WO2025252565A1 - Mousse de soins buccodentaires à base de lactoferrine et d'hydroxyapatite - Google Patents

Mousse de soins buccodentaires à base de lactoferrine et d'hydroxyapatite

Info

Publication number
WO2025252565A1
WO2025252565A1 PCT/EP2025/064758 EP2025064758W WO2025252565A1 WO 2025252565 A1 WO2025252565 A1 WO 2025252565A1 EP 2025064758 W EP2025064758 W EP 2025064758W WO 2025252565 A1 WO2025252565 A1 WO 2025252565A1
Authority
WO
WIPO (PCT)
Prior art keywords
oral care
care foam
formulation
oral
lactoferrin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/064758
Other languages
English (en)
Inventor
Martina BIANCARDI
John PAWLUS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tdc Technology Dedicated To Care Srl
Pawlus Dental
Original Assignee
Tdc Technology Dedicated To Care Srl
Pawlus Dental
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tdc Technology Dedicated To Care Srl, Pawlus Dental filed Critical Tdc Technology Dedicated To Care Srl
Publication of WO2025252565A1 publication Critical patent/WO2025252565A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/046—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/14—Liposomes; Vesicles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/24—Phosphorous; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof

Definitions

  • the formation of the plaque in the mouth, in particular on the teeth surfaces and in interdental spaces, is absolutely physiological.
  • a further drawback lies in the fact that periodical professional dental cleanings can be expensive.
  • Another way to prevent the formation of the dental plaque and tartar is the regular use of toothpaste with fluoride in it, which strengthens tooth enamel and reduces the risk of teeth decay.
  • Another way for preventing dental plaque formation is the incorporation of a mouthwash or an oral care product in the daily oral hygiene routine.
  • OBJECTS OF THE INVENTION Object of the present invention is to provide an oral care foam formulation that can protect tooth enamel, prevents dental plaque and caries while maintaining a fresh breath for a long time.
  • Another object of the present invention is to provide an oral care foam formulation that provides for a non-invasive use.
  • Another object of the present invention is to provide an oral care foam formulation that can be used by a non-medical qualified people and in a non-medical context.
  • a further object of the present invention is to provide an oral care foam formulation which is cost-effective.
  • Another object of the present invention is to provide an oral care foam formulation which is easy to use even when the user is traveling or, in general, is away from home.
  • a further object of the present invention is to provide an oral care foam formulation which can be formulated with different flavors in order to result as pleasant not only for human beings but also for other animals such as, but not limited to, dogs, cats, and horses.
  • an oral care foam formulation comprising lactoferrin in liposomes and hydroxyapatite, as active ingredients.
  • the oral care foam subject matter of the present invention is useful for the prevention of dental plaque and caries, for maintaining a healthy oral biofilm composition and for the treatment of mouth diseases.
  • caries is one of the most prevalent diseases affecting centuries. It is caused by a dysbiosis or imbalance of the oral biofilm.
  • the oral care foam should both neutralize the acidic pH and prevent the acidophilic and acid producing bacteria from multiplying, which is what creates the imbalance of bacteria associated with a dysbiotic oral biofilm.
  • the use of the oral care foam prevents the decay, remineralize the teeth and does not allow the cariogenic bacteria to multiply and quickly create unhealthy plaque. In the long run these actions will dramatically reduce the amount of tartar buildup on the tooth.
  • the lactoferrin comprised in the oral care foam of the present invention is conveyed by means of liposomes (ie., embedded in liposomes).
  • Lactoferrin is a multifunctional protein belonging to the transferrin family. In particular, it is a bilobed glycoprotein consisting of about 690 amino acids. Each lobe can reversibly bind one ferric ion. Lactoferrin is widely present in various secretory fluids, such the saliva, and represents one of the most important factors in the innated defense of the immunity system of the body, mainly at the mucosae level.
  • Lactoferrin is a natural chelator of metals, which shows antimicrobial activity against bacteria, fungi and pathogenic viruses that can infect the tissue.
  • lactoferrin inhibits the growth of these pathogenic microorganisms by chelating iron, which is a necessary co-factor for their development.
  • lactoferrin is embedded in liposomes in order to prevent its direct bound to minerals that are naturally present in the formulation as well as in the oral environment and, once bounded to the lactoferrin, can impair its antibacterial activity.
