Oral hygiene formulation

Abstract

The present invention relates to an oral-hygiene composition comprising at least one probiotic and at least one enzyme disruptor and at least one lysozyme disruptor capable of degrading oral biofilm, plaque, food debris or sulphur-containing substrates. The composition acts by degrading oral biofilms and substrates for volatile sulphur compound formation while supporting recolonisation of the oral cavity with beneficial bacteria, as well as maintaining the gastrointestinal microbiome balance through probiotic activity upon swallowing and helping in digestion.

Description

[0001] TITLE OF THE INVENTION: “ORAL HYGIENE FORMULATION”

[0002] FIELD OF THE INVENTION

[0003] The present invention generally relates to a formulation for oral hygiene.

[0004] BACKGROUND OF THE INVENTION

[0005] Halitosis, commonly referred to as bad breath, is a widespread condition affecting a large portion of the global population. It can significantly impact an individual’s social interactions, confidence, and overall psychological well-being. Among the primary causes of halitosis are volatile sulfur compounds (VSCs) produced by bacterial activity in the oral cavity. VSCs are responsible for the foul odor characteristic of bad breath and primarily include compounds such as hydrogen sulfide (H2S), methyl mercaptan (CH3SH), and dimethyl sulfide ((CH3)2S). These sulfur-containing compounds are released as by-products of anaerobic bacterial metabolism, particularly in areas of the mouth with limited oxygen availability.

[0006] The oral environment presents a complex ecosystem where various microorganisms reside, including aerobic and anaerobic bacteria. Anaerobic bacteria, specifically gram-negative species, are particularly active in producing VSCs. They thrive in low-oxygen environments such as periodontal pockets, crevices on the tongue’s dorsum, and deep in gingival sulci. These bacteria metabolize proteins and sulfur- containing amino acids, such as cysteine and methionine, found in food residues, saliva, blood, and desquamated epithelial cells. The breakdown of these amino acids results in the release of sulfur-containing gases like hydrogen sulfide and methyl mercaptan, which are then expelled into the breath.

[0007] Several studies have shown that high levels of VSCs correlate strongly with the presence of halitosis. Additionally, specific VSCs, such as methyl mercaptan, have been linked to the progression of periodontal disease, suggesting that these compounds may also play a role in deteriorating oral health. As such, there is a compelling need to control and reduce VSC production in the mouth, not only to address halitosis, but also to support overall oral health.

[0008] Traditional methods for managing halitosis focus primarily on mechanical plaque removal, including brushing and flossing, and the use of mouthwashes containing antiseptics. While these methods can temporarily reduce bacterial load and mask bad breath, they are often insufficient for long-term control of VSCs. Antiseptic mouthwashes may kill or inhibit bacteria temporarily but can also disturb the natural balance of beneficial microorganisms in the oral cavity, leading to potential side effects such as dry mouth and / or altered taste.

[0009] In recent years, research has focused on identifying more targeted approaches to reduce VSC production without disrupting the oral microbiome. These approaches have included the use of zinc compounds, which can bind to sulfur and form stable, odorless complexes, and natural extracts known to reduce VSC levels or inhibit the activity of VSC-producing bacteria. Zinc ions, for instance, have been shown to neutralize hydrogen sulfide and methyl mercaptan by forming insoluble complexes with these compounds. Additionally, certain natural ingredients, such as tea polyphenols and essential oils, have demonstrated antibacterial and deodorizing effects specifically targeted at VSC-producing bacteria.

[0010] Various probiotic-based commercial products attempt to address aspects of halitosis. For example, the product ProBiora® Professional Strength Oral Probiotics for Teeth and Gums, available on Amazon, comprises capsule-based probiotics intended for oral wellness. The formulation contains a blend of three naturally occurring strains, Streptococcus oralis KJ3®, Streptococcus uberis KJ2®, and Streptococcus rattus JH14. However, the formulation consists solely of probiotics, without any enzymes or biofilm-disrupting components. The corresponding patent US10,688,038 B2, which pertains to such compositions, discloses isolated Streptococcus strains, including LDH-deficient S. mutans and specific S. oralis and S. uberis strains, for maintenance of oral health including halitosis. However, as evident from the working examples of US10,688,038 B2, the compositions function primarily by competitive inhibition and suppression of periodontopathic species. They do not provide any mechanism for breaking down oral biofilm, plaque, food debris or sulphur-containing substrates, which are central contributors to oral odour formation.

[0011] Similar limitations are observed in other commercially available products. Chewable probiotics marketed by Probiotiv® comprise a blend of Bifidobacterium laclis, Lactobacillus paracasei and Lactobacillus reuteri. Natprime® markets a probiotic lozenge comprising Lactobacillus paracasei, Lactobacillus royale. Lactobacillus salivarius, Bifidobacterium laclis. Bifidobacterium infantis and Streptococcus salivarius, supplemented with minerals (Zn, P, Ca) and natural prebiotics such as inulin. Velbiom® markets Enkor-D®, a multistrain probiotic supplement for oral health and immunity, while Bug Buddy® markets another supplement containing Lactobacillus salivarius and Lactobacillus reuteri for tooth decay and halitosis. Despite differences in strain selection and formulation, all these commercially available products share a fundamental limitation, i.e., they rely exclusively on probiotics and do not include enzymes or biofilm-disrupting components.

[0012] Biofilms form a protective extracellular polymeric matrix composed of proteins, polysaccharides and lipids, which shelters pathogenic anaerobes and prevents effective probiotic access and colonisation. Without enzymatic disruption, such as proteolysis, amylolysis, lipolysis or lysozyme-mediated cell-wall degradation, probiotics alone cannot adequately penetrate or destabilise biofilm structures. Moreover, volatile sulphur compounds responsible for halitosis originate from enzymatic degradation of sulphur-containing amino acids trapped within biofilms and debris; unless these substrates are actively broken down and cleared, odour reduction is slow, incomplete and easily reversible. Thus, while existing probiotic- only formulations may modulate the oral microbiome over time, they lack an immediate mechanism for cleaning the oral cavity, disrupting mature biofilms, removing debris, and reducing VSC levels.

[0013] Despite these advances, there therefore remains a need for a more effective and comprehensive oral hygiene formulation that combines multiple mechanisms to inhibit VSC production, neutralize odor-causing compounds, and maintain a healthy balance of oral bacteria. Such a formulation would provide a lasting solution for individuals affected by halitosis, improve quality of life, and contribute to better oral health maintenance.

[0014] OBJECTIVE OF THE INVENTION

[0015] The primary object of the present invention is to provide an oral-hygiene composition that achieves reduction of halitosis by combining at least one probiotic with an enzyme and a lysozyme disruptor, in a formulation adapted for direct action within the oral cavity.

