Compositions and methods for reducing oral biofilm
Inventors
LoVetri, Karen • Madhyastha, Srinivasa • Yakandawala, Nandadeva • Gawande, Purushottam V. • Froehlich, Gord
Assignees
Publication Number
US-11090366-B2
Publication Date
2021-08-17
Expiration Date
2032-06-27
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Abstract
Compositions comprising iron-sequestering glycoproteins, chelating agents, stabilizing agents, binding agents, surfactants, fluorides, antimicrobials and a pH adjuster or buffer for the prevention and treatment of oral cavity diseases caused by dental plaque/biofilm, such as dental caries, gingivitis and periodontitis, through anti-infective properties are disclosed. The anti-infective properties of a composition include reduction or killing of anaerobic/aerobic/facultative gram-negative and gram-positive oral bacteria occurring in polymicrobial dental biofilms. The composition may be in the form of wash, rinse, soak, paste, gel, spray, or other suitable form. Additionally, the invention offers an efficient method of delivering the formulated composition containing a PEGylated or fluorinated iron-sequestering glycoprotein and one or two chelating agents or chelating agents alone using either a liposomal or a nanoparticle delivery system.
Core Innovation
The invention provides compositions and methods for the prevention and treatment of oral cavity diseases caused by dental plaque or biofilm, including dental caries, gingivitis, and periodontitis. The compositions comprise iron-sequestering glycoproteins combined with chelating agents and pharmaceutically acceptable excipients. These compositions exhibit anti-infective properties that include reducing or killing various anaerobic, aerobic, and facultative gram-negative and gram-positive oral bacteria present in polymicrobial dental biofilms.
The invention addresses the difficulty in effectively controlling bacterial growth and biofilm formation on tooth surfaces that leads to oral diseases. Conventional oral care products often contain antibacterial agents effective only against planktonic bacteria, not bacteria in established biofilms, and may cause adverse effects such as discoloration, toxicity, or imbalance of oral flora. Therefore, there is a need for biologically safe and effective oral care products that not only inhibit bacterial growth but also disrupt and inhibit biofilm formation.
The compositions may be formulated with additional components such as surfactants, fluorides, antimicrobials, stabilizing agents, and buffers. The invention also includes efficient delivery methods using liposomal or nanoparticle systems to enhance stability and efficacy, and to deliver PEGylated or fluorinated iron-sequestering glycoproteins combined with chelating agents. The compositions can be prepared in various forms including washes, rinses, pastes, gels, sprays, and foods, suitable for oral administration for both humans and animals.
Claims Coverage
The patent contains multiple independent claims covering compositions with specific combinations of chelating agents and zinc salts for reducing oral bacterial biofilms, and methods of reducing biofilm formation.
Composition comprising EDTA, citrate, and zinc salt for reducing bacterial biofilm
A composition for reducing bacterial biofilm formation in the oral cavity consisting essentially of: (a) EDTA at about 250 mg/L to 1000 mg/L; (b) one or more citrate selected from sodium citrate and potassium citrate at about 1600 mg/L to 3200 mg/L; and (c) a zinc salt selected from zinc lactate, zinc gluconate, zinc citrate, and zinc chloride at 25 mg/L to 100 mg/L. The composition is prepared as one or more of mouthwash, oral rinse, spray, dentifrice, denture wash or soak, topical agent, denture adhesive or cement, lozenge, or pet chew biscuit.
Composition for reducing bacterial oral biofilms comprising specific concentrations of sodium citrate, disodium EDTA, and zinc salt
A composition consisting essentially of sodium citrate at about 3.2 mg/ml, disodium EDTA at about 0.5 mg/ml, and a zinc salt (zinc lactate, zinc gluconate, zinc citrate, or zinc chloride) at about 0.025 to 0.100 mg/ml, formulated as one or more of various oral care products including mouthwash, rinse, injectable, dentifrice, denture products, lozenge, and pet chew biscuit.
Composition further comprising additional oral care ingredients
The composition further comprises one or more ingredients selected from water, buffer, stabilizing agent, binding agent, gelling agent, desensitizing agent, teeth whitening agent, antiplaque deposition aide, surfactant, herbal, vitamin, mineral, pH adjuster, flavor, and color.
Composition wherein EDTA is disodium EDTA at about 500 mg/L
The EDTA in the composition is specified as disodium EDTA, preferably at about 500 mg/L concentration.
Composition optionally comprising liposomal or nanoparticle delivery system
The composition may be formulated using a liposomal or nanoparticle delivery system to enhance stability and efficacy.
A method of reducing bacterial biofilm formation in the oral cavity
A method comprising orally administering the composition defined above to reduce biofilms caused by bacteria selected from a broad group of oral bacteria associated with dental diseases including Streptococcus spp., Actinomyces spp., Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, and others.
The independent claims cover oral compositions comprising specific ranges of EDTA, citrate, and zinc salts formulated for various oral care products and methods for oral biofilm reduction, with optional inclusion of delivery systems and additional oral care ingredients.
Stated Advantages
The compositions provide effective antimicrobial and antibiofilm activity against bacteria associated with oral diseases including dental caries, gingivitis, and periodontitis.
The delivery systems such as liposomal or nanoparticle formulations enhance the stability and efficacy of the active compounds.
The compositions avoid adverse effects common with other chemical and biological agents, such as tooth staining, toxicity, and imbalance of oral flora.
Lower concentrations of active ingredients are effective, potentially reducing side effects.
Documented Applications
Prevention and treatment of oral cavity diseases caused by dental plaque/biofilm including dental caries, gingivitis, periodontitis, and related oral bacterial infections.
Use in oral care formulations such as mouthwashes, rinses, pastes, gels, sprays, dentifrices, denture washes, lozenges, pet chew biscuits, and other oral hygiene products for humans and animals.
Administration to pets (e.g., dogs) through drinking water or feed to reduce plaque, gingivitis, and calculus as demonstrated in a Beagle dog trial.
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