  • Calcium for example, is one of the main mineral constituents of hydroxyapatite and plays a key role in the structure and strength of bone and teeth.
  • the association, inside the same liquid formulation, of lactoferrin and hydroxyapatite, without losing the antibacterial activity of the former, is made possible by its encapsulation in liposomes, which, as previously stated, prevents the bond between lactoferrin and calcium, of which hydroxyapatite is rich, leaving the bounding sites of lactoferrin free for the iron chelation and, as consequence, allows the maintenance of its antibacterial activity.
  • Lactoferrin provides unique advantage in the oral care thanks to its capacity to selectively attack the harmful bacteria, while keeping a healthy microbiome. Unlike some traditional mouthwashes which can indiscriminately kill both harmful and healthy bacteria, the specificity of lactoferrin in liposomes of the oral care foam of the present invention leads to a steadier and better equilibrium between the microorganisms of the oral cavity.
  • lactoferrin makes it a promising ingredient for oral hygiene products. Its ability of integrating the natural protective mechanisms of saliva brings about an improved biological equilibrium of oral cavity and contributes to the general oral health.
  • liposome it is meant a vesicle consisting of at least one lipid bilayer and one core of aqueous solution encapsulated within the lipid bilayer.
  • the lipids constituting the liposome bilayer can comprise mixtures composed essentially of phospholipids, such as for example phosphatidylcholine, and cholesterol in a lower amount.
  • lipids useful to constitute the lipid bilayer of liposome are a mixture of lipids comprising at least 50% phosphatidylcholine.
  • the liposome can also comprise, in its lipid bilayer, further compounds of non-lipid nature, e.g., other organic compounds.
  • the liposomes can further comprise surfactants; according to the present invention, said surfactants may be ionic or non-ionic surfactants, preferably non-ionic, such as polysorbate 80 (also known as Tween 80®).
  • surfactants may be ionic or non-ionic surfactants, preferably non-ionic, such as polysorbate 80 (also known as Tween 80®).
  • the lactoferrin comprised in the liposomes is the one described in TH 02008901644744.
  • lactoferrin The encapsulation of lactoferrin into liposomes prevents the glycoprotein’s degradation, thus ensuring higher stability and an improved bioavailability thereof as well as the maintenance of its antibacterial ability.
  • the product when the product comprises hyaluronic acid as component, PEG, preferably PEG 40 can also be comprised, and vice versa.
  • the products of the invention can comprise lactoferrin and hyaluronic acid in combination with PEG, preferably PEG 40.
  • the product of the invention comprises hyaluronic acid
  • the hyaluronic acid can be inside or outside the lipid bilayer of liposomes.
  • the product of the invention comprises hyaluronic acid
  • the hyaluronic acid is encapsulated inside the lipid bilayer and solubilized in the core of aqueous solution inside the liposome lipid bilayer.
  • the products of the invention comprise PEG, preferably PEG 40, such PEG preferably forms a coating of the lipid bilayer of the liposomes.
  • the lactoferrin, encapsulated in liposomes is present in the oral care foam formulation in a percentage by weight, with respect to the total weight of the composition, between 0.1% and 1%.
  • the oral care foam which is the subject-matter of the present invention, further comprises hydroxyapatite.
  • Hydroxyapatite is the major component of teeth hard tissue, corresponding to 97% of the enamel and up to 70% of dentin.
  • the hydroxyapatite is present in the oral care foam formulation in a percentage by weight, with respect to the total weight of the composition, between 0.1% and 2%.
  • Aloe vera gel is a compound extracted from the Aloe barbaradensis plant. Said plant belongs to the Liliaceae family and contains various minerals and vitamins (including vitamin A, C, E, Bl, B2, B3, B6, choline, folic acid, alpha-tocopherol, beta-carotene, vitamin Bl 2).
  • the aloe vera gel is present in the oral care foam formulation in a percentage by weight, with respect to the total weight of the composition, between 0.1% and 1%.
  • trimethylglycine is in the oral care foam formulation in a percentage by weight, with respect to the total weight of the composition, between 1% and 5%.
  • xanthan gum is in the oral care foam formulation in a percentage by weight, with respect to the total weight of the composition, between 0.1% and 1%.
  • the oral care foam, object of the present invention can be formulated and produced following all the techniques known by the expert of the field and by adding all the necessary excipients normally employed in the related technical field. For example, but not limited to, water, organic short chain alcohols, wetting agents (humectants), preservatives, colorants, surfactants, foaming agents, thickeners, antioxidants, sweeteners, flavoring agents.
