DESC:FIELD OF THE INVENTION
The present invention relates to an oral composition to promote remineralization of tooth enamel due to loss of tooth enamel related to dental conditions such as dental caries and/or dental erosion. More particularly, the present invention relates to tooth remineralization composition comprising primarily theobromine, herbal extracts, and excipients.
BACKGROUND OF THE INVENTION
Dental caries is a prevalent non communicative disease worldwide and is one of the most important public health concerns globally. Dental caries is the result of multifactorial process that affects the enamel and the mineralized dental structures. Enamel of tooth protects the tooth from decay. Enamel contains 96 to 97% mineral salts and 3 to 4% organic substances.
Demineralization is the process of loss of minerals from tooth enamel. Demineralization may occur due to lack of nutritious diet, presence of fruit acids in diet, mechanical damage to the dental tissue, frequent whitening of tooth, or damage due to oral bacteria. Demineralization results in a change in color of tooth enamel, teeth becoming porous, sensitive which may lead to formation of cavities.
Remineralization is the process of regenerating enamel through generation of hydroxyapatite (HAP) on teeth. The saliva helps in natural remineralization of the tooth surface as saliva contains calcium, fluorine and phosphate ions which are essential for remineralization. Further, saliva cleanses the oral cavity from food residues and neutralizes the action of food acids.
When exposed to carbohydrates, oral bacteria can produce organic acids that lower the pH of dental plaque. Caries progresses through demineralization and remineralization phases on the tooth surface before invading deeper layers.
A large number of remineralization agents are available, of which fluoride is the most popular and widely used. While fluoride has been widely used for its effectiveness in preventing tooth decay and promoting remineralization to some extent, it is associated with some disadvantages like dental fluorosis causing discoloration and weakening of tooth enamel, fluoride is not effective in conditions such as dry mouth or enamel defects. Remineralizing dental products comprising theobromine are also in use nowadays. Theobromine based composition were found to be not so effective in the literature. Other known remineralization agents in the art use potassium nitrates, bioactive glass compositions, strontium chloride, strontium acetate, or amorphous calcium phosphates as treatments, but there is ambiguity on the effectiveness of the said compounds.
Accordingly, there is a need for oral care compositions for remineralization of tooth and to prevent and treat dental erosion and/or dental caries. The said oral composition should be safe, affordable and effective when used in daily routine of oral care by a consumer.
SUMMARY OF THE INVENTION
The present invention provides new compositions that provide an effective solution to remineralization of teeth and prevent and treat dental erosion and/or dental caries. The compositions of the present invention are alternatives to fluoride therapy for the remineralization of teeth.
The present invention provides a tooth remineralization composition comprising (i) a remineralizing agent present in a range from 0.1% to 2% by weight of the composition and (ii) a herbal extract present in a range from 0.1% to 5% by weight of the composition and excipients. The remineralizing agent is theobromine and the herbal extract comprises extracts of Kalimirch (Piper nigrum), Pippali (Piper longum), Sunthi (Zingiber officinale) in the composition of the present invention.
The excipients in said tooth remineralization composition are selected from the group comprising abrasives, essential oil mixture, surfactant, binder, thickening agents, humectants, sweetener, carrier, preservatives, and colouring agents.
The excipient abrasive for the composition is selected from sodium metaphosphate, dicalcium phosphate, calcium pyrophosphate, abrasive silica, hydrated silica, alumina, chalk, calcium carbonate, insoluble bicarbonate salts, and mixtures thereof and the abrasives are present in a range from 30% to 50% by weight of the composition.
The excipient essential oil for the composition is a mixture of Clove oil (Oil of Syzygium aromaticum), Menthol (Mentha piperita), and Camphor (Cinnamomum camphora) and wherein the essential oil mixture is present in a range from 0.1% to 3% by weight of the composition.
The excipient surfactant for the composition is selected from sodium lauryl sulphate, cocamidopropyl betaine, sodium methyl cocoyl taurate, sodium cocoyl glutamate, sodium dodecylbenzene sulphonate and sodium lauryl sarcosinate and the surfactant is present in a range from 0.5% to 10% (w/w).
