FIELD OF THE INVENTION

The present invention relates to a dentifrice, particularly toothpaste. Specifically, the present invention relates to rinse free toothpaste. The present invention further relates to rinse free toothpaste, which is safe to swallow. The present invention further relates to rinse free safe to swallow toothpaste formulation, composed of ecofriendly ingredients and devoid of any harmful chemicals.

BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Toothpaste is an abrasive that aids in removing dental plaque and remains of food from the teeth, assists in suppressing tooth decay and gum disease. Toothpaste is used to promote oral hygiene irrespective of age and gender. Generally, toothpastes are derived from a variety of components, the three main ones being abrasives, fluoride, and detergents in addition to 20%–42% water. Most of the currently available toothpastes in the domestic and overseas markets contain chemicals harmful to human health, such as sodium dodecyl sulfate (SDS), sodium lauroyl sarcosinate, lauryl glycol amides, such as sodium polyacrylate, and therefore can be toxic if swallowed while brushing with toothpaste. Some toothpaste contain additional antibacterial agent like Triclosan or zinc chloride to prevent gingivitis and help reduce tartar and bad breath. The mouth is highly absorbent, so chemicals lurking in the toothpaste get a fast-track into the bloodstream. While brushing and swishing, the ingredients in the toothpaste enter the mouth and gums, which act as gateway to every system in the body. While triclosan has been shown to help prevent gingivitis, this chemical has been linked to concerns over antibiotic resistance and endocrine disruption. Swallowing a large amount of regular toothpaste may be toxic and can cause stomach pain and possible intestinal blockage.
[0004] Rinse-free toothpaste is a great way to reduce or preclude use of water for oral hygiene. Since no water is required, rinse-free toothpaste can be used even by people living in areas where water is scarce, including campers, backpackers, defense personnel in remote areas, and the like.
[0005] There is therefore, a need in the art for safe to swallow toothpaste formulation that is devoid of, or at least alleviates, the disadvantages associated with known toothpaste formulations. Need is also felt of rinse-free toothpaste formulation that does not contain harmful chemicals, comprises safe and nontoxic ingredients, and simultaneously demostrates the function of tooth protection and tooth decay prevention.