  • the wetting agents are, for example but not limited to, sorbitol and glycerol.
  • the betaine can act as a wetting agent.
  • the preservatives of the oral care foam can be a mixture of different compounds such as, but not limited to, phenoxyethanol, sodium benzoate, potassium sorbate, ethylhexylglycerin, benzyl alcohol, capryl glycol, ethylenediaminetetraacetic acid (EDTA), etcetera.
  • the oral care foam comprises:
  • Lactoferrin encapsulated in liposomes from 0.1% to 1% by weight to the total weight of the formulation;
  • Hydroxyapatite from 0.1% to 2% by weight to the total weight of the formulation
  • Xantan gum from 0.1 to 1% by weight to the total weight of the formulation
  • Aloe vera gel from 0.1% to 1% by weight to the total weight of the formulation
  • Hyaluronic acid from 0.01% to 0.5% by weight to the total weight of the formulation; and other excipients such as, at least, water and preservatives as listed above, to reach 100%.
  • the oral care foam formulation of the present invention is preferably packed in cans, more preferably under pressure.
  • the oral care foam formulation furthermore comprises propellants.
  • the oral care foam formulation of the present invention is in the form of a spray.
  • the oral care foam formulation of the present invention comprising lactoferrin in liposomes and hydroxyapatite, is for use in the prevention of dental plaque formation and buildup and in the maintenance of a healthy oral biofilm composition in mammals, preferably humans.
  • said oral care foam is intended for use in the veterinary field, for example but not limited to, in dogs, cats, horses, etcetera.
  • the oral care foam formulation of the present invention can also comprise some ingredient responsible for imparting a flavor pleasant for animals, such as, but not limited to, liver flavor.
  • the oral care foam of the invention has a preventive and therapeutic properties towards diseases, and in particular towards mouth diseases. It has been surprisingly found that the combination of lactoferrin, in particular lactoferrin conveyed in liposomes, and hydroxyapatite in the product of the invention show a surprising preventive and therapeutic effect on dental plaque and caries. Such effects are demonstrated in the following experimental section, which exemplify the present invention without any limiting effect.
  • the oral care foam of the present invention shows also other advantages with respect to the prior art.
  • it is easy to use and to transport, can be carried in suitcases and purses with no leaking problems, and used everywhere.
  • the basic formulation of the oral care foam, composed by the active ingredients and the main excipients, can be adapted to the veterinary use, simply by substituting the flavoring ingredient with a flavor suitable for the target animal.
  • the preferred foam formulation is easy to administer.
  • Another advantage of the oral care foam of the present invention is related to the treatment of the oral cavity in the pediatric and geriatric population. Both of these populations, in fact, often lack proper oral hygiene as they do not have the manual dexterity to perform effective brushing.
  • a novel oral cleaning system was proposed for those subjects which consists in a “360° toothbrush” which utilizes a tray as brushing system that is capable of ultrasonically cleaning all the teeth at once in about 30 seconds without the need to use your hands.
  • a toothpaste product with such a system
  • the oral care foam of the present invention has been shown, on the contrary, to be ideal for this type of ultrasonic device. This is particularly helpful for parents of younger children, the disabled and nursing home populations.
  • Orthodontics is another area in which the oral care foam of the present invention has proven to be highly effective. Brackets on teeth make the mechanical removal of plaque far more difficult. This resultant increase in plaque leads to demineralization around these brackets which causes permanent white spots on the teeth.
  • the oral care foam used after eating or drinking dramatically reduces the plaque buildup around brackets.
  • the oral care foam can be effectively and easily employed also in the veterinary field. For examples, dogs’ and cats’ oral health can be highly improved with the regular use of the oral care foam of the invention adapted, only in the flavor aspect, for pets. In fact, most pet owners do not regularly brush their pets’ teeth on a regular basis. As a result, plaque builds up which eventually leads to the buildup of tartar on the teeth.
  • the oral care foam of the present invention provides an ideal technology that is both easy to implement on a daily basis and helps improve the overall health of pets.
  • An oral care foam formulation according to the present invention was prepared with the components as reported in the following Table 1.
