Intraoperative topically-applied non-implantable rapid release patch
Inventors
Goldberg, Manijeh Nazari • LaPorte, Brandon • Manzi, Aaron M. • Jahjaa, Amani
Assignees
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Publication Number
US-11872319-B2
Publication Date
2024-01-16
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. 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 provides a device for rapid delivery of a therapeutic agent to a surgical cavity, comprising a polymeric matrix with first and second opposed surfaces. The matrix comprises chitosan and includes a particle adhesion inhibitor comprising hydroxypropylmethylcellulose (HPMC), a plurality of particles having an average diameter between 500 nm and 2000 nm, and one or more additives selected from a hydration promotor, a particle aggregation inhibitor, and combinations thereof.
The particles are embedded within the matrix so as to be directly surrounded by, and in contact with, the matrix. The particles comprise the therapeutic agent and chitosan, so that the particle phase carrying the therapeutic agent is coupled directly to the chitosan matrix.
The device is sterilized and is designed to provide release of approximately 20% to 100% of the therapeutic agent within 20 minutes of application to the surgical cavity. The described device form aims at topical, non-implantable rapid delivery to tissue-contact surfaces of a surgical cavity, with a porous, mucoadhesive, freeze-dried chitosan-based polymeric matrix structure and embedded therapeutic particles.
Claims Coverage
The document contains one independent claim. It defines a rapid-release, sterilized, chitosan-based patch for surgical cavities with embedded therapeutic particles directly surrounded by the matrix, and requires specific structural elements, additives, particle size range, and a release performance target within 20 minutes.
Chitosan polymeric matrix for a surgical cavity
A polymeric matrix having first and second opposed surfaces, wherein the matrix comprises chitosan; 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 therapeutic particles in direct matrix contact
A plurality of particles having an average diameter between 500 nm and 2000 nm, wherein the particles are embedded within the matrix so as to be directly surrounded by, and in contact with, the matrix; wherein the particles comprise the therapeutic agent and chitosan.
Mutually distinct adhesion, hydration, and aggregation additives
The matrix comprises a particle adhesion inhibitor comprising hydroxypropylmethylcellulose (HPMC) and one or more additives selected from the group consisting of a hydration promotor, a particle aggregation inhibitor, and combinations thereof, wherein when present, the particle adhesion inhibitor, the hydration promotor, and the particle aggregation inhibitor are compounds mutually distinct from one another.
Sterilized rapid release performance
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.
Overall, the independent claim focuses on a sterilized, topical chitosan-based polymeric matrix patch with embedded therapeutic particles directly surrounded by the matrix, using HPMC as a particle adhesion inhibitor and additional mutually distinct additives for hydration and/or particle aggregation, together with a specified rapid release target 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.
Enables rapid delivery of a therapeutic agent to a surgical cavity through a tissue-contact surface of the device.
Does not significantly modify agents such as cisplatin after gamma ray sterilization.
Documented Applications
Topically applied, non-implantable use to deliver a therapeutic agent to a surgical cavity.
Use with therapeutic agents including chemotherapeutics (e.g., cisplatin, oxaliplatin, 5-fluorouracil) and anti-infective/anti-bacterial/anti-viral agents.
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