The excipient binder is selected from sodium carboxymethylcellulose (CMC), sodium alginate, sodium silicate neutral (Balsara), carrageenan, synthetic polymers like sodium polyacrylate and inorganic clay minerals as bentonite and laponite and the binder is present in a range from 0.1% to 1% by weight of the composition.
The excipient thickening agent is selected from carbomer, xanthan gum, precipitated silica and hydroxyethyl cellulose and the thickening agent is present in a range from 0.1% to 10% by weight of the composition.
The excipient humectant is selected from sorbitol, xylitol, propylene glycol and polyethylene glycol and the humectant is present in a range from 10% to 40% by weight of the composition.
The excipient sweetener is selected from saccharin sodium IP, sodium cyclamate, aspartame, xylitol, stevia, mannitol and combinations thereof and the carrier is present in a range from 0.1 to 1% by weight of the composition.
The excipient carrier in tooth remineralization composition is water.
The excipient preservative is selected from sodium benzoate, methylparaben and ethylparaben and the preservative is present in a range from 0.1% to 0.5% by weight of the composition.
The excipient colouring agent is gairic powder (Red ochre) and the coloring agent is present in a range from 0.2% to 3% by weight of the composition.
The tooth remineralization composition of the present invention is in form of a toothpaste, gel, varnish, and mouth rinse.
All other aspects of the present invention will more readily become apparent upon considering the detailed description and examples which follow.
DESCRIPTION OF THE INVENTION
The following description is presented to enable any person skilled in the art to make and use the invention. For purposes of explanation, specific nomenclature is set forth to provide a thorough understanding of the present application. However, it will be apparent to one skilled in the art that these specific details are not required to practice the invention. Descriptions of specific applications are provided only as representative examples. The present application is not intended to be limited to the embodiments shown but is to be accorded the widest possible scope consistent with the principles and features disclosed herein.
Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed method and compositions belong.
Similarly, the words "comprise", "comprises", and "comprising" are to be interpreted inclusively rather than exclusively. Likewise, the terms "include", "including" and "or" should all be construed to be inclusive, unless such a construction is clearly prohibited from the context. However, the embodiments provided by the present disclosure may lack any element that is not specifically disclosed herein. Thus, a disclosure of an embodiment defined using the term "comprising" is also a disclosure of embodiments "consisting essentially of” and "consisting of” the disclosed components. Where used herein, the term "example," particularly when followed by a listing of terms, is merely exemplary and illustrative, and should not be deemed to be exclusive or comprehensive. Any embodiment disclosed herein can be combined with any other embodiment disclosed herein unless explicitly indicated otherwise.
The invention relates to dentistry, and more particularly to a novel composition in the form of an oral composition for remineralization of teeth and/or for prevention of conditions or diseases (disorders) characterized by the loss of minerals and salts from the teeth enamel.
The primary focus of the present invention is to provide an oral composition comprising different chemical compounds, herbal extracts along with excipients that promote healthy oral cavity function in addition to elevated mineral levels for the purpose of mineralizing and remineralizing teeth.
It is noted that, as used in this specification and the appended claims, the singular forms “a”, “an”, and “the”, include plural referents unless expressly and unequivocally limited to one referent.
The term ‘oral composition’ as used herein means a paste, powder, liquid, gum or other preparation for cleaning the teeth or other surfaces in the oral cavity, preventing dental erosion and helping in remineralization of the teeth.
The term ‘effective amount’ as used herein refers to the amount of the said oral care composition when administered, prevents dental erosion or tooth decay or reduction of dental erosion and provides re-hardening and remineralization of tooth enamel, etc.
The term ‘remineralization’ is a natural process in which a tooth's minerals are restored or replaced. Remineralization reverses the process of decay and/or erosion caused from demineralization. Remineralization is encouraged to prevent and treat dental caries. Remineralization occurs when a mineral is added to the teeth to replace mineral components that have been depleted from the teeth. One of the most common remineralizing agents is fluoride. There are several other remineralizing agents, including Amorphous Calcium Phosphate (ACP), tricalcium phosphate, Casein Phosphoprotein-ACP, bioactive glass-calcium sodium phosphosilicate, and Arginine bicarbonate-calcium carbonate complex.