OBJECTS OF THE INVENTION
[0006] An object of the present invention is to provide a toothpaste formulation for maintaining good oral hygiene.
[0007] An object of the present disclosure is to provide a toothpaste formulation which that satisfies the existing needs, as well as emerging ones, and generally overcomes the deficiencies found in the prior art.
[0008] Another object of the present invention is to provide a toothpaste formulation having antimicrobial activity.
[0009] Another object of the present invention is to provide a toothpaste formulation which is rinse free and does not require the use of water.
[0010] Another object of the present disclosure is to provide a toothpaste formulation which is safe to swallow.
[0011] Another object of the present disclosure is to provide a rinse-free safe to swallow toothpaste formulation, which is composed of ecofriendly ingredients.
[0012] Another object of the present disclosure is to provide a rinse-free safe to swallow toothpaste formulation, which is free from synthetic harmful chemicals.
[0013] Another object of the present disclosure is to provide a rinse-free toothpaste formulation which does not have any side effects even it is swallowed and is safe for use.
[0014] The other objects and preferred embodiments and advantages of the present invention will become more apparent from the following description of the present invention when read in conjunction with the accompanying examples and figures, which are not intended to limit scope of the present invention in any manner.
SUMMARY OF THE INVENTION
[0015] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in Detailed Description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[0016] The present invention relates to rinse free toothpaste. Specifically, the present invention relates to rinse free toothpaste, which is safe to swallow.
[0017] The present invention further relates to rinse free safe to swallow toothpaste formulation, composed of ecofriendly ingredients and devoid of any harmful chemicals.
[0018] The present invention relates to a rinse free safe to swallow toothpaste formulation having antimicrobial properties.
[0019] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation comprising natural surfactant, natural anti-microbial peptide, essential oils, thickener, sweetener, pH adjuster, coloring agent, flavoring agent and aqueous solvent.
[0020] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural surfactant used is Rhamnolipid.
[0021] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein essential oils can be selected from but not limited to Thyme oil, Peppermint oil, spearmint oil, Oregano oil, fresh mint, lemon oil or their combinations and the like.
[0022] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural anti-microbial peptide is Nisin.
[0023] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein antimicrobial property is provided by the combination of essential oils, natural surfactant and natural antimicrobial peptide.
[0024] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural sweetener used is Xylitol.
[0025] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein thickener used is selected from Carbopol, Xanthum gum, Triethanolamine (TEA) or their combination and the like.
[0026] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein pH adjuster is selected from sodium hydroxide, sodium benzoate, Triethanolamine and the like, preferably sodium hydroxide.
[0027] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein artificial coloring agents is a natural food color, preferably light blue food color.
[0028] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation wherein flavoring agent is Lime Tahiti. Lime Tahiti concentrate is used as a flavoring agent that gives lime flavor to the toothpaste.
[0029] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation exhibiting antimicrobial activity against bad oral bacteria.
[0030] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation comprising
a) Rhamnolipid;
b) Nisin;
c) Xanthan Gum;
d) Carbopol;
e) Xylitol;
f) Oregano Oil;
g) Thyme Oil;
h) Spearmint oil;
i) Peppermint Oil;
j) Sodium hydroxide;
k) Lime Tahiti; and
l) distilled water.
[0031] In one aspect, the present invention relates to rinse free safe to swallow toothpaste formulation comprising :
a) 0.01 % to 1 % natural surfactant;
b) 0.001 % to 1 % natural antimicrobial;
c) 0.001 % to 5 % essential oils;
d) 0.1 % to 5% thickener;
e) 15 % to 50 % sweetener;
f) pH adjuster;
g) 0.001 % to 1 % Coloring agent;
h) 0.5 % to 5 % Flavoring agent; and
i) 65.4 % to 90.12 % Distilled water.
[0032] Other aspects of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learnt by the practice of the invention.

BRIEF DESCRIPTION OF DRAWINGS THE INVENTION
[0033] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.
Figure 1: Illustrates the measurement of anti-microbial activity of the toothpaste by calculating the zone of inhibition.

