ORAL HYGIENE FOAM BASED ON LACTOFERRIN AND HYDROXYAPATITE

Description

DESCRIPTION of the invention having the title: “ORAL CARE FOAM BASED ON LACTOFERRIN AND HYDROXYAPATITE” On behalf of: 50% TDC Technology Dedicated to Care srl, an Italian company with operational headquarters in Via Copernico 38, 20125 Milan 5 50% Pawlus Dental, a US company with headquarters at 4001 W. Goeller Blvd, Suite C, Columbus, IN 47201 Inventors: Martina Biancardi, Italian national, resident in Spain John Pawlus, American national, resident in the United States of America **** 10 S T A T E OF ART The formation of plaque in the mouth, particularly on the surfaces of the teeth and in the spaces interdental, it is absolutely physiological. However, it is important to remove dental plaque through careful dental hygiene to avoid the formation of tartar and tooth decay which can lead to mouth diseases such as 15 inflammation of the gums, namely gingivitis, periodontitis and finally tooth decay. There are currently several methods to prevent plaque formation on the surface of the teeth and in the interdental spaces. The most effective way to prevent plaque and tartar formation is dental cleaning periodic professional, which is performed using specific tools. More specifically, such 20 tools allow you to scrape the surface of the teeth to mechanically remove the plaque already formed and calcified spots. The main drawback of professional dental cleaning for plaque removal dental lies in its invasiveness, as it requires the simultaneous action of several instruments in the patient's mouth. 25 Another drawback of professional teeth cleaning is that it must be performed by qualified medical personnel, such as dentists or hygienists, and in a dental office authorized. An additional drawback is that periodic professional dental cleaning can be expensive. 30 Another way to prevent the formation of dental plaque and tartar is the regular use of a fluoride toothpaste, which strengthens tooth enamel and reduces the risk of tooth decay. However, there is currently increased concern in the world about the toxicity and side effects of long-term fluoride. Another method to prevent the formation of dental plaque and tartar is to incorporate more effective tools in daily oral hygiene practice. For example, it has been demonstrated that using an electric toothbrush is more effective in removing plaque than the manual toothbrush. Additionally, in combination with dental floss it is possible 5 Reach the most hidden spots for better results. The main drawback of these solutions is that it is difficult to be consistent. with the use of this type of deep cleaning every day, for compliance reasons and / or when when travelling or, more generally, when you are away from home. Another way to prevent dental plaque formation is to incorporate a mouthwash or 10 an oral hygiene product in the daily practice of oral hygiene. However, the mouthwashes already available on the market must be used consistently, at least twice a day. times a day, to be effective. This can be a limitation for people who have a active life and am often away from home. Another drawback of these mouthwashes is that they are in liquid form, which makes it difficult 15 transport them and adapt their use to places other than home. Currently some mouthwashes already available on the market for humans are intended for can also be used in the veterinary field. The disadvantages of these products lie in the fact that these mouthwashes are liquid and therefore not easily administered to animals and furthermore they are formulated with agents 20 flavorings, such as mint or cinnamon, that are pleasant to humans but can be unpleasant to animals. For all the above reasons there remains the need for an oral hygiene composition / the mouthwash capable of overcoming all the drawbacks of the prior art, which can be used by humans but also in the veterinary field. In particular, it remains 25 still need an oral hygiene / oral wash product that is easy to use and transportable, stable under different environmental conditions, effective in preventing plaque formation and its removal, which restores and maintains fresh breath. PURPOSES OF THE INVENTION The object of the present invention is to provide a foam formulation for 30 oral hygiene can protect tooth enamel, prevent dental plaque and tooth decay while maintaining fresh breath for a long time. Another object of the present invention is to provide a foam formulation for oral hygiene that involves non-invasive use. Another object of the present invention is to provide a foam formulation for oral hygiene that can be used by non-medically qualified persons and in a non-medical context. A further object of the present invention is to provide a formulation in 5 cost-effective oral hygiene foam. Another object of the present invention is to provide a foam formulation for oral hygiene that is easy to use even when the user is travelling or, in General, he is far from home. A further object of the present invention is to provide a formulation in 10 oral hygiene foam that can be formulated with different flavors so as to be pleasant not only for humans, but also for other animals such as, but not limited to, dogs, cats and horses. DESCRIPTION OF THE INVENTION The purposes stated above, as well as other purposes, are achieved thanks to the matter in 15 object of the present invention, namely, a foam formulation for oral hygiene which includes lactoferrin in liposomes and hydroxyapatite as active ingredients. As will be shown in the experimental section, the oral hygiene foam, which is the subject matter of the present invention, is useful for