Osmotic delivery systems and piston assemblies for use therein
First Claim
1. An osmotic delivery system for delivering an active agent formulation to a fluid environment, comprising:
- a reservoir comprising an interior wall defining 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, wherein the piston assembly comprises a columnar body that (i) has a core made of a polymeric material comprising an ultra high molecular weight polyethylene, (ii) produces volatile leachates of less than about 1.4 μ
g/ml when exposed to benzyl benzoate at 40°
C. for at least about 45 days, and (iii) further comprises a rim at a distal end thereof for engaging and sealing against the interior wall of the reservoir, and a spring retained at the distal end for biasing the rim against the wall of the reservoir.
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Accused Products
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.
151 Citations
22 Claims
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1. An osmotic delivery system for delivering an active agent formulation to a fluid environment, comprising:
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a reservoir comprising an interior wall defining 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, wherein the piston assembly comprises a columnar body that (i) has a core made of a polymeric material comprising an ultra high molecular weight polyethylene, (ii) produces volatile leachates of less than about 1.4 μ
g/ml when exposed to benzyl benzoate at 40°
C. for at least about 45 days, and (iii) further comprises a rim at a distal end thereof for engaging and sealing against the interior wall of the reservoir, and a spring retained at the distal end for biasing the rim against the wall of the reservoir. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. An osmotic delivery system for delivering an active agent formulation to a fluid environment, comprising:
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a reservoir having a lumen which contains the active agent formulation and an osmotic agent formulation, wherein the reservoir comprises a titanium alloy; the active agent formulation comprising a suspension formulation comprising (i) a particle formulation comprising interferon, sucrose, methionine, citric acid monohydrate, and sodium citrate, and (ii) a suspension vehicle comprising benzyl benzoate and polyvinylpyrrolidone; the osmotic agent formulation comprising two cylindrical tablets, each tablet comprising sodium chloride salt with cellulosic and povidone binders; a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation, wherein (i) the piston assembly comprises a columnar body having an hour-glass shape constructed and arranged for positioning in the lumen, and (ii) the columnar body having a core made of an ultra-high molecular weight polyethylene that produces volatile leachates of less than about 1.4 μ
g/ml when exposed to benzyl benzoate at 40°
C. for at least about 45 days, further the columnar body comprises a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and a canted coil spring retained at the distal end for biasing the rim against the wall of the reservoir;a semipermeable membrane positioned at a first distal end of the reservoir adjacent the osmotic agent formulation, wherein the semipermeable membrane comprises polyurethane; and a flow modulator positioned at a second distal end of the reservoir adjacent the active agent formulation, wherein the flow modulator comprises polyetheretherketone.
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Specification