Bismuth-thiol compositions and methods for treating wounds
Inventors
Assignees
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Publication Number
US-12036200-B2
Publication Date
2024-07-16
Expiration Date
Abstract
The invention relates to bismuth-thiol compounds and pharmaceutical preparations thereof. The invention further relates to methods for treating a topical wound, comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising a bismuth-thiol compound, wherein the composition is applied to the infection. Methods for treating microbial infections such as diabetic foot infections are also provided.
Core Innovation
The invention relates to treating, managing, or healing a wound in a subject by topically applying a therapeutically effective amount of a pharmaceutical composition comprising a bismuth-thiol (BT) compound suspended therein as microparticles. The composition comprises a plurality of microparticles containing the BT compound, and the microparticles have specified particle-size distribution constraints, including a D90 of less than 2 μm and/or a D50 of less than or equal to 0.72 μm to 1.3 μm, and/or a D10 of less than or equal to 0.33 μm to 0.70 μm.
The patent describes topical BT microparticle compositions directed to infected wounds and microbial biofilms associated with infected wounds. It states effects on microbial biofilms, including reducing and/or disrupting biofilms, impairing biofilm growth/formation, preventing reformation and spread, and prevention of exotoxin secretion, with broad pathogen coverage including numerous bacterial and fungal species.
The disclosed compositions can include excipients such as Tween 80 (polysorbate 80), sodium chloride, optional methylcellulose, and optional sodium phosphate, with pH described around 7.4. The patent further links these formulations to wound healing and/or wound closure, wound size reduction, reduced infection severity, and reduced risk of amputation or infection-related surgery.
Claims Coverage
The consolidated claim coverage centers on one independent wound-treatment claim using a BT compound in topical microparticle form with specified particle-size distribution constraints. Additional claim content further specifies BT compound selection, formulation components, and wound-healing timing, giving four inventive features in total.
Topical wound treatment with BT microparticles
A method for treating, managing, or healing a wound by topically applying to the wound a therapeutically effective amount of a pharmaceutical composition comprising a bismuth-thiol (BT) compound suspended therein.
Microparticles with specified particle-size distribution constraints
The composition comprises a plurality of microparticles comprising said BT compound, wherein the microparticles have a D90 of less than 2 μm and/or a D50 of less than or equal to 0.72 μm to 1.3 μm, and/or a D10 of less than or equal to 0.33 μm to 0.70 μm.
BT compound selection from specified bismuth-thiol candidates
The method is carried out using a BT compound selected from the specified bis-thiol/bismuth-thiol compounds or related bismuth/mercapto-propanol compound.
Formulation with polysorbate 80, sodium chloride, optional methylcellulose, and optional sodium phosphate at about pH 7.4
The method is further carried out with a composition that includes polysorbate 80 and sodium chloride, optionally methylcellulose, and optionally sodium phosphate at about pH 7.4 within the stated concentration ranges.
The inventive concept is topical treatment of a wound using a BT-containing pharmaceutical composition in microparticle form with specified D90, D50, and/or D10 particle-size distribution constraints, with additional claim content on BT identity and formulation components.
Stated Advantages
Reduced infection severity in diabetic foot infection.
Wound healing and/or wound closure.
Wound size reduction.
Anti-biofilm activity, including reducing/disrupting biofilms and preventing reformation and spread.
Prevention of exotoxin secretion.
Reduced risk of amputation or infection-related surgery.
Limited systemic bismuth exposure.
Potential benefits for reinfection/relapse prevention at end of study.
Reduced target-ulcer amputations.
Documented Applications
Treating, managing, or healing a wound in a subject, including wounds associated with microbial infections.
Treating diabetic foot infection and diabetic foot ulcer outcomes, including reduced infection severity and improved wound healing/closure with reduced wound size.
Topical treatment directed to microbial biofilms in infected wounds.
Reducing risk of amputation and/or infection-related surgery in the context of diabetic foot infection.
Clinical evaluation of topical BisEDT dose-ranging in diabetic foot infection, including measurement of wound severity and assessment of clinical cure, microbiological response, biofilm scoring, and infection-related surgeries and amputations at test of cure, end of treatment, and end of study.
Use-case context includes reinfection/relapse prevention and reduction of target-ulcer amputations in diabetic foot infection settings.
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