Composition for mouthwash for oral hygiene

Abstract

A mouthwash composition consisting of: 1-2% w / w Triphala powder; 0-0.02 wt% of a leaf extract of Satpudina (Mentha spp.); 8-9% by weight of an invert sugar syrup; 85-90 wt.% of warm, purified water; 0.5-1 wt% sodium benzoate; 0.05-0.1 wt% of methyl paraben sodium; 0.02-0.05 wt% of propyl paraben sodium; 0.05-0.1 wt% citric acid as acidifying agent; 0-0.02 wt% of an apple-green color; and 0.10-0.15% by weight peppermint flavoring.

Description

AREA OF INVENTION

[0001] The present invention relates to a mouthwash composition for oral care. BACKGROUND OF THE INVENTION

[0002] Dental plaque is a sticky biofilm or mass of bacteria that is commonly found between the teeth, at the gum line, and below the gum line. Plaque can cause tooth decay and periodontal diseases such as gingivitis and periodontitis. Tooth decay, or enamel demineralization, is caused by acids produced during the bacterial breakdown of fermentable sugars.

[0003] Mouthwashes are commonly used to clean teeth and gums. The liquid penetrates the oral mucosa and removes food debris. Many commercially available mouthwashes are based on high concentrations of alcohol or chlorhexidine (CHX). Alcoholic mouthwashes can cause oral mucosal irritation and dry mouth, while 0.2% CHX—although a recognized antiseptic—is generally safe for oral use. - can lead to brown tooth discoloration, taste disturbances, mucosal erosion, and supragingival tartar buildup. Many herbal mouthwashes on the market are poorly standardized; the content of phenols and essential oils varies widely, as do quality parameters such as pH value, surface tension, and contaminant levels. Numerous mouthwashes are available on the market, including: A solution comprises a one-component oral care composition consisting of 0.1 to 2 wt% of a tin(II) ion source; 0.2 to 5 wt% nitric acid or a water-soluble nitrate salt; 0.8 wt% or more of a water-soluble alkali metal polyphosphate comprising a pyrophosphate, tripolyphosphate, tetraphosphate, hexametaphosphate, or a combination of two or more thereof; and more than 10 wt% water. The one-component oral care composition has a molar ratio of nitric acid or water-soluble nitrate salt to the tin(II) ion source of approximately 1:1 to approximately 5:1 and a molar ratio of alkali metal polyphosphate to the tin(II) ion source of approximately 1:1 to approximately 5:1. All wt% percentages refer to the total weight of the one-component oral care composition.

[0004] In a further solution, an oral care composition comprising an aqueous phase; tin(II) ions solvated in the aqueous phase; nitrates solvated in the aqueous phase; wherein the total nitrate content is such that the molar amount of nitrogen in the aqueous phase, measurable as nitrate, is less than twice the molar amount of solvated tin(II) ions; and a flavoring substance.

[0005] Conventional mouthwashes are based on high concentrations of alcohol or chlorhexidine (CHX), which can lead to mucosal irritation and dry mouth. Furthermore, they have a high surface tension, preventing them from spreading evenly across the tooth surfaces. Therefore, there is a need for a mouthwash with a special formulation for oral care. SUMMARY OF THE INVENTION

[0006] The present invention relates to a mouthwash composition for oral care.

[0007] In one embodiment, a mouthwash is provided for oral hygiene. The composition comprises 1-2 wt% Triphala powder; 0-0.02 wt% Satpudina (Mentha spp.) leaf extract; 8-9 wt% invert sugar syrup; 85-90 wt% warm, purified water; 0.5-1 wt% sodium benzoate; 0.05-0.1 wt% methylparaben sodium; 0.02-0.05 wt% propylparaben sodium; 0.05-0.1 wt% citric acid as an acidifying agent; 0-0.02 wt% apple green colorant; and 0.10-0.15 wt% peppermint flavoring.

[0008] In a further embodiment, an optimized composition comprises 1.77 wt% Triphala powder; 0.01 wt% Satpudina (Mentha spp.) leaf extract; 8.84 wt% invert sugar syrup; 88.37 wt% warm purified water; 0.66 wt% sodium benzoate; 0.09 wt% methylparaben sodium; 0.04 wt% propylparaben sodium; 0.09 wt% citric acid; 0.01 wt% apple green coloring; and 0.13 wt% peppermint flavoring.

