Description:TITLE OF THE INVENTION

Oral care composition for children

FIELD OF THE INVENTION

The present invention relates generally to a safe and effective cleansing composition for dental use, more particularly to an oral care composition for infants and toddlers with food grade ingredients that do not comprise any harmful chemical ingredients.

OBJECTIVE OF THE INVENTION

It is an objective of the present invention to provide a safe dental care composition that providing oral care hygiene to infants and toddlers in their growing age.

It is one another objective of the present invention to provide a unique
composition with ingredients that are safe and food grade designed specifically as oral care for infants and toddlers.

It is yet another objective of the present invention to provide the oral care composition that are food grade to cause no harm even if the same is swallowed during the oral care training in infants and toddlers.

BACKGROUND OF THE INVENTION

Oral care products are defined as products used for care of the teeth and the mouth. Various products are available based on their special clinical
indications including toothpastes, mouthwashes, tooth-whitening products, and denture care materials. Although these products have gone through standard safety evaluations prior to marketing, and have been approved by the regulatory bodies, local and systemic adverse reactions associated with different materials in each category have been reported.

Research for new ingredients in oral care formulation and regulation are directed towards the use of safe and harmless ingredients. However, the regulations and safety of the ingredients are always tested for adult tolerance and safety. 24% of children under 3 years have early childhood caries. This number increases to 57% in children aged 3+ years. Good dental care at a young age not only protects young children from cavities, but also helps reinforce good dental hygiene habits that translate to better oral care throughout their life. Furthermore, children toothpaste formulations consist of same or similar ingredients with lesser percentages that are tolerated in children. For example, one such childcare toothpaste advertised for above six years indicate the below ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Phosphate, Sodium Saccharin, Sodium Hydroxide, CI 45430 (FD&C Red No. 3).

It shall be noted that Sodium Lauryl Sulfate (foaming agent) and silica, an abrasive are not natural ingredients. Furthermore, the toothpaste indicates that children 2 to 6 years to use only a pea sized amount and needs to be supervised during child's brushing and rinsing (to minimize swallowing). It should be noted that Sodium Lauryl Sulfate, although is considered to be safe, it can still cause irritation and allergy depending on the concertation within the formula and prolonged exposure or pre-existing health condition such as general sensitivity or eczema. Further in case of oral care, SLS is known to irritate mucosa – a natural lining of the mouth.

Hydrated silica is found in many children’s toothpastes as it’s a mild abrasive made from a crystallized compound found in quartz, sand, and flint. It helps to scrub off the tartar found on teeth and whiten them, but in doing so has been shown to have a negative effect on the tooth enamel causing problems with remineralization. As it shall be noted that, remineralization of children’s teeth plays a huge role in tooth health and in preventing cavities.

In addition, many children’s toothpastes are loaded with dyes (most
commonly blue 1, blue 2, and red 40) in order to make them appealing to
kids, but most FD & C dyes are linked with many healthy problems like ADHD, severe allergic reactions, asthma attacks, headaches, nausea, fatigue, nervousness, lack of concentration. Besides the negative health associations, they’re also a synthesized petroleum-based product which means the child’s toothpaste has crude oil in it.

Sodium hydroxide (NaOH), also known as lye or caustic soda, is a metallic base, used in textiles, drain cleaners and industrial detergents. It's used in toothpaste, even in few toothpastes claimed as “natural”, to neutralize the pH of certain ingredients. One other ingredient that is most common form of sweetener used in toothpaste is sodium saccharine. It is actually about 300 times sweeter than sugar and is known to have carcinogenic properties. It is still known to be added in toothpaste.

One of the major challenges in formulating a safe and effective children oral care formulation is the flavour and sweetener ingredients. On one hand, while common sweetening agents in toothpaste may not directly
contribute to tooth decay, many experts are concerned about other side effects that they could cause. For example, Aspartame, a common toothpaste sweetening agent, is a potential neurotoxin, and could contribute to depression, dizziness, and impaired vision. Its constituent chemicals are known to be carcinogenic in nature.

Additionally, ingestion of small amounts of artificial sweetening agents over time may begin confusing your body by stimulating cravings for more food. It is even possible, though not probable, that sweetening agents could indirectly contribute to serious conditions such as diabetes. When these ingredients are provided to children in their age of dental trainings, they tent to swallow the toothpaste that over a long time leads to a liking towards sugar and an adaptive taste to foods rich in sugar.

Any use of flavouring agents as well provide artificial likeliness towards the same and an increased tendency to incorporate the same or similar flavour in the kid’s diet preferences. These behaviours are likely to cause confusion psychologically in not aiding them to favouring bland or less flavoured and healthy food options.