DETAILED DESCRIPTION
[0034] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
[0035] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[0036] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0037] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0038] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[0039] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
[0040] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[0041] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
[0042] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[0043] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.
[0044] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0045] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[0046] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0047] The term “toothpaste” refers to paste, powder, and tooth gel formulations unless otherwise specified.
[0048] The term “essential oils” refers to volatile material derived by a physical process from odorous plant material of a single botanical form and species with which it agrees in name and odor. Essential oils generally constitute the odorous principles of the plants in which they exist. Essential oils are either distilled or expressed.
[0049] The term “thickener” refers to materials that provide consistency and shape to the toothpaste. Thickeners are also referred to as emulsifiers.
[0050] The term “surfactant” refers to materials that produce foam in the toothpaste.
[0051] The terms “sweetener” and “flavoring agents” refer to compounds that improve the taste and flavor of the toothpaste.
[0052] The term “Antibacterial agent” refers to compounds that have the ability to kill bacteria and prevent dental plaque. These also act as Preservatives.
[0053] The term “pH adjuster” refers to a neutralizer, used to adjust the pH of the formulation to desired value. Generally, pH adjusters are either basic compounds or buffers.
[0054] The present invention relates to rinse free toothpaste. Specifically, the present invention relates to rinse free toothpaste, which is safe to swallow.
[0055] The present invention further relates to rinse free safe to swallow toothpaste formulation, composed of ecofriendly ingredients and devoid of any harmful chemicals.
[0056] The present invention relates to a rinse free safe to swallow toothpaste formulation having antimicrobial properties.
[0057] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation comprising natural surfactant, natural anti-microbial peptide, essential oils, thickener, sweetener, pH adjuster, coloring agent, flavoring agent and aqueous solvent.
[0058] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural surfactant used is Rhamnolipid.
[0059] In one embodiment, the present invention relates to a rinse free safe to swallow toothpaste formulation wherein Rhamnolipid acts as cleansing agent.
[0060] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein essential oils can be selected from but not limited to Thyme oil, Peppermint oil, spearmint oil, Oregano oil, fresh mint, lemon oil or their combinations and the like.
[0061] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural anti-microbial peptide is Nisin.
[0062] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural sweetener used is Xylitol.
[0063] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein thickener used is selected from Carbopol, Xanthum gum, triethanolamine or their combination and the like.
[0064] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein pH adjuster is selected from sodium hydroxide, sodium benzoate, triethanolamine and the like, preferably sodium hydroxide. Triethanolamine acts as a pH adjuster as well as thickener. pH adjusters are required to adjust the pH of the final formulation within the desired range.
[0065] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein artificial coloring agents is a natural food color preferably light blue food color.
[0066] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein flavoring agent is Lime Tahiti. Lime Tahiti concentrate is used as a flavoring agent that gives lime flavor to the toothpaste.
[0067] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation comprising
a) Rhamnolipid;
b) Nisin;
c) Xanthan Gum;
d) Carbopol;
e) Xylitol;
f) Oregano Oil;
g) Thyme Oil;
h) Spearmint oil;
i) Peppermint Oil;
j) Sodium hydroxide;
k) Lime Tahiti; and
l) distilled water.
[0068] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation comprising :
a) 0.01 % to 1 % natural surfactant;
b) 0.001 % to 1 % natural antimicrobial;
c) 0.001 % to 5 % essential oils;
d) 0.1 % to 5% thickener;
e) 15 % to 50 % sweetener;
f) pH adjuster;
g) 0.001 % to 1 % Coloring agent;
h) 0.5 % to 5 % Flavoring agent; and
i) 65.4 % to 90.12 % Distilled water.
[0069] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural surfactant is present in an amount ranging from about 0.01% to about 1% by weight of the composition, preferably in the amount ranging from about 0.05 % to about 0.5 % by weight of the composition.
[0070] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein natural antimicrobial is present in an amount ranging from about 0.001 % to about 1% by weight of the composition, preferably in the amount ranging from about 0.01 % to about 0.5 % by weight of the composition.
[0071] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein essential oils is present in an amount ranging from about 0.001% to about 5% by weight of the composition, preferably in the amount ranging from about 0.01 % to about 0.5 % by weight of the composition.
[0072] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein oregano oil is present in an amount ranging from about 0.001% to about 0.1% by weight of the composition, preferably in the amount ranging from about 0.005 % to about 0.5 % by weight of the composition.
[0073] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein thyme oil is present in an amount ranging from about 0.001% to about 2% by weight of the composition, preferably in the amount ranging from about 0.05 % to about 0.5 % by weight of the composition.
[0074] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein spearmint/fresh mint oil is present in an amount ranging from about 0.001% to about 0.1% by weight of the composition, preferably in the amount ranging from about 0.005 % to about 0.5 % by weight of the composition.
[0075] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein peppermint oil is present in an amount ranging from about 0.001% to about 0.1% by weight of the composition, preferably in the amount ranging from about 0.005 % to about 0.5 % by weight of the composition.
[0076] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein thickener is present in an amount ranging from about 0.1% to about 5% by weight of the composition, preferably in the amount ranging from about 0.5 % to about 2 % by weight of the composition.
[0077] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein sweetener is present in an amount ranging from about 15% to about 50% by weight of the composition, preferably in the amount ranging from about 20 % to about 35 % by weight of the composition.