The term ‘toothpaste’ as used herein means a paste or gel dentifrice for use with a toothbrush to perform the said functions of cleaning the oral cavity and remineralization of tooth.
The present invention provides an oral care composition for remineralization of teeth comprising abrasives, theobromine as remineralizing agent, herbal extracts, essential oil mixture, surfactants, binders, thickening agents, humectants, sweetener, colouring agent, preservatives, carrier water and optionally flavor.
Abrasives are normally present in toothpaste and some gels. Abrasives are the substances that are used for abrading, grinding or polishing the teeth. They help in bringing the natural luster by removing substances adhering to the surface of the teeth without scratching it. These may include sodium metaphosphate, dicalcium phosphate, calcium pyrophosphate, abrasive silica, hydrated silica, alumina, chalk, calcium carbonate, insoluble bicarbonate salts, and mixtures thereof. Preferably, the abrasive for the present invention is calcium carbonate. For the purpose of the present invention, the amount of abrasives may range from about 30% to about 50% by weight of the composition.
Theobromine (3,7-dimethylxanthine) is a primary alkaloid derived from the cacao plant and is considered as a possible alternative to fluorides. It is believed theobromine, in the presence of calcium and phosphate, forms hydroxyapatite crystallites of an increased size that strengthen the enamel, making it less susceptible to acid attack, which eventually leads to cavitation. Theobromine acts as a remineralizing agent and is present in the composition of the present invention in a range from 0.1% to 2% by weight of the composition.
The composition of the present invention includes aqueous herbal extracts. Suitable herbal extracts for the present invention are selected from the group comprising Kalimirch (Piper nigrum), Pippali (Piper longum), Sunthi (Zingiber officinale) preferably present in a range from 0.1% to 5% by weight of a composition. The herbal extract mixture is obtained from Dabur International Limited, Dubai.
The composition of the present invention includes essential oils. Essential oils for the purpose of the present invention are selected from Clove oil (Oil of Syzygium aromaticum), Menthol (Mentha piperita), Camphor (Cinnamomum camphora) preferably present in a range from 0.1% to 3% by weight of the composition. The essential oil mixture is obtained from Dabur International Limited, Dubai.
Surfactants may either be anionic, nonionic, cationic or amphoteric. Suitable surfactants for the present invention are selected from sodium lauryl sulphate, cocamidopropyl betaine, sodium methyl cocoyl taurate, sodium cocoyl glutamate, sodium dodecylbenzene sulphonate and sodium lauryl sarcosinate. For the present invention, the surfactants may be present in an amount from about 0.5% to about 10% by weight of the composition. Suitable surfactants for the present invention is Sodium lauryl sulfate.
Binders are generally used in toothpaste to provide appropriate viscoelasticity and to prevent the separation of powder and liquid ingredients. They can prevent the toothpaste from drying out by binding water. Also, they have an influence on dispersion, foaming, rinsing and other qualities of the toothpaste in the oral cavity. The common binders for an oral care composition includes sodium carboxymethylcellulose (CMC), sodium alginate, sodium silicate neutral (Balsara), carrageenan, synthetic polymers like sodium polyacrylate and inorganic clay minerals as bentonite and laponite. Preferably, the binder for the present invention is sodium silicate neutral (Balsara) present in a range from 0.1% to 1% by weight of the composition.
Thickening agent in toothpaste helps to create the desired consistency and texture, ensuring the paste remains stable and easy to apply. The common thickeners for an oral care composition include carbomer, xanthan gum, precipitated silica and hydroxyethyl cellulose. Preferably, the thickening agent for the present invention is xanthan gum present in a range from 0.1% to 1% by weight of the composition and precipitated silica is present in a range from 1% to 8% by weight of the composition.
