Biotechnological mixture for producing oral care products

Abstract

The present invention relates to a biotechnological mixture for producing oral care products, which comprises: lactoferrin as an antimicrobial agent and a caries and dental plaque prevention agent; xylitol as a bacterial growth inhibitor, which prevents the formation of caries and reduces tooth sensitivity; and coconut oil (Cocos nucifera L.) as an antimicrobial agent, dental plaque reducer, anti-inflammatory agent, humectant and emollient. The invention also relates to oral care products comprising the biotechnological mixture proposed in the invention.

Description

[0001] BIOTECHNOLOGICAL MIXTURE FOR THE MANUFACTURE OF ORAL CARE PRODUCTS

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] The present invention relates to the technical fields of Biotechnology and Health, since it provides a biotechnological mixture to produce oral care products; it also provides said oral care products that comprise said biotechnological mixture.

[0004] BACKGROUND OF THE INVENTION

[0005] Oral diseases, common and non-contagious, such as tooth decay and periodontitis (diseases of the tissues surrounding and supporting the teeth), affect people throughout their lives, causing pain, discomfort, disfigurement, and even life-threatening risks. These conditions impact approximately half the world's population, affecting 3.58 billion people.

[0006] Currently, Mexico and most countries worldwide face a significant oral health problem, with approximately 95% of the population experiencing or having experienced tooth decay at some point in their lives (WHO). This is why science and medicine are exploring new alternatives, based on natural compounds and methods, to prevent and improve oral health. Thanks to advancements and the application of new technologies, the antimicrobial properties of extracts from various plants and naturally occurring proteins have been discovered and better understood.

[0007] Specifically in Mexico, the magnitude of this impact is considerable, affecting 90% of the population with cavities and 70% with periodontal diseases, and current products on the market do not effectively meet the preventive needs of the population.

[0008] Current oral care products only provide a very short-lived ability to prevent plaque formation, 30-60 minutes at best. Furthermore, many of these products contain chemicals harmful to health and the environment, such as fluoride and irritating cleaning agents like sodium lauryl sulfate (SLS). This means they cannot be used by everyone, and are particularly harmful to people with hypothyroidism, lupus, syndromes affecting the salivary glands, and children, among others. In addition, these conventional oral products cause an imbalance in the oral microbiota, as well as irritation or dryness in areas of the mouth such as the cheeks, tongue, and gums.

[0009] Due to the multifunctionality of lactoferrin, its use in therapy has been proposed. It has been reported that the use of lactoferrin, xylitol, or their combination in in vitro studies on the structure of P. aeruginosa biofilms has resulted in a reduction in viability of >2 log when used in combination. This is due to the ability of xylitol to disrupt the biofilm structure and the bacterial permeabilization caused by lactoferrin. Therefore, the combined use of both molecules is currently proposed for the treatment of biofilm elimination.