[0009] In another embodiment, the Triphala powder contains Emblica officinalis Gaertn, Terminalia Chebula Retz and Terminalia bellirica (Gaertn.) Roxb. in the same proportions.

[0010] In another embodiment, the predefined amount of Triphala powder is 1.77 wt.%, the leaf extract of Satpudina (Mentha spp.) is 0.01 wt.%, the invert sugar syrup is 8.84 wt.%, the warm purified water is 88.37 wt.%, the sodium benzoate is 0.66 wt.%, the methylparaben sodium is 0.09 wt.%, the propylparaben sodium is 0.04 wt.%, the citric acid is 0.09 wt.%, the apple green colorant is 0.01 wt.%, and the peppermint flavor is 0.13 wt.%.

[0011] In another embodiment, the Triphala powder is produced by mixing equal proportions of Emblica powder officinalis Gaertn, Terminalia Chebula Retz and Terminalia bellirica (Gaertn.) Roxb.

[0012] In another embodiment, the invert sugar syrup serves as a humectant and sweetener, with the satpudina (Mentha spp.) and peppermint flavoring providing a pleasantly cooling and minty taste and masking bitterness.

[0013] In another embodiment, sodium benzoate, methylparaben sodium and propylparaben sodium protect against bacteria, yeasts and molds, with the citric acid adjusting the mouthwash to a slightly acidic pH of 4.5.

[0014] In another embodiment, the invert sugar syrup contributes to the sweetness and viscosity, while the apple-green color provides an appealing appearance.

[0015] Another objective of the present disclosure is to provide a mouthwash that eliminates the mucosal irritation, dry mouth and taste disturbances associated with conventional alcohol-based mouthwashes.

[0016] Another objective of the present disclosure is to provide a mouthwash that helps to avoid tooth discoloration, taste disturbances and tartar buildup associated with chlorhexidine (CHX) mouthwashes. DETAILED DESCRIPTION:

[0017] It will be clear to those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not to be understood as a limitation of it.

[0018] References to “an aspect”, “another aspect”, or similar phrases in this description mean that a particular feature, structure, or property described in connection with the embodiment is included in at least one embodiment of the present disclosure. Therefore, phrases such as “in one embodiment”, “in another embodiment”, and similar expressions in this description may, but do not necessarily, all refer to the same embodiment.

[0019] The terms "includes," "comprehensive," or similar expressions denote non-exclusive inclusion. For example, a method or procedure that contains a list of steps does not only include those steps but may also include further steps not explicitly listed or inherent in the method or procedure. Likewise, the statement "includes..." for one or more devices, subsystems, elements, structures, or components does not, without further limitations, exclude the existence of other devices, subsystems, elements, structures, or components.

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meanings generally known to those skilled in the art in the field to which this invention belongs. The systems, methods, and examples described herein serve only for illustration and are not to be understood as limiting.

[0021] The present invention relates to a mouthwash for oral care, the composition of which comprises: 1-2 wt% Triphala powder; 0-0.02 wt% leaf extract of a Satpudina (Mentha spp.); 8-9 wt% invert sugar syrup; 85-90 wt% warm, purified water; 0.5-1 wt% sodium benzoate; 0.05-0.1 wt% methylparaben sodium; 0.02-0.05 wt% propylparaben sodium; 0.05-0.1 wt% citric acid as an acidifying agent; 0-0.02 wt% apple green coloring; and 0.10-0.15 wt% peppermint flavoring.

[0022] In another embodiment, the predefined amount of Triphala powder is 1.77 wt.%, the leaf extract of Satpudina (Mentha spp.) is 0.01 wt.%, the invert sugar syrup is 8.84 wt.%, the warm purified water is 88.37 wt.%, the sodium benzoate is 0.66 wt.%, the methylparaben sodium is 0.09 wt.%, the propylparaben sodium is 0.04 wt.%, the citric acid is 0.09 wt.%, the apple green colorant is 0.01 wt.%, and the peppermint flavor is 0.13 wt.%.

[0023] In another embodiment, the Triphala powder is produced by mixing equal proportions of Emblica powder officinalis Gaertn, Terminalia Chebula Retz and Terminalia bellirica (Gaertn.) Roxb.