the prevention of dental plaque and caries, for the maintenance of a healthy composition of the oral biofilm and for the treatment of diseases 20 of the mouth. As previously reported, tooth decay is one of the most common diseases affecting the human race. It is caused by dysbiosis or an imbalance of the oral biofilm. The time when tooth decay develops and the biofilm becomes dysbiotic is shortly after eating. and drank; after consuming a food or drink rich in carbohydrates, the pH drops to 25 below 5.2 due to acid-producing bacteria. At this acidic pH, hydroxyapatite, which forms the outer matrix of tooth enamel, begins to be released from the surface of the enamel. Saliva takes about 20 minutes to neutralize the acid and stop the demineralization of the teeth. If a sufficient portion of the tooth surface becomes demineralized, then a cavity forms which must then be removed and treated in a dental practice 30 dental. In light of the above, a new product, such as an oral hygiene foam, is needed. that can be used immediately after eating or drinking, while the use immediate brushing of a toothbrush is not recommended due to the risk of greater damage mechanically to the surface of the teeth. In particular, oral hygiene foam should neutralize the acid pH and prevent the multiplication of acidophilic and acid-producing bacteria, which is what creates the bacterial imbalance associated with a dysbiotic oral biofilm. Therefore, the use Oral hygiene foam prevents tooth decay, remineralizes teeth and does not allow bacteria cariogenic bacteria to multiply and rapidly create unhealthy plaque. In the long term, these 5 actions will dramatically reduce the amount of tartar buildup on your teeth. After intensive research, the applicant succeeded in developing the formulation in oral hygiene foam of the present invention, which is able to solve the problems above mentioned technicians and showing all the advantages which will be clearly reported in the description and in the experimental part that follows. 10 The lactoferrin contained in the oral hygiene foam of the present invention is conveyed by means of liposomes (i.e., incorporated into liposomes). Lactoferrin is a multifunctional protein belonging to the transferrin family. In particular, it is a bilobed glycoprotein consisting of approximately 690 amino acids. Each lobe can reversibly bind a ferric ion. Lactoferrin is widely present in various 15 secretory fluids, such as saliva, and represents one of the most important factors in the innate defense of the body's immune system, especially at the level of the mucous membranes. Lactoferrin is a natural metal chelator, which shows antimicrobial activity against Pathogenic bacteria, fungi, and viruses that can infect tissues. More specifically, lactoferrin inhibits the growth of these pathogenic microorganisms by chelating iron, which is a co-factor 20 necessary for their development. In the present invention, lactoferrin is incorporated into liposomes to prevent it from binding directly to the minerals naturally present in the formulation as well as in the oral environment which, once bound to lactoferrin, can compromise its antibacterial activity. Calcium, for example, is one of the main mineral constituents of hydroxyapatite and plays a 25 plays a fundamental role in the structure and strength of bones and teeth. The association, within of the same liquid formulation, of lactoferrin and hydroxyapatite, without losing the activity antibacterial of the first, is made possible by the encapsulation of the latter in liposomes, done which, as previously stated, prevents the binding between lactoferrin and calcium, of which hydroxyapatite is rich, leaving the binding sites of lactoferrin free for chelation of the 30 iron and, consequently, allows the maintenance of its antibacterial activity. Lactoferrin provides a unique advantage in oral hygiene due to its ability to attach selectively kills harmful bacteria while maintaining a healthy microbiome. Unlike some traditional mouthwashes that can indiscriminately kill both harmful bacteria and healthy bacteria, the specificity of lactoferrin in oral hygiene foam liposomes This invention leads to a more stable and better balance between the microorganisms in the cable Oral. By selectively inhibiting the growth of harmful bacteria, such as, but not limited to, Streptococcus mutans and Porphyromonas gingivalis, while sparing healthy bacteria, 5 Lactoferrin promotes a healthier microbial environment. This microbial ecosystem balanced is essential to maintain good oral hygiene and to prevent the development of oral diseases such as tooth decay and periodontal disease. Furthermore, the combination of efficacy, specificity and safety of lactoferrin makes it a promising ingredient for oral hygiene products. Its ability to complement the 10 natural protective mechanisms of saliva determines an improved biological balance of the oral cavity and contributes to the general health of the mouth. In the present invention, the term “liposome” means a vesicle consisting of at least one lipid bilayer and an aqueous solution core encapsulated in the lipid bilayer. The lipids that constitute the liposomal bilayer (or the lipids that form liposomes) can 15 include mixtures composed essentially of phospholipids, such as phosphatidylcholine and cholesterol in smaller quantities. For example, the lipids useful for building Liposome lipid bilayer is a mixture of lipids comprising at least 50% of phosphatidylcholine. The liposome may also include, in its lipid bilayer, further compounds of a non-lipid nature, such as other organic compounds. For example, but not limited to, 20 