[0078] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein Coloring agent is present in an amount ranging from about 0.001% to about 1% by weight of the composition, preferably in the amount ranging from about 0.01 % to about 0.5 % by weight of the composition.
[0079] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein flavoring agent is present in an amount ranging from about 0.1% to about 10% by weight of the composition, preferably in the amount ranging from about 0.5 % to 5 % by weight of the composition.
[0080] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation comprising :
a) Rhamnolipid 0.1g;
b) Nisin 0.026g;
c) Xanthan Gum 0.5g;
d) Carbopol 940 1g;
e) Xylitol 30g;
f) Oregano Oil 0.01ml;
g) Thyme Oil 0.1ml;
h) Spearmint/Freshmint Oil 0.01ml;
i) Peppermint Oil 0.01ml;
j) Sodium Hydroxide (Adjusted using 10M Stock solution);
k) Lime Tahiti 1ml;
l) Natural colors 0.06ml;
m) Distilled water quantity sufficient to make 100mL.
[0081] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation wherein antimicrobial property is provided by the combination of essential oils, natural surfactant and natural antimicrobial peptide.
[0082] The present disclosure is based, at least in part, on the premise of unexpected discovery that combination of rhamnolipid, nisin, oregano oil, peppermint oil and thyme oil exhibit better antimicrobial efficacy compared to utilization thereof individually, the antimicrobial efficacy which has not been previously reported. Surprisingly, only specific concentration showed mutual effects of increased antimicrobial activity, the antimicrobial activity drastically decreased if one component is removed or added in less concentration.
[0083] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation exhibits antimicrobial activity against bad oral bacteria.
[0084] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation exhibits antimicrobial activity against Streptococcus mutans, Treponema denticola, Porphyromonas gingivali and the like.
[0085] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation which is free of synthetic harmful chemicals or any kind of artificial ingredients like Titanium dioxide, Sodium lauryl sulfate, Ethanol, Paraben, Dicalcium Phosphate or the like.
[0086] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation which exists as thick cream or gel. Preferably, the toothpaste exists in waterless rinse free gel formulation, which is creamy in color, is lime flavored, has sweet taste and smooth texture. The toothpaste can be applied directly on the teeth in uniform manner using finger or toothbrush. After the cleansing action is complete, the toothpaste can be swallowed or spit out, as per user’s satisfactions. All the ingredients used in the toothpaste are natural and biocompatible that can be swallowed. Active ingredients used in the formulation are recognized as safe. The final toothpaste formulation is stable at room temperature and gave good results when tested for consistency, uniformity, taste, smell and texture.
[0087] In a preferred embodiment, the toothpaste exists in waterless rinse free gel formulation, which is creamy in color, is lime flavored, has sweet taste and smooth texture.
[0088] The toothpaste according to embodiments of the present invention is useful for conditions where rinsing with water is not possible or convenient, for example, for patients in hospitals, elderly population, kids, for travelers, pregnant women etc.
[0089] In one embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation which cleanses the teeth in about 0.5-2 minutes, preferably in 1 minute.
[0090] In another embodiment, the present invention relates to rinse free safe to swallow toothpaste formulation which is safe for use by anyone, even children and elderly, without any harmful side effects.
[0091] In one embodiment, the present invention relates to the process of preparing rinse free safe to swallow toothpaste formulation.
[0092] In another embodiment, the present invention relates to the process of preparing rinse free safe to swallow toothpaste formulation comprising the steps of:
a) dissolving one thickener in essential oils;
b) Mixing surfactant, other thickeners and sweetener in distilled water;
c) Adding the oil solution prepared in step a) to the water solution prepared in step b);
d) Stirring the solution obtained in step c) for 30 minutes at 70 ?C;
e) Adding anti-microbial peptide, flavoring agent and coloring agent to the mixture obtained in step d) and
f) Adjusting the total volume of mixture to the desired value and stirring the solution for 10 min; and
g) Adjusting the pH of the mixture obtained in step f) to pH 8-9.
[0093] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
[0094] The present invention is further explained in the form of following examples. However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.
[0095] Example 1: Formulation of rinse free safe to swallow toothpaste
[0096] The rinse free, safe to swallow anti-microbial toothpaste according to the embodiments of the present invention, comprises:
a) Rhamnolipid 0.1g;
b) Nisin 0.026g;
c) Xanthan Gum 0.5g;
d) Carbopol 940 1g;
e) Xylitol 30g;
f) Oregano Oil 0.01ml;
g) Thyme Oil 0.1ml;
h) Spearmint/Freshmint Oil 0.01ml;
i) Peppermint Oil 0.01ml;
j) Sodium Hydroxide (Adjusted using 10M Stock solution);
k) Lime Tahiti 1ml;
l) Natural colors 0.06ml;
m) Distilled water quantity sufficient to make 100mL.
[0097] Example 2: Preparation of rinse free safe to swallow toothpaste
[0098] All the ingredients used in the toothpaste are of IP grade and were purchased commercially. All active ingredients are categorized as safe, for usage.
[0099] The formulation was prepared by mixing the ingredients of the formulation in a particular order. Initially, xanthan gum was dissolved in essential oils, followed by addition of xylitol, rhamnolipid, and carbopol in a stepwise manner to 50 mL of distilled water. The initially prepared oil solution containing xanthan gum was added to the water solution and stirred at least for 30 minutes using magnetic beads on a magnetic stirrer at 70°C. Nisin was added later as it is sensitive to heat. Finally, nisin, coloring agent and flavoring agent were added to the above solution and then the volume was made up to 100 mL and kept for stirring for at least 10 minutes for proper mixing. The pH of the formulation was adjusted to pH 8-9, using sodium hydroxide as a pH adjuster.
[00100] Example 3: Evaluation of different parameters for the toothpaste formulation
[00101] The toothpaste formulation according to the embodiments of the present invention was evaluated for several parameters as described below:
[00102] Evaluation of pH of the toothpaste: A 10% uniform suspension was used to measure pH of the solution. pH value of the toothpaste formulation was found to be less basic as compared to other commercial toothpastes like Colgate and Pepsodent as indicated in Table 1. Ideally, the pH should be in the range of 7.5-8.
Table 1
S. No. Toothpaste formulation pH
1 According to present invention as shown in Example 1 7.7-7.8
2 Colgate 9,12
3 Pepsodent 9.24

