Antimicrobial-antibiofilm compositions and methods of use thereof
Inventors
Gawande, Purushottam V. • LoVetri, Karen • Yakandawala, Nandadeva • Froelich, Gordon • Madhyastha, Srinivasa
Assignees
Publication Number
US-9980497-B2
Publication Date
2018-05-29
Expiration Date
2033-04-26
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Abstract
Compositions comprising chelating agents, metal ion salts, gelling agents or a buffer, antimicrobials, antibiofilm agents and a pH adjuster or a buffer for the prevention and treatment of wound infections and food-borne diseases involving bacterial biofilms are disclosed. The anti-infective properties of a composition include reduction or killing of anaerobic/aerobic/facultative gram-negative and gram-positive wound infection associated bacteria occurring in polymicrobial biofilms. The composition may be in the form of lotion, cream, ointment, dressing, bandage, rinse, soak, gel, spray, or other suitable forms, including certain devices. Additionally, the invention offers an efficient method of delivering the formulated composition containing one or two chelating agents or chelating agents alone or in combination with a metal ion salt using either a nanoparticle or other efficient delivery systems.
Core Innovation
The invention discloses compositions and methods for the prevention and treatment of wound infections and food-borne diseases involving bacterial biofilms. The compositions comprise chelating agents, metal ion salts, gelling agents or buffers, antimicrobials, antibiofilm agents, and pH adjusters or buffers. These compositions are effective in reducing or killing anaerobic, aerobic, and facultative gram-negative and gram-positive bacteria associated with wound infections occurring in polymicrobial biofilms.
The compositions may take various forms suitable for topical or environmental application, including lotions, creams, ointments, dressings, bandages, rinses, soaks, gels, sprays, and other devices. The invention also provides efficient methods of delivering the formulated compositions, which may contain one or two chelating agents alone or combined with metal ion salts, using nanoparticles or other delivery systems.
The problem addressed is the difficulty in treating chronic and acute wound infections caused by bacteria in biofilm form, which are highly resistant to antibiotics, antimicrobials, and the body's immune defenses. Wounds provide an environment conducive to microbial colonization, and polymicrobial biofilms are implicated in delayed healing and persistent infections. There is a significant unmet clinical need for effective antibiofilm and antimicrobial wound care products that are safe and cost-effective.
Furthermore, the invention addresses the problem of microbial contamination in meat processing plants, where conventional antimicrobials like sodium hypochlorite pose safety concerns due to harmful residues on meat. There is a need for antimicrobial agents that provide long-lasting antimicrobial activity and safety for humans, maintaining the freshness of meat products while preventing foodborne infections.
Claims Coverage
The patent includes multiple independent claims focused on antimicrobial and antibiofilm compositions and methods of use, covering key ingredients and their applications.
Composition comprising disodium or tetrasodium EDTA and citrate salts for inhibiting bacterial growth and biofilm formation
A composition comprising (a) disodium or tetrasodium EDTA at concentrations between about 0.125 mg/mL and about 0.25 mg/mL, (b) sodium citrate or potassium citrate at concentrations between about 1.5 mg/mL and about 3 mg/mL, and optionally (c) a zinc salt selected from zinc chloride, zinc gluconate, zinc lactate, zinc citrate, zinc sulfate, and zinc acetate.
Specific combinations of EDTA, citrate, and zinc salts
The composition may specifically comprise disodium EDTA and sodium citrate, and optionally zinc chloride, with zinc chloride concentrations ranging from about 100 mg/L up to about 5000 mg/L.
Formulations incorporating additional ingredients for enhanced properties
Compositions may further include ingredients such as water, buffer, stabilizing agents, gelling agents, surfactants, herbals, vitamins, minerals, extracellular matrix components, antimicrobials, antibiotics, and pH adjusters to suit various formulations.
Diverse formulation types for various delivery modes
The composition may be prepared as disinfecting solutions, dip solutions, lotions, creams, ointments, gels, sprays, dressings, gauzes, bandages, thermoreversible gel sprays, wraps, adhesives, tapes, and balms.
Delivery using advanced systems
The composition may be delivered using liposomal, nanoparticle, or other suitable device delivery systems to enhance stability and efficacy.
Inclusion of various anti-infective compounds
The composition can include anti-infective compounds such as DispersinB, alginate lyase, nisin, lactoferricin, serotransferrin, ovotransferrin, ovalbumin, ovomucoid, protamine sulfate, chlorhexidine, cetylpyridinium chloride, triclosan, silver sulfadiazine, benzalkonium chloride, hydrogen peroxide, citric acid, potassium citrate, 5-fluorouracil, cis-2-decenoic acid, DNase I, proteinase K, silver, gallium, bacteriocins, and antimicrobial peptides.
Methods of preventing or treating wound infections
Topical or non-topical use of the composition to prevent or treat various wound infections, including cuts, bruises, surgical sites, lacerations, abrasions, punctures, incisions, gunshots, burns, pyoderma, otitis media, mastitis, atopic dermatitis, eczema, pressure ulcers, leg ulcers, and diabetic foot ulcers in humans and animals.
Methods for preventing or treating meat spoilage and disinfecting meat
Topical or non-topical use of the composition on meat or meat products, including intestine parts or collagen casings, via coating, spraying, misting, injecting, soaking, flushing, dipping, or rinsing to prevent spoilage and disinfect meat.
The independent claims cover compositions comprising specified ranges of chelating agents and citrate salts, optionally with zinc salts, formulated with various excipients and delivery systems to inhibit bacterial growth and biofilm formation. Methods of treating wounds and disinfecting meat using these compositions are also claimed.
Stated Advantages
The compositions provide enhanced inhibitory effects on bacterial growth and biofilm formation compared to individual components alone.
The invention offers effective antibiofilm and antimicrobial activity against polymicrobial biofilms associated with chronic and acute wound infections.
The compositions are generally recognized as safe (GRAS) and food/feed additive status for all ingredients, avoiding antibiotic resistance and safety issues.
The compositions can be formulated in diverse forms suitable for wound care, disinfectants, cosmetics, and food/meat industry applications.
Use of nanoparticle or liposomal delivery systems enhances stability and efficacy of the compositions.
Documented Applications
Prevention and treatment of acute and chronic wound infections including infections of cuts, bruises, surgical sites, lacerations, abrasions, punctures, incisions, gunshots, burns, pyoderma, atopic dermatitis, eczema, pressure ulcers, venous and artery leg ulcers, diabetic foot ulcers, cystic fibrosis-associated infections, and community or hospital acquired infections.
Veterinary use for wound infections, mastitis, and otitis associated bacteria and yeasts in domestic and farm animals.
Decontamination and disinfection of fruits, vegetables, food processing facilities, meat processing plants, hospitals, barns, medical instruments, and other industrial and institutional facilities.
Prevention and treatment of meat spoilage and contamination by topical or non-topical application to meat or meat products including processes such as coating, spraying, misting, injecting, soaking, flushing, dipping, and rinsing.
Use in cosmetics such as shampoos and antimicrobial body lotions and creams.
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