Osmotic Delivery Systems and Piston Assemblies for Use Therein

• US 20140378900A1
• Filed: 06/27/2014
• Published: 12/25/2014
• Est. Priority Date: 08/09/2006
• Status: Active Grant

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: Intarcia Therapeutics, Inc.
• Inventors: Alessi, Thomas R., DesJardin, Michael A., Lam, Stan, Lautenbach, Scott D., Zamora, Pauline C.
• Granted Patent: US 10,527,170 B2
• Time in Patent Office: Days
• US Class Current: 604/150
• 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 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: F16J 9/26 characterised by the use of particular materials
• CPC Class Codes: F16J 9/28 of non-metals
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An osmotic delivery system is disclosed for delivering an active agent formulation to a fluid environment. The osmotic delivery system typically comprises a reservoir having a lumen that contains the active agent formulation and an osmotic agent formulation and a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation. The piston assembly typically comprises a body constructed and arranged for positioning in the lumen. The body is typically made of a polymeric material that is, for example, resistant to leaching in an organic solvent. In one embodiment, the body is a columnar body having a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and the piston assembly further comprises a spring retained at the distal end of the columnar body for biasing the rim of the columnar body against the wall of the reservoir.

Claims

1-27. -27. (canceled)

28. A piston assembly for positioning in a lumen of a reservoir of an osmotic delivery system, comprising a columnar body and one or more O-rings, wherein (i) the columnar body and one or more O-rings are constructed and arranged for positioning in the lumen, (ii) the columnar body has a core made of a first material that is an incompressible material, (iii) the columnar body further comprises one or more concentric grooves, and (iv) each groove retains one of the one or more O-rings and each of the one or more O-rings are made of a second material that is an elastomeric material.

29. The piston assembly according to claim 28, wherein the elastomeric material comprises a perfluoroelastomer.

30. The piston assembly according to claim 28, wherein the incompressible material is chosen from an ultra high molecular weight polyethylene and polyaryletherketone.

31. The piston assembly according to claim 30, wherein the polyaryletherketone is chosen from polyetherketone and polyetheretherketone.

32. The piston assembly according to claim 30, wherein the incompressible material produces volatile leachates of less than 1.4 μ

g/mL when exposed to benzyl benzoate at 40°

C. for at least 45 days.

33. The piston assembly according to claim 28, wherein each O-ring engages and maintains a seal against the inner wall of the reservoir.

34. The piston assembly according to claim 33, wherein the piston assembly is movable within the reservoir in response to pressure within the reservoir.

35. The piston assembly according to claim 32, wherein the incompressible material produces volatile leachates of less than 1.4 μ

g/mL when exposed to benzyl benzoate at 40°

C. for about 90 days.

36. The piston assembly according to claim 32, wherein the incompressible material produces volatile leachates of less than 1.4 μ

g/mL when exposed to benzyl benzoate at 40°

C. for longer than 90 days.

37. The piston assembly according to claim 28, wherein the osmotic delivery system is an osmotic delivery system for delivering an active agent formulation to a fluid environment.

38. The piston assembly according to claim 37, wherein the osmotic delivery system further comprises a semipermeable membrane positioned at a first end of the reservoir adjacent an osmotic agent formulation.

39. The piston assembly according to claim 37, wherein the osmotic delivery system further comprises a flow modulator positioned at a second end of the reservoir adjacent the active agent formulation, the flow modulator having an orifice for delivering the active agent formulation to the fluid environment.

40. The piston assembly according to claim 37, wherein the active agent formulation comprises a particle formulation comprising active agent, and a suspension vehicle comprising one or more organic solvent.

41. The piston assembly according to claim 40, wherein the organic solvent is chosen from benzyl benzoate, lauryl lactate, and lauryl alcohol.

42. The piston assembly according to claim 40, wherein the active agent in the particle formulation is chosen from a peptide, a polypeptide, and a protein.

43. The piston assembly according to claim 42, wherein the polypeptide is chosen from glucagon like protein (GLP-1), GLP-1 derivative polypeptides and analog polypeptides, exendin-4, and exendin-4 derivative polypeptides and analog polypeptides.