Compositions and methods for delivery of hydrophobic active agents
Inventors
Slager, Joram • Swan, Dale G. • DuMez, Darin • Ventura, Joseph • Wadman, Shannon • McGonigle, Joseph Schmidt • Hergenrother, Robert W.
Assignees
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Publication Number
US-11246963-B2
Publication Date
2022-02-15
Expiration Date
Abstract
Disclosed herein is a delivery composition for administering a hydrophobic active agent. In one embodiment, a delivery composition for local administration of a hydrophobic active agent to a tissue or organ of a patient is disclosed. In one embodiment, the delivery composition includes a cationic delivery agent, a therapeutically effective amount of a hydrophobic active agent and a pharmaceutically acceptable aqueous carrier. In one embodiment, the cationic delivery agent includes polyethyleneimine (PEI). In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a vinyl amine polymer. Methods of making the delivery composition, as well as kits and methods of use are also included herein.
Core Innovation
The document describes a drug delivery device and/or drug delivery coating including a substrate, an uncharged hydrophilic polymer layer disposed on the substrate, and a coated therapeutic agent particle layer disposed on the uncharged hydrophilic polymer layer. The uncharged hydrophilic polymer layer comprises a biostable synthetic hydrophilic polymer comprising one or more of acrylic monomers, vinyl monomers, and ether monomers.
The coated therapeutic agent particle layer is configured as an outermost layer of the drug delivery device for direct contact with an in vivo environment. The coated therapeutic agent particles comprise a particulate hydrophobic therapeutic agent and PVP-co-pNVA at a mol fraction range of 20:80 PVP:pNVA to 80:20 PVP:pNVA.
The disclosed device formats include a drug-containing balloon catheter and a medical device having a capsule housing, control circuitry disposed in the capsule housing, and at least one moveable element operably connected to the capsule housing. The moveable element includes a substrate and a coating having the uncharged hydrophilic polymer layer and the coated therapeutic agent particle layer as an outermost layer for direct contact with an in vivo environment.
Claims Coverage
The independent claims include three inventive features centered on the same coating architecture: an uncharged hydrophilic biostable polymer layer made from acrylic, vinyl, or ether monomers; an outermost coated therapeutic agent particle layer; and, in one claim, a capsule housing medical device with control circuitry and a movable element carrying the coating.
Outer hydrophilic biostable polymer layer and coated particle outermost contact
A drug delivery device comprising a substrate, an uncharged hydrophilic polymer layer comprising a biostable synthetic hydrophilic polymer comprising one or more of acrylic monomers, vinyl monomers, and ether monomers, and a coated therapeutic agent particle layer consisting of coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent and PVP-co-pNVA at a mol fraction of 20:80 PVP:pNVA to 80:20 PVP:pNVA, wherein the layer is configured as an outermost layer for direct contact with an in vivo environment.
Uncharged hydrophilic polymer surface and outermost coated therapeutic agent particle coating
A drug delivery coating comprising a polymeric layer with an uncharged hydrophilic surface configured to be disposed on a substrate, the uncharged hydrophilic polymer layer comprising a biostable synthetic hydrophilic polymer comprising one or more of acrylic monomers, vinyl monomers, and ether monomers, and a coated therapeutic agent particle layer disposed on the hydrophilic surface, the coated particles comprising a particulate hydrophobic therapeutic agent core and PVP-co-pNVA at a mol fraction of 20:80 PVP:pNVA to 80:20 PVP:pNVA.
Capsule housing medical device with control circuitry and movable element coating
A medical device comprising a capsule housing, control circuitry disposed in the capsule housing, and at least one moveable element operably connected to the capsule housing, the moveable element comprising a substrate and a coating comprising an uncharged hydrophilic polymer layer and a coated therapeutic agent particle layer with a particulate hydrophobic therapeutic agent and PVP-co-pNVA at a mol fraction of 20:80 PVP:pNVA to 80:20 PVP:pNVA.
Coverage centers on the coating/device structure combining an uncharged hydrophilic biostable polymer layer with an outermost coated therapeutic agent particle layer. The coated particles are defined by a particulate hydrophobic therapeutic agent together with PVP-co-pNVA in the specified mol-fraction range, and the medical device claim further specifies a capsule housing, control circuitry, and a movable element carrying the coating.
Stated Advantages
Not explicitly described in patent.
Documented Applications
A drug-containing balloon catheter.
A medical device having a capsule housing, control circuitry, and at least one moveable element.
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