liposomes may further comprise surfactants; according to the present invention, said Surfactants can be ionic or non-ionic surfactants, preferably non-ionic, such as ® polysorbate 80 (also known as Tween 80). The lactoferrin contained in the liposomes, according to the invention, is preferably encapsulated within the lipid bilayer, and even more preferably is solubilized in the core of the 25 aqueous solution that is typically enclosed in the lipid bilayer. According to a non-limiting preferred embodiment, the lactoferrin contained in the liposomes is the one described in IT102008901644744. As stated previously, lactoferrin exhibits antimicrobial activity against bacteria, pathogenic fungi and viruses that can infect tissues. More specifically, lactoferrin inhibits 30 the growth of these pathogenic microorganisms by chelating iron, which is a necessary co-factor for their development. Encapsulation of lactoferrin in liposomes prevents degradation of the glycoprotein, thus ensuring greater stability and improved bioavailability of the same, as well as maintaining its antibacterial capacity. The liposomes according to the present invention may comprise, in addition to lactoferrin, at least one component selected from hyaluronic acid and / or polyethylene glycol (PEG, “polyethylene glycol”), preferably PEG40. According to a particular aspect of the invention, when the product comprises the acid 5 hyaluronic acid as a component, may also contain PEG, preferably PEG 40, and vice versa. In other words, the products of the invention may contain lactoferrin and hyaluronic acid in combination with PEG, preferably PEG 40. When the product of the invention includes hyaluronic acid, hyaluronic acid can be found inside or outside the bilayer lipid of liposomes. 10 According to another aspect, when the product of the invention comprises hyaluronic acid, Hyaluronic acid is encapsulated within the lipid bilayer and solubilized in the core of the aqueous solution within the lipid bilayer of the liposome. When the products of the invention comprise PEG, preferably PEG 40, such PEG forms preferably a lipid bilayer coating of liposomes. 15 According to a preferred aspect of the present invention, lactoferrin, encapsulated in liposomes, It is present in the oral hygiene foam formulation in a percentage by weight, compared to to the total weight of the composition, between 0.1% and 1%. The oral hygiene foam, which is the subject matter of the present invention, comprises also hydroxyapatite. Hydroxyapatite is the main component of the hard tissue of teeth, which 20 corresponds to 97% of the enamel and up to 70% of the dentin. According to a preferred aspect of the present invention, hydroxyapatite is present in the oral hygiene foam formulation in a percentage by weight, relative to the total weight of the composition, between 0.1% and 2%. In a particular aspect, the oral hygiene foam of the present invention can 25 also include other active agents, such as aloe vera gel. Aloe vera gel is a compound extracted from the Aloe barbaradensis plant. This plant belongs to the Liliaceae family and contains various minerals and vitamins (including vitamin A, C, E, B1, B2, B3, B6, choline, folic acid, alpha-tocopherol, beta-carotene, vitamin B12). According to a preferred aspect of the present invention, aloe vera gel is present in the 30 oral hygiene foam formulation in a percentage by weight, compared to the total weight of the composition, between 0.1% and 1%. Optionally, the oral hygiene foam of the present invention may comprise also arbutin, a natural substance derived from hydroquinone. Specifically, arbutin is a glycosylated derivative of hydroquinone extracted from the bearberry plant, particularly from its leaves. According to another aspect, the oral hygiene foam of the present invention can also include one or more ingredients responsible for its flavour and capable of giving a 5 sensation of prolonged freshness in the mouth. More specifically, it may also include, for example: for example, but not limited to, Menthol, Eucalyptus, Licorice, Green Tea or Pomegranate. According to a further aspect, the oral hygiene foam of the present invention can include betaine (trimethylglycine), an amino acid derivative found in plants, in particularly in beetroot, used to moisturize and protect oral mucous membranes, and 10 xanthan gum, used to stabilize the solution. When present, trimethylglycine is in the oral hygiene foam formulation in a percentage by weight, with respect to the total weight of the composition, between 1% and 5%. When present, xanthan gum is in the oral hygiene foam formulation in a percentage by weight, with respect to the total weight of the composition, between 0.1% and 1%. 15 According to a preferred aspect, the oral foam formulation of the present invention includes hyaluronic acid. When present, said hyaluronic acid is preferably 0.01%. at 0.5% by weight of the total weight of the formulation. The oral hygiene foam of the present invention can be formulated and produced following all the techniques known to the expert in the field and adding all the necessary excipients 20 normally used in the relevant technical sector. For example, but not limited to, water, short-chain organic alcohols, wetting agents (humectants), preservatives, colorants, surfactants, foaming agents, thickeners, antioxidants, sweeteners, flavoring agents. In a preferred aspect of the invention, the wetting agents are, for example but not limited to limitation, sorbitol and glycerol. Betaine can also act as a wetting agent. 