Research for child safe toothpaste focusses majorly on natural ingredients and are otherwise loaded with favour and sweetening agents. These so called “natural” ingredients are not food safety i.e., they are not food grade ingredients when it is to be used in children. Furthermore, there is no toothpaste in the present market for infants and toddlers especially between 0-3 years of age. However, difficulty occurs in formulating an oral care composition, wherein the composition provides safe, effective, natural, Food grade and swallowable formulation that can be used for all children including infants and toddlers.

Hence there is a need to develop an oral care formulation truly “food safe” with ingredients approved by the Food and Safety authorities. The present invention provides means and composition comprising natural and food safe ingredients that can be used for oral hygiene in children including infants and toddlers.

SUMMARY OF THE INVENTION

The following presents a simplified summary of one or more embodiments in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments and is intended to neither identify key or critical elements of all embodiments nor delineate the scope of any or all embodiments. Its sole purpose is to present some concepts of one or more embodiments in a simplified form as a prelude to the more detailed description that is presented later.

In accordance with one aspect of the present invention provides means
and an oral care composition for toddlers that is safe, natural and has only of approved food grade ingredients that provide effective oral care. In one embodiment, the present invention provides an oral care composition for use in children between the ages of 12 months and 3 years, wherein the said composition comprises calcium carbonate, glycerine, purified water, xylitol xanthan gum and citric acid monohydrate. In one embodiment, the present invention is designed to specifically be devoid of any flavouring agent or sweetener such that when used for toddlers it helps reinforce good dental hygiene habits that translate to better oral care throughout their life.

The foregoing has outlined rather broadly the features and technical advantages of the present invention so that those skilled in the art may better understand the detailed description of the invention that follows. Additional features and advantages of the invention will be described hereinafter that form the subject of the claims of the invention. Those skilled in the art should appreciate that they may readily use the conception and the specific embodiment disclosed as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the invention in its broadest form.

DETAIL DESCRIPTION OF THE INVENTION

Before undertaking the detailed description of the invention below it may be advantageous to set forth definitions of certain words and phrases used throughout this patent document: the terms “include” and “comprise ” as well as derivatives thereof mean inclusion without limitation; the term
“or ” is inclusive meaning and/or; the phrases “associated with” and “associated therewith ” as well as derivatives thereof may mean to include be included within interconnect with contain be contained within connect to or with couple to or with be communicable with cooperate with interleave juxtapose be proximate to be bound to or with have a property of or the like. Definitions for certain words and phrases are provided throughout this patent document those of ordinary skill in the art should understand that in many if not most instances such definitions apply to prior as well as future uses of such defined words and phrases.

Certain terms are used throughout the description and claims to refer to particular system components. As one skilled in the art will appreciate consumer electronic equipment manufacturers may refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to some one skilled in the art that embodiments of the present invention may be practised without some of these details.

If the specification states a component or feature “may”, “can”, “could”, or “might”, be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

As used in the description herein and throughout the claims that follow, the meaning of “a”, “an”, and “the”, includes plural references 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.

In some embodiments, the numbers expressing quantities or dimensions of items, 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 embodiment, 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 measures.

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.

Various terms as used herein 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.

Applicants have recognized that there is a need for an oral care composition that provides safe and effective dental care for children including toddlers and more particularly a composition that performs the functions of commercially available dental care ingredients and are swallow safe so it can be administered to kids.

In one embodiment, the oral care composition of the present invention with swallow safe ingredients comprising calcium carbonate, Glycerine, Xylitol, Xanthan Gum, citric acid monohydrate and purified water.

In one embodiment, the calcium carbonate of the present invention acts as a mild abrasive, for use in the safe oral care composition. The abrasive used in the composition aids in removal of plaque that are bacterial accumulation in the tooth and provides gentle polishing of the surface stains of the tooth.

In one embodiment, the calcium carbonate provides the essential calcium to the tooth and aids in strengthening the same. It also protects the enamel of the tooth and the said abrasive used in the present composition is food grade and safe for children.

In one another embodiment, the glycerine used in the oral care composition is a humectant. Glycerine used in the said composition prevents the dehydration or loss of water from the composition and prevents the composition from crumbling or drying-out. The humectant of the present invention which is the glycerine if vegetable glycerine and is food grade and considered safe for use in children.

In one embodiment, the xylitol used in the present invention of the children safe oral care composition acts as a natural mild sweetener. The xylitol in the composition masks the other ingredients and makes the oral care composition palatable for use in cleansing the teeth. In addition, the xylitol in the present composition disrupts the digestion process of mouth bacteria, depriving them of nutrition and subsequent starvation while also disrupt the plaque structure caused by these bacteria.

In one embodiment, the xylitol of the present invention has been shown to reduce overall acid production by the mouth bacteria and improve tooth remineralisation and shown to reduce cavities in the tooth.