[0016] Another object of the invention is to provide an oral -hygiene composition that is capable of degrading oral biofilms, plaque, food debris and sulphur-containing substrates, thereby removing ecological niches that support the proliferation of volatile sulphur compound producing bacteria.

[0017] A further object of the invention is to provide a composition that enables enhanced probiotic colonisation by using enzymatic disruption to open access to oral surfaces, fissures and interdental spaces, facilitating long-term microbiome restoration and maintenance of oral hygiene.

[0018] It is also an object of the invention to provide a composition with a dual-action for oral-plus-gastrointestinal benefit, wherein the composition not only acts locally to reduce oral odour but also supports gastrointestinal microbiome balance through probiotic activity, upon swallowing. Another object of the invention is to offer a composition that provides synergistic effects from the combined action of probiotics, enzymes and lysozyme disruptor, resulting in enhanced biofilm removal, reduced recolonisation of pathogenic bacteria, improved oral freshness and / or superior VSC suppression, compared to probiotic-only or enzyme-only compositions.

[0019] SUMMARY OF THE INVENTION

[0020] In one aspect of the invention, there is provided an oral-hygiene composition comprising: at least one probiotic, at least one enzyme disruptor, and at least one lysozyme disruptor capable of degrading oral biofilm, plaque, food debris and / or volatile sulphur-containing substrates, wherein the probiotic is present in an amount of about 5 billion CFU to 8 billion CFU in the composition, the enzyme disruptor is present in an amount of 35mg to 90mg and the lysozyme disruptor is present in an amount of about 5mg to 40 mg.

[0021] In one aspect of the invention, the probiotic is selected from the group comprising Lactobacillus thermophilus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium coagulans, Streptococcus thermophilus and combinations thereof.

[0022] In one aspect of the invention, at least one enzyme disruptor is selected from the group comprising glucose oxidase, catalase, amylase, papain, amyloglucosidase, peptizyme SP, lactoferrase, protease, lipase, diastase and combinations thereof.

[0023] In one aspect of the invention, the composition may be an orally dissolving effervescent tablet, effervescent powder, soft gel capsule, oral gel, lozenge, gummy, mouth dissolving tablet, chewable tablet, oral liquid concentrate, oral mouthwash, or oral thin film.

[0024] In another aspect of the invention, the orally dissolving effervescent tablet is a bilayer tablet comprises a first layer containing at least one probiotic; a second layer containing at least one digestive enzyme disruptor; and an outer coating of lysozyme disruptor dispersed in a film-forming polymer matrix. The film forming polymer matrix is selected from the group comprising hydroxypropyl methylcellulose, hypromellose, pullulan, polyvinyl alcohol, polyvinylpyrrolidone, cellulose acetate phthalate, methacrylate copolymers, and combinations thereof.

[0025] In an aspect, the composition has an oral disintegration time ranging between 30 seconds to 180 seconds.

[0026] The composition of the present invention further comprises an acid, a salt or a combination thereof. The acid is citric acid and the salt is sodium bicarbonate. The composition further comprises one or more excipients selected from the group comprising sweeteners, flavors, binders, anti-caking agents and stabilizers.

[0027] In another aspect of the present invention, there is provided a kit for oral hygiene comprising: an oral liquid composition comprising at least one probiotic in a total amount of 5 to 8 billion CFU; and a separately packaged combination of a lysozyme disruptor in an amount of 5 mg to 40 mg and at least one enzyme disruptor in an amount of 35 mg to 90 mg; configured to be co-administered. The disruptor components (ii) are provided in a sachet, vial, ampoule or dropper bottle and are added to the oral liquid composition (i) immediately before administration.

[0028] In another aspect of the present invention, there is provided use of the composition for preventing or reducing halitosis, oral malodour, biofilm accumulation, plaque formation, gingivitis, gum inflammation, cavity formation, or dry mouth.

[0029] In yet another aspect of the present invention, there is provided a method for improving oral hygiene in a subject in need thereof, comprising administering once or more daily the composition or the kit.

[0030] DETAILED DESCRIPTION OF THE INVENTION

[0031] Embodiments of the present disclosure, disclose an oral hygiene formulation. The terms “comprises”, “comprising”, or any other variations thereof used in the specification, are intended to cover a non-exclusive inclusion, such that a mechanism and method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such mechanism or method.

[0032] The terms ‘formulation’, ‘preparation’, ‘dosage form’, ‘product’ and ‘composition’ may be used interchangeably throughout the specification.

[0033] For the purposes of promoting an understanding of the principles of the disclosure, reference will be made to specific embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alterations and further modifications in the illustrated methods, and such further applications of the principles of the disclosure as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention pertains.

[0034] The present invention relates to an oral-hygiene composition comprising (i) at least one probiotic, (ii) at least one enzyme and (iii) a lysozyme disruptor capable of degrading oral biofilm, plaque, food debris and / or sulphur-containing substrates.

[0035] In an embodiment of the present invention, the at least one probiotic may include agent(s) selected from, but is not limited to, Lactobacillus thermophilus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium coagulans, Streptococcus thermophilus and combinations thereof In an embodiment of the invention, the formulation may comprise more than one probiotic. The probiotic out-competes harmful bacteria present in the oral cavity, for space and nutrients. Of the many harmful bacteria, the oral hygiene formulation of the present disclosure prevents one or more of Porphyromonas gingivalis and S. mutans from thriving in the oral cavity. The probiotic, therefore, neutralises harmful odor causing bacteria in the mouth. Additionally, the probiotic may reduce production of Volatile Sulphur Compounds (VSCs) that is usually the reason for halitosis.

[0036] The term “colony forming unit” (“CFU”) is defined as number of bacterial cells as revealed by microbiological counts on agar plates. In an embodiment of the present invention, each probiotic is present in an amount of about 5 billion CFU to 8 billion CFU in the composition. In preferable embodiments, the total probiotic content is at least 5 billion CFU in the composition. Such a CFU load is designed to naturally create and maintain a healthy mouth environment, reduce the build-up of odourcausing microbes, and promote long-lasting fresh breath by acting at the microbial level rather than simply masking odour. The probiotics may be present as freeze- dried powders, microencapsulated preparations, or protected coatings to enhance stability in the composition.

