Solvent/polymer solutions as suspension vehicles
First Claim
1. An implantable osmotic drug delivery device, comprising:
- a reservoir containing a stable, nonaqueous suspension formulation, the suspension formulation comprisinga particle formulation comprising an active agent and an excipient, wherein the active agent comprises a peptide, polypeptide, or protein, and the excipient comprises methionine, anda nonaqueous, single-phase vehicle consisting essentially of about 10% to about 90% (w/w) polyvinylpyrrolidone and about 90% to about 10% (w/w) benzyl benzoate,wherein the vehicle has a viscosity of between approximately 10,000 poise to approximately 20,000 poise measured at 37°
C.;
a semipermeable membrane;
an osmotic engine;
a piston; and
a diffusion moderator.
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Accused Products
Abstract
A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.
137 Citations
16 Claims
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1. An implantable osmotic drug delivery device, comprising:
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a reservoir containing a stable, nonaqueous suspension formulation, the suspension formulation comprising a particle formulation comprising an active agent and an excipient, wherein the active agent comprises a peptide, polypeptide, or protein, and the excipient comprises methionine, and a nonaqueous, single-phase vehicle consisting essentially of about 10% to about 90% (w/w) polyvinylpyrrolidone and about 90% to about 10% (w/w) benzyl benzoate, wherein the vehicle has a viscosity of between approximately 10,000 poise to approximately 20,000 poise measured at 37°
C.;a semipermeable membrane; an osmotic engine; a piston; and a diffusion moderator. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of making an implantable osmotic drug delivery device, the method comprising:
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lubricating a reservoir and a piston with silicon and inserting the piston into the reservoir; dispensing polyethylene glycol into the reservoir and inserting osmotic tablets into the polyethylene glycol in the reservoir, wherein the osmotic tablets are adjacent the piston; inserting a semipermeable membrane into a first end of the reservoir, wherein the semipermeable membrane is adjacent the osmotic tablets; loading a suspension formulation into the reservoir through a second end of the reservoir, wherein the suspension formulation is a nonaqueous suspension formulation comprising a particle formulation comprising an active agent and an excipient, wherein the active agent comprises a peptide, polypeptide, or protein, and the excipient comprises methionine, and a nonaqueous, single-phase vehicle consisting essentially of about 10% to about 90% (w/w) polyvinylpyrrolidone and about 90% to about 10% (w/w) benzyl benzoate, wherein the vehicle has a viscosity of between approximately 10,000 poise to approximately 20,000 poise measured at 37°
C.; andinserting a diffusion moderator into a second end of the reservoir, wherein the diffusion moderator is adjacent the suspension formulation.
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Specification