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 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 body constructed and arranged for positioning in the lumen, the body being made of a polymeric material that is resistant to leaching in an organic solvent, and the body further comprising means for engaging and sealing against a wall of the reservoir.
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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.
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Citations
27 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 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 body constructed and arranged for positioning in the lumen, the body being made of a polymeric material that is resistant to leaching in an organic solvent, and the body further comprising means for engaging and sealing against a 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, 22, 23, 24, 25, 27)
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26. 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 omega 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 comprising ultra-high molecular weight polyethylene, further the columnar body having 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