Bioerodible drug delivery implants
Inventors
Whitfield, Garrett • Mathew, Idicula • Devlin, Matthew • McVey, Anthony
Assignees
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Publication Number
US-12274797-B2
Publication Date
2025-04-15
Expiration Date
Abstract
Disclosed herein are bioerodible drug delivery devices including one or more active agents, and related methods. The devices are useful for administering a wide variety of agents over prolonged periods of time.
Core Innovation
The invention relates to a bioerodible drug delivery device comprising a non-woven sheet with a length, width, and thickness, where the non-woven sheet is in a rolled configuration comprising multiple turns. The multiple turns are arranged along an axis parallel to the sheet length and perpendicular to the sheet width, defining the device structure after rolling.
The non-woven sheet comprises electrospun bioerodible polymer and at least one active agent. The non-woven sheet is electrospun from a solution in which the bioerodible polymer concentration is from 25–50 mg/ml and the polymer-to-active-agent weight ratio is from 2.5:1 to 1:2.5, with poly(L-lactic acid) as the bioerodible polymer and etonogestrel as the active agent in the described embodiment.
After implantation of the device into a patient, a therapeutic amount of the active agent is released for at least 18 months. The device size is defined by the non-woven sheet length from about 25–75 mm and a device diameter from about 2–4 mm, and the described device configuration is intended to provide controlled, preferably non-burst, prolonged release with consistent release profiles.
Claims Coverage
The document provides coverage centered on one independent claim (clm-00001). Across the inventive feature scope, the claims require a rolled, multi-turn electrospun non-woven sheet made from poly(L-lactic acid) and etonogestrel, with specified formulation constraints and implantable release duration, and a dependent claim refines the multi-turn geometry by adding turn density (clm-00002).
Rolled multi-turn electrospun non-woven sheet geometry
A bioerodible drug delivery device comprising a non-woven sheet having a length, width and thickness, wherein the non-woven sheet is in a rolled configuration comprising multiple turns along an axis parallel to the sheet length and perpendicular to the sheet width.
Electrospun polymer/active-agent non-woven sheet
The non-woven sheet comprises an electrospun bioerodible polymer and at least one active agent.
Specified electrospinning formulation constraints for polymer and active agent
The non-woven sheet is electrospun from a solution comprising the bioerodible polymer at a concentration from 25–50 mg/ml, wherein the solution comprises the bioerodible polymer and active agent at a weight ratio from 2.5:1 to 1:2.5.
Poly(L-lactic acid) with etonogestrel active agent
The bioerodible polymer is poly(L-lactic acid), and the active agent is etonogestrel.
Sized device with long-term therapeutic release after implantation
The non-woven sheet has a length from about 25–75 mm and the device has a diameter from about 2–4 mm, wherein after implantation of the device into a patient, a therapeutic amount of the active agent is released for a period of at least 18 months.
Turn-density constraint across sheet width
The non-woven sheet has a width from 20–500 mm, and wherein the non-woven sheet comprises at least 2 turns per 50 mm of width.
Overall, the claim coverage requires an implantable bioerodible device formed from an electrospun non-woven sheet rolled into a multi-turn configuration, using poly(L-lactic acid) and etonogestrel with specified polymer concentration and polymer:active-agent weight ratio, and with defined sheet/device dimensions that support release of a therapeutic amount for at least 18 months. Dependent coverage further narrows rolled-sheet geometry through a turn-density requirement across the sheet width.
Stated Advantages
Prolonged release for at least 18 months after implantation.
Controlled, preferably non-burst release with consistent release profiles [stated in provided description].
Controlled degradation rate enabling prolonged release [stated in provided description].
Documented Applications
Implantation into a patient to release a therapeutic amount of etonogestrel for at least 18 months [as required by the claims].
Contraceptive use via etonogestrel as the preferred contraceptive active agent [stated in provided description].
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