Drug delivery device
Inventors
Mendelsohn, Adam D. • Fischer, Kathleen E. • Yoshie, Tomoyuki • Roorda, Wouter
Assignees
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Publication Number
US-11931453-B2
Publication Date
2024-03-19
Expiration Date
Abstract
Embodiments of the invention include devices, compositions and methods for the controlled release of therapeutic substances, such as drugs. Control over the rate of release of the therapeutic substances from the devices is achieved by the use of nanoporous membranes in which the pore size is matched to the molecular diameter of the therapeutic substances. Some embodiments of the invention achieve zero-order release by the use of membranes with a pore diameter that is more than five times the Stokes' diameter of the therapeutic substance released.
Core Innovation
The disclosed invention provides an implantable drug delivery device and a method for non-Fickian release of a therapeutic agent. The device is implantable via a capsule suitable for implantation and includes a reservoir encapsulated by the capsule that is suitable for containing a pharmaceutically acceptable formulation of the therapeutic agent.
Non-Fickian release is enabled by at least one nanoporous membrane in fluid contact with the reservoir. The nanoporous membrane comprises nanopores whose diameters are matched to the therapeutic agent by a specified relationship to the therapeutic agent’s molecular diameter, with nanopore diameters described as at least 6 times greater to about 19 times greater than the molecular diameter of the therapeutic agent.
The therapeutic agent is described as exenatide, and the scope includes peptides and proteins. The disclosure also addresses pore size distribution concepts, including mono/polydispersity and bimodal examples, and describes non-Fickian release with near zero-order behavior for substantial periods when nanopore sizes are selected relative to exenatide’s molecular diameter.
Claims Coverage
The partial content identifies one independent claim (clm-00001) with three main inventive elements: an implantable capsule/reservoir device for exenatide, a nanoporous membrane with nanopore diameters specified relative to exenatide’s molecular diameter, and a method step of placing the device in an aqueous environment to allow non-Fickian release.
Non-Fickian release from an implantable capsule and reservoir device for exenatide
A method for non-Fickian release of a therapeutic agent from an implantable device, the method comprising providing the device containing the therapeutic agent, wherein the therapeutic agent is exenatide; the device comprising a capsule suitable for implantation and a reservoir encapsulated by the capsule, the reservoir suitable for containing a pharmaceutically acceptable formulation of the therapeutic agent; and placing the device in an aqueous environment and allowing the non-Fickian release of the therapeutic agent.
Nanopore diameter matched to molecular diameter of exenatide to produce non-Fickian release
The device further comprises at least one nanoporous membrane in fluid contact with the reservoir, wherein the nanoporous membrane comprises nanopores, wherein the nanopores have diameters of at least 6 times greater to about 19 times greater than the molecular diameter of the therapeutic agent.
Overall claim coverage centers on achieving non-Fickian release from an implantable capsule/reservoir device for exenatide by using nanoporous membranes with nanopore diameters specified as at least 6 times greater to about 19 times greater than the therapeutic agent’s molecular diameter, followed by placing the device in an aqueous environment to allow release.
Stated Advantages
Allows non-Fickian release of the therapeutic agent from an implantable device.
Enables near zero-order release for substantial periods when nanopore sizes are selected relative to the therapeutic agent’s molecular diameter.
Reports therapeutic-agent stability with HPLC purity and no irreversible aggregates by SDS-PAGE.
Documented Applications
Non-Fickian release delivery of exenatide from an implantable device, including application to Type 2 diabetes.
Subcutaneous implantation/use in a physiological environment.
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