25 For example, oral hygiene foam preservatives can be a mixture of several compounds such as, but not limited to, phenoxyethanol, sodium benzoate, potassium sorbate, ethylhexylglycerin, benzyl alcohol, capryl glycol, ethylenediaminetetraacetic acid (EDTA, “ethylenediaminetetraacetic acid”), etc. In a preferred aspect of the present invention, the oral hygiene foam comprises: 30 lactoferrin encapsulated in liposomes from 0.1% to 1% by weight with respect to the total weight of the formulation; hydroxyapatite from 0.1% to 2% by weight with respect to the total weight of the formulation; betaine from 1% to 5% by weight with respect to the total weight of the formulation; xanthan gum from 0.1 to 1% by weight with respect to the total weight of the formulation; aloe vera gel from 0.1% to 1% by weight of the total weight of the formulation; hyaluronic acid from 0.01% to 0.5% by weight with respect to the total weight of the formulation; and other excipients such as, at least, water and preservatives as listed above, for reach 100%. 5 The oral hygiene foam formulation of the present invention is preferably packaged in cans, preferably under pressure. In this aspect, the formulation oral hygiene foam also includes propellants. According to a preferred aspect, the oral hygiene foam formulation of this invention is in the form of a spray. 10 The oral hygiene foam formulation of the present invention, which comprises lactoferrin in liposomes and hydroxyapatite, is for use in the prevention of the formation and accumulation of dental plaque and in maintaining a healthy composition of the oral biofilm in mammals, preferably humans. According to another aspect, this oral hygiene foam is intended for use in the field of 15 veterinarian, for example, but not limited to, in dogs, cats, horses, etc. According to this last aspect, the oral hygiene foam formulation of the present invention may also include an ingredient responsible for imparting a flavor pleasant to animals, such as, but not limited to, the aroma of liver. The oral hygiene foam of the invention has preventive and therapeutic properties in 20 comparisons of diseases and in particular with respect to oral diseases. It was surprisingly found that the combination of lactoferrin, especially lactoferrin carried in liposomes, and hydroxyapatite in the product of the invention shows a surprising preventive and therapeutic effect on dental plaque and caries. These effects are demonstrated in the following experimental section, which exemplifies the present invention without any effect 25 limiting. In addition to its increased activity against the formation of dental plaque, the foam for The oral hygiene of the present invention also shows other advantages compared to the technique front. In particular, it is easy to use and carry, it can be carried in a suitcase and in bag without leakage problems and can be used anywhere. The basic formulation of the 30 oral hygiene foam, composed of the active ingredients and the main excipients, can be adapted for veterinary use, simply by replacing the flavouring ingredient with an aroma suitable for the desired animal. In addition, the preferred foam formulation is easy to administer. Another advantage of the oral hygiene 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 because they do not have the manual skills necessary for brushing teeth effectively. A new method has recently been proposed 5 oral cleaning system for these subjects which consists of a “360° toothbrush” which uses a tray-like brushing system capable of ultrasonic cleaning of all teeth simultaneously in about 30 seconds, without having to use your hands. How can you Imagine, it is very difficult to use a toothpaste product with such a system, but the oral hygiene foam of the present invention has proven, on the contrary, to be 10 ideal for this type of ultrasound device. This is especially useful for parents of younger children, for disabled people and for people living in retirement homes. Orthodontics is another area where the oral hygiene foam of the present invention finds its application. It has proven to be very effective. Dental braces make removal much more difficult. plaque mechanics. The resulting increase in plaque leads to demineralization 15 around these devices that cause permanent white spots on the teeth. The foam for Oral hygiene used after eating or drinking dramatically reduces plaque accumulation around the appliances. Furthermore, as previously reported, oral hygiene foam can be effectively and easily used also in the veterinary field. For example, oral health 20 of dogs and cats can be significantly improved with regular use of hygiene foam oral version of the invention adapted, only in terms of flavour, to domestic animals. In fact, the Most pet owners don't brush their pets' teeth regularly. pets. As a result, plaque builds up, which eventually leads to the accumulation of tartar on the teeth. Over time, this buildup can cause periodontal disease, which 25 often results in tooth loss as well as increased inflammation systemic. This leads to an increased risk of numerous chronic diseases such as diabetes, coronary heart disease and cancer. As dogs / cats age, it becomes much more It is dangerous to perform general anesthesia to remove these tartar deposits in a dental office. veterinary. The oral hygiene foam of the present invention provides a technology 30 ideal, which is easy to apply on a daily basis and which helps improve health general of pets. The invention will be exemplified in the following experimental section for illustrative purposes and non-limiting. EXPERIMENTAL SECTION Example 1 A foam formulation for oral hygiene according to the present invention has been prepared with the components as reported