[0037] As used herein, the term “disruptor” refers to an enzyme or combination of enzymes capable of disrupting, degrading, weakening or dismantling oral biofilms, plaque, food debris, proteinaceous substrates, polysaccharides, lipids, or volatile sulphur compound precursors while improving digestion. The term includes two categories of enzymes: (i) antimicrobial enzymes, which act by lysing bacterial cell walls, inhibiting bacterial adhesion, preventing biofilm formation, and reducing the viable load of pathogenic species, such as a lysozyme,; and (ii) digestive enzymes, which act by breaking down proteins, carbohydrates or lipids present in oral debris and plaque, thereby dismantling the biofilm matrix and reducing fermentable substrates that support VSC-producing bacteria . These digestive enzymes also help in improved digestion and reduced bloating. Accordingly, the term “disruptor” as used in the present invention explicitly includes antimicrobial enzymes, digestive enzymes, and mixtures thereof. In preferred embodiments the oral hygiene composition comprises a digestive enzyme disruptor and a lysozyme disruptor. The terms “enzyme disruptor” and “digestive enzyme disruptor” may be used interchangeably, and are different from the “lysozyme disruptor” when the latter is present in the composition.

[0038] In an embodiment of the present invention the disruptor includes enzymes that may be selected from, but is not limited to, lysozyme, catalase, amylase, papain, amyloglucosidase, peptizyme SP (serratiopeptidase), lactoferrase, glucose oxidase, protease, lipase, diastase and combinations thereof. In one embodiment of the present invention, the formulation comprises more than one disruptor. The disruptor enzymes are capable of degrading key structural components of oral biofilms and debris, including proteins, polysaccharides and lipids, thereby loosening the biofilm matrix and enhancing probiotic access to mucosal surfaces, making it easier for the probiotics to colonize the oral cavity and compete with the harmful bacteria. Once the biofilm and debris are broken down, probiotics can more effectively restore and maintain a healthy oral microbiome. The disruptors quickly degrade organic matter and proteins in the mouth that contribute to bad breath, while probiotics help eliminate the bacteria responsible for VSC production over time. Therefore, the enzymes, apart from the above role, also ensure complete digestion starting from the oral cavity to the gut.

[0039] In an embodiment of the present invention, Lysozyme is present as the disruptor which plays an essential role in maintaining oral health due to its antibacterial properties. Lysozyme works as follows: a) Antibacterial Activity: Lysozyme targets and breaks down the cell walls of certain bacteria, especially Gram-positive bacteria, by cleaving the P (1,4)- glycosidic bonds between the N-acetylmuramic acid (NAM) and N- acetylglucosamine (NAG) residues in the peptidoglycan layer. This action compromises the integrity of the bacterial cell wall, leading to cell lysis (destruction of the bacterial cell). b) Disruption of Biofilm Formation: In the oral cavity, harmful bacteria often aggregate to form biofilms, which are difficult to remove. Lysozyme helps inhibit biofilm formation by preventing bacterial adhesion to the tooth surface, thereby reducing plaque formation. c) Synergistic Action with Other Antimicrobial Agents: Lysozyme works in concert with other antimicrobial peptides (like lactoferrin and peroxidase enzymes that may be present in the saliva) to enhance the overall defense mechanism in the mouth. Together, they can limit the growth of bacteria that contribute to dental caries (cavities) and periodontal disease (gum disease). d) Anti-inflammatory Effects: Beyond its antibacterial function, lysozyme may also have anti-inflammatory effects in the oral cavity. By reducing the bacterial load, lysozyme can decrease the production of harmful byproducts like bacterial endotoxins that trigger inflammation in the gums. e) Protection Against Oral Pathogens: It has a specific effect against oral pathogens like Streptococcus mutans, which is responsible for dental caries. By lysing these bacteria, lysozyme can help control their population and prevent the onset of tooth decay.

[0040] Lysozyme supports oral health through its antibacterial, anti-biofilm, and antiinflammatory properties, contributing to the prevention of oral infections, tooth decay, and gum disease. It is part of the body’s innate immune defense, helping maintain a balanced oral microbiome. Clinical trials involving lysozyme have demonstrated promising results in oral health applications, including plaque control, gingivitis reduction, dry mouth relief, and caries prevention. While prior art data supports its efficacy in specific contexts, more large-scale studies may be needed to fully establish its role in routine dental care.

[0041] In an embodiment, Lipase, an enzyme primarily known for breaking down dietary fats (lipids) into free fatty acids and glycerol, is used as the disruptor in the oral hygiene formulation of the present invention. While lipase plays a key role in the digestive system, its presence and relevance in oral health are less studied compared to enzymes like amylase or lysozyme. The possible mechanisms through which lipase may contribute to oral health includes breakdown of dietary fats in the oral cavity; production of free fatty acids from triglycerides present in the diet, which help to reduce the bacterial load and contribute to a balanced oral microbiome; prevention of dry mouth and saliva maintenance; supporting dental health through fat metabolism, thereby preventing the accumulation of food residues on teeth and gums, and limiting the substrate available for bacterial colonization.

[0042] There is limited direct clinical trial data specifically focused on lipase and its role in oral health. Lipase is primarily studied in the context of its role in digestive health, particularly for treating conditions like pancreatic insufficiency, malabsorption, and fat digestion disorders. However, research on lipase in oral health is scarce compared to enzymes like lysozyme or amylase. Thus, while lipase is not a primary defense enzyme in oral health, its role in fat digestion and its influence on the oral microbiota through the production of antimicrobial fatty acids may contribute to maintaining oral hygiene. Further research could help clarify its full potential in oral health applications, particularly in the context of biofilm control and microbiome balance. Direct clinical trials on the role of lipase in oral health (as a treatment for conditions like dental plaque, caries, or periodontal disease) are not readily available. Most of the focus in enzyme-related oral care research has been on lysozyme, amylase, and peroxidases rather than lipase.

[0043] In another embodiment, Fungal diastase (also known as fungal amylase), a commercially available enzyme derived from fungal sources (typically Aspergillus oryzae), is used as a disruptor in the oral hygiene composition of the present invention. It primarily breaks down complex carbohydrates, such as starch, into simpler sugars like maltose and dextrin. While the prior art is replete with references that describe Fungal diastase as a commonly used additive in digestive enzyme supplements to improve digestion, its role in oral health is not well explained or studied. There is limited direct clinical trial data on fungal diastase specifically related to oral health. Fungal diastase (amylase) may influence oral health by helping break down starchy foods in the mouth, potentially reducing the accumulation of fermentable carbohydrates that bacteria use to produce acids, thus minimizing the risk of dental plaque and tooth decay. However, its effect has been known thus far to be indirect and largely related to improving the enzymatic digestion of carbohydrates, rather than acting directly on oral pathogens. No specific clinical trials directly address the use of fungal diastase in oral health.