[00103] Evaluation of foaming ability of the toothpaste: 10% aqueous toothpaste solution was poured into graduated cylinder and covered with parafilm. The cylinder was shaken for 25 times. Placed the graduated cylinder on the lab bench and measured the height of the foam above the water in cm. Foaming power can be calculated as:
V1 -V2, wherein V1 is Volume in ml of foam with water and V2 -Volume in ml of water only.
[00104] The foaming power of toothpaste according to the present invention was found to be very less as compared to other commercial toothpaste brands as no synthetic surfactant, with high foaming ability has been added to the formulation. Results are depicted in Table 2. Synthetic surfactants such as SLS if ingested cause nausea, vomiting and diarrhea and hence are not safe. The toothpaste according to the present invention, though has less foaming ability but has excellent cleansing properties and is safe even if swallowed.

Table 2
S. No. Toothpaste formulation Foaming ability (cm)
1 According to present invention as shown in Example 1 2
2 Colgate 5
3 Pepsodent 8

[00105] Evaluation of the spreading ability of the toothpaste: 1g of toothpaste sample weighed and placed at the center of a glass slide and carefully placed another glass slide over the sample in order to avoid sliding of the slide. Placed 1kg of weight on top of the glass slide and after 10 minutes, the weight was removed and the diameter of the paste was measured in centimeters. Spreading ability of toothpaste formulation of the present invention was found similar to other toothpaste brands. Results are described in Table 3.
Table 3
S. No. Toothpaste formulation Spreading ability (cm)
1 According to present invention as shown in Example 1 3.2
2 Colgate 3.1
3 Pepsodent 3

[00106] Evaluation of the anti-microbial activity of the toothpaste: Antimicrobial activity of the toothpaste according to the present invention was evaluated against various microbial strains as depicted in Table 4. The anti-microbial activity was measured by calculating the zone of inhibition. Results are depicted in Figure 1, indicating that the toothpaste according to the present invention has excellent anti-microbial activity against various different strains.

