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A Novel Non Aqueous Oral Care Composition

Abstract: A NOVEL NON-AQUEOUS ORAL CARE COMPOSITION The present invention relates to non-aqueous oral care compositions having germicidal properties. In particular, the invention relates to natural oil-based compositions formulated for use as oral care comprising edible oils seasame oil, coconut oil, a mixture of essential oils and/or their actives and additives.

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Patent Information

Application #
Filing Date
24 February 2021
Publication Number
38/2022
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
patents@inttladvocare.com
Parent Application
Patent Number
Legal Status
Grant Date
2024-01-01
Renewal Date

Applicants

DABUR INDIA LIMITED
8/3, Asaf Ali Road, New Delhi- 110 002

Inventors

1. Bandyopadhyay Prasun
Villa Q6 Chaithanya Samarpan Kadugodi-Whitefield Main Road Bangalore 560067, India
2. Sirdesai Amit
601, Olive CHS, Neptune Colorscape, Pt Dindayal Upadhye Marg, Mulund West, Mumbai – 400080, India
3. Sharma Naveen
E 155 Tagore Garden Extension New Delhi 110027, India
4. Nagar Kavita
B-17, Nehru Apartment, Nehru Nagar, Ghaziabad, Uttar Pradesh, India

Specification

A NOVEL NON-AQUEOUS ORAL CARE COMPOSITION

FIELD OF THE INVENTION

The present invention relates to a non-aqueous oral care composition having germicidal properties. In particular, the invention relates to natural oil-based compositions formulated for use as oral care composition comprising edible oils seasame oil, coconut oil, a mixture of essential oils and/or their actives and additives.
BACKGROUND OF THE INVENTION
Oral diseases pose a major health burden for many countries and affect people throughout their lifetime, causing pain, discomfort, disfigurement and even death. These diseases share common risk factors with other major non-communicable diseases. It is estimated that oral diseases affect nearly 3.5 billion people.
The oral microbiota is complex, multi-kingdom, interactive, and involves extensive biofilm formation. While dominated by bacteria, Candida fungus is a frequent member of this microbiota; however, several other potentially pathogenic fungi (among around 100 identified species) appear to reside in some individuals, including Streptococcus, Cryptococcus, Aspergillus, and Fusarium. Tooth decay, gum and dental disease, malodour can be caused by bacterial and fungal infection resulting from plaque formation around the teeth and/or the entrapment of food particles in interstices between teeth. As a result, decreasing the number of bacteria and fungus in the mouth has long been the target of dental care professionals.
Dental plaque is a biofilm or mass of bacteria that grows on surfaces within the mouth. It is commonly found between the teeth, on the front of teeth, behind teeth, on chewing surfaces, along the gumline, or below the gumline cervical margins. Dental plaque is also known as microbial plaque, oral biofilm, dental biofilm, dental plaque biofilm or bacterial plaque biofilm. Bacterial plaque is one of the major causes for dental decay and gum disease. Dental plaque can give rise to tooth decay and periodontal problems such as gingivitis and periodontitis.

