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Publication Number
US-10071199-B2
Publication Date
2018-09-11
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 describes a multi-stage biodegradable drug delivery platform for subcutaneous tissue. The platform includes a body of a first biodegradable material that includes a skin penetrating pointed end, where the body and skin penetrating pointed end are configured to penetrate the skin of a mammal and be lodged in subcutaneous tissue. The body is at least partially hollow to define a primary cavity, and a first therapeutic agent dosage is carried in the primary cavity and disposed outside a shell.
Within the body, a shell defines a secondary cavity and comprises a second biodegradable material. The first therapeutic agent dosage is disposed outside the shell and is releasable within the mammal by in vivo biodegradation of the body after a first time period. The second therapeutic agent dosage is disposed within the secondary cavity of the shell and is releasable within the mammal by in vivo biodegradation of the shell after a second time period subsequent to release of the first dosage.
The platform controls release timing using biodegradable material selection and shell geometry. The shell has a wall thickness in the range of about 1 to about 20 thousandths of an inch, and in one configuration about 1 to about 10 thousandths of an inch, with specified shell weights. Additional described embodiments extend the platform to a three-stage configuration with a tertiary cavity for a third therapeutic agent dosage released after a third time period following release of the first therapeutic agent.
The described examples associate the staged release behavior with vaccine regimens and booster schedules. Examples of therapeutic agent types include vaccines for human and bovine applications, with listed vaccine types and scheduling examples tied to the multi-stage biodegradable platform.
Claims Coverage
The partial document contains two independent claims. Across the independent claims, the coverage is centered on sequential, in vivo biodegradation-controlled release of a first and a second therapeutic agent dosage, with a broader description also including a three-stage configuration.
Sequential biodegradable release from primary body and secondary shell
A multi-stage biodegradable drug delivery platform where a body with a primary cavity biodegrades in vivo over a first time period to release a first therapeutic agent dosage, and a shell with a secondary cavity biodegrades in vivo after a second time period to release a second therapeutic agent dosage after the first therapeutic dosage.
Skin-penetrating pointed body lodged subcutaneously by finger-applied mechanical force
A platform comprising a body having a skin penetrating pointed end configured to penetrate the skin of a mammal and be lodged in subcutaneous tissue by application of a mechanical force on the body applied by a user's fingers, with the body being at least partially hollow to define the primary cavity.
Shell thickness and weight parameters for the secondary cavity
The shell has a wall thickness of about 1 to about 20 thousandths of an inch and a weight of about 90 mg to about 150 mg, with the shell disposed within the body and comprising a second biodegradable material defining the secondary cavity.
Magnesium alloy shell with defined wall thickness and weight
A platform where the secondary cavity is defined by a shell comprising a magnesium alloy comprising magnesium and at least one of zinc, manganese, aluminum, calcium, lithium, zirconium, or yttrium, with the shell having a first wall thickness of from about 1 to about 10 thousandths of an inch and a weight of about 93 mg to about 141 mg.
Overall, the independent claim coverage is directed to a finger-applied, skin-penetrating, subcutaneously lodged biodegradable device having a primary cavity and an inner secondary cavity. The device releases a first therapeutic agent dosage after biodegradation of the body over a first time period, and then releases a second therapeutic agent dosage after biodegradation of the shell over a second time period subsequent to release of the first.
Stated Advantages
Controls release timing using biodegradable material selection and shell geometry.
Provides stage-ordered release.
Documented Applications
Vaccine regimens and booster schedules.
Vaccines for human applications.
Vaccines for bovine applications.
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