[0010] Thanks to the antimicrobial activity of lactoferrin, formulations using activated lactoferrin (ALF) have been developed that prevent the interaction of bacteria with tissues. These types of preparations will generate benefits for human health, including oral health (plaque control, mouthwashes, denture cleaning, etc.). For example, Ammonsa et al. (2009) examined the potentially synergistic relationship between lactoferrin and xylitol in reducing the viability of a P. aeruginosa biofilm derived from a chronic wound cultured in vitro. To do this, an isolate of P. aeruginosa 215 from clinical wounds (Southwest Regional Wound Clinic, Lubbock, TX) was cultured overnight in 10% trypsin soybean broth (TSB) at 37 °C in flow cell reactors and used to inoculate the reactor. TSB at 10% was used for both batch growth mode and flow mode for flow cell reactors.The overnight culture of P. aeruginosa 215 was grown in 100% brain-heart infusion (BHI) broth at 37°C and used to inoculate 10% BHI broth at room temperature for CDC reactors. For lactoferrin or xylitol treatments, 2% (w / v) lactoferrin (Bioferrin®; Glanbia Nutritionals Inc., Monroe, WI) or 5% (w / v) xylitol (Sigma-Aldrich, St. Louis, MO) was added to the flow medium (10% BHI broth). They found that the combined treatment of established biofilm with lactoferrin and xylitol showed almost complete disruption of the P. aeruginosa biofilm structure, with few bacterial cells still attached to the growth surface (lower right panel). E1 patent document CN113633574A refers to an anti-caries mouthwash and method of preparing the same.The mouthwash has sterilizing, anti-inflammatory, anti-caries, and breath-freshening effects, effectively protecting the oral cavity to keep it clean and healthy. The anti-caries mouthwash contains, by mass percentage, 2-3% modified cyclodextrin antibacterial inclusion complex, 0.5-2% lysozyme, 2-5% humectant, 0.2-1% surfactant, 0.1-0.5% flavoring, 1-2% xylitol, and the remainder is deionized water. The modified cyclodextrin antibacterial inclusion complex is obtained by grafting lactoferrin onto a p-cyclodextrin inclusion complex, and the p-cyclodextrin inclusion complex is a p-cyclodextrin inclusion complex of tea polyphenols and coconut oil. Preferably, the modified cyclodextrin antibacterial inclusion complex is prepared as follows: lactoferrin and p-cyclodextrin inclusion complex are added to a borate buffer solution with a pH of 8.0-8.5, and then genipin is added, stirred and dispersed, and then stirred in a stirring box at a constant temperature of 37°C for 5-6 h, cooled to room temperature, dialyzed and lyophilized to obtain the modified cyclodextrin antibacterial inclusion complex. It also comprises humectants such as sorbitol, glycerol or a combination of both. The modified cyclodextrin antibacterial inclusion compound can be well absorbed on the tooth surface, and the polyphenols from tea and coconut oil that are continuously released have bactericidal effects, especially against the dental caries pathogenic bacteria Streptococcus mutans.It has a good inhibitory and lethal effect and, with the cooperation of surfactants, can penetrate the spaces between teeth and dental cavities, inhibit the growth and reproduction of pathogenic bacteria in the oral cavity, reduce the local deposition of dental plaque, reduce the possibility of tooth decay and improve gum health.

[0011] As can be seen, document CN113633574A mentions the use of lactoferrin to modify p-cyclodextrin, but not for use as a toothpaste. In addition to containing anhydrous coconut oil ethanol, it contains p-cyclodextrin and tea polyphenols to form an antibacterial complex, thus achieving antimicrobial, antioxidant, anti-inflammatory, and caries and plaque prevention effects. Therefore, the mouthwash described in this document has a complex formulation and manufacturing method to achieve the same results.

[0012] Patent document CN10322103A describes oral compositions comprising a zinc compound and an antimicrobial agent. The compositions comprise: a first component of a compound that raises the pH of the oral cavity, such as pH regulators, hydrogen peroxide, oxyhalogen compounds (sodium chlorite and sodium bromite), fermentable sugars, etc.; and a second component of a zinc compound capable of providing free zinc ions, such as zinc chloride, zinc acetate, zinc lactate, etc., although it may also include CPC; essential oils, desensitizing agent; bleaching agent (sodium bicarbonate); antimicrobial agent; antibiotic and / or antifungal agent; antiviral agent; anti-cavity agent; anti-plaque agent (zinc oxide); anti-tartar agent; antioxidants; anti-inflammatory agent; deodorant; polishing agent (calcium carbonate, sodium bicarbonate and zinc oxide); detergents (sodium lauryl sarcosinate); film-forming agent; mineralizers or re-mineralizer; dry mouth reliever (lactoferrin); colorants; humectants (xylitol and sorbitol); sweeteners (xylitol and sorbitol); flavorings; and pharmaceutically acceptable carriers (xylitol).