[0024] In another embodiment, the invert sugar syrup serves as a humectant and sweetener, with the satpudina (Mentha spp.) and peppermint flavoring providing a pleasantly cooling and minty taste and masking bitterness.

[0025] In another embodiment, sodium benzoate, methylparaben sodium and propylparaben sodium protect against bacteria, yeasts and molds, with the citric acid adjusting the mouthwash to a slightly acidic pH of 4.5.

[0026] The invert sugar syrup contributes to the sweetness and viscosity, while the apple-green color ensures an appealing appearance.

[0027] In another embodiment, the raw materials are sourced from a GMP-certified Ayurvedic pharmacy. Triphala Churna is made from equal parts of powdered Amalaki, Haritaki, and Bibhitaki fruits. Other ingredients include Satpudina extract, invert sugar, purified water, sodium benzoate, sodium methylparaben, sodium propylparaben, citric acid, apple green coloring, and peppermint flavoring.

[0028] In one embodiment, a mouthwash is provided for oral hygiene. The composition comprises 1-2 wt% Triphala powder; 0-0.02 wt% Satpudina (Mentha spp.) leaf extract; 8-9 wt% invert sugar syrup; 85-90 wt% warm, purified water; 0.5-1 wt% sodium benzoate; 0.05-0.1 wt% methylparaben sodium; 0.02-0.05 wt% propylparaben sodium; 0.05-0.1 wt% citric acid as an acidifying agent; 0-0.02 wt% apple green colorant; and 0.10-0.15 wt% peppermint flavoring.

[0029] In a further embodiment, an optimized composition comprises 1.77 wt% Triphala powder; 0.01 wt% Satpudina (Mentha spp.) leaf extract; 8.84 wt% invert sugar syrup; 88.37 wt% warm purified water; 0.66 wt% sodium benzoate; 0.09 wt% methylparaben sodium; 0.04 wt% propylparaben sodium; 0.09 wt% citric acid; 0.01 wt% apple green coloring; and 0.13 wt% peppermint flavoring.

[0030] In another embodiment, the Triphala powder consists of Emblica officinalis Gaertn., Terminalia chebula Retz, and Terminalia bellirica (Gaertn.) Roxb. Triphala combines equal parts of Amalaki (Emblica) in the same ratio, Haritaki (Terminalia chebula), and Bibhitaki (Terminalia bellirica). Their tannins, phenols, and organic acids contribute to overlapping effects. Anti-adhesion / Anti-EPS: Hydrolyzable tannins precipitate bacterial adhesins and inhibit glucosyltransferase (Gtf) → less plaque matrix. Membrane effects: Low molecular weight phenols increase membrane permeability → Co-active substances reach their target molecules more effectively (potentiation). Redox / anti-inflammatory support: Gallic acid, ellagic acid and ascorbates modulate oxidative stress, which promotes plaque formation.

[0031] In combination, these mechanisms reduce initial colonization and early biofilm formation more effectively than any single fruit extract with the same total phenol content.

[0032] In another embodiment, invert sugar (approx. 8.84%) lowers the surface tension (approx. 37.7 mN / m), thus improving the wetting / covering of the enamel pellicles, allowing polyphenols to come into even contact with the surface. Peppermint / Satpudina enhances taste sensitivity and prolongs the mouthwash time (effective contact time). Citric acid maintains the pH at approximately 4.5, buffers the ingredients, stabilizes tannins, and mildly inhibits microbial growth. Preservatives (sodium benzoate + parabens) form a barrier that complements the effect of the polyphenols without the need for ethanol.

[0033] Mild acid + preserved vehicle + polyphenol triad + improved wetting = greater functional effect than the sum of the parts on the early stages of plaque formation (adhesion / EPS), even when the classic bactericidal MIC is weak. Defined active ingredients and carrier substance: Total phenol content ≈ 0.4 mg GAE / ml, essential oil ≈ 0.05% (v / v), pH value ≈ 4.5, surface tension ≈ 37.7 mN / m, ethanol ~0.01% (v / v). These values ​​show that the system is optimized for wetting and stability and releases measurable polyphenols. Organoleptic properties and quality assurance: Pleasant minty aroma / astringent taste; aflatoxins below the limit of detection; parameters within the limits for liquid oral dosage forms. This supports feasibility, safety, and user acceptance.

