Bismuth-thiol compositions and methods for treating wounds
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Publication Number
US-11324715-B2
Publication Date
2022-05-10
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 a pharmaceutical composition comprising BisEDT suspended therein, where the composition comprises a plurality of microparticles comprising BisEDT. The microparticles have a D90 of less than 2 bcm, and the disclosed microparticle suspension form supports topical application for wound-related indications.
The invention addresses diabetic foot infections and chronic wounds by providing compositions and dosing regimens for treating and preventing infection and promoting wound healing and wound closure. The disclosed approach includes reducing and/or dispersing microbial and biofilms, and, optionally, inhibiting exotoxin secretion and inhibiting planktonic and biofilm growth.
In embodiments, the formulation includes polysorbate 80, sodium chloride, methylcellulose, and sodium phosphate, including pH 7.4. In embodiments, the microparticle size distribution is further characterized by VMD criteria and D90/D50 constraints, and therapeutic outcomes are described, including reduced wound size and reduced risk of amputation and infection-related surgery within a defined healing or closure timeframe.
Claims Coverage
The claim set centers on a BisEDT pharmaceutical composition as a microparticle suspension with a specific microparticle size constraint defined by D90 less than 2 bcm. The inventive features include tightened microparticle size and distribution criteria, excipient and pH constraints, liquid suspension form, and a treatment duration range.
BisEDT microparticles with D90 less than 2 bcm
A pharmaceutical composition comprising BisEDT suspended therein, wherein the composition comprises a plurality of microparticles comprising said BisEDT, wherein the microparticles have a D90 of less than 2 bcm.
Tightened D90 microparticle limit
The pharmaceutical composition has microparticles with a D90 of less than or equal to 1.6 bcm.
Volumetric mean diameter distribution criterion
At least 80% of the microparticles have a volumetric mean diameter (VMD) between about 0.4 bcm and about 2.5 bcm.
Excipients and pH refinement
The pharmaceutical composition comprises polysorbate 80, sodium chloride, optionally methylcellulose, and sodium phosphate at about pH 7.4 within the stated concentration ranges.
Liquid suspension formulation
The pharmaceutical composition is formulated as a liquid suspension.
Treatment duration range
Administering the pharmaceutical composition for a treatment duration ranging from about one week to about 12 weeks.
Claim coverage centers on a BisEDT-suspended pharmaceutical composition defined by microparticle size, particularly with D90 below 2 bcm, and is further narrowed by dependent quantitative particle-size distribution criteria. Additional dependent limitations refine the formulation composition, the formulation type as a liquid suspension, and the treatment duration range.
Stated Advantages
Concluded to be safe/tolerable with limited systemic bismuth exposure.
Potential benefits in reinfection/relapse prevention.
Reduced target-amputation and infection-related surgery rates.
Reduced biofilm presence and improved wound-healing endpoints.
Avoid systemic adverse effects while providing increased local concentration at the wound.
Disrupt biofilms and inhibit pathogen growth and/or virulence.
Reducing and/or dispersing microbial and biofilms.
Optionally inhibiting exotoxin secretion and inhibiting planktonic and biofilm growth.
Promote wound healing or wound closure within 12 weeks.
Reduce wound size.
Reduce risk of amputation and infection-related surgery.
Promoting wound healing and wound closure.
Documented Applications
Clinical study assessment for diabetic foot infection (DFI), including evaluation of BisEDT versus placebo using ulcer size reduction, DFI wound score endpoints, microbiological response categories, biofilm scoring, reinfection/relapse at EOS, and ulcer healing metrics.
Topical treatment of infected wounds, including diabetic foot infections (DFI) and chronic ulcers.
Use against susceptible bacterial and fungal pathogens associated with DFI and chronic ulcers, including Staphylococcus aureus and MRSA, and pathogens such as Escherichia coli and Pseudomonas aeruginosa.
Treating and/or preventing diabetic foot infections and chronic wounds using topical BisEDT compositions.
Using topical administration for diabetic foot ulcers with outcomes including wound healing/closure and reduced risk of amputation and infection-related surgery.
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