Most oral health conditions are largely preventable and can be treated in their early stages. The most common way of maintaining oral hygiene is to brush and floss the teeth regularly. Brushing teeth removes most food, bacteria and plaque from the surface of your teeth. Flossing helps in removing germs between teeth and also helps in cleaning tongue. The dental regime becomes more effective by following it with rinsing mouth using mouthwash. Mouthwash result in clear reduction in dental plaque and gingivitis. Mouthwash helps in mouth feeling and smelling fresher. Mostly mouthwash solution contain anti-microbial agents such as chlorhexidine digluconate, povioidine, cetylpyridinium chloride, zinc salts, and etc. Mouthwash compositions has been proposed for the treatment of gum disease using a wide variety of germicidal agents, but none has achieved widespread commercial use. The germicidal oral care composition should provide effective therapeutic effect and the person using it should not find it irritating to oral cavity. The use of chemical compounds as germicidal agents often causes irritation and sharp sensation in the oral cavity.
U.S. Pat. No. 5,747,005 discloses an oil-based, anti-plaque dentifrice comprising vitamin E and an enzyme in an admixture which is effective to dissolve plaque and to resist plaque formation. The preferred dentifrice composition is substantially anhydrous, and includes a chelating agent and a promoter to assist the enzyme in fighting plaque. The oil base is about 55 to 70 percent of the total composition derived from flavouring or taste-enhancing oils of wintergreen, spearmint, peppermint, cinnamon or clove.
U.S. Pat. No. 5,776,435 discloses an oral composition comprising in an orally acceptable aqueous solution, about 5-30% of a siliceous polishing agent, about 0.25%-0.35% of triclosan, at least one of a surface active agent and a flavouring oil, and about 0.05-4% of a copolymer of maleic acid or anhydride with methyl vinyl ether.
Accordingly, there is continued interest in the development of new natural oral care compositions that provide adequate cleaning properties while at the same time provide for improved comfort to the user without irritating and damaging the teeth, gums or the bone around one's teeth. Hence, there exists a need for an effective germicidal oral care composition, preferably a mouthwash composition without chemical compounds and is 100%) herbal and natural oil based. The present invention herein provides a natural non-

aqueous oral care composition, preferably a mouthwash composition with germ kill property.
OBJECT OF THE INVENTION
It is an object of the present invention to provide a 100%> natural oil and/or its actives based oral care composition with no synthetic active to overcome the above limitations.
It is yet another object of the present invention to provide a non-aqueous oral care composition with germ kill property and kills 99.9% problem causing bacteria and 99.9% fungus in the oral cavity.
It is yet another object of the present invention to provide a non-aqueous oral care composition with stability and efficacy during shelf-life.
It is yet another object of the present invention to provide a palatable non-aqueous oral care composition addressing the stability and rancidity of the natural oils.
SUMMARY OF THE INVENTION
The present invention relates to a novel non-aqueous oral care composition comprising edible oils, essential oils and/ their actives and additives wherein the edible oils are coconut oil present in a range from 0.1 to 10.0%> wt./wt. and seasame oil present in a range from 50 to 99.9% wt./wt.. The essential oils for the purpose of the present invention are selected from the group comprising of clove oil, mint oil, cinnamon oil, tulsi oil and ajwain oil.
In an embodiment of the invention, in the non-aqueous oral care composition the clove oil is present in a range from 0.1 to 10% wt./wt.; the mint oil is present in a range from 0.1 to 5.0%) wt./wt.; the cinnamon oil is present in a range from 0.1 to 10%> wt./wt; the tulsi oil is present in a range from 0.0001 to 0.1%> wt./wt.; the ajwain oil is present in a range from 0.0001 to 0.1% wt./wt.

In another embodiment of the invention, in the non-aqueous oral care composition the additive is saccharin present in a range from 0.01 to 0.5% wt./wt; and antioxidant tocopherol acetate (Vitamin E) present in a range from 0.01 to 0.5% wt./wt..
DETAILED DESCRIPTION OF THE INVENTION
Discussed below are some representative embodiments of the current invention. The invention in its broader aspects is not limited to the specific details and representative methods. The illustrative examples are described in this section in connection with the embodiments and methods provided. The invention according to its various aspects is particularly pointed out and distinctly claimed in the attached claims read in view of this specification, and appropriate equivalents.
It is to be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes a mixture of two or more compounds. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
The present invention provides a novel oral care composition effective for maintenance of oral health and prevent formation of dental plaque and other gum and dental diseases. The invention provides a non-aqueous oral care with unique combination of herbal oils and extracts which exhibit effective germicidal effect. The components of non-aqueous oral care demonstrates synergistic effect in killing bacteria and fungus present in the oral cavity. The non-aqueous oral care of the present invention prevents formation of dental plaque, cavities and oral thrush.
Commonly used Chlorhexidine mouthwashes are used as an adjunct to the clinical management of caries and periodontal diseases. However, it is associated with slightly lower compliance due to its unpleasant taste and unwanted effects (staining). In addition, the stannous within this oral rinse is associated with extrinsic staining of teeth, while the zinc and stannous salts have organoleptic properties, limiting its use to only