Humectants help in conserving water and prevent the toothpaste from hardening due to loss of water when toothpaste is exposed to air. They also provide a creamy texture. These are short-chained polyalcohols such as glycerol, sorbitol (highly concentrated aqueous solution), xylitol, propylene glycol and polyethylene glycol. Preferably, the humectant for the composition of the present invention is sorbitol 70%IP present in a range from 10% to 40% by weight of the composition, preferably 20% to 35% by weight of the composition. Sorbitol 70%IP also provides sweetness to the composition.
The composition of the present invention may also include sweetening agents. Suitable sweetening agents may be selected from saccharin sodium IP, sodium cyclamate, aspartame, xylitol, stevia, mannitol and combinations thereof. For the purpose of the present invention sweetening agent is saccharin present in an amount from 0.1 to 0.25% by weight of the composition.
The composition comprises carrier as water, wherein water is present in a quantity sufficient to make 100% by wt. of the composition.
The composition of the present invention comprises coloring agent gairic powder (Red ochre), which helps prevent bleeding of gums, soothes burns, ulcers, and boils in mouth. Ayurvedic Literature describes gairic powder as Vrana ropaka. Gairic powder is present in the composition of the present invention in a range from 0.2% to 3% by weight of the composition.
Preservatives are used in the composition of the present invention for preventing micro-organisms growth in toothpaste and mouthwashes during usage. The preservatives include sodium benzoate, methylparaben and ethylparaben preferably, sodium benzoate and the preservative is present in a range from 0.1 to 0.5% by weight of the composition.
The tooth remineralization composition comprises the excipient colouring agent as gairic powder (Red ochre) and the coloring agent is present in a range from 0.2% to 3% by weight of the composition.
Any suitable flavoring material may also be employed. Examples of suitable flavoring constituents are flavoring oils, e.g. oil of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, orange, and methyl salicylate.
The present disclosure incorporates a method of preparation of the disclosed tooth remineralization composition.
The present invention also provides a method for treating or preventing tooth decay or erosion and remineralization of teeth, the method comprising applying an effective amount of the present oral care composition.
The oral care composition of the present invention may be effective at whitening teeth even in the absence of oxidative whitening compound and in a preferred embodiment the composition is substantially free of oxidative whitening compound.
The composition of the present application may be in the form selected from a toothpaste, gel, varnish, mouth rinse or sealant. In one embodiment, the composition is toothpaste.
EXAMPLES
Reference will now be made in detail to certain embodiments of the invention. While the invention will be described in conjunction with the illustrated embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover all alternatives, modifications, and equivalents that may be included within the invention as defined by the appended claims. The headings below are not meant to limit the disclosure in any way; embodiments under anyone heading may be used in conjunction with embodiments under any other heading.
Example 1: Preparation of tooth mineralization compositions of the present invention
The method of preparation of the tooth mineralization composition comprises following steps:
Step I: Weighing Sorbitol and Purified Water in a predefined amount as stated in the range provided in Table 1 followed by heating the mixture in a gel kettle.
Step II: Weighing required quantity of Xanthan Gum and dispersing it slowly into the heated mixture of Step I while mixing, ensuring that no lumps are formed.
Step III: Dispersing required amount of Sodium Saccharin and Sodium Benzoate in Purified water separately. This dispersion is added to mixture of Step II in the gel kettle.
Step IV: Weighing Sodium Silicate and sterilized herbal extract in required amount and adding them to the material of Step III in the gel kettle and mixing while maintaining the temperature. After homogenous mixing the mixture is transferred to the main mixer following quality assurance approval.
Step V: Gairic powder, calcium carbonate and tricalcium phosphate is sifted through a sieve to give amount for making the formulation.
Step VI: Precipitated silica is added to the formulation in main mixer of Step IV under vacuum while stirring followed by gradual addition of sifted Gairic powder, tricalcium phosphate and Calcium Carbonate of Step V under vacuum.
Step VII: Required amount of Sodium Lauryl Sulphate is weighed as per the required formulation and is mixed with the composition in the main mixer under vacuum.
Step VIII: This is followed by optional addition of flavour to the main reactor at lower temperature is mixed under vacuum to give final product.