[0034] In one embodiment, a mouthwash for oral care contains the following ingredients: Triphala powder (1.77%), Satpudina extract (0.01%), invert sugar (8.84%), purified water (88.37%), sodium benzoate (0.66%), methylparaben sodium (0.09%), propylparaben sodium (0.04%), citric acid (0.09%), apple green (0.01%), and peppermint flavor (0.13%). Physicochemical reference values ​​are given (pH ≈ 4.5; refractive index 1.3479; total solids content 9%; ethanol 0.01%; total phenol content 0.4 mg GAE mL). -1 , essential oil 0.05%; surface tension 37.7 mN m -1 ; aflatoxins below the limit of detection).

[0035] In another embodiment, the invert sugar syrup serves as a humectant and sweetener, reducing the surface tension to approximately 37.7 mN m. -1Satpudina extract (0.01%) and peppermint flavoring (0.13%) provide a pleasantly cooling and minty taste and mask the bitterness. Together, these properties improve wettability, palatability, and the overall mouthfeel.

[0036] In another embodiment, citric acid (0.09%) ensures a slightly acidic pH value of approximately 4.5 for the mouthwash. The buffering capacity (13.3 × 10 -3 at pH 8.0 and 5.0 × 10 -3 (at pH 3.0) ensures a stable pH value during storage. The acidic environment protects polyphenols and inhibits microbial growth, while remaining harmless to the oral mucosa.

[0037] In another embodiment, a multi-stage preservation system—consisting of sodium benzoate (0.66%), sodium methylparaben (0.09%), and sodium propylparaben (0.04%)—protects against bacteria, yeasts, and molds. A mild acidity further inhibits growth. Aflatoxin tests yielded values ​​below the limit of detection; the preservatives are dissolved separately and added under controlled conditions.

[0038] In another embodiment, a flavoring blend of satpudina (cooling mint) and peppermint provides a pleasant taste. Invert sugar contributes to sweetness and viscosity, while the coloring agent (0.01%) ensures an appealing appearance. The final product has a pleasant minty aroma and a slightly bitter, but tolerable taste.

[0039] In another embodiment, physicochemical data show that the invention meets or exceeds the typical specifications for liquid oral preparations. Its extremely low alcohol content, defined phenol content, and low surface tension distinguish it from CHX and essential oil-alcohol mouthwashes. From an economic perspective, the formulation uses readily available ingredients (Triphala powder, invert sugar, citric acid, and inexpensive preservatives) and a simple manufacturing process (heating water, dispersing Triphala, adding preservatives / humectants, adjusting pH, adding color / flavorings, filtering, and bottling). The omission of expensive essential oils or high-dose antiseptics reduces raw material costs and makes the product cost-effective. Low in alcohol yet effective: The formula contains only 0.01% (v / v) ethanol. Most commercially available mouthwashes are based on 15-30% alcohol as a solvent and preservative. This extremely low alcohol content prevents oral mucosal irritation, dry mouth, and taste disturbances that can occur with conventional alcohol-based mouthwashes. Furthermore, it avoids tooth discoloration, taste impairment, and tartar buildup associated with chlorhexidine mouthwashes. Defined polyphenol active ingredients: The active ingredient is Triphala powder (1.77% w / w), an equal mixture of Emblica officinalis, Terminalia chebula, and Terminalia bellirica. These fruits are rich in polyphenols, tannins, flavonoids, and organic acids. The formulation specifies the total phenol content (0.4 mg gallic acid equivalents per ml) and the essential oil content (0.05% v / v), whereas most herbal rinses do not specify or standardize their bioactive load. Balanced physicochemical profile: It offers a mild acidity (pH ≈ 4.5) to stabilize tannins and inhibit microbial growth. A buffer system ensures pH stability. Invert sugar (8.84%) reduces the surface tension to approximately 37.7 mN / m. -1This improves wetting and mouthfeel. These properties differ from many conventional mouthwashes, which either have high surface tension (poor wetting) or high acidity without buffering. Comprehensive preservation system: An effective preservative blend of sodium benzoate, sodium methylparaben, and sodium propylparaben provides broad-spectrum antimicrobial protection while maintaining a very low alcohol content. Aflatoxin levels are below the detection limit, and the pH and phenol content minimize the risk of contamination.