[0044] In a further embodiment, Amylase, an enzyme primarily responsible for the breakdown of starches (complex carbohydrates) into simpler sugars like maltose, dextrin, and glucose, is used as a disruptor in the oral hygiene formulation of the present invention. In the context of oral health, the enzyme salivary amylase (also known as ptyalin) plays a key role in the initial digestion of dietary carbohydrates while food is still in the mouth. This process starts immediately upon mastication (chewing) and continues in the oral cavity before food reaches the stomach. There are clinical trial data on amylase, particularly in relation to its role in digestive health and, to some extent, oral health. However, most of the studies and clinical trials focus on digestive enzymes or enzyme supplementation rather than amylase alone. The present disclosure provides oral hygiene formulations where Amylase plays an essential role in maintaining oral health by aiding in the early digestion of starches and reducing the potential for plaque buildup and acid formation. Amylase also helps in maintaining the oral pH in the desired range, to thereby prevent or reduce halitosis.

[0045] In another embodiment of the present invention, Protease, an enzyme that break down proteins into smaller peptides and amino acids, is used as a disruptor in the oral hygiene formulation of the present invention. While proteases are mainly known for their role in the digestion of dietary proteins in the gastrointestinal tract, they also play a significant role in oral health. These enzymes can contribute to maintaining oral hygiene by reducing bacterial colonization, breaking down proteins in the oral cavity, helping manage plaque formation and gingivitis, and reducing gum inflammation.

[0046] In an embodiment of the present invention, the one or more disruptors are present in an amount ranging from 5 mg to 90 mg each by total weight of the composition. In a preferred embodiment, the enzyme disruptor and lysozyme disruptor are present in an amount of 30mg each by total weight of the composition. In a highly preferred embodiment, the disruptor is present in an amount ranging from 5 mg to 90 mg, comprising enzyme disruptor (35-90 mg) and lysozyme disruptor (5-40 mg).

[0047] The oral hygiene formulation of the present invention uses one or more probiotics and one or more enzymes or disruptors to provide an effective formulation for treating and / or preventing halitosis, commonly known as bad breath. In one embodiment the blend of probiotics and digestive enzymes in the oral hygiene formulation of the present invention help primarily in maintaining oral hygiene and preventing Halitosis.

[0048] In one embodiment, the oral hygiene formulation of the present invention supports healthy teeth, gums and mouth, thus improving oral health by acting as the first line of defense in neutralizing harmful bacteria in the mouth.

[0049] The oral hygiene formulation of the present invention improves digestion and relieves bloating, apart from addressing halitosis. The presence of enzymes ensures improved digestion, leading lower incidences of indigestion, acidity, acid reflux, and emanation of odour due to VSCs generated in the gastrointestinal tract. As a result, the oral hygiene formulation of the present invention helps by addressing the root cause of deteriorating oral health.

[0050] The combination of one or more probiotics and one or more enzymes is more effective for oral hygiene and halitosis than probiotics alone. The oral hygiene formulation of the present invention works synergistically to tackle both the microbial imbalance and the physical biofilm or debris that contribute to oral health issues. The synergistic impact is achieved by the action of the probiotics and the enzymes, wherein the formulation acts by

[0051] (i) targeting harmful bacteria and balancing the microbiome - Probiotics introduce beneficial bacteria into the oral cavity, helping to restore the balance of the oral microbiome, thereby reducing the bacterial load that leads to plaque, cavities, and halitosis; and they reduce the production of VSCs by inhibiting the bacteria responsible for their creation. The probiotic is eventually swallowed, and as a result, the gut micro-environment also improves;

[0052] (ii) breaking down biofilm and organic debris - Enzymes work by breaking down the biofilms and food particles that harmful bacteria thrive on, breaking down leftover food particles in the mouth, and reducing the substrate that harmful bacteria feed on to produce VSCs and cause cavities. In one embodiment, the oral hygiene formulation of the present invention helps restore and maintain mouth moisture. The presence of digestive enzymes and oral probiotics stimulates salivary flow and supports physiological mechanisms that keep the oral mucosa hydrated. By promoting saliva production, the formulation helps to naturally moisten the mouth and maintain lasting oral moisture throughout the day, which is important because dry mouth is predisposed to halitosis, plaque accumulation and caries.

[0053] In another embodiment, the oral hygiene formulation supports healthy gums by replenishing and balancing the oral microbiome. The probiotics strengthen the immune defences in the mouth cavity, and reduce periodontal pathogens and inflammatory stimuli, thereby assisting in maintaining gingival tissues and reducing gum bleeding, infections and inflammation.

[0054] In yet another embodiment, the formulation promotes teeth health and improves cavity defence. The combined action of probiotics and enzymes helps prevent plaque formation, supports gum repair, reduces the incidence of cavities, and contributes to maintaining strong, healthy teeth.

[0055] In certain embodiments, the formulation is used after professional dental cleaning. As such procedures temporarily neutralize both beneficial and undesirable bacteria, administration of the formulation enables rapid recolonisation by beneficial probiotics and helps re-establish a balanced oral microbiome, prolonging the benefits of the dental procedure.

[0056] In an embodiment, the oral hygiene formulation is designed to balance good and bad bacteria in the mouth. The synergistic action of probiotics and enzymes restores microbial equilibrium and reinforces the natural defences of the mouth cavity against infections.

[0057] In another embodiment, the formulation freshens breath and may assist in gentle whitening. By reducing odour-causing bacteria and limiting plaque and debris accumulation, the formulation keeps the mouth feeling fresh for extended periods and may gradually reduce extrinsic staining associated with plaque.

[0058] In another embodiment, the formulation prevents cavities, gum disease and plaque accumulation by inhibiting pathogenic bacteria and aiding in maintaining optimal oral micro-ecology. This root-cause-based mechanism offers a superior alternative to temporary masking agents such as mints, gums and conventional mouthwashes.

[0059] In another embodiment, the formulation assists in maintaining both dental and gastrointestinal health. It helps manage cavities, gum infections and inflammation, while simultaneously supporting digestive comfort and reducing VSC generation in the gut.

[0060] In some embodiments, the formulation serves as a healthier alternative to mouth fresheners, sprays or alcohol-based mouthwashes, offering sustained confidence and oral health support without harsh or drying effects.

[0061] The benefits of the combination are much needed for oral hygiene and halitosis. A faster reduction of bad breath is achieved because the enzymes in the oral hygiene formulation break down debris and biofilm, providing immediate benefits by eliminating the materials that bacteria feed on. The probiotics then inhibit the bacteria that produce foul-smelling VSCs, providing long-term control over bad breath. The oral formulations of the present invention provide comprehensive oral hygiene because the probiotics restore a healthy oral microbiome, while enzymes break down biofilms and organic matter that brushing might miss. This combination leads to reduced plaque, cavities, and gum disease. Finally, the oral hygiene formulation of the present invention provides better biofilm control as the enzymes help remove stubborn biofilms, allowing probiotics to act more efficiently in keeping harmful bacteria in check.

