface exposed to a fluid in an external environment, and a passageway providing a fluid flow path between the osmotic solute and the driving compartment, the wall being comprised of a material that is permeable to the external fluid and having a sufficient degree of impermeability to the solute to generate an osmotic pressure differential across the wall when exposed to the external fluid, at least 30% of the wall which is in contact with the osmotic solute also being exposed to the external environment;

wherein in operation, the external fluid is imbibed through the wall into the osmotic engine to form a solution of the osmotic solute, the solution being pumped through the passageway into the driving compartment as fresh fluid is imbibed through the wall, thereby exerting pressure on the piston and forcing the piston to move within the syringe chamber and deliver the beneficial agent from the beneficial agent-containing compartment to the environment of use.

2. The device of claim 1, wherein the osmotic engine comprises a shaped wall surrounding a layer of an osmotically effective solute, the shaped wall also surrounding a layer of a rigid, non-dissolving material, the rigid material providing a rigid support for the shaped wall in order to fixedly attach the osmotic engine to the syringe.

3. The device of claim 2, wherein the passageway extends through both the wall and the rigid, non-dissolving layer to provide a fluid flow path between the osmotic solute and the driving compartment.

4. The device of claim 2, wherein the rigid, non-dissolving layer is comprised of a material selected from the group consisting of rigid plastics, metals, ceramics and glasses.

5. The device of claim 4, wherein the rigid, non-dissolving layer is comprised of micropolyethylene wax.

6. The device of claim 1, wherein the syringe is comprised of plastic.

7. The device of claim 6, wherein the plastic comprises polypropylene.

8. The device of claim 1, wherein the semipermeable wall material is comprised of a cellulose ester.

9. The device of claim 1, wherein the cellulose ester is selected from the group consisting of cellulose acetate and cellulose acetate butyrate.

10. The device of claim 1, wherein the external fluid comprises water.

11. The device of claim 1, wherein the osmotically effective solute is selected from the group consisting of sodium chloride, potassium chloride, glucose, lactose and hydrophilic polymers.

12. The device of claim 1, wherein the osmotic engine is adhered to the syringe.

13. The device of claim 12, wherein the osmotic engine is adhered to the syringe using an acrylic-based adhesive.

14. The device of claim 1, wherein at least 50% of the wall which is in contact with the osmotic solute is also exposed to the external environment.

15. The device of claim 1, wherein substantially all of the wall which is in contact with the osmotic solute is also exposed to the external environment.

16. The device of claim 1, wherein the beneficial agent-containing compartment contains a liquid beneficial agent.

17. The device of claim 1, wherein the beneficial agent-containing compartment has a maximum volume when the volume of the driving compartment is essentially zero.

18. The device of claim 1, wherein the environment of use is within an animal body.