Table 1: Remineralization composition of the present invention
Component Function Range of components (% by weight of the composition)
Calcium carbonate and tricalcium phosphate Abrasive 30 to 50
Theobromine Re-mineralizing agent 0.1 to 2
Herbal Extract comprising Kalimirch (Piper nigrum), Sunthi (Zingiber officinale), Pippali (Piper longum). Anti-inflammatory/ anti-bacterial 0.1 to 5
Essential oil mixture comprising clove oil, menthol, camphor Flavouring agent 0.5 to 3
Sodium lauryl sulphate Surfactant 1.8 to 3
Sodium silicate Neutral (Balsara) Binder 0.2 to 1
Xanthan gum Thickening agent 0.7 to 1
Precipitated Silica Thickening agent 1 to 8
Sorbitol solution 70% IP Humectants 20 to 35
Saccharin sodium IP Sweetener 0.1 to 0.25
Gairic Powder Colouring agent 0.2 to 3
Sodium benzoate IP Preservative 0.1 to 0.5
D.M. water Carrier q.s.

Example 2: Compositions of the present invention
The different components from Table 1 are taken in the specified amount as given in Table 2 and prepared by process described in Example 1 to form exemplary remineralization compositions for efficacy studies.
Table 2: Exemplary remineralization composition of the present invention
Component Function Formulation 1 (% w/w) Formulation 2 (% w/w) Formulation 3 (% w/w)
Calcium carbonate and tricalcium phosphate Abrasive 50 44 30
Theobromine Re-mineralizing agent 0.1 0.8 2
Herbal Extract comprising Kalimirch (Piper nigrum), Sunthi (Zingiber officinale), Pippali (Piper longum) Anti-inflammatory/ anti-bacterial 0.1 2.8 5
Essential oil mixture comprising clove oil, menthol, camphor Flavouring agent 0.5 1.5 3
Sodium lauryl sulphate Surfactant 1.8 2.4 3
Sodium silicate Neutral (Balsara) Binder 0.2 0.6 1
Xanthan gum Thickening agent 0.7 0.8 1
Precipitated Silica Thickening agent 1 4 8
Sorbitol solution 70% IP Humectants 20 28 35
Saccharin sodium IP Sweetener 0.1 0.15 0.25
Gairic Powder Colouring agent 0.2 1.5 3
Sodium benzoate IP Preservative 0.1 0.25 0.5
D.M. water Carrier q.s. q.s. q.s.
Example 3: Study for assessing the remineralization of the compositions of the present invention.
An experimental study was designed to evaluate the remineralization efficacy of the composition of the present invention. The efficacy of the present invention composition was compared with a market available product CDC. The market available product CDC comprises of calcium carbonate, water, sorbitol, sodium lauryl sulfate, arginine, flavor, hydrated silica, titanium dioxide, carrageenan, sodium monofluorophosphate, potassium nitrate, sodium bicarbonate, sodium silicate, benzyl alcohol, sodium saccharin, and limonene.
A detailed description of the experimental study is provided below:
Materials and Methods
Study Design: This in vitro comparative study was conducted at the Department of Conservative Dentistry and Endodontics, JSS Dental College and Hospital, Mysuru. The study protocol was approved by the Institutional Research Ethics Committee.
Sample Size and Groups: A total of 45 freshly extracted maxillary premolars were utilized, divided equally into three groups (n=15 per group). Sample size calculation was based on data from similar studies, ensuring 80% power and 95% confidence interval.
Sample Collection and Preparation: Maxillary premolars, extracted for orthodontic reasons, were obtained from the Department of Oral and Maxillofacial Surgery. Teeth were cleaned of debris, sectioned mesio-distally, and embedded in acrylic resin. Buccal and lingual enamel surfaces were ground and polished sequentially with abrasive paper and diamond polishing paste, ensuring a flat surface for testing.
Artificial Caries Induction: Artificial caries lesions were induced by demineralizing the enamel specimens in a pH 5.0 demineralizing solution for 48 hours. The demineralization process was monitored using quantitative light-induced fluorescence (QLF), with demineralization stopped upon achieving predetermined ?F values indicating lesion depth.