[0062] In an embodiment, the formulation addresses halitosis arising due to imbalance of the microbiome in both, the oral cavity and the digestive tract. The probiotic and enzyme disruptor combination of the oral hygiene formulation of the present invention thus offers a dual-action approach wherein the enzymes provide immediate mechanical cleaning, and the probiotics restore long-term microbial balance, making this combination particularly effective for improving oral hygiene and reducing halitosis.

[0063] The formulation may be provided in the form of, including but not limited to, orally dissolving effervescent tablets, effervescent powder, soft gel capsules, oral gels, lozenges, gummies, mouth dissolving tablets, chewable tablets, oral liquid concentrates, oral mouthwashes, oral thin films and the like. Here, the terms “effervescent”, “dissolving” and “disintegrating” must be understood in traditional context of pharmaceutical terminologies, and relate to compositions that dissolve or disintegrate in the oral cavity.

[0064] The one or more probiotics and the one or more disruptors present in the oral hygiene formulation of the present invention is preferably formulated into an effervescent oral tablet formulation that is easy to administer, as well as easy to store and carry. Upon placement in the mouth, the effervescent system facilitates dispersion of active components across oral surfaces and activates enzymatic breakdown, while probiotics colonise exposed epithelial surfaces and niches. Typically, the effervescent oral tablet formulation contains an acid, such as citric acid, and a salt, such as sodium bicarbonate, which interacts upon exposure to moisture or water, such as saliva, to release gas (carbon dioxide), which leads to disintegration of the tablet and release of the probiotic(s) and enzyme(s) in the mouth. The effervescent oral tablet formulation is formulated to ensure that the tablet disintegrates within 3 minutes (180 seconds) or less, in the mouth. It may have a lower disintegration time if administered after prehydration of the mouth, i.e. after having water or fluid to hydrate the oral mucosa. In preferred embodiments the disintegration time of the composition in the oral cavity is between 30 seconds and 180 seconds. In one embodiment of the present invention there is provided a bi-layer, orally disintegrating tablet comprising:

[0065] (i) a first layer comprising at least one probiotic;

[0066] (ii) a second layer containing at least one digestive enzyme;

[0067] (iii)outer coating of lysozyme dispersed in a film-forming polymer matrix.

[0068] In certain embodiments, the outer coating layer comprises a film-forming polymer matrix selected from hydroxypropyl methylcellulose (HPMC), hypromellose, pullulan, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), cellulose acetate phthalate, methacrylate copolymers (such as Eudragit® types), or combinations thereof. Such polymers form uniform, flexible films capable of incorporating lysozyme and other actives while protecting the underlying layers. The coating solution or dispersion may be prepared by dissolving or dispersing the selected polymer(s) in purified water or an aqueous-alcoholic medium, followed by incorporation of lysozyme, plasticizers such as glycerol or polyethylene glycol, and optional sweeteners, flavours or colouring agents. The prepared coating suspension is then applied onto the bilayer tablet core using standard pharmaceutical coating techniques, including perforated pan coating or fluid-bed coating. During coating, parameters such as inlet air temperature, spray rate, pan rotation speed and exhaust temperature are controlled to ensure uniform deposition and to preserve enzyme activity. The coated tablets are subsequently dried to achieve the desired film integrity, weight gain and disintegration profile.

[0069] In one embodiment, the oral hygiene formulation of the present disclosure contains one or more probiotics, one or more enzymes, citric acid, sodium bicarbonate, one or more sweetening agents, one or more flavoring agents, disintegrants, lubricants, glidants, and optionally chelating agents, preservatives and antioxidants. The tablets are prepared by processes conventional in the art, such as by direct compression or by dry granulation and compaction. The use of water and / or moisture is avoided so as to prevent interaction of the effervescent components of the tablet during manufacturing and storage. The excipients from various functional categories that can be used in the formulation may be selected from the Handbook of pharmaceutical excipients, 9thedition by Paul Sheskey et al, which provides comprehensive guidance on selection, use and suitable quantities of these excipients.

[0070] In another embodiment of the present invention, the composition is in the form of an oral liquid composition such as an oral liquid concentrate, or oral mouth wash. In such cases, the composition is provided in the form of a kit.

[0071] In a preferred embodiment, there is provided a kit for oral hygiene comprising: (i) an oral liquid composition comprising at least one probiotic in a total amount of 5 to 8 billion CFU; and

[0072] (ii) a separately packaged combination of a lysozyme disruptor in an amount of 5 mg to 40 mg and at least one enzyme disruptor in an amount of 35 mg to 90 mg; configured to be co-administered.

[0073] The oral liquid composition and the disruptor component are configured to be coadministered. The enzyme disruptor component in the kit is provided in a sachet, vial, ampoule or dropper bottle and is added to the oral liquid composition immediately before administration. Alternatively, the two components of the kit may be administered sequentially.

[0074] Oral liquid formulations according to the present invention may be prepared by conventional techniques well known in the art. Such techniques include dissolving, dispersing or suspending the probiotic and enzyme components in a pharmaceutically acceptable aqueous or hydroalcoholic vehicle, followed by the incorporation of suitable excipients as required. The components may be added sequentially or simultaneously, with gentle mixing conditions employed to preserve probiotic viability and enzyme activity. The resulting oral liquid composition may be filled into bottles, vials, sachets or unit-dose containers suitable for administration.

[0075] The present invention also provides use of the composition or the kit for preventing or reducing halitosis, oral malodour, biofilm accumulation, plaque formation, gingivitis, gum inflammation, cavity formation, or dry mouth. The present invention also provides a method for improving oral hygiene in a subject in need thereof, comprising administering the composition or the kit once or more daily. In an embodiment, the formulation is administered once or more daily, preferably after meals. The dosage form is simple to use and suitable for integration into routine oral -care habits.

[0076] In some embodiments, the formulation is all-natural or substantially free of harsh chemicals and is suitable for consumption by children and adults, including diabetic or pregnant individuals under professional guidance.

[0077] While various aspects and embodiments have been disclosed hereinabove, other aspects and embodiments will be apparent to those skilled in the art. However, it will be apparent to those skilled in the art that various changes and modifications may be made without departing from the scope of the invention.

[0078] Examples

[0079] Example 1

[0080] Preparation of Orally Disintegrating Tablet formulation

[0081] An orally disintegrating tablet was prepared comprising a first probiotic layer, an enzyme-mint second layer, and an outer lysozyme-based antimicrobial film coat. The batch size corresponds to 10,000 bi-layer film coated tablets. The first layer containing the probiotic blend and supporting excipients was prepared as shown in Table 1.

