Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10130760-B2
Publication Date
2018-11-20
Expiration Date
Abstract
Embodiments of the invention provide multi-stage biodegradable drug delivery platforms and methods for the subcutaneous delivery of therapeutic agents (TA). Embodiments of the platform may be configured to subcutaneously deliver a first dose of a first TA which is absorbed into the body and/or blood stream (BBS) to produce a first therapeutic effect for a first selectable time period (STP), and subsequently after a second STP, deliver a second dose of a second TA which is absorbed into the BBS to produce a second therapeutic effect for a third STP. An embodiment of the platform may comprise a body having a tissue-penetrating end, a primary cavity having a first TA dose and a shell having a secondary cavity having a second TA dose. The first TA dose is released after the first STP and the second TA dose is released after the second STP by biodegradation of the shell.
Core Innovation
The invention relates to a method for multi-stage drug delivery in which a drug delivery platform is lodged beneath the skin of a patient in a muscular tissue layer. The platform contains at least a first and second dosage of therapeutic agent, with the first dosage contained in a first biodegradable structure and the second dosage contained in a second biodegradable structure positioned inside the first structure. The first biodegradable structure comprises a core body having a tissue penetrating end.
The second biodegradable structure comprises a shell having a shell wall with a thickness of about 1 to about 20 thousandths of an inch and a weight of about 90 mg to about 150 mg. The second biodegradable structure is configured to have a longer period of in vivo biodegradation for release of its therapeutic dosage than the first structure. The method biodegrades the first structure in vivo over a first period of time until the first structure’s integrity degrades sufficiently to release the first therapeutic agent dosage into the tissue.
After releasing the first therapeutic agent dosage, the method biodegrades the second structure in vivo over a second period of time until the second structure’s integrity degrades sufficiently to release the second therapeutic agent dosage, with the entirety of the platform biodegraded. A vaccine variant applies the same nested, multi-stage biodegradable release concept to a multi dose vaccine regimen in which all doses are inserted at the same time and are released sequentially into tissue as the nested structures biodegrade.
Claims Coverage
The partial content includes two independent claims. Each independent claim centers on a nested, multi-stage biodegradable platform that releases a first dosage after a first in vivo biodegradation period and releases a second dosage after a second, longer in vivo biodegradation period, with the platform biodegraded in its entirety.
Nested multi-stage biodegradable drug delivery platform in muscular tissue
Lodging a drug delivery platform beneath the skin of a patient in a muscular tissue layer containing at least a first and second dosage of therapeutic agent, where the first dosage is contained in a first biodegradable structure with a core body having a tissue penetrating end and the second dosage is contained in a second biodegradable structure positioned inside the first structure.
Biodegradation-timed staged release of first and second therapeutic dosages
Biodegrading the first structure in vivo over a first period of time until its integrity degrades sufficiently to release the first therapeutic agent dosage into the tissue, then biodegrading the second structure in vivo over a second period of time until its integrity degrades sufficiently to release the second therapeutic agent dosage after complete release of the first therapeutic agent dosage, wherein the entirety of the platform is biodegraded.
Second structure shell wall thickness and longer in vivo biodegradation period
Configuring the second biodegradable structure to have a longer period of in vivo biodegradation for release of its therapeutic dosage than the first structure, with the second structure comprising a shell having a shell wall with a thickness of about 1 to about 20 thousandths of an inch and a weight of about 90 mg to about 150 mg.
Nested multi-dose vaccine regimen platform inserted at the same time
Delivering a multi dose vaccine regimen by lodging a vaccine delivery platform beneath the skin of a patient in a muscular layer, where the platform contains at least a first and second dosage of vaccine, with the first dosage contained in a first biodegradable structure having a core body with a tissue penetrating end and the second dosage contained in a second biodegradable structure positioned inside the first structure.
Magnesium alloy shell with specified thickness/weight and longer biodegradation for vaccine release
Making the second structure comprise a shell having a shell wall thickness of about 1 to about 20 thousandths of an inch and a weight of about 90 mg to about 150 mg, where the shell is comprised of a magnesium alloy comprising magnesium and at least one of zinc, manganese, aluminum, calcium, lithium, zirconium, or yttrium, and is configured to have a longer period of in vivo biodegradation for release of its vaccine dosage than the first structure.
Sequential in vivo biodegradation release into tissue with entire platform biodegraded
Biodegrading the first structure in vivo over a first period of time until its integrity degrades sufficiently to release the first vaccine dosage, then releasing the first vaccine dosage into the tissue, biodegrading the second structure in vivo over a second period of time until its integrity degrades sufficiently to release the second vaccine dosage, wherein the entire platform is biodegraded, and releasing the second vaccine dosage into the tissue after release of the first vaccine dosage.
Across the two independent claims, the main claim coverage is the nested positioning of first and second biodegradable structures within a platform lodged in muscular tissue, with sequential in vivo biodegradation and tissue release timed by having the second structure configured for a longer in vivo biodegradation period than the first; in the vaccine method, the second structure shell is defined as a magnesium alloy with specified thickness and weight.
Stated Advantages
Documented Applications
No documented applications found
Interested in licensing this patent?