Composition comprising a polymer and a bioactive agent and method of preparing thereof

Inventors

Katsarava, Ramaz • Tugushi, David • BERIDZE, Vakhtang • Tawil, Nancy

Assignees

Precisio Biotix Therapeutics Inc

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Publication Number

US-10772964-B2

Patent

Publication Date

2020-09-15

Expiration Date


Abstract

Amino acid based polymers and polymer blends. Compositions comprising at least one amino acid based polymer or polymer blend, at least one bioactive agent, and optionally at least one filler. Additionally, compositions comprising at least one bacteriophage and at least one salt or buffer, which, for example, are in the form of a dry powder, and methods of preparing thereof are disclosed.

Core Innovation

The invention relates to bacteriophage adsorbed on a substrate, where the substrate includes at least one salt and is dispersed in a polymer selected from poly (ester amide urea), poly (ester urethane urea), poly (ester amide urethane urea), poly (ester amide urethane), poly (ester urea), and poly (ester urethane). The polymers are biodegradable amino-acid based polymers and polymer blends, with diol and diacid building blocks defined by HO—R1—OH and HO—(CO)—R3—(CO)—OH, and amino acids selected from naturally occurring and non-naturally occurring amino acids.

The invention also addresses bacteriophage-compatible biodegradable polymers that are synthesized under mild conditions without toxic catalysts and that are formulated as polymer layers or polymer-dispersed systems. Polymer architecture includes random block distributions, block ratio embodiments, and grindable and low molecular weight embodiments, and polymer blends include at least two non-identical polymers with specific diol/diacid/amino-acid selections.

A further aspect provides compositions in dry powder form in which the bacteriophage is adsorbed on a substrate including at least one salt. The document also describes film, patch, and spray forms, and salt-based substrates and polymer integration are described as supporting bacteriophage stabilization.

Claims Coverage

The independent claims identified across the input cover three inventive features: bacteriophage adsorbed on a salt-containing substrate dispersed in specific biodegradable amino-acid based polymers, the same bacteriophage/salt adsorption concept in dry powder form, and a substrate salt mixture defined as calcium carbonate and magnesium carbonate.

Bacteriophage adsorbed on salt-containing substrate dispersed in defined biodegradable polymers

A composition comprising a bacteriophage adsorbed on a substrate, wherein the substrate includes at least one salt and is dispersed in a polymer selected from poly (ester amide urea), poly (ester urethane urea), poly (ester amide urethane urea), poly (ester amide urethane), poly (ester urea), and poly (ester urethane), with diol and diacid formula constraints and amino-acid selection from naturally occurring and non-naturally occurring amino acids.

Dry powder bacteriophage adsorbed on salt-containing substrate

A composition comprising a bacteriophage and a substrate, wherein the bacteriophage is adsorbed on the substrate, the substrate includes at least one salt, and the composition is in the form of a dry powder.

Salt mixture substrate with calcium carbonate and magnesium carbonate

A composition comprising at least one bacteriophage and at least one substrate, wherein the bacteriophage is adsorbed on the substrate and the at least one salt is a mixture of calcium carbonate and magnesium carbonate.

The claims are directed to bacteriophage adsorption on a salt-containing substrate, with one independent claim further requiring dispersion of the substrate in a defined family of biodegradable amino-acid based polymers. Additional independent coverage is provided for dry powder form and for a substrate salt mixture of calcium carbonate and magnesium carbonate.

Stated Advantages

Maintaining bacteriophage activity.

Supporting improved process conditions and solvent choices for suitability in bacteriophage-containing compositions.

Enables phage-compatible biodegradable polymers under mild conditions without toxic catalysts.

Addresses limitations of antibiotics and some antiseptics/toxic catalysts for deep wound infection management.

The document reports bacteriophage retention/adsorption data for the disclosed compositions.

The document reports faster completion than prior solution polycondensation.

Documented Applications

Wound-healing compositions.

Non-woven porous polymeric materials.

Bacteriophage-containing wound dressings.

Deep wound infection management and wound dressings, including phage therapy.

Wound healing contexts, including ulcerative wound treatment.

Non-woven porous polymeric materials formed via salt leaching.

Film, patch, and spray forms for topical wound use.

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