[0082] Table 1

[0083] Target weight: 600 mg / tablet; theoretical batch weight 6,000 g; with overage: 6,384 g.

[0084] Strains used: Lactobacillus acidophilus (MTCC25346); Lactobacillus paracasei (MTCC25632); Bifidobacterium lactis(MTCC25633) ; Bacillus coagulans(MTCC25157) ; Streptococcus thermophillus(MTCC25431)

[0085] The probiotic layer was prepared by blending the probiotic mix with mannitol, isomalt, inulin / FOS, crospovidone, mint flavour, sweetener, colloidal silicon dioxide and magnesium stearate. The theoretical batch quantity for 10,000 tablets was 6,000 g; however, applying 20% overage for probiotic CFU and 3% overage for excipients resulted in a target dispensed quantity of 6,384 g. Specifically, 1,200 g of probiotic blend was increased to 1,440 g, while mannitol (3,200 g), isomalt (800 g), inulin (400 g), crospovidone (200 g), flavour (80 g), sweetener (40 g), colloidal silica (40 g) and magnesium stearate (40 g) were adjusted by 3% to target 3,296 g, 824 g, 412 g, 206 g, 82.4 g, 41.2 g, 41.2 g and 41.2 g respectively. The final blend was compressed to form the first layer weighing approximately 600 mg per tablet. The second layer containing digestive enzymes and a mint base was prepared as shown in Table 2 and Table 3

[0086] Table 2- Enzyme formulation Target weight: 900 mg / tablet; theoretical batch weight 9,000 g; with overage: 9,287.5 g.

[0087] Table 3- Mint base formulation The enzyme layer was prepared to form the second compressed portion of the bi- layer tablet. Digestive enzymes including papain, amylase, amyloglucosidase, glucose oxidase and catalase were incorporated into a mint-flavoured ODT excipient base composed of mannitol, isomalt, xylitol, crospovidone, mint flavour, menthol, sweetener, colloidal silicon dioxide and magnesium stearate. A theoretical weight of 9,000 g was required; application of 10% overage for enzymes and 3% overage for excipients resulted in a target dispensed quantity of 9,287.5 g. Papain (50 g), amylase (40 g), amyloglucosidase (40 g), glucose oxidase (30 g) and catalase (40 g) were adjusted to 55 g, 44 g, 44 g, 33 g and 44 g respectively. Mannitol (4,300 g) was increased to 4,429 g, isomalt (2,500 g) to 2,575 g and xylitol (1,200 g) to 1,236 g. Crospovidone (400 g) was dispensed as 412 g, mint flavour (100 g) as 103 g, menthol (50 g) as 51.5 g, sweetener (30 g) as 30.9 g, colloidal silica (70 g) as 72.1 g and magnesium stearate (100 g) as 103 g. The enzyme blend was compressed over the probiotic layer to create a stable two-layer tablet structure.

[0088] The outer lysozyme film coat was prepared with components as per Table 4 below:

[0089] Table 4

[0090] Target coat: 50 mg / tablet; theoretical solids 500 g; with overage 518.5 g.

[0091] PEG-400) and mint flavour / sweetener as required. For 10,000 tablets, a theoretical coating solid load of 500 g was required, which increased to 518.5 g after applying 10% overage to lysozyme and 3% to the remaining components. Accordingly, lysozyme (50 g) was adjusted to 55 g, HPMC / pullulan (350 g) to 360.5 g, plasticizer (50 g) to 51.5 g and flavour / sweetener / colour (50 g) to 51.5 g. The coating solids were dispersed in purified water to form a uniform coating suspension, which was applied using a standard perforated-pan coating process to yield a smooth, uniform film coat.

[0092] The final quantities dispensed for the 10,000-tablet batch were 6,384 g for the probiotic core layer, 9,287.5 g for the enzyme + mint layer and 518.5 g for the lysozyme coating solids. Tablets produced by this method showed robust mechanical strength, rapid oral-dissolution characteristics and stable retention of enzyme and probiotic activity. The tri-layer functionality was retained in the bilayer coated format by positioning the probiotic layer as the protected inner layer, the digestive enzyme matrix as the middle layer and the lysozyme antimicrobial system on the exterior.

[0093] Example 2: Preparation of Streptococcus mutans suspension

[0094] A stock culture of S. mutans, preserved at (-)80°C in 50% Beef Heart Infusion (BHI) glycerol solution, was removed from long-term storage and allowed to thaw at room temperature until liquefied. The entire thawed culture was aseptically transferred into 5 mL of fresh BEEF HEART INFUSION broth in a sterile culture tube. The inoculated broth was incubated overnight at 37°C in a 5% CO2 incubator to allow the bacteria to reach late exponential phase.

[0095] After overnight incubation, 500 pL of the resulting culture was transferred to 4.5 mL of fresh BEEF HEART INFUSION broth. The new culture was incubated at 37°C, 5% CO2, with monitoring of optical density at 600 nm (ODeoo) until it reached approximately 0.4, corresponding to a viable cell count of approximately 109CFU / mL (mid-exponential phase).

[0096] A 1 : 100 dilution of the mid-exponential phase culture was performed in Beef Heart Infusion broth to obtain a working suspension containing approximately 107CFU / mL of S. mutans .The resulting S. mutans suspension (~107CFU / mL) was used in further examples below.

[0097] Example 3: Effect of Lysozyme on Viability of Streptococcus mutans An overnight culture of S. mutans was adjusted to ODeoo = 0.9 (~109CFU / mL). Aliquots of 200 pL bacterial suspension were mixed with various concentrations of lysozyme in distilled water and incubated for 2 minutes and 5 minutes at 37°C. At each time point, 100 pL was withdrawn, serially diluted in saline, plated on BHI agar, and incubated for 48 hours at 37°C. The results are shown in table 5 below.

[0098] Table 5

[0099] The results of this study demonstrate that lysozyme exerts a rapid and concentration-dependent bactericidal effect on Streptococcus mutans. Even at the lower concentration of 50 pg / mL, lysozyme caused a measurable reduction in viable cell counts within two minutes of exposure, indicating that the enzyme acts quickly on the bacterial cell wall. Increasing the concentration to 100 pg / mL further enhanced the killing efficiency, resulting in more than half of the bacterial population being eliminated within five minutes. This rapid onset of antimicrobial activity is particularly significant because it aligns with the expected in-mouth residence time of the oral dissolving tablet. These findings confirm that the lysozyme layer of the formulation provides immediate antimicrobial action capable of reducing the burden of S. mutans during typical product use, thereby contributing directly to oral hygiene benefits.

