Intraoperative topically-applied non-implantable rapid release patch
Inventors
Goldberg, Manijeh Nazari • LaPorte, Brandon • Manzi, Aaron • Jahjaa, Amani
Assignees
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Publication Number
US-10478403-B1
Publication Date
2019-11-19
Expiration Date
Abstract
A device for delivery of a therapeutic agent to a surgical cavity, including: a porous, mucoadhesive, freeze-dried polymeric matrix having first and second opposed surfaces, the matrix formed by a composition including chitosan; a plurality of particles embedded within the matrix, the particles containing the therapeutic agent and having a coating around the therapeutic agent, the coating including chitosan; and an additive selected from the group consisting of a hydration promoter, a particle adhesion inhibitor, a particle aggregation inhibitor, and combinations thereof. The first surface of the matrix is configured to be applied to the surgical cavity; the device releases the particles through the first surface; the device is also sterilized and provides release of approximately 20% to 100% of the therapeutic agent within 20 minutes of application to the surgical cavity.
Core Innovation
The invention relates to a device for rapid delivery of a therapeutic agent to a surgical cavity. The device includes a porous, mucoadhesive, freeze-dried polymeric matrix with first and second opposed surfaces, where the matrix is formed from a composition comprising chitosan and a particle adhesion inhibitor comprising hydroxypropylmethylcellulose (HPMC). The first surface is configured to be applied to the surgical cavity, and the device is configured to provide release of the particles through the first surface.
Embedded within the freeze-dried matrix is a plurality of particles having an average diameter between 500 nm and 2000 nm. The particles contain the therapeutic agent and include a coating around the therapeutic agent, where the coating comprises chitosan. This structure provides controlled release of the therapeutic agent from the particles through the first opposed surface of the matrix.
The device includes one or more additives selected from a hydration promoter, a particle aggregation inhibitor, and combinations thereof. The device is sterilized, and it is configured to provide release of approximately 20% to 100% of the therapeutic agent within 20 minutes of application to the surgical cavity. The particle adhesion inhibitor, and when present the hydration promoter and the particle aggregation inhibitor, are compounds mutually distinct from one another and are present in amounts sufficient to achieve the controlled release of the particles without preventing formation of the freeze-dried matrix.
The described embodiments further include a backing layer on the second surface to limit significant diffusion-related loss of payload components and, optionally, to protect the device from an environment. Representative materials for the backing layer include polyacrylate adhesive and/or non-woven polyester fabric backing. Example embodiments also describe therapeutic-agent selections such as cisplatin, oxaliplatin, 5-fluorouracil, and anti-infective/anti-bacterial/anti-viral agents, within the same rapid-release, chitosan-based, freeze-dried porous patch framework.
Claims Coverage
Independent claim clm-00001 covers a sterilized, porous, mucoadhesive, freeze-dried chitosan polymeric matrix device for intraoperative rapid delivery into a surgical cavity, including embedded chitosan-coated therapeutic-agent particles with defined particle size and controlled release through a first opposed surface, while incorporating mutually distinct adhesion/optional hydration/optional anti-aggregation compounds to enable formation of the freeze-dried matrix and rapid release performance (approximately 20% to 100% within 20 minutes).
Porous mucoadhesive freeze-dried chitosan matrix with adhesion inhibitor
A porous, mucoadhesive, freeze-dried polymeric matrix having first and second opposed surfaces, the matrix formed by a composition comprising chitosan, and a particle adhesion inhibitor comprising hydroxypropylmethylcellulose (HPMC), where the first surface is configured to be applied to the surgical cavity and release is provided through the first surface.
Chitosan-coated therapeutic-agent particles embedded in the matrix
A plurality of particles embedded within the matrix so as to be directly surrounded by, and in contact with, the matrix, where the particles contain the therapeutic agent and have a coating around the therapeutic agent, the coating comprising chitosan so as to provide controlled release of the therapeutic agent from the particles through the first opposed surface of the matrix, with an average diameter between 500 nm and 2000 nm.
Mutually distinct hydration and aggregation additives enabling freeze-dried matrix formation
One or more additives selected from the group consisting of a hydration promoter, a particle aggregation inhibitor, and combinations thereof, wherein the particle adhesion inhibitor, and when present the hydration promoter and the particle aggregation inhibitor, are compounds mutually distinct from one another and present in amounts sufficient to achieve the controlled release of the particles without preventing formation of the freeze-dried matrix.
Sterilized rapid-release performance in the surgical cavity
The device is sterilized and provides release of approximately 20% to 100% of the therapeutic agent within 20 minutes of application to the surgical cavity.
The claim coverage centers on a sterilized, freeze-dried chitosan-based porous mucoadhesive patch with embedded chitosan-coated therapeutic-agent particles of defined size, controlled release through the first surface to a surgical cavity, and incorporation of mutually distinct adhesion inhibitor (HPMC) plus optional hydration promoter and/or particle aggregation inhibitor to support freeze-dried matrix formation while enabling rapid release (approximately 20% to 100% within 20 minutes).
Stated Advantages
Provides release of approximately 20% to 100% of the therapeutic agent within 20 minutes of application to the surgical cavity.
Provides controlled release of the therapeutic agent from chitosan-coated particles through the matrix first surface.
Allows formation of the freeze-dried matrix without preventing controlled release of the particles.
Limits significant diffusion-related loss of payload components via a backing layer on the second surface.
Optionally protects the device from an environment via the backing layer.
Documented Applications
Rapid delivery of a therapeutic agent to a surgical cavity, configured for intraoperative application to the cavity.
Treatment of surgical cavities using a non-implantable rapid-release patch.
Use of therapeutic agents such as cisplatin, oxaliplatin, 5-fluorouracil, and anti-infective/anti-bacterial/anti-viral agents in the rapid delivery device.
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