Intraoperative topically-applied non-implantable rapid release patch

Inventors

Goldberg, Manijeh NazariLaPorte, BrandonManzi, Aaron M.Jahjaa, Amani

Assignees

Privo Technologies Inc

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Publication Number

US-12318491-B2

Patent

Publication Date

2025-06-03

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 relates to a device for rapid delivery of a therapeutic agent to a surgical cavity. The device includes a polymeric matrix with first and second opposed surfaces and a backing layer disposed on the second surface, and the polymeric matrix comprises chitosan and is configured so that the first surface is applied to the surgical cavity.

A plurality of particles is embedded in the chitosan polymeric matrix, and the particles comprise the therapeutic agent and chitosan. The particles include a particle adhesion inhibitor comprising hydroxyproplymethylcellulose (HPMC) and a hydration promotor comprising propylene glycol, and the particles are released through the first surface to deliver therapeutic agent to 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 disclosed patch formulation includes a porous, mucoadhesive, freeze-dried chitosan polymeric matrix and chitosan-coated therapeutic-agent particles configured for controlled release through a tissue-contact surface.

Claims Coverage

The only explicitly identified independent claim is clm-00001. It contains a concentrated set of inventive features governing the structure of a sterilized chitosan-based, particle-loaded, backed device and the rapid release performance into a surgical cavity, in combination with specific excipients and particle size constraints.

Sterilized rapid-delivery device for a surgical cavity with backed chitosan matrix

A device for rapid delivery of a therapeutic agent to a surgical cavity comprising a polymeric matrix having first and second opposed surfaces and a backing layer disposed on the second surface, where the first surface is configured to be applied to the surgical cavity and the device provides release of the particles through the first surface, the device being sterilized.

Chitosan polymeric matrix with HPMC adhesion inhibitor and propylene glycol hydration promotor

The polymeric matrix comprises chitosan, a particle adhesion inhibitor comprising hydroxyproplymethylcellulose (HPMC), a plurality of particles having an average diameter between 500 nm and 2000 nm, and a hydration promotor comprising propylene glycol.

Chitosan therapeutic-agent particles embedded in the matrix

The particles comprise the therapeutic agent and chitosan.

Rapid release performance within 20 minutes

The device provides release of approximately 20% to 100% of the therapeutic agent within 20 minutes of application to the surgical cavity.

Across the independent claim, the inventive coverage centers on a sterilized, backed device with a chitosan polymeric matrix and embedded chitosan/therapeutic-agent particles, using HPMC as a particle adhesion inhibitor and propylene glycol as a hydration promotor, where the configured first surface applied to a surgical cavity enables release of about 20% to 100% of the therapeutic agent 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.

Documented Applications

Intraoperative delivery of a therapeutic payload to a surgical cavity using a non-implantable rapid-release patch.

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