Solution Preparation: The demineralizing solution was prepared as per the protocol by ten Cate and Duijsters, comprising 2.2 mM calcium chloride, 2.2 mM potassium dihydrogen orthophosphate, 0.05 mM acetic acid, and distilled water adjusted to pH 4.5. Artificial saliva was prepared following Sato et al.'s method.
Interventional Agents: Remineralizing agents i.e., composition of the present invention and the market sample, in the form of pastes, were diluted in a 1:3 ratio with artificial saliva to simulate clinical conditions.
pH Cycling Protocol: Specimens underwent a 21-day pH cycling regime, alternating between 30-minute demineralization phases in fresh demineralizing solution and 6-hour remineralization phases in artificial saliva. This cycling mimicked daily oral pH fluctuations and treatment protocols.
Microhardness Assessment: Surface microhardness (MH) was evaluated using a Vickers hardness testing machine at baseline and after 21 days of pH cycling. Each specimen underwent three indentations, and the mean Vickers Hardness Number (VHN) was calculated.
Quality Control: Throughout the study, rigorous quality control measures were implemented, including regular inspection and replacement of damaged specimens to ensure consistency and reliability of results.
Formulation 2 from Table 2 was used for assessment of remineralization efficacy of the compositions of the present invention. The results of the test are represented in Table 3 below:
Table 3: Results of efficacy of remineralization composition of the present invention.
Groups Baseline Microhardness (MH) (SD) 3 weeks
Microhardness MH (SD) P value (paired sample t test) Mean difference (SD)
TP1 (Herbal Extract) 40.47 (20.14) 119.47 (18.73) P=0.00 -78.99 (25.56)
TP2 (Herbal Extract + Theobromine 0.8%) 37.91 (19.79) 169.93 (10.58) P=0.00 -132.02 (23.94)
TP3 (CDC) Market available product 41.91 (15.81) 120.36 (30.83) P=0.00 -78.45 (31.03)
TP4 (Theobromine 0.8%) 42.22 (15.67) 146.48 (20.18) P=0.00 -104.25 (16.48)
TP5 (Without Herbal Extract and Theobromine) 39.96 (12.31) 120.94 (33.18) P=0.00 -80.97 (28.56)
CONTROL (With saliva) 36.41 (14.10) 74.36 (22.76) P=0.00 -37.95 (25.55)

The experimental data in Table 3 compares formulations containing a combination of Herbal Extract (made with herbs like Kalimirch, Sunthi, and Pippali) along with theobromine, which is compared with product containing only herbal extract, market available product CDC, only theobromine, toothpaste without herbal extract and theobromine and the control artificial saliva.
The mean difference and the microhardness at the end of three weeks clearly shows that the composition of the present invention comprising herbal extract along with theobromine show unexpected increase in the microhardness hence, the composition of the present invention effectively remineralizes the teeth.
3.1 Superior Remineralization Efficacy of Combination Formulation:
o The formulation TP2 (Herbal Extract + Theobromine 0.8%) shows a significant increase in mean teeth remineralization scores from baseline (37.91, SD 19.79) to 3 weeks (169.93, SD 10.58), resulting in a mean difference of -132.02 (SD 23.94) with a p-value of 0.00.
o This indicates that the combination of Herbal Extract and theobromine synergistically enhances teeth remineralization compared to individual ingredients or conventional toothpaste formulations or market available product.
2. Distinctiveness of Herbal Extract and Theobromine Combination:
o Herbal Extract formulated with herbs like sunthi, kalimirch and pippali combined with theobromine at 0.8% concentration, demonstrates unique benefits in teeth remineralization not achieved by individual components.
o The synergistic action of these components provides a novel formulation that significantly outperforms traditional toothpaste formulations, as evidenced by the substantial mean difference and significant p-value.
3. Statistical Robustness and Experimental Validation:
o The use of paired sample t-tests across multiple treatment groups (TP1, TP2, TP3, TP4, TP5, CONTROL) ensures rigorous statistical validation of the observed improvements in teeth remineralization scores within the Herbal Extract + Theobromine formulation.
o All treatment groups involving theobromine (TP2 and TP4) consistently show superior remineralization efficacy compared to controls (CONTROL with saliva) and other treatment groups without theobromine, validating the formulation's effectiveness.