[0013] While it is true that the compositions in document CN10322103A mention, in their numerous variations, the optional use of lactoferrin, xylitol, sorbitol, sodium lauryl sarcocinate, sodium bicarbonate, calcium carbonate, and zinc oxide, the examples of the formulations are made only with water, benzoate pH regulator, sodium chlorite, glycerin, inactive ingredients, zinc chloride, and CPC. Therefore, simply listing the ingredients is not sufficient for a person skilled in the art to readily deduce the present invention, as no method for using the listed ingredients is indicated.

[0014] Although there are already oral hygiene products that eliminate the use of fluoride and chemical detergents, and instead propose the use of natural, organic compounds, among others, their ability to prevent the formation of bacterial plaque remains for a period much less than 60 minutes after brushing, for example.

[0015] Therefore, in order to contribute to the solution of the problems found in the state of the art, a biotechnological mixture has been developed to make oral care products; likewise, oral care products comprising said biotechnological mixture have been formulated.

[0016] The characteristic details of the present invention are clearly shown in the following detailed description, examples and figures, which accompany to illustrate the conception and some embodiments of the present invention, where:

[0017] Figure 1 is a flowchart of the method for manufacturing a dental care product, according to the present invention.

[0018] DESCRIPTION OF THE INVENTION

[0019] A. Biotechnological mixture for the production of oral care products.

[0020] A first object of the present invention is a biotechnological mixture for the preparation of oral care products, which comprises:

[0021] lactoferrin, present in an amount of 0.07 to 2%, as an antimicrobial agent and preventative of caries and dental plaque; and where it is suggested that the lactoferrin have a purity greater than 90%; xylitol, as an agent that inhibits bacterial growth, prevents the formation of caries and reduces dental sensitivity; and

[0022] Coconut oil (Cocos nucifera L.), as an antimicrobial agent, dental plaque reducer, anti-inflammatory, humectant and emollient. A preferred embodiment of the biotechnological mixture for the preparation of oral care products, according to the present invention, is when the lactoferrin is bovine lactoferrin.

[0023] Another form of the biotechnological mixture, according to the present invention, is when xylitol is present in an amount of 0.1 to 15%; and coconut oil is present in an amount of 0.1 to 10%.

[0024] A preferred embodiment of the biotechnological mixture according to the present invention is that it may further comprise zinc oxide as a polishing, astringent and bleaching agent; which is suggested to be added in an amount of 0.5 to 5%.

[0025] B. Oral care product.

[0026] Another object of the present invention is a product for oral care, which comprises the biotechnological mixture proposed by the present invention; and water as a diluting agent, or some other diluting agent or solvent, depending on the product to be developed.

[0027] One embodiment of the oral care product, in accordance with the present invention, is when water is present in an amount of 0.1 to 40%.

[0028] A further embodiment of the oral care product, according to the present invention, is that it may also comprise a foaming cleansing mixture, which in turn contains:

[0029] cocobetaine, as a cleansing agent, mild foaming agent, and is mucosa-tolerant; and sodium lauryl sarcosinate, as a cleansing agent, mild foaming agent, and provides tolerance to sensitive teeth and gums.

[0030] A preferred embodiment of said product is when cocobetaine is present in an amount of 0.1 to 3%; and sodium lauryl sarcosinate is present in an amount of 0.1 to 5%.

[0031] Another variation of the product in question is when it also includes at least one thickening and stabilizing agent, present in an amount of 0.1 to 1%. Examples of foaming and stabilizing agents that may be used in the product are: gum arabic, carboxymethylcellulose, and combinations thereof, to name a few.

[0032] Another preferred embodiment of the oral care product according to the present invention is that it may further comprise at least one polishing and texture-providing agent, wherein said agent is present in an amount of 0.1 to 50%. An example of the polishing and texture-providing agent is calcium carbonate, etc.

[0033] Another modality of the oral care product, according to this invention, is that it also comprises at least one pH regulating agent, which is present in an amount of 0.1 to 3%; and an example of this pH regulating agent is sodium bicarbonate.