[0100] Example 4: Effect of Lysozyme on Biofilm formation by Streptococcus mutans

[0101] Biofilm assays were conducted using 12-well flat-bottom plates. For biofilm formation, 50 pL of S. mutans suspension (approximately 107CFU / mL, prepared as in Example 2) was mixed with 950 pL of fresh Beef Heart Infusion (BHI) broth, yielding a final volume of 1,000 pL per well. The entire 1,000 pL mixture was distributed into individual wells of the 12-well plate. For negative control wells (no S. mutans), 1,000 pL of BHI broth alone was added under the same conditions. Plates were incubated at 37°C, 5% CO2, for 24 hours to allow robust biofilm formation on the well surfaces.

[0102] After incubation, culture media was carefully decanted. Each well was washed three times with sterile saline to remove non-adherent cells while leaving the attached biofilm intact. Biofilms were fixed with 100 pL of cold Carnoy’s fixative (75% ethanol: 25% acetic acid) for 10 minutes. Wells were rinsed with distilled water. Biofilms were stained with 100 pL of 0.5% (w / v) crystal violet for 3 minutes. Excess stain was removed by gently washing with water. Bound crystal violet was solubilized by adding 600 pL of 0.5% SDS in 90% ethanol. The absorbance of the extracted dye was measured at A590 nm using a spectrophotometer. All experiments were performed in triplicate, with three independent experimental runs.

[0103] To evaluate the inhibitory effect of lysozyme, 50 pL of S. mutans suspension (107CFU / mL) was mixed with 950 pL of BHI broth containing different concentrations of lysozyme: 0 pg (control), 50 pg, 100 pg and 200 pg. The enzyme-treated S. mutans suspensions were incubated at 37°C for 1 hour. After incubation, 1,000 pL of each preparation was dispensed into individual wells of a 12-well plate. Biofilm inhibition was calculated from crystal-violet absorbance values. The results are shown in table 6 below:

[0104] TABLE 6

[0105] Biofilm biomass, quantified using the crystal -violet assay, showed that untreated S. mutans cultures (0 pg / mL lysozyme) formed robust biofilms, corresponding to 0% inhibition. Treatment with 100 pg / mL lysozyme resulted in a 42% reduction in biofilm formation relative to the control.

[0106] The results show that lysozyme substantially inhibits the ability of S. mutans to form biofilms, even though some cells survive initial antimicrobial exposure. The 42% reduction at 100 pg / mL indicates that lysozyme interferes with processes required for early surface adherence and matrix establishment. This supports another mode of action for lysozyme beyond bacterial killing: namely, suppression of biofilm development. The findings demonstrate that lysozyme in the formulation not only reduces suspended-cell survival but also significantly limits the transition to structured biofilm growth.

[0107] Example 5: Effect of Digestive Enzymes on Biofilm formation by Streptococcus mutans with non-stimulated saliva

[0108] Non-stimulated saliva was collected from healthy volunteers and diluted 1 :2 with sterile growth medium. The diluted saliva was centrifuged and the clarified supernatant was sterile-filtered through a 0.22 pm membrane filter. 12-well flatbottom plates were coated with sufficient saliva filtrate to cover each well surface. Plates were incubated for 1 hour at 37°C to allow saliva film deposition and early biofilm matrix formation. After incubation, the saliva solution was discarded aseptically. Half of the saliva-coated wells were treated with 100 pL of a digestive enzyme mixture (containing 100 pg / mL of each enzyme mentioned in example 1). Wells were incubated with the enzyme mixture for 1 hour at 37°C. The remaining wells served as untreated controls. After treatment, wells were washed once gently with growth medium to remove residual enzyme while maintaining the underlying saliva-derived matrix.

[0109] A culture of S. mutans prepared in example 2 was diluted into BHI broth to obtain 1,000 pL of working bacterial suspension per well. 1 mL of the S. mutans suspension was added to each well (both enzyme-treated and untreated saliva biofilm wells). Plates were incubated at 37°C for 6 hours to permit bacterial attachment and biofilm formation. After incubation, the media and non-adherent cells were carefully removed. Wells were washed with sterile saline to eliminate loosely attached bacteria.

[0110] Biofilms were fixed with Carnoy’s fixative, stained with 0.5% crystal violet, washed, and destained using 0.5% SDS in 90% ethanol. The absorbance of solubilized stain was measured at A595 nm. Results are shown in table 7 below.

[0111] Table 7

[0112] The findings of this study demonstrate that the digestive enzyme mixture effectively disrupts the saliva-derived conditioning film, which normally provides an attachment scaffold that promotes strong and rapid biofilm formation by S. mutans. Treatment with the enzyme mixture resulted in approximately 35% reduction in early biofilm accumulation compared with untreated saliva-coated controls, indicating that the enzymes degrade key proteinaceous and polysaccharide components required for bacterial adhesion. By weakening this foundational layer, the digestive enzymes reduce the ability of S. mutans to attach to the surface and initiate matrix formation. These results confirm that the digestive enzyme layer of the tablet acts through a mechanism distinct from lysozyme, targeting the extracellular environment rather than the bacteria themselves. This contributes an important secondary mode of action that enhances the overall anti-biofilm performance of the formulation.

[0113] Example 6: Effect of Lysozyme on Hydrogen sulfide (H2S) production

[0114] Overnight cultures of Streptococcus mutans prepared in Example 2 were diluted in fresh Beef Heart Infusion broth to obtain a suspension with an optical density of ODeoo = 0.9, corresponding to approximately 109cells / mL. Aliquots of 200 pL of the standardized bacterial suspension were added to microcentrifuge tubes containing 500 pL of distilled water with varying concentrations of lysozyme. Control tubes were prepared in an identical manner but without lysozyme. The mixtures were gently stirred and pre-incubated at 37°C for 5 minutes. 5 mL of fresh Tryptic Soy Broth (TSB) was added aseptically to each tube. A strip of lead acetate- soaked paper was suspended in each tube, ensuring that the strip did not come into direct contact with the liquid culture. The tubes were sealed and incubated under suitable conditions to allow for hydrogen sulphide production, which would be indicated by blackening of the lead acetate paper.

[0115] Example 7: Cell adhesion assay

[0116] A HEp-2 epithelial cell adhesion assay was performed to evaluate the ability of the probiotic strains used in the oral hygiene formulation to attach to mammalian epithelial surfaces. HEp-2 cells (ATCC CCL-23) were cultured in high-glucose DMEM supplemented with 10% heat-inactivated bovine serum and maintained at 37°C in a humidified 5% CO2 incubator. Upon reaching near confluence, the cells were detached using 0.05% trypsin-EDTA, resuspended in antibiotic-free DMEM containing 10% serum, and adjusted to a concentration of 2 * 105cells / mL. One millilitre of this suspension was seeded onto sterile glass coverslips placed in the wells of a 24-well tissue culture plate and incubated overnight to allow formation of a uniform monolayer.