[0040] The present invention is free of chlorhexidine (CHX) and virtually alcohol-free, thus avoiding these side effects while simultaneously achieving a plant-based antimicrobial effect. The mouthwash achieves comparable wetting properties and a similar taste through the use of invert sugar and satpudina / peppermint flavoring with a very low ethanol content.

[0041] A physicochemical analysis of the mouthwash revealed it to be a dark brown, transparent liquid with a pleasant minty odor and an astringent taste. The pH value (4.5) indicates a slight acidity, which inhibits microbial growth but is within the safe range for the oral mucosa. The refractive index (1.3479) provides information about dissolved solids and sugars. The total solids content (9%) and the ethanol content (0.01% v / v) are within the acceptable limits for herbal mouthwashes. The total phenol content (0.4 mg GAE mL) -1 The presence of bioactive phytochemicals is confirmed by the presence of the saturation and the content of essential oils (0.05% v / v). The surface tension is lower than that of pure water (72 mN / m). -1 ), which indicates sufficient wetting properties. The acidity (0.3% w / v as citric acid) and the buffering capacity (13.3 × 10 -3 at pH 8.0; 5.0 × 10 -3Stability is ensured at pH 3.0. The aflatoxins are below the limit of detection. Organoleptic (sensory) evaluation: The organoleptic properties are assessed by three independent testers. Color, odor, and appearance are evaluated under natural light. Taste is tested by diluting 5 ml of mouthwash with 5 ml of water. The results are compared with the standard properties of Triphala mouthwash. Physicochemical analysis: All analyses are performed at 25 ± 1 °C. The pH of the mouthwash is determined by preparing a 50% aqueous suspension (10 g mouthwash plus 10 ml boiled and cooled water) and measuring it within five minutes using a calibrated digital pH meter. The refractive index is measured with an Abbe refractometer at 27 °C using the sodium D line (589.3 nm). The total solids content is determined by evaporating 10 ml of sample to dryness and then drying the residue to constant weight at 105 °C. The ethanol content is quantified by gas chromatography. The total phenol content is determined using the Folin-Ciocalteu method and is expressed as mg gallic acid equivalents per ml of mouthwash. The essential oil content is determined by steam distillation. Surface tension is measured using the Du-Noüy ring method at 20 °C.The acidity is expressed as citric acid equivalent (% w / v) by titration with sodium hydroxide. The buffering capacity at pH 8.0 and pH 3.0 is determined by titration with 0.1 M hydrochloric acid and sodium hydroxide, respectively. This involves calculating the amount of acid or base required to change the pH by one unit. Aflatoxin contamination is analyzed using high-performance liquid chromatography (HPLC). Antimicrobial activity: Growth of S. mutans and S. sanguinis was observed in all tubes containing dilution series of the mouthwash up to a concentration of 100%. Therefore, a minimum inhibitory concentration could not be determined under the experimental conditions. This indicates that the tested formulation, at the concentrations investigated, did not exhibit a measurable bactericidal effect against these caries-causing bacteria. Physicochemical properties: The prepared mouthwash has a pH of approximately 4.5, a refractive index of 1.3479, a total solids content of 9%, and a very low ethanol content (0.01% v / v). It contains 0.4 mg gallic acid equivalents per ml of total phenols and 0.05% essential oil, with a surface tension of 37.7 mN / m. -1 and a mild acidity (0.3% citric acid). The buffering capacity is 13.3 × 10⁻⁶. -3 at pH 8.0 and 5.0 × 10 -3 at pH 3.0. Aflatoxins are below the limit of detection, and the ethanol content is negligible. Microbiology: In vitro MIC tests against Streptococcus mutans and S. sanguinis showed no inhibition at mouthwash concentrations from 0.39% to 100%; growth occurred in all tubes. This suggests that the formulation has no bactericidal activity under standard MIC conditions, but does not rule out anti-adhesive or biofilm-modulating effects. Organoleptic data: The mouthwash is a dark brown, transparent liquid with a pleasant, minty odor and astringent taste. Its physicochemical parameters comply with the pharmacopoeial limits for liquid oral preparations. A low ethanol, defined phenol, and essential oil content, as well as a mild acidity, indicate a consistent, stable, and gentle mouthwash. The absence of detectable aflatoxins and the use of a preservative blend ensure microbiological safety. These properties suggest that the mouthwash is suitable and well-tolerated for daily use, eliminating concerns about discoloration and irritation associated with chlorhexidine mouthwashes.