in the following Table 1. Table 1: Qualitative-quantitative composition of a hygiene foam formulation 5 oral according to the invention. Component Percentage (by weight of total weight) water up to 100 sorbitol 20 cocamidopropyl betaine 7 lactoferrin encapsulated in liposomes 1 1.5 hydroxyapatite glycolipids 3 betaine 1 menthyl lactate 0.2 sodium benzoate 0.2 potassium sorbate 0.2 phenoxyethanol 1 benzyl alcohol 0.5 Aloe barbaradensis leaf juice 0.1 sorbitan sesquicaprylate 0.5 sodium lauroyl sarcosinate 1.5 VP / VA 0.8 copolymer hyaluronic acid 0.2 xanthan gum 0.3 glycerin 4 propylene glycol 2 xylitol 0.1 Punica granatum fruit extract 0.1 (glyceric extract) menthol 0.1 Peppermint 0.1 Eucalyptus globulus leaf oil 0.1 Rubus idaeus fruit extract 0.1 (glyceric extract) Glycerrhiza glabra root extract 0.1 (glyceric extract) Camellia sinensis leaf extract 0.1 (glyceric extract) arbutin 0.5 theobromine 0.5 lysozyme 0.5 papain 0.5 tocopherol 0.2 hydrogenated castor oil PEG 40 1 sucralose 0.1 propylene glycol 3 sodium bicarbonate to reach a pH of 6.3 Production stages of oral hygiene foam reported in Table 1 and according to the invention. 1. Preparation of the aqueous phase (1): mix all the aqueous components together, 5 previously weighed, at low stirring speed, until the phase appears homogeneous, for example by shaking for no less than 5 minutes. Once a homogeneous phase is reached, add the thickening agent (e.g. xanthan gum) and wait for it to gel of the solution. 2. Preparation of the surfactant mixture (2): Mix the surfactants together 10 previously weighed, with low stirring, until a homogeneous mixture is obtained. 3. Preparation of the extract mixture (3): Weigh and shake together lightly all the extracts until you get a smooth mixture. 4. Add the extract mixture (3) to the surfactant mixture (2) and shake gently until phase (3)+(2) appears homogeneous. Then add the aqueous phase (1) to phase (3)+(2) 15 stirring at low speed until a homogeneous solution is obtained (3)+(2)+(1). 5. Measure the pH of the solution (3)+(2)+(1) and, if necessary, add sodium bicarbonate to reach a pH value around pH 6. Note: The initial pH of the oral hygiene formulation in Table 1, before correction with sodium bicarbonate, it was equal to pH 5.78. Following the addition of bicarbonate, the pH has reached a value equal to pH 6.3. Example 2 5 An oral hygiene foam formulation according to the present invention has been prepared with the components as reported in the following Table 2. Table 2: Qualitative-quantitative composition of a hygiene foam formulation oral according to the invention. Component Percentage (by weight of total weight) water up to 100 sorbitol 4 cocamidopropyl cetaine 9 Lactoferrin encapsulated in liposomes 1 hydroxyapatite 2 glycolipids 5 betaine 1.5 menthyl lactate 0.4 sodium benzoate 0.5 potassium sorbate 0.5 polysorbate 20 1 benzyl alcohol 0.5 Aloe barbaradensis leaf juice 1 sorbitan sesquicaprylate 0.1 sodium lauroyl sarcosinate 7 hyaluronic acid 0.5 clove essential oil 0.2 spearmint flavor 0.4 glycerin 5 propylene glycol 2 xylitol 0.1 Punica granatum fruit extract 0.1 (glyceric extract) menthol 0.2 peppermint 0.2 Eucalyptus globulus leaf oil 0.2 Rubus idaeus fruit extract 0.1 (glyceric extract) Glycerrhiza glabra root extract 0.1 (glyceric extract) Camellia sinensis leaf extract 0.1 (glyceric extract) arbutin 0.5 xanthan gum 0.2 rosemary essential oil 0.1 10% citric acid solution 0.1 tocopherol 0.2 sucralose 0.01 The production process is consistent with that reported for example 1 above. Example 3: Study protocol on the effects of the oral foam formulation of this invention on plaque accumulation and oral biofilm composition in populations 5 risk This study protocol will be applied to determine the degree of reduction of plaque accumulation and the influence of the formulation on the oral biofilm composition in oral foam of the invention. Specifically, the formulation prepared according to the table and method described in Example 10 1 is intended to be used as a test formulation in the protocol described below. In particular, the study will use a controlled trial design. randomized, with five different population groups at risk: Group 1 - adolescents with a history of caries; Group 2 - elderly people and disabled individuals with insufficient manual dexterity for brushing 15 teeth; Group 3 - individuals wearing orthodontic appliances at risk of decalcification; Group 4 - pets (dogs and cats); Group 5 - individuals with xerostomia. Participants will be assigned to the intervention group, which receives the foam formulation for oral hygiene of the present invention (Table 1) containing hydroxyapatite and lactoferrin liposomal, or to the control group, which receives a placebo oral foam. The study will evaluate plaque accumulation and oral biofilm composition using indices 5 standardized as the Plaque Index and an OraRisk Caries test, by OralDNA, for determine the composition of the biofilm and the risk of caries. The data will be collected at the line baseline, after four weeks and again at eight weeks. A statistical analysis will be conducted to compare outcomes between the intervention and control groups within each of the five study groups. 10 The proposed study aims to investigate the effects of hydroxyapatite and liposomal lactoferrin on plaque accumulation and oral biofilm composition in at-risk populations. The results of this research will contribute to the development of innovative interventions for oral hygiene, adapted to the specific needs of individuals with a history of caries, limited dexterity, orthodontic appliances, dry mouth, and pets prone to tartar buildup.