  • Table 1 qualitative-quantitative composition of an oral care foam formulation according to the invention.
  • Preparation of the aqueous phase (1) mix together all aqueous components, previously weighted, at a low stirring rate, until the phase appears homogeneous, for example stir for not less than 5 minutes. Once reached a homogeneous phase, add the thickening agent (ie., xanthan gum) and wait for the gelation of the solution.
  • the thickening agent ie., xanthan gum
  • An oral care foam formulation according to the present invention was prepared with the components as reported in the following Table 2.
  • Table 2 qualitative-quantitative composition of an oral care foam formulation according to the invention.
  • Example 3 Study protocol on the effects of the oral foam formulation of the present invention on plaque buildup and oral biofilm composition in at-risk populations
  • the present study protocol is applied in order to determine the degree of reduction of plaque buildup and the influence on the composition of the oral biofilm of the oral foam formulation of the invention.
  • Example 1 the formulation prepared according to the table and the method described in Example 1 is intended to be used as test formulation in the below described protocol.
  • the study utilizes a randomized controlled trial design, with five different groups of at-risk population:
  • Group 1 adolescents with a history of caries
  • Group 4 - pets dogs and cats
  • the study assesses plaque buildup and oral biofilm composition using standardized indices such as the Plaque index and an OraRisk Caries test, from OralDNA, to determine biofilm composition and caries risk.
  • test is performed using a saliva or biofilm sample collected from the patient’s mouth. This sample is then subjected to Polymerase Chain Reaction (PCR) to identify the presence and the quantity of bacteria involved in the caries formation, such as Streptococcus mutans and Lactobacillus spp.
  • PCR Polymerase Chain Reaction
  • the patients who received the oral care foam formulation of the present invention showed an improvement in the physiological bacterial flora, including but not limited to Streptococcus salivarius and Streptococcus mitis.
  • the patients who received the oral care foam formulation of the present invention also showed a notably inhibition of the proliferation of bacteria, such as Streptococcus mutans, keeping it within physiological limits.
  • the use of the oral foam containing hydroxyapatite and liposomal lactoferrin offers significant benefits in maintaining oral microbiota balance and preventing the overgrowth of cariogenic bacteria in patients prone to periodontal diseases.
  • lactoferrin The encapsulation of lactoferrin within liposomes protects the lactoferrin from denaturation and also enables its slow, controlled release, thereby preventing biofilm formation.
  • Liposomal lactoferrin plays a multifaceted role in treated patients; by way of example, but not limited to, liposomal lactoferrin exercises a bactericidal activity by directly interacting with bacterial cell walls, leading to the disruption of pathogenic microorganisms. In other words, the liposomal lactoferrin inhibits bacterial proliferation.
  • liposomal lactoferrin displays iron-chelating activity which allows to deprive bacteria of the essential iron needed for their growth.
  • this triple-action mechanism of liposomal lactoferrin not only limits harmful bacterial activity but also promotes a balanced oral microbiome.
  • the hydroxyapatite contained in the formulation of the present invention compensate for dysbiosis resulting from prolonged intake of carbohydrates and acids.
  • hydroxyapatite acts as a protective agent for the tooth surface, preventing excessive demineralization that typically occurs within the 20-minute window before saliva neutralizes the acidic environment generated by the consumption of carbohydrates and acids.
  • hydroxyapatite promotes the restoration of the mineral balance, the filling micro-lesions and the sealing dentinal tubules, which contributes to a smoother, healthier tooth surface.
  • the control group shows less healthy dental conditions, characterized by an increased plaque accumulation, persistent dentinal hypersensitivity and a greater tendency to develop caries due to continued demineralization and bacterial activity.
  • the anti-inflammatory properties of liposomal lactoferrin contribute to the reduction of gingival inflammation and the inhibition of plaque formation, supporting overall periodontal health.
  • lactoferrin levels in saliva are physiologically downregulated.
  • the low levels of lactoferrin quickly saturate, thus nullifying its antibacterial and antibiofilm action.
  • the proposed study aimed to investigate the effects of hydroxyapatite and liposomal lactoferrin on plaque buildup and oral biofilm composition in at risk populations.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Birds (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cosmetics (AREA)