[0042] Unlike conventional mouthwashes containing chlorhexidine (CHX) or essential oils and alcohol, this product is virtually alcohol-free and CHX-free. The standardized polyphenol content and lower surface tension ensure uniform wetting and defined exposure to bioactive substances. The available data therefore support the assumption that this mouthwash represents a safe, standardized, and potentially effective alternative to conventional antiseptic mouthwashes.

[0043] The formula uses readily available and inexpensive raw materials: Triphala powder, invert sugar, citric acid, and sodium benzoate / parabens. Unlike products with high-quality essential oils or high-dose antiseptics, these plant-based ingredients and preservatives are inexpensive, giving the mouthwash excellent value for money.

[0044] Only standard mixing equipment is required for production: Heat purified water to approximately 60 °C; disperse Triphala; add preservative solution, invert sugar, and Satpudina; adjust the pH with citric acid; add color and flavor; filter and bottle. Since no special reactors or vacuum systems are required, investment costs are minimal. The short process time (all steps within one hour) optimizes throughput.

[0045] The aflatoxins are below the limit of detection, and the physicochemical parameters comply with pharmacopoeial standards. This reduces the risk of batch rejections and the associated costs. The absence of alcohol and chlorhexidine simplifies compliance in markets with alcohol restrictions and reduces labeling requirements. Synergistic effect: The polyphenol triad acts on multiple target structures (intrinsic synergy). Triphala combines equal parts of Amalaki (Emblica officinalis), Haritaki (Terminalia chebula), and Bibhitaki (Terminalia bellirica). Its tannins, phenols, and organic acids contribute to overlapping effects: Anti-adhesion / Anti-EPS: Hydrolyzable tannins precipitate bacterial adhesins and inhibit glucosyltransferase (Gtf) → less plaque matrix. • Membrane effects: Low molecular weight phenols increase membrane permeability → Co-active substances reach their target molecules more effectively (potentiation). • Redox / anti-inflammatory support: Gallic acid, ellagic acid and ascorbates modulate oxidative stress, which promotes plaque formation.

[0046] In combination, these mechanisms reduce initial colonization and early biofilm formation more effectively than any single fruit extract with the same total phenol content.

[0047] Alternatively, certain elements can be divided into multiple functional elements. Elements of one embodiment can be added to another embodiment. For example, the sequence of the procedures described here can be changed and is not limited to the manner described here. Furthermore, the actions of a flowchart need not be performed in the sequence shown; nor do all actions necessarily need to be carried out. Actions that do not depend on other actions can be performed in parallel with the other actions. The scope of the embodiments is in no way limited by these specific examples. Numerous variations, whether explicitly stated in the description or not, such as differences in structure, dimensions, and material usage, are possible.

Claims

[1] A mouthwash composition consisting of: 1-2% w / w Triphala powder; 0-0.02 wt% of a leaf extract of Satpudina (Mentha spp.); 8-9% by weight of an invert sugar syrup; 85-90 wt.% of warm, purified water; 0.5-1 wt% sodium benzoate; 0.05-0.1 wt% of methyl paraben sodium; 0.02-0.05 wt% of propyl paraben sodium; 0.05-0.1 wt% citric acid as acidifying agent; 0-0.02 wt% of an apple-green color; and 0.10-0.15% by weight peppermint flavoring. [2] Composition according to claim 1, wherein an optimized composition comprises 1.77 wt% Triphala powder, 0.01 wt% Satpudina (Mentha spp.) leaf extract, 8.84 wt% invert sugar syrup, 88.37 wt% warm purified water, 0.66 wt% sodium benzoate, 0.09 wt% sodium methylparaben, 0.04 wt% sodium propylparaben, 0.09 wt% citric acid, 0.01 wt% apple green colouring and 0.13 wt% peppermint flavouring. [3] Composition according to claim 1, wherein the Triphala powder contains Emblica officinalis Gaertn, Terminalia Chebula Retz and Terminalia bellirica (Gaertn.) Roxb. in equal proportions.