4. Commercial Viability and Market Differentiation:
o The demonstrated efficacy of the Herbal Extract + Theobromine formulation presents a clear pathway for industrial application in oral care products focused on enhancing dental health and remineralization.

5. Conclusion:
In conclusion, the data strongly supports the technical advancement of formulations combining Herbal Extract (comprising herbs like kalimirch, Sunthi, and pippali) with theobromine (0.8%) for superior teeth remineralization effects. The significant improvements observed in remineralization scores compared to controls and other formulations underscore the enhanced efficacy of this combination.
It will be apparent to those skilled in the art that various modifications and variations can be made to various embodiments described herein without departing from the scope of the teachings herein. Thus, it is intended that various embodiments cover other modifications and variations of various embodiments within the scope of the present teachings.
,CLAIMS:We claim:
1. A tooth remineralization composition comprising:
- a remineralizing agent present in a range from 0.1% to 2% by weight of the composition;
- a herbal extract present in a range from 0.1% to 5% by weight of the composition; and excipients.
2. The tooth remineralization composition as claimed in claim 1, wherein the excipients are selected from the group comprising abrasives, essential oil mixture, surfactant, binder, thickening agents, humectants, sweetener, carrier, preservatives, and colouring agents.
3. The tooth remineralization composition as claimed in claim 1, wherein the remineralizing agent is theobromine.
4. The tooth remineralization composition as claimed in claim 1, wherein the herbal extract comprises extracts of Kalimirch (Piper nigrum), Pippali (Piper longum), Sunthi (Zingiber officinale).
5. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient abrasives are selected from sodium metaphosphate, dicalcium phosphate, calcium pyrophosphate, abrasive silica, hydrated silica, alumina, chalk, calcium carbonate, tricalcium phosphate, insoluble bicarbonate salts, and mixtures thereof and the abrasives are present in a range from 30% to 50% by weight of the composition.
6. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient essential oil is a mixture of Clove oil (Oil of Syzygium aromaticum), Menthol (Mentha piperita), and Camphor (Cinnamomum camphora) and wherein the essential oil mixture is present in a range from 0.1% to 3% by weight of the composition.
7. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient surfactant is selected from selected from sodium lauryl sulphate, cocamidopropyl betaine, sodium methyl cocoyl taurate, sodium cocoyl glutamate, sodium dodecylbenzene sulphonate and sodium lauryl sarcosinate and the surfactant is present in a range from 0.5% to 10% (w/w).
8. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient binder is selected from sodium carboxymethylcellulose (CMC), sodium alginate, sodium silicate neutral (Balsara), carrageenan, synthetic polymers like sodium polyacrylate and inorganic clay minerals as bentonite and laponite and the binder is present in a range from 0.1% to 1% by weight of the composition.
9. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient thickening agent is selected from carbomer, xanthan gum, precipitated silica and hydroxyethyl cellulose and the thickening agent is present in a range from 0.1% to 10% by weight of the composition.
10. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient humectant is selected from sorbitol, xylitol, propylene glycol and polyethylene glycol and the humectant is present in a range from 10% to 40% by weight of the composition.
11. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient sweetener is selected from saccharin sodium IP, sodium cyclamate, aspartame, xylitol, stevia, mannitol and combinations thereof and the sweeterner is present in a range from 0.1 to 1% by weight of the composition.
12. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient carrier is water present in a quantity sufficient to make 100% by wt. of the composition.
13. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient preservative is selected from sodium benzoate, methylparaben and ethylparaben and the preservative is present in a range from 0.1% to 0.5% by weight of the composition.
14. The tooth remineralization composition as claimed in claims 1 and 2, wherein the excipient colouring agent is gairic powder (Red ochre) and the coloring agent is present in a range from 0.2% to 3% by weight of the composition.
15. The tooth remineralization composition as claimed in claim 1, wherein the composition is in form of a toothpaste, gel, varnish, and mouth rinse.