[0034] A further embodiment of the oral care product, as proposed in the present invention, is that it may also comprise at least one flavoring, humectant and consistency enhancer, which is present in an amount of 0.1 to 15%; where an example of the flavoring, humectant and consistency enhancer is sorbitol.

[0035] As can be seen, the product achieved in the present invention has a reduced number of chemical agents, which guarantees less irritating care for the mucous membranes, teeth, and gums. In contrast, conventional toothpastes, even fluoride-free ones, usually contain a variety of ingredients such as Sodium Lauryl Sulfate (SLS), a foaming detergent, glycerin, artificial flavorings, colorings, among others. In some cases, not only is fluoride avoided, but also detergents or cleaning agents, or ingredients with ineffective antimicrobial properties against bacterial growth, which can result in minimal or no effect on prevention, as they lack scientific support. This makes them merely at-home polishing products rather than preventative ones.

[0036] In summary, this product has the ability to increase the period of effectiveness against biofilm formation compared to fluoridated and non-fluoridated toothpastes, maintaining a period of more than 60 minutes without biofilm appearing after brushing, even with a brushing time of less than 2 minutes. Furthermore, thanks to its active ingredients, it is also possible to reduce the amount of toothpaste needed for brushing. EXAMPLES

[0037] The following examples are included only to illustrate the concept, technical advantages, and some embodiments of the present invention. Therefore, these examples should not be considered as limiting the scope of protection of this invention.

[0038] Example 1. Making toothpaste.

[0039] Ingredients and functions:

[0040] - Bovine lactoferrin (transferrin family) as an antimicrobial, antioxidant, anti-inflammatory agent, and preventative of caries and dental plaque;

[0041] - Coconut oil (Cocos nucifera L.), which has antimicrobial action, reduces dental plaque, is anti-inflammatory, and has flavor, feel, and compatibility with natural ingredients;

[0042] - Xylitol, as a bacterial growth inhibitor, preventative of caries formation and development, reduction of tooth sensitivity and pleasant taste; - Sorbitol, as a flavoring agent, humectant, improves consistency and stabilizes the formula mixture; - Sodium Lauryl Sarcosinate, cleansing function and creation of foam with gentleness and good tolerance (non-irritating);

[0043] - Cocobetaine, cleansing function and foam creation with gentleness and good tolerance (non-irritating);

[0044] - Sodium bicarbonate, for its mild abrasive action, acid neutralizer, whitening agent; - Calcium carbonate, controlled abrasive action, texture and formula stabilizer, enamel remineralization, oral pH balance;

[0045] - Zinc oxide, as a polishing agent, astringent, light stain remover, antimicrobial;

[0046] - Gum arabic, thickening agent;

[0047] - Carboxymethylcellulose, as a thickening agent; and

[0048] - Water, as a wetting agent.

[0049] - Menthol.

[0050] - Flavoring

[0051] Manufacturing process for a quantity of 100 g of toothpaste:

[0052] First, Carboxymethyl Cellulose was mixed at 1%, gum arabic at 0.7%, and Zinc Oxide at 3%; with coconut oil which was present at 7%; obtaining a mixture 1.

[0053] Calcium carbonate was mixed separately at 30%, sodium bicarbonate at 1%, and added to water that was at a quantity of 40% and that contained bovine lactoferrin mixed at 0.1%; thus obtaining a mixture 2.

[0054] Then mixture 1 was mixed with mixture 2, and subsequently xylitol was added at 11%, sorbitol at 9%, cocobetaine at 2% and sodium lauryl sarcosinate at 4.5%; menthol and a flavoring.

[0055] This oral care product has overcome the limitations of conventional toothpastes by providing a unique solution: the ability to prevent the formation of "biofilm" for an extended period, surpassing the effectiveness of the most well-known options worldwide, which are generally limited to 30-60 minutes if brushing lasts 2 minutes.

