Particle-based multi-layer therapeutic delivery device and method
Inventors
Goldberg, Manijeh Nazari • LaPorte, Brandon • Manzi, Aaron • Birdi, Amritpreet
Assignees
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Publication Number
US-11938228-B2
Publication Date
2024-03-26
Expiration Date
Abstract
A device for delivery of a first therapeutic agent and a second therapeutic agent to a site in epithelial tissue includes a first layer having a first, freeze-dried polymeric matrix having first and second opposed surfaces, formed by a composition including chitosan, a hydration promoter, a particle adhesion inhibitor, and a particle aggregation inhibitor, and a plurality of first particles embedded within the first matrix so as to be directly surrounded by, and in contact with, the first matrix, the first particles containing the first therapeutic agent and having a coating around the first therapeutic agent, the coating including chitosan. The device further includes a second layer, adjacent to the first layer, having a second, freeze-dried polymeric matrix containing the second therapeutic agent, the first layer and/or the second layer is configured to be attached to the site in the epithelial tissue.
Core Innovation
The disclosed invention is a device for delivery of a first therapeutic agent and a second therapeutic agent to a site in epithelial tissue using a multilayer, freeze-dried, chitosan-based construction. The device includes a first porous, mucoadhesive, freeze-dried polymeric matrix with first and second opposed surfaces, and the first matrix is formed by a composition comprising chitosan, a hydration promoter, a particle adhesion inhibitor comprising hydroxypropylmethylcellulose (HPMC), and a particle aggregation inhibitor in a defined concentration range by weight.
Within the first porous mucoadhesive matrix, a plurality of first particles is embedded so that the first particles are directly surrounded by and in contact with the first matrix. The first particles encapsulate the first therapeutic agent and comprise chitosan so that controlled release of the first therapeutic agent occurs from the first particles through one of the opposed surfaces of the first matrix. The first particles further comprise sodium tripolyphosphate.
An adjacent second layer is provided next to the first layer, where the second layer comprises a second, freeze-dried polymeric matrix with third and fourth opposed surfaces formed by a composition comprising chitosan and a plurality of second particles embedded within the second matrix. The second particles comprise the second therapeutic agent, and the device includes a covering over the fourth surface of the second layer, the covering being configured to restrict passage of any therapeutic agent through the fourth surface while still being water permeable. The first surface of the first layer is configured to be attached to the site in epithelial tissue, and the device optionally includes cisplatin as at least one therapeutic agent.
Claims Coverage
The independent claim defines a multilayer, freeze-dried, chitosan-based epithelial delivery device with seven main inventive features that structurally and compositionally define the first porous mucoadhesive matrix, controlled release from chitosan-based particles containing sodium tripolyphosphate, and an adjacent second freeze-dried matrix with therapeutic agent-containing particles and a water-permeable covering that restricts agent passage.
Multilayer freeze-dried chitosan device for epithelial delivery
A device for delivery of a first therapeutic agent and a second therapeutic agent to a site in epithelial tissue, the device comprising a first layer adjacent to a second layer, both being freeze-dried polymeric matrices configured for attachment and layered interfacing within epithelial tissue.
Porous mucoadhesive first freeze-dried polymeric matrix composition
A first porous, mucoadhesive, freeze-dried polymeric matrix having first and second opposed surfaces, the first matrix formed by a composition comprising chitosan, a hydration promoter, a particle adhesion inhibitor comprising hydroxypropylmethylcellulose (HPMC), and a particle aggregation inhibitor in a concentration range by weight.
Controlled-release first chitosan-encapsulated particles in first matrix
A plurality of first particles embedded within the first matrix so as to be directly surrounded by, and in contact with, the first matrix, the first particles encapsulating the first therapeutic agent and comprising chitosan so as to provide controlled release of the first therapeutic agent from the first particles through one of the opposed surfaces of the first matrix.
First particles with sodium tripolyphosphate
The first particles further comprising sodium tripolyphosphate.
Second freeze-dried chitosan matrix with second drug-containing particles
A second, freeze-dried polymeric matrix adjacent to the first layer, the second matrix formed by a composition comprising chitosan and a plurality of second particles embedded within the second matrix, wherein the second particles comprise the second therapeutic agent.
Water-permeable covering restricting agent passage on second layer
The fourth surface of the second layer is covered with a film, layer, or membrane configured to restrict passage of any therapeutic agent through the fourth surface while still being water permeable.
Epithelial attachment and cisplatin option
The first surface of the first layer is configured to be attached to the site in the epithelial tissue, and at least one of the first therapeutic agent and second therapeutic agent is cisplatin.
Overall, claim coverage is centered on a two-layer, freeze-dried, chitosan-based epithelial delivery device where the first layer is a porous mucoadhesive matrix with specific adhesion and aggregation components and contains chitosan-encapsulated, sodium tripolyphosphate-containing particles for controlled release, and the second layer contains chitosan matrix-embedded particles with a water-permeable covering that restricts therapeutic agent passage.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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