concentrations. The composition of the present invention is not associated with any such side effects.
The benefits of the compositions of the present invention are not limited only to the oral cavity. In fact, according to ancient Indian Ayurveda text, oil based mouthwash composition can be used for the prevention and treatment of different diseases, which vary from headaches, migraines, thrombosis, and eczema; to fatal diseases such as diabetes and asthma.
The composition of the invention is useful for maintaining oral hygiene and provides effective cleaning of the mouth, teeth and gums. The oral health composition, according to an embodiment of the invention, inhibit growth of various oral bacteria and fungus that are associated with formation of dental plaque, gingivitis, periodontitis, oral thrush and other oral health problems. It has been observed that the composition of the present invention have intrinsic properties as anti-inflammatory activity, anti- oxidant activity and is highly efficacious against bacteria and fungus found in oral cavity. Thus, the non-aqueous oral care composition of the present invention provide multiple oral care benefits simultaneously.
The composition of the present invention is non-aqueous i.e. that it does not contain any water and comprises an oil mixture which has germicidal effect. In an embodiment of the invention the non-aqueous oral care composition comprise a mixture of natural oils and/ or its actives extracted from plants which shows desired germicidal properties. The natural plant derived oils includes vegetable oil, flavouring oils, edible oils, essential oils, carrier oils, or a combination thereof.
The composition of the present invention may include one or more additives in ranges well known to a person skilled in art to make the non-aqueous oral care composition more appealing for oral care. The additives may include but not limited to, cleaning agents, softening agents, chelating agents, surfactants, processing aids, colouring or pigment agents, flavouring agents, sweetening agents (e.g., sucrose, saccharin, or sodium or calcium cyclamate, among others), antiseptics (e.g., antibacterial agents, antiviral agents, antifungal agents, or a combination thereof, among others), preservatives (e.g., ethyl, n-

propyl, or p-hydroxy benzoate, among others), and stimulants, or a combination thereof, among others.
In an embodiment of the invention, the non-aqueous oral care composition comprises primarily seasame oil, or coconut oil or a combination thereof. The non-aqueous oral care composition further comprises a mixture of essential oils and/or its actives.
Essential oils are compounds extracted from plants. The oils capture the plant's scent and flavour, or "essence." Unique aromatic compounds give each essential oil its characteristic essence. Essential oils are obtained through distillation (via steam and/or water) or mechanical methods, such as cold pressing. The essential oils used in the non-aqueous compositions are but not limited to cinnamon bark oil, clove oil, mint oil, tulsi (Basil) oil, ajwain oil, eucalyptus oil, ginger oil, tomar seed oil, flax seeds oil, camphor, babul, anise, miswak, blackseed, jaiphal, borneol, iso-berneol, thymol, wintergreen oil, spearmint, etc. and combinations thereof. Most preferably, the non-aqueous composition comprises essential oils and/or its actives: cinnamon bark oil, clove oil, mint oil, tulsi (Basil) oil, ajwain oil or combinations thereof.
Sesame oil is obtained from Sesamum indicum. Sesame oil reduces plaque induced gingivitis. Root of Sesame contains chlorosesamone which has antifungal activity. Also polyunsaturated fatty acids present in sesame oil reduces free radical injury occurring in oral cavity. Sesame oil does not have side effects like staining, lingering aftertaste, and allergy. Sesame is a good source of vitamins and minerals like manganese, calcium, magnesium, phosphorous, zinc, selenium, vitamin E, and vitamin B1. Sesame has high levels of potent antioxidants, namely sesamol and sesamin that reduce lipid peroxidation by diminishing the free radical injury to oral tissues. It is due to these antioxidants that sesame oil usually has a fairly long shelf life and is not prone to rancidity.
Coconut oil is an easily available edible oil. Coconut oil, or copra oil, is an edible oil extracted from the kernel or meat of mature coconuts harvested from the coconut palm (Cocos nucifera). Coconut oil is composed of 92% saturated acids, with lauric acid making up for 50% of these saturated acids. Monolaurin and monoglycerides of lauric acid have been identified to have antimicrobial activity against a range of microorganisms. These include Helicobacter pylori, Staphylococcus aureus, Escherichia