[0056] Its biotechnological basis, developed and tested on strains of Streptococcus mutans bacteria, not only offers prolonged protection against biofilm formation but also exerts a balancing effect on the oral microbiota. This microbial balance is essential for oral and general health, thus ensuring truly effective preventive activity lasting longer than the 60 minutes offered by fluoridated toothpastes. Furthermore, by omitting fluoride as the sole preventive ingredient, this product presents itself as a more inclusive option for those with restrictions on fluoride intake. This includes individuals with hypothyroidism, lupus, syndromes affecting the salivary glands, children, and others.

[0057] LITERATURE CITED

[0058] Mary Cloud B . Ammonsa, Loren S . Wardb, Steve T . Fishera, Randall D. Wolcottc, Garth A. Jamesa . 2009. In vitro susceptibility of established biofilms composed of a clinical wound isolate of Pseudomonas aeruginosa treated with lactoferrin and xylitol . Int J Antimicrob Agents .

[0059] 2009 March; 33 (3) : 230-236. doi : 10.1016 / . ij antimicag .2008.08.013

Claims

CLAIMS 1. A biotechnological mixture for the manufacture of oral care products, characterized in that it comprises: Lactoferrin, present in an amount of 0.07 to 2%, as an antimicrobial agent, and preventive of caries and dental plaque; Xylitol, as a bacterial growth inhibitor, prevents tooth decay and reduces tooth sensitivity; and Coconut oil (Cocos nucifera L.), as an antimicrobial agent, plaque reducer, anti-inflammatory, moisturizer and emollient.

2. The mixture of claim 1, wherein the lactoferrin has a purity greater than 90%.

3. The mixture according to claim 1, wherein the lactoferrin is bovine lactoferrin.

4. The mixture according to claim 1, wherein xylitol is present in an amount of 0.1 to 15%.

5. The mixture according to claim 1, wherein coconut oil is present in an amount of 0.1 to 10%.

6. The mixture of claim 1, characterized in that it further comprises zinc oxide as a polishing, astringent and bleaching agent.

7. The mixture of claim 6, wherein zinc oxide is present in an amount of 0.5 to 5%.

8. An oral care product, characterized in that it comprises: the biotechnological mixture, in accordance with claims 1 to 7; and water as a diluent.

9. The product of claim 8, wherein water is present in an amount of 0.1 to 40%.

10. The product according to claim 8, characterized in that it further comprises a foaming cleaning mixture, which contains: cocobetaine, as a cleansing agent, is a mild foaming agent and is mucosa-tolerant; and sodium lauryl sarcosinate, as a cleansing agent, mild foaming agent, and provides tolerance to sensitive teeth and gums.

11. The product according to claim 10, wherein cocobetaine is present in an amount of 0.1 to 3%; and sodium lauryl sarcosinate is present in an amount of 0.1 to 5%.

12. The product according to claim 10, characterized in that it further comprises at least one thickening and stabilizing agent, which is present in an amount of 0.1 to 1%.

13. The product of claim 12, wherein the thickening and stabilizing agent is gum arabic, carboxymethylcellulose, and a combination thereof.

14. The product according to claim 12, characterized in that it further comprises at least one polishing agent and provides a consistent texture, wherein said agent is present in an amount of 0.1 to 50%.

15. The product according to claim 14, wherein the at least one polishing agent that provides a consistent texture is calcium carbonate.

16. The product according to claim 14, characterized in that it further comprises at least one pH regulating agent, which is present in an amount of 0.1 to 3%.

17. The product of claim 16, wherein the, at least one, pH regulating agent is sodium bicarbonate.

18. The product as claimed in claim 16, characterized in that it further comprises at least one flavoring, humectant and consistency improver, which is present in an amount of 0.1 to 15%.

19. The product of claim 18, wherein the at least one flavoring, humectant and consistency improver is sorbitol.

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