Table 4
S. No. Antimicrobial Activity of The Toothpaste under different conditions
A Antimicrobial activity of the toothpaste Against Streptococcus mutan in undiluted form
B Antimicrobial activity of the toothpaste Against Streptococcus mutan in 10% diluted form
C Antimicrobial activity of the toothpaste Against Treponema denticola in undiluted form
D Antimicrobial activity of the toothpaste Against Treponema denticola in diluted form
E Antimicrobial activity of the toothpaste Against Porphyromonas gingivali in undiluted form
F Antimicrobial activity of the toothpaste Against Porphyromonas gingivali in undiluted form
G Antimicrobial activity of the toothpaste Against S. Aurous in undiluted form
H Antimicrobial activity of the toothpaste Against S. Aurous in diluted form

[00107] The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

ADVANTAGES OF THE PRESENT INVENTION
[00108] The present invention provides rinse-free safe to swallow toothpaste formulation for maintaining good oral hygiene.
[00109] The present invention provides a rinse-free safe to swallow toothpaste formulation which satisfies the existing needs, as well as emerging ones, and generally overcomes the deficiencies found in the prior art.
[00110] The present invention provides a rinse-free safe to swallow toothpaste formulation which is rinse free and does not require the use of water.
[00111] The present invention provides a rinse-free safe to swallow toothpaste formulation which has antimicrobial properties.
[00112] The present invention provides a rinse-free safe to swallow toothpaste formulation, which is composed of ecofriendly ingredients.
[00113] The present invention provides a rinse-free safe to swallow toothpaste formulation, which is free from synthetic harmful chemicals.
[00114] The present invention provides a rinse-free safe to swallow toothpaste formulation which does not have any side effects even it is swallowed and is safe for use.

We Claim:

