Osmotic delivery systems and piston assemblies for use therein
First Claim
1. A method of treating diabetes in a subject in need of such treatment, comprising administering an osmotic delivery system loaded with a suspension formulation comprising an active agent to the subject, wherein the osmotic delivery system comprises:
- a reservoir comprising an interior wall defining a lumen that contains the suspension formulation and an osmotic agent formulation;
a piston assembly positioned in the lumen to isolate the suspension formulation from the osmotic agent formulation, wherein the piston assembly comprises;
a columnar body that has a core made of a polymeric material comprising an ultra-high molecular weight polyethylene,a rim at a distal end thereof for engaging and sealing against the interior wall of the reservoir, anda spring retained at the distal end for biasing the rim against the wall of the reservoir;
the suspension formulation comprises a suspension vehicle comprising one or more organic solvents selected from the group consisting of benzyl benzoate and benzyl alcohol;
the suspension formulation comprises less than 9.0 μ
g/mL of non-volatile leachates produced by the piston assembly and resulting from an interaction between the suspension formulation and the piston assembly; and
the active agent is exendin-4.
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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.
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Citations
12 Claims
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1. A method of treating diabetes in a subject in need of such treatment, comprising administering an osmotic delivery system loaded with a suspension formulation comprising an active agent to the subject, wherein the osmotic delivery system comprises:
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a reservoir comprising an interior wall defining a lumen that contains the suspension formulation and an osmotic agent formulation; a piston assembly positioned in the lumen to isolate the suspension formulation from the osmotic agent formulation, wherein the piston assembly comprises; a columnar body that has a core made of a polymeric material comprising an ultra-high molecular weight polyethylene, 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; the suspension formulation comprises a suspension vehicle comprising one or more organic solvents selected from the group consisting of benzyl benzoate and benzyl alcohol; the suspension formulation comprises less than 9.0 μ
g/mL of non-volatile leachates produced by the piston assembly and resulting from an interaction between the suspension formulation and the piston assembly; andthe active agent is exendin-4. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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Specification