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Publication Number
US-11944780-B2
Publication Date
2024-04-02
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 multi-stage biodegradable subcutaneous drug delivery platform that lodges in a tissue layer beneath skin of a patient and contains at least a first dosage and a second dosage of therapeutic agent. The first dosage is contained in a primary cavity of a first biodegradable structure having a core body, and the second dosage is contained in a secondary cavity of a second biodegradable structure. The second biodegradable structure is contained in the primary cavity of the first biodegradable structure and has a material composition different from the first biodegradable structure.
The second biodegradable structure comprises a shell having a shell wall with a thickness and a weight, and the shell wall material composition is selected to time release of the second dosage to a specified time subsequent to release of the first dosage. The method includes biodegrading the first biodegradable structure in vivo over a first period of time to release the first therapeutic agent dosage into the tissue of the patient. The method further includes biodegrading the second biodegradable structure in vivo over a second period of time and releasing the second dosage into the tissue after release of the first dosage.
The disclosed extensions describe a three-stage biodegradable drug delivery platform with an additional secondary-shell compartment arrangement, including a secondary shell and a tertiary cavity to deliver third and later doses over staggered time periods. The timing of later-dose release is controlled by shell material composition and shell wall thickness, including use of magnesium and magnesium alloys. The disclosure also discusses scheduling concepts such as quiescent periods between releases in relation to booster-dose timing for therapeutic agent delivery.
Claims Coverage
The independent claim covers a sequential, two-dosage in vivo drug delivery method using nested biodegradable structures that biodegrade over different periods to time releases. The inventive features include lodging beneath skin, nested primary/secondary cavities with different biodegradable structures, and composition/thickness-based timing of the second release relative to the first release.
Lodging a nested two-cavity biodegradable platform beneath skin
Lodging a drug delivery platform in a tissue layer beneath skin of a patient, where a first dosage is contained in a primary cavity of a first biodegradable structure and a second dosage is contained in a secondary cavity of a second biodegradable structure contained in the primary cavity.
Different biodegradable structure compositions for staged release timing
Providing the second biodegradable structure with a material composition different from the first biodegradable structure, where the second biodegradable structure comprises a shell having a shell wall.
Shell-wall composition, thickness, and timing of second dosage release after first dosage release
Selecting the shell wall material composition, together with shell wall thickness and weight, to time release of the second dosage to a specified time subsequent to release of the first dosage.
Biodegradation of first structure over a first period releases the first dosage
Biodegrading the first biodegradable structure in vivo over a first period of time to release the first therapeutic agent dosage into the tissue of the patient.
Biodegradation of second structure over a second period releases the second dosage after first release
Biodegrading the second biodegradable structure in vivo over a second period of time and releasing the second dosage of therapeutic agent into the tissue of the patient after release of the first dosage of therapeutic agent.
Across the independent-claim scope, the staged delivery is achieved by lodging a platform beneath skin with nested primary and secondary cavities holding first and second dosages in different biodegradable structures, where biodegradation over first and second periods releases each dosage in sequence. Release timing of the second dosage is defined by the shell-wall material composition and shell wall thickness/weight to occur at a specified time subsequent to the first release.
Stated Advantages
The disclosure provides staged release of multiple dosages by biodegrading biodegradable structures over different time periods.
The disclosure is motivated by extending shelf life and avoiding refrigeration and sterile technique constraints.
Documented Applications
Vaccine use cases are described, including booster-dose scheduling in humans and bovines.
Example vaccine types and schedules are discussed, including hepatitis, tetanus/diphtheria/pertussis, HPV, varicella, meningococcal, and polio, and corresponding bovine vaccine schedules.
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