vulneris, Enterobcater, and Candida species, including Candida glabrata, Candida albicans, Candida stellatoidea, Candida parapsilosis, Candida tropicalis, and Candida krusei and various viruses. It is unique because it contains predominantly medium chain fatty acids of which 45-50 percent is lauric acid. Laurie acid has proven anti-inflammatory and antimicrobial effects. Coconut oil was found to prevent Streptococcus mutans, an acid-producing bacteria found in the mouth, majorly responsible for causing tooth decay. This can be attributed to the fact that coconut oil is a good source of Vitamin E which is a powerful antioxidant along with lauric acid and monolaurin that lend anti-bacterial properties.
Cinnamon essential oil contains cinnamaldehyde, which is the active component that kills the bacteria Porphyromonas gingivalis found in people with gingivitis. Both cinnamaldehyde and cinnamon essential oil works by destroying Porphyromonas gingivalis membrane. This in turn, reduces plaque formation and can treat gingivitis, by acting as a natural antimicrobial agent.
Clove oil is obtained from Eugenia caryophyllus. Clove oil can be obtained from distillation of buds, leaf or stem, each resulting in an oil having different characteristics of oil. Clove oil suppresses the oral microorganisms effectively. These properties are due to high percentage of eugenol, eugenyl acetate and caryophyllene. Clove oil reduces the bacteria that cause gum disease and helps create a balanced oral biome. Clove oil also reduces gum swelling and irritation owing to its anti-inflammatory properties, stimulates circulation, due to its "hot" nature, enhancing gum tissue health, and helps remineralize teeth due to the protective properties of eugenol against acids (that can erode dentin).
Mint oil is obtained from Mentha x piperita, also known as Mentha balsamea. Mint oil is one of the most widely used essential oils in oral care products, widely due to the antibacterial, antifungal, and biofilm-inhibiting properties. Mint oil has the ability to inhibit biofilm formation in the oral cavity in addition to providing a therapeutic benefit treating periodontitis, gingivitis, and halitosis.
Tulsi is obtained from Ocimum tenuiflorum, also known as Ocimum sanctum. Tulsi (Basil) oil contains significant amount of Eugenol (l-hydroxy-2-methoxy-4 allylbenzene) hence it acts as COX-2 inhibitors similar to modern analgesics. Ocimum sanctum (Tulsi)

leaves contain 0.7% volatile oil consisting about 71% eugenol and 20% methyl eugenol. Tulsi leaves are quite effective in treating common oral infections. When chewed, tulsi leaves help in maintaining oral hygiene. Antibacterial agents namely carvacrol and terpene are present in this plant.
Ajwain oil is obtained from Trachyspermum ammi. Ajwain oil serve as a potential, natural, nontoxic, and economical therapeutic antiplaque agent. Thymol is the major constituent along with p-cymene, y-terpinene, a-pinene, P-pinene and a-terpinene in ajwain oil. The principal constituents which are responsible for typical flavour of ajwain seed essential oil are thymol and carvacrol.
In embodiments of the present invention the natural oil-based composition includes vitamin E (Tocopherol acetate). Vitamin E component of the dentifrice composition substantially reduces or eliminates the oily sensation, or unpleasant mouth feel, of the oil base and tends to reduce oxidation of the oil base. This is particularly important where the oil base constitutes the major component of the dentifrice composition as in the present invention.
Additionally, it is believed that inclusion of vitamin E (Tocopherol acetate) assists in providing beneficial oral health of the tissues adjacent a user's teeth, usually in conjunction with the removal of plaque by means such as a toothbrush, dental floss or the like. That is, it is believed that the inclusion of a sufficient source of vitamin E in the oil base is of assistance as part of an oral health program for users with gingival irritations, and may be useful following oral surgery, or for users, with incipient gum deterioration.
Further, it has been discovered that the vitamin E component, when combined with saliva, forms a thin coating or film on the oral substrate. This coating or film acts as a prophylaxis which reduces or prevents new plaque formation for a period after use of the dentifrice composition.
In some embodiments, the non-aqueous oral care compositions of the present invention may comprise sweetening agents. Sweetening agents can be added to the compositions as a sensate. These include saccharin, dextrose, sucrose, sucralose, lactose, xylitol, maltose, levulose, aspartame, sodium cyclamate, D-tryptophan, dihydrochalcones,