[0117] Bacterial cultures of Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium lactis, and Lactobacillus paracasei were grown overnight in DMEM at 37°C with shaking (180 rpm). The optical density of each culture was measured at 600 nm, and an inoculum corresponding to approximately 106CFU was added to duplicate wells containing HEp-2 cell monolayers, with parallel wells lacking HEp-2 cells serving as inoculum controls. Following a 4-hour incubation at 37°C, the monolayers were washed three times with warm DPBS to remove nonadherent bacteria. Coverslips were then removed, fixed briefly in 70% ethanol, stained with 1% crystal violet, and examined microscopically under a 100X objective. The number of adherent bacteria per HEp-2 cell was quantified as shown in table 8 below. TABLE 8

[0118] The probiotic strains demonstrated measurable adhesion to HEp-2 epithelial cells, with mean adhesion values of 4.25 bacteria per cell for Streptococcus thermophilus, 5.2 for Lactobacillus acidophilus, 6.6 for Bifidobacterium lactis, and 4.7 for

[0119] 5 Lactobacillus paracasei. B. coagulans does not show any adhesion activity in the oral cavity since these probiotics primarily act on the gut. These results confirm that the selected probiotic strains possess the ability to adhere to epithelial surfaces, an important prerequisite for colonisation of the oral cavity and for exerting competitive exclusion against pathogenic oral microorganisms. 0 Example 8: Disintegration time of the tablet formulation The orally disintegrating tablet formulation of Example 1 was analyzed for disintegration time The antimicrobial enzyme component comprises 15 mg of lysozyme, which functions as the initial disruptor agent. The digestive enzyme blend (35 mg) includes glucose oxidase, amyloglucosidase, catalase, papain and amylase. The probiotic component provides 5 billion CFU per serving and includes Lactobacillus acidophilus, Lactobacillus paracasei. Bifidobacterium laclis. Bacillus coagulans and Streptococcus thermophilus. The disintegration time of the tablets was tested using a disintegration apparatus (basket-rack with tubes and mesh screen) in water at about 37 °C. One tablet was placed in each tube, and the basket was raised and lowered at a fixed frequency, as defined in the United States Pharmacopoeia. The time until each tablet was completely disintegrated (no palpable core or palpable mass on the screen) was recorded. The outer film-coating layer containing lysozyme released 60-120 seconds, the middle digestive-enzyme layer released within 120-300 seconds, and the inner probiotic layer released within 300-420 seconds. The tablets were found to disintegrate at an average time of less than 180 seconds in this in vitro test.

[0120] The tablet was also tested in vivo in healthy volunteers by placing the same in the oral cavity or under the tongue, after the mouth was rinsed with water. The test was conducted in 12 volunteers, and the average disintegration time was found to be less than 3 minutes in the mouth.

[0121] Dissolution of the outer film coating resulted in release of lysozyme, which demonstrated antimicrobial activity and inhibition of biofilm formation. Subsequent release of the digestive enzymes, representing hydrolase classes, facilitated cleavage of polymeric food residues within the oral cavity, including in interdental gaps and along the gingival and mucosal surfaces. Finally, release of the probiotic layer enabled colonisation of the oral mucosa with beneficial bacteria, completing the sequential functional delivery intended for the oral tablet formulation.

Claims

We claim:

1. An oral-hygiene composition comprising:(i) at least one probiotic,(ii) at least one enzyme disruptor, and(iii) at least one lysozyme disruptor capable of degrading oral biofilm, plaque, food debris and / or volatile sulphur-containing substrates, wherein the probiotic is present in an amount of about 5 billion CFU to 8 billion CFU in the composition, the enzyme disruptor is present in an amount of 35 mg to 90 mg and the lysozyme disruptor is present in an amount of about 5mg to 40 mg.

2. The composition as claimed in claim 1, wherein at least one probiotic is selected from the group comprising Lactobacillus thermophilus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium coagulans, Streptococcus thermophilus and combinations thereof.

3. The composition as claimed in claim 1, wherein at least one enzyme disruptor is selected from the group comprising glucose oxidase, catalase, amylase, papain, amyloglucosidase, peptizyme SP, lactoferrase, protease, lipase, diastase and combinations thereof.

4. The composition as claimed in claim 1, wherein the composition may be an orally dissolving effervescent tablet, effervescent powder, soft gel capsule, oral gel, lozenge, gummy, mouth dissolving tablet, chewable tablet, oral liquid concentrate, oral mouthwash, or oral thin film.

5. The composition as claimed in claim 4, wherein the orally dissolving effervescent tablet is a bi-layer tablet comprising:(iv)a first layer containing at least one probiotic;(v) a second layer containing at least one digestive enzyme disruptor; and(vi) an outer coating of lysozyme disruptor dispersed in a film-forming polymer matrix.

6. The composition as claimed in claim 5, wherein the film forming polymer matrix is selected from the group comprising hydroxypropyl methylcellulose, hypromellose, pullulan, polyvinyl alcohol, polyvinylpyrrolidone, cellulose acetate phthalate, methacrylate copolymers, and combinations thereof.

7. The composition as claimed in claims 5 and 6, wherein the composition has an oral disintegration time ranging between 30 seconds to 180 seconds.

8. The composition as claimed in claim 5, wherein the composition further comprises an acid, a salt or a combination thereof.

9. The composition as claimed in claim 8, wherein the acid is citric acid.

10. The composition as claimed in claim 8, wherein the salt is sodium bicarbonate.

11. The composition as claimed in claim 1, wherein the composition further comprises one or more excipients selected from the group comprising sweeteners, flavours, binders, anti-caking agents and stabilisers.

12. A kit for oral hygiene comprising:(i) an oral liquid composition comprising at least one probiotic in a total amount of 5 to 8 billion CFU; and(ii) a separately packaged combination of a lysozyme disruptor in an amount of 5 mg to 40 mg and at least one enzyme disruptor in an amount of 35 mg to 90 mg; configured to be co-administered13. The kit as claimed in claim 12, wherein the disruptor components (ii) are provided in a sachet, vial, ampoule or dropper bottle and are added to the oral liquid composition (i) immediately before administration.

14. Use of the composition of any of the preceding claims for preventing or reducing halitosis, oral malodour, biofilm accumulation, plaque formation, gingivitis, gum inflammation, cavity formation, or dry mouth.

15. A method for improving oral hygiene in a subject in need thereof, comprising administering once or more daily the composition as claimed in any of the preceding claims or the kit as claimed in claim 13.

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