In yet another embodiment, the child safe oral care composition comprises Xanthan gum, wherein the Xanthan gum is used as the thickening agent. The thickening agent, Xanthan Gum of the present invention provides holds the chemical and liquid components of the oral care formulation.

In yet another embodiment, the xanthan gum of the present invention provides provide means to retain the moisture and hence used as safe saliva substitute for use in persons with chronic dry mouth.

In one embodiment, the xanthan gum used in the present composition is food grade gradient and safe for use in oral care composition in children including toddlers.

In one embodiment, the preservative used in the present oral care composition is citric acid monohydrate. The said citric acid monohydrate of the present invention provides antioxidant properties and provides stability to the other active ingredients of the oral care composition.
In one embodiment, the citric acid of the present invention is a naturally occurring in citrus fruits and is a natural preservative. Monohydrate
citric acid has one water molecule as part of the chemical formula of citric acid and exists as a white powder.

In one embodiment, the edible oral care composition of the present invention with swallow safe ingredients comprising 40%-45% calcium carbonate, 10%-15% Xylitol, Xanthan Gum, citric acid monohydrate, Glycerine and purified water.

In one embodiment, the edible oral care composition of the present invention with swallow safe ingredients comprising 45% calcium carbonate, 15% Xylitol, Xanthan Gum, citric acid monohydrate, Glycerine and purified water.

In one embodiment, the purified water added to the oral care composition should be devoid of any fluoride or chloride or other pesticides in the water to enable safe and effective use of the oral care composition of the present invention for toddlers.

In yet another embodiment, the dental care composition comprises toothpastes, tooth gels, mouth rinse, oral sprays, pastes, ointments, films and dental gels.

In one another embodiment the oral care composition if edible and safe and effective for use with children including toddlers between the age of 0-12 years. More particularly for toddlers between the age of 2-5 years to ensure oral hygiene habits with safe and effective edible toothpaste composition.

The present invention is particularly designed to be devoid of any flavouring agent or sweeteners and chemical compounds that are harmful for use in children and toddlers during the earlier days of oral hygiene habits.

Although the invention has been described in terms of preferred embodiment it is not limited thereto. Those skilled in this technology can make various alterations and modifications without departing from the scope and spirit of the invention. Therefore, the scope of the invention shall be defined and protected by the following claims and their equivalents.

Examples

Effect of the present composition on the pH of Saliva

To study the difference in saliva pH before and after brushing with edible toothpaste of the present invention in subjects were randomly selected, and the experiment was conducted in the Morning. The subjects were allowed to gargle 10ml of distilled water and collected in a beaker B1. The pH of the water collected was noted. Further, the subject was administered with the composition of the present invention and allowed to brush the teeth for 2 minutes and rinse the mouth with distilled water. The Subjects were then allowed to gargle 10ml of distilled water and is collected in another beaker B2. The pH of water collected in B2 is noted. The results are tabulated as below:

Table 1: pH of water collected in B1 and B2.

S. No pH of Water collected in B1 (Before Using the Composition of the Present
Invention) pH of water Collected in B2 (Before Using the Composition of the Present Invention)
Subject 1 6.67 6.98
Subject 2 6.01 6.64
Subject 3 6.30 6.95
Subject 4 7.30 7.54
Subject 5 7.01 7.44

It shall be concluded, from the above observations, using the composition of the present invention significantly increases the oral pH.

Dated this the 29th day of April 2023

Patent Agent for the Applicant
Priyadarsini Shanmugam / Chenthoori Pughazendhi
Registration No. IN/PA-1677
, Claims:CLAIMS

We Claim:

1. An edible oral care composition for safe and effective use in children comprising:
a) calcium carbonate,
b) Xylitol,
c) Citric acid monohydrate,
d) Xanthan Gum,
d) Glycerine; and
e) Purified water

2. An edible oral care composition according to claim 1, wherein the calcium carbonate is within the range of 20% to 40% of the said composition.

3. An edible oral care composition according to claim 1, wherein the xylitol is within the range of 4% to 15% of the said composition.

4. An edible oral care composition according to claim 1, wherein the citric acid monohydrate is within the range of 0.1% to 2% of the said composition.

5. An edible oral care composition according to claim 1, wherein the Xantham Gum is within the range of 0.3% to 3%.

6. An edible oral care composition according to claim 1, wherein the glycerine is within the range of 20% to 50%.

7. An edible oral care composition according to claim 1, wherein the said composition is for use in children in the age of 2 years to 7 years.

8. An edible oral care composition for use in children comprising 36% calcium carbonate, 15% xylitol, 45% glycerin, 2% Xanthan gum, 2% citric acid monohydrate & purified water.

Dated this the 29th day of April 2023
Patent Agent for the Applicant

Priyadarsini Shanmugam / Chenthoori Pughazendhi
Registration No. IN/PA-1677