Abstract

L'invention concerne une mousse de soins buccodentaires comprenant de la lactoferrine et de l'hydroxyapatite, utilisées en tant que principes actifs, pour empêcher la formation de plaque dentaire et de caries dans la cavité buccale et sur la surface des dents.
PCT/EP2025/064758 2024-06-03 2025-05-28 Mousse de soins buccodentaires à base de lactoferrine et d'hydroxyapatite Pending WO2025252565A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202400012607 2024-06-03
IT102024000012607 2024-06-03

Publications (1)

Publication Number Publication Date
WO2025252565A1 true WO2025252565A1 (fr) 2025-12-11

Family

ID=92208897

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/064758 Pending WO2025252565A1 (fr) 2024-06-03 2025-05-28 Mousse de soins buccodentaires à base de lactoferrine et d'hydroxyapatite

Country Status (1)

Country Link
WO (1) WO2025252565A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008081424A (ja) * 2006-09-27 2008-04-10 Lion Corp 歯の美白用セット
JP4875381B2 (ja) * 2006-02-24 2012-02-15 サンスター株式会社 ラクトフェリン内包リポソームを含有する口腔用組成物
WO2013068020A1 (fr) * 2011-11-08 2013-05-16 Coswell S.P.A. Produits de soin dentaire contenant des particules d'hydroxyapatite biomimétiques à surface fonctionnalisée par de la lactoferrine
DE102010063720B4 (de) * 2010-12-21 2020-06-18 Lr Health & Beauty Systems Gmbh Silberhaltige Zahnpflegezusammensetzung
JP6804911B2 (ja) * 2016-09-16 2020-12-23 サンスター株式会社 抗ポルフィロモナス・ジンジバリス組成物
CN115624499A (zh) * 2022-11-17 2023-01-20 杭州三品良道商贸有限责任公司 一种美白抗过敏牙膏
CN117482026A (zh) * 2023-11-30 2024-02-02 阳亿孚科技(上海)有限公司 一种含有乳铁蛋白的可修复牙釉质的抑菌牙膏组合物

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4875381B2 (ja) * 2006-02-24 2012-02-15 サンスター株式会社 ラクトフェリン内包リポソームを含有する口腔用組成物
JP2008081424A (ja) * 2006-09-27 2008-04-10 Lion Corp 歯の美白用セット
DE102010063720B4 (de) * 2010-12-21 2020-06-18 Lr Health & Beauty Systems Gmbh Silberhaltige Zahnpflegezusammensetzung
WO2013068020A1 (fr) * 2011-11-08 2013-05-16 Coswell S.P.A. Produits de soin dentaire contenant des particules d'hydroxyapatite biomimétiques à surface fonctionnalisée par de la lactoferrine
JP6804911B2 (ja) * 2016-09-16 2020-12-23 サンスター株式会社 抗ポルフィロモナス・ジンジバリス組成物
CN115624499A (zh) * 2022-11-17 2023-01-20 杭州三品良道商贸有限责任公司 一种美白抗过敏牙膏
CN117482026A (zh) * 2023-11-30 2024-02-02 阳亿孚科技(上海)有限公司 一种含有乳铁蛋白的可修复牙釉质的抑菌牙膏组合物

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