1. A rinse free safe to swallow toothpaste formulation comprising natural surfactant, natural anti-microbial peptide, essential oils, thickener, sweetener, pH adjuster, flavoring agent, coloring agent, and aqueous solvent, wherein the natural surfactant is Rhamnolipid and the natural antimicrobial peptide is Nisin.
2. The toothpaste formulation as claimed in claim 1, wherein essential oils can be selected from Thyme oil, Peppermint oil, spearmint oil, Oregano oil, fresh mint, lemon oil or their combinations.
3. The toothpaste formulation as claimed in claim 1, wherein natural sweetener used is Xylitol.
4. The toothpaste formulation as claimed in claim 1, wherein thickener is selected from Carbopol, Xanthum gum, triethanolamine or their combination.
5. The toothpaste formulation as claimed in claim 1, wherein pH adjuster is selected from sodium hydroxide, triethanolmaine or sodium benzoate.
6. The toothpaste formulation as claimed in claim 1, wherein flavoring agent is lime Tahiti.
7. The toothpaste formulation as claimed in claim 1, comprising:
a) Rhamnolipid;
b) Nisin;
c) Xanthan Gum;
d) Carbopol;
e) Xylitol;
f) Oregano Oil;
g) Thyme Oil;
h) Spearmint oil;
i) Peppermint Oil;
j) Sodium hydroxide;
k) Lime Tahiti; and
l) distilled water.
8. The toothpaste formulation as claimed in claim 1, wherein natural surfactant is present in an amount ranging from about 0.01% to about 1% by weight of the composition, preferably in the amount ranging from about 0.05 % to about 0.5 % by weight of the composition.
9. The toothpaste formulation as claimed in claim 1, wherein natural antimicrobial is present in an amount ranging from about 0.001 % to about 1% by weight of the composition, preferably in the amount ranging from about 0.01 % to about 0.5 % by weight of the composition.
10. The toothpaste formulation as claimed in claim 1, wherein essential oils is present in an amount ranging from about 0.001% to about 5% by weight of the composition, preferably in the amount ranging from about 0.01 % to about 0.5 % by weight of the composition.
11. The toothpaste formulation as claimed in claim 1, wherein oregano oil is present in an amount ranging from about 0.001% to about 0.1% by weight of the composition, preferably in the amount ranging from about 0.005 % to about 0.5 % by weight of the composition.
12. The toothpaste formulation as claimed in claim 1, wherein thyme oil is present in an amount ranging from about 0.001% to about 2% by weight of the composition, preferably in the amount ranging from about 0.05 % to about 0.5 % by weight of the composition.
13. The toothpaste formulation as claimed in claim 1, wherein spearmint/fresh mint oil is present in an amount ranging from about 0.001% to about 0.1% by weight of the composition, preferably in the amount ranging from about 0.005 % to about 0.5 % by weight of the composition.
14. The toothpaste formulation as claimed in claim 1, wherein peppermint oil is present in an amount ranging from about 0.001% to about 0.1% by weight of the composition, preferably in the amount ranging from about 0.005 % to about 0.5 % by weight of the composition.
15. The toothpaste formulation as claimed in claim 1, wherein thickener is present in an amount ranging from about 0.1% to about 5% by weight of the composition, preferably in the amount ranging from about 0.5 % to about 2 % by weight of the composition.
16. The toothpaste formulation as claimed in claim 1, wherein thickener is present in an amount ranging from about 0.1% to about 5% by weight of the composition, preferably in the amount ranging from about 0.5 % to about 2 % by weight of the composition.
17. The toothpaste formulation as claimed in claim 1, wherein coloring agent is present in an amount ranging from about 0.001% to about 1% by weight of the composition, preferably in the amount ranging from about 0.01 % to about 0.5 % by weight of the composition.
18. The toothpaste formulation as claimed in claim 1, wherein flavoring agent is present in an amount ranging from about 0.1% to about 10% by weight of the composition, preferably in the amount ranging from about 0.5 % to 5 % by weight of the composition.
19. The toothpaste formulation as claimed in claim 1,comprising :
a) Rhamnolipid 0.1g;
b) Nisin 0.026g;
c) Xanthan Gum 0.5g;
d) Carbopol 940 1g;
e) Xylitol 30g;
f) Oregano Oil 0.01ml;
g) Thyme Oil 0.1ml;
h) Spearmint/Freshmint Oil 0.01ml;
i) Peppermint Oil 0.01ml;
j) Sodium Hydroxide (Adjusted using 10M Stock solution);
k) Lime Tahiti 1ml;
l) Natural colors 0.06ml;
m) Distilled water quantity sufficient to make 100mL.
20. The toothpaste formulation as claimed in claim 1, wherein antimicrobial property is provided by the combination of essential oils, natural surfactant and natural antimicrobial peptide.
21. The toothpaste formulation as claimed in claim 1, having antimicrobial activity against Streptococcus mutans, Treponema denticola and Porphyromonas gingivali.
22. The toothpaste formulation as claimed in claim 1, which exists as thick cream or gel.
23. A process of preparing rinse free safe to swallow toothpaste formulation, as claimed in claim 1, comprising the steps of:
a) dissolving one thickener in essential oils;
b) Mixing surfactant, other thickeners and sweetener in distilled water;
c) Adding the oil solution prepared in step a) to the water solution prepared in step b);
d) Stirring the solution obtained in step c) for 30 minutes at 70 ?C;
e) Adding anti-microbial peptide, flavoring agent and coloring agent to the mixture obtained in step d) and
f) Adjusting the total volume of mixture to the desired value and stirring the solution for 10 min; and
g) Adjusting the pH of the mixture obtained in step f) to pH 8-9.