Systems and methods relating to medical applications of inverse thermosensitive polymer foam formulations
Inventors
Donaldson, Ross I. • Armstrong, Jonathan • Buchanan, Oliver • Cambridge, John • Fisher, Timothy • Cristerna, Nely
Assignees
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Publication Number
US-12410293-B2
Publication Date
2025-09-09
Expiration Date
Abstract
Disclosed herein is a pressurized therapeutic composition configured to be stored in a valved container designed to maintain an inverse thermosensitive polymer foam composition under pressure and dispense the composition upon opening the valve thereof. After the composition is dispensed from the container the evaporation of an expanding component (e.g., compressed gas or volatile liquid) can cause the inverse thermosensitive polymer solution to foam. The reduced pressure produced from dispensing the inverse thermosensitive polymer solution can reduce its temperature so as to facilitate distribution in a more liquid foam form. The inverse thermosensitive polymer solution can undergo a reverse phase change from a liquid to a gel upon warming (e.g., once dispensed onto or into a body part).
Core Innovation
The invention relates to a pressurized inverse thermosensitive polymer foam formulation stored in a valved container that maintains the formulation under pressure and dispenses it upon opening a valve. The formulation includes an aqueous solution of a copolymer of ethylene oxide and propylene oxide configured to undergo a reverse phase change from a liquid to a gel, and an expanding component comprising a liquified hydrofluorocarbon gas causes the formulation to foam after the formulation is dispensed from the container.
The formulation is configured for topical application and is initially deployed from the container at a lower viscosity to spread more easily. Upon contact with the body, the formulation becomes more viscous, consistent with the reverse phase change from liquid to gel and resulting in a gel foam barrier. The formulation further comprises one or more antibiotics including vancomycin at a concentration between about 0.1% w/w and about 6.0% w/w, a preservative, and a pH adjuster, and the formulation comprises a stable and macroscopically homogenous solution.
The invention also includes a pressurized valve container configured to deploy the formulation such that the liquified hydrofluorocarbon gas causes foaming after dispensing and that supports topical application. The container may include a piston that separates a pressurized inverse thermosensitive polymer foam formulation from a driving gas, and the driving gas may be the same liquified hydrofluorocarbon gas as the expanding component. An applicator tip with a spreader may be provided to disperse the foam over a surface area.
Claims Coverage
The document provides two independent claims covering a pressurized inverse thermosensitive polymer foam formulation and a pressurized valve container that stores and deploys the formulation. The inventive coverage centers on a reverse liquid-to-gel inverse thermosensitive polymer system, antibiotic content including vancomycin, foaming by a liquified hydrofluorocarbon expanding component, and low initial viscosity that increases upon contact with the body.
Pressurized inverse thermosensitive polymer foam formulation in a valved container
A pressurized inverse thermosensitive polymer foam formulation stored in a valved container designed to maintain the formulation under pressure and dispense the formulation upon opening a valve, the formulation comprising an aqueous solution of a copolymer of ethylene oxide and propylene oxide configured to undergo a reverse phase change from a liquid to a gel, one or more antibiotics including vancomycin at about 0.1% w/w to about 6.0% w/w, a preservative, a pH adjuster, and an expanding component that is a liquified hydrofluorocarbon gas that causes the formulation to foam after dispensed, wherein the formulation is a stable and macroscopically homogenous solution, configured to be applied topically, and configured to initially be deployed at a lower viscosity to spread more easily and becomes more viscous upon contact with the body.
Pressurized valve container dispensing a foaming inverse thermosensitive antibiotic foam
A pressurized valve container comprising a container including a valve and a pressurized inverse thermosensitive polymer foam formulation stored in the container, the container configured to maintain the formulation under pressure and dispense the formulation upon opening the valve, the formulation comprising an aqueous solution of a copolymer of ethylene oxide and propylene oxide configured to undergo a reverse phase change from a liquid to a gel, one or more antibiotics including vancomycin at about 0.1% w/w to about 6.0% w/w, a preservative, a pH adjuster, and an expanding component that is a liquified hydrofluorocarbon gas, wherein the formulation comprises a stable and macroscopically homogenous solution, wherein the container is configured to deploy the formulation such that the liquified hydrofluorocarbon gas causes the formulation to foam after the formulation is dispensed from the container, the formulation is configured to be applied topically following deployment, and the formulation is configured to initially be deployed at a lower viscosity to spread more easily and becomes more viscous upon contact with the body.
The independent claims are directed to valve-controlled, pressurized delivery of an aqueous ethylene oxide/propylene oxide inverse thermosensitive copolymer formulation that undergoes a reverse liquid-to-gel change, uses a liquified hydrofluorocarbon expanding component to cause foaming after dispensing, contains an antibiotic component including vancomycin within a specified concentration range, and provides low initial viscosity for spreading that increases upon contact with the body. The container claim additionally covers the pressurized valve-container structure configured for deployment of this foaming formulation.
Stated Advantages
Provides a stable and macroscopically homogenous solution.
Initial deployment at a lower viscosity to spread more easily.
Becomes more viscous upon contact with the body.
Liquified hydrofluorocarbon gas causes the formulation to foam after dispensing, supporting topical application.
Documented Applications
Topical application of the inverse thermosensitive polymer foam formulation following deployment from the container.
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