Claims

1. An oral hygiene foam formulation comprising hydroxyapatite and liposomes containing lactoferrin.

2. The oral hygiene foam formulation according to claim 1 characterized in that said hydroxyapatite is from 0.1% to 2% by weight with respect to the total weight of the formulation.

3. The oral hygiene foam formulation according to claim 1 or 2 characterized in that said liposomes containing lactoferrin comprise at least one component selected from hyaluronic acid and / or polyethylene glycol (PEG).

4. The oral hygiene foam formulation according to any of the preceding claims characterised in that said liposomes containing lactoferrin are from 0.1% to 1% by weight with respect to the total weight of the formulation.

5. The oral hygiene foam formulation according to any of the preceding claims characterised in that it further comprises betaine, said betaine preferably being from 1% to 5% by weight with respect to the total weight of the formulation.

6. The oral hygiene foam formulation according to any of the preceding claims characterised in that it further comprises Aloe vera gel, said Aloe vera gel preferably being from 0.1% to 1% by weight with respect to the total weight of the formulation.

7. The oral hygiene foam formulation according to any of the preceding claims characterised by being packaged in cans, preferably under pressure.

8. The foam formulation for oral hygiene according to claims 1-7 characterised by being in the form of a spray.

9. The oral hygiene foam formulation according to claim 1 for use in the prevention of dental plaque formation and accumulation and in maintaining a healthy oral biofilm composition in humans.

10. The oral hygiene foam formulation according to claim 1 for use in the prevention of dental plaque formation and accumulation and in maintaining a healthy oral biofilm composition, in the veterinary field, preferably in cats, dogs and horses.