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Publication Number
US-10792481-B2
Publication Date
2020-10-06
Expiration Date
Abstract
The invention pertains to implantable medical devices for controlled delivery of therapeutic agents. Some devices according to the invention have a titanium reservoir, and a porous titanium oxide based membrane to control the rate of release of the therapeutic agent. The reservoir contains a formulation of the active agent, and means to promote water uptake into the reservoir upon implantation. In some embodiments the means include a gas with a higher solubility in than air water.
Core Innovation
The invention relates to an implantable drug delivery device that includes a capsule suitable for implantation and a reservoir encapsulated by the capsule. The device further includes at least one nanoporous membrane in fluid contact with the reservoir, and a therapeutic agent contained in the reservoir is hydrated in a body fluid.
To promote hydration of the therapeutic agent in the body fluid, the device contains a quantity of gas within the reservoir. The quantity of gas comprises one or more gases having a solubility in water at a temperature of 37°C and a pressure of 1 atmosphere that is greater than the solubility of air in water at the same temperature and pressure.
The described approach addresses hydration of the therapeutic agent after implantation by using water-soluble gases as a promoter of hydration, in which the reservoir is in fluid communication with the body fluid through the nanoporous membrane. The document further describes implantable device implementations that preserve the gas environment and, optionally, include in-situ gas generation from solid acid and solid salt to form a gas such as CO2.
The disclosed device configuration is applied to extended release drug delivery, with examples including a therapeutic agent that is hydrated in body fluid and release monitoring associated with type 2 diabetes treatment context using exenatide.
Claims Coverage
The independent claim covers an implantable drug delivery device comprising a capsule and reservoir containing a hydrated therapeutic agent and a quantity of gas, where the gas has water solubility at 37°C and 1 atmosphere greater than air in water under the same conditions. Additional claims refine the gas quantity, gas identity, solubility threshold, and delivery structure such as nanoporous membranes configured for extended release, and optionally specify example therapeutic agents such as exenatide.
Hydration-promoting gas with enhanced water solubility at 37°C and 1 atmosphere
An implantable drug delivery device where the therapeutic agent and a quantity of gas are contained within a reservoir, and the quantity of gas comprises one or more gases with a water solubility at 37°C and 1 atmosphere greater than the solubility of air in water at 37°C and 1 atmosphere.
Nanoporous membrane in fluid contact with the reservoir
An implantable drug delivery device including at least one nanoporous membrane in fluid contact with the reservoir holding the therapeutic agent and the quantity of gas.
Extended release using nanoporous membrane
The implantable drug delivery device where the nanoporous membrane is configured to provide extended release of a therapeutic agent.
Hydration gas at specified minimum gas weight fraction
The implantable drug delivery device characterized by a gas quantity that includes at least 10% by weight of one or more water-soluble gases meeting specified solubility conditions at 37°C and 1 atmosphere.
Substantially pure gas satisfying solubility criterion
The implantable drug delivery device where the gas component is substantially pure and has water solubility greater than 22 mg/L at 37°C and 1 atmosphere.
Selected water-soluble gases satisfying solubility criterion
The implantable drug delivery device including at least one gas selected from CO2, N2O, and Ar having water solubility greater than 22 mg/L at 37°C and 1 atmosphere.
Therapeutic agent as exenatide
The implantable drug delivery device characterized by using the peptide exenatide.
Overall, the claim coverage is anchored on containing a therapeutic agent and a hydration-promoting quantity of gas within an implantable capsule reservoir, where the gas has water solubility at 37°C and 1 atmosphere greater than air in water. Additional coverage refines the gas to include minimum weight fraction and/or substantially pure and/or specific gases (CO2, N2O, Ar) meeting a solubility threshold, and specifies nanoporous membrane arrangements for extended release as well as example use with exenatide.
Stated Advantages
Promotes hydration of a therapeutic agent in a body fluid using a quantity of gas whose water solubility at 37°C and 1 atmosphere is greater than air in water.
Documented Applications
Extended release implantable drug delivery for a therapeutic agent hydrated in body fluid, with example context for type 2 diabetes treatment using exenatide.
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