Device and method for sustained release of low water solubility therapeutic agent in solubilizer
Inventors
Crowley, Michael • Goodall, Randy • Hudson, Lee
Assignees
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Publication Number
US-10369340-B2
Publication Date
2019-08-06
Expiration Date
Abstract
Devices and methods for administering a therapeutic agent, including an implantable delivery device. Exemplary embodiments include a reservoir in fluid communication with a channeled member, and a compound including the therapeutic agent and a solubilizer disposed within the reservoir.
Core Innovation
The disclosed invention relates to an implantable device for administering a therapeutic agent with sustained release. The device includes a reservoir and a channeled member in fluid communication with the reservoir, and a compound comprising the therapeutic agent and a solubilizer is disposed within the reservoir and supplied to the channeled member.
The solubilizer comprises an oil, and the channeled member comprises a nanochannel having a dimension in the range of 150-250 nm, enabling delivery from the reservoir through the nanochannel. The disclosed configuration is used to release a therapeutic agent into an area of human or animal anatomy.
The disclosed approach also includes release through an implantable structure configured for substantially constant release over a dosage period. In the described device and method, at least a portion of the therapeutic agent and a portion of the solubilizer comprising the oil are released from the device into the area of human or animal anatomy.
Claims Coverage
Two independent claims are identified: one directed to an implantable device and one directed to a method of administering the therapeutic agent. Across the independent claims, the inventive features are centered on an implantable reservoir with an oil-based solubilizer compound, delivery through a nanochannel with a defined dimension range of 150-250 nm, and release of the therapeutic agent and, in the method claim, a portion of the oil-based solubilizer.
Implantable reservoir with oil-solubilized therapeutic agent
An implantable device comprising a reservoir and a compound comprising the therapeutic agent and a solubilizer disposed within the reservoir in fluid communication with a channeled member, wherein the solubilizer comprises an oil.
Nanochannel delivery with defined dimension range
A channeled member in fluid communication with the reservoir, wherein the channeled member comprises a nanochannel and the nanochannel has a dimension in the range of 150-250 nm.
Method of releasing therapeutic agent and oil-solubilizer into anatomy
A method comprising inserting a device into an area of a human or animal anatomy, wherein the device comprises a reservoir, a channeled member in fluid communication with the reservoir, and a compound comprising the therapeutic agent and a solubilizer disposed within the reservoir and in fluid communication with the channeled member, wherein the solubilizer comprises an oil, the channeled member comprises a nanochannel, and the nanochannel has a dimension in the range of 150-250 nm, and releasing at least a portion of the therapeutic agent and a portion of the solubilizer comprising the oil from the device into the area of the human or animal anatomy.
Claim coverage centers on an implantable reservoir containing an oil-solubilized compound for a therapeutic agent, with delivery through a channeled member comprising a nanochannel having a dimension range of 150-250 nm, and release of the therapeutic agent and a portion of the oil solubilizer into human or animal anatomy.
Stated Advantages
Enables sustained, substantially constant release of a low-water-solubility drug by dissolving the API in an oil-based solubilizer within a reservoir.
Reduces burst effects associated with higher initial release.
Allows steadier reservoir conditions that can relax geometric constraints.
Enables prolonged dosing periods, including at least one week, at least one month, at least six months, and up to about one year.
Achieves steadier plasma drug concentration over the dosing period.
Documented Applications
Administering a therapeutic agent by inserting an implantable device into an area of human or animal anatomy and releasing at least a portion of the therapeutic agent and an oil-based solubilizer portion into that area.
Prolonged testosterone dosing using a device configured for nanochannel-mediated delivery of testosterone, including testosterone esters, salts, and ether forms, with an oil-based solubilizer.
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