acesulfame, sucralose, neotame, and mixtures thereof. Preferably, the sweeting agent suitable for use in the compositions of the present invention is saccharin. Sweetening agents are generally used in composition of the present invention in range from about 0.01% to about 0.5%, by weight of the composition.
In some embodiments, the non-aqueous oral care compositions of the present invention may comprise preservatives. Suitable preservatives include, for example, benzoic acid, benzyl alcohol, potassium sorbate, methylisothiazolinone, paraben preservatives, for example methyl p-hydroxybenzoate, propyl p- hydroxybenzoate, and mixtures thereof.
In some embodiments, the non-aqueous oral care compositions of the present invention comprise one or more odor-neutralizing agents. Suitable odor neutralizing agents include, without limitation, chlorine dioxide; peroxides such a hydrogen peroxide; chlorite salts and bicarbonate salts, e.g. sodium chlorite and sodium bicarbonate; essential oils such as eucalyptus, menthol, methyl salicylate and thymol; flavor cocktails; and zinc salts such as, for example and not limited to, zinc chloride, zinc citrate, zinc acetate and zinc sulfate.
In some embodiments, the non-aqueous oral care compositions of the present invention comprise one or more coloring agents. Suitable coloring agents include without limitation natural/artificial coloring agents like Ponceu4R, FDC Red 40, and other allowed in oral care. The coloring agents are preferably in a range of 0.0001-1% wt./wt.
The inventors of the present invention have observed that only coconut oil based composition or the non-aqueous oral care composition with high amount of coconut oil was not physically stable as solidification occurs at low temperature. Also, when seasame oil was used in high amount the non-aqueous oral care composition was not organoleptically acceptable. It was with repeated experiments, trial and errors that the inventors have arrived at the present non-aqueous oral care composition which is physically stable without any solidification, sedimentation even at low temperature and demonstrates an exceptional germicidal effect and kills 99.9% problem causing bacteria and 99.9%) fungus in the oral cavity.
The oral care compositions of this invention provide effective antimicrobial activity without the presence of other types of antimicrobial compounds. For example, the

compositions of this invention do not require known antimicrobial nitrogen-containing organic compounds, such as chlorhexidine gluconate and the like, to achieve effective antimicrobial activity. Thus, the reduced alcohol and alcohol-free natural oil containing oral care compositions of this invention are particularly advantageous over the compositions of the prior art.
In an embodiment of the invention the non-aqueous oral care compositions comprises the mixture of natural edible and essential oils and/or their actives as shown in Table 1 below:
Table 1: Composition of non-aqueous oral care composition

Ingredients % (wt./wt.)
Coconut Oil 0.1-10.00
Antioxidant (Tocopherol Acetate optional) 0.01-0.50
Sesame Oil 50-99.9
Sweeterner (Saccharin optional) 0.01-0.5
Clove Oil or Eugenol 0.1-10
Mint oil and/or menthol 0.1-5.0
Cinnnamon Oil and/or cinnamaldehyde 0.1-10
Tulsi oil (Eugenol) 0.0001-0.1
Ajwain Oil and/or thymol 0.0001-0.1
Colorants (optional) 0.0001-1
The non-aqueous oral care composition is stable during shelf life and do not freeze or precipitates at lower temperature. The oral care compositions of the present invention does not comprise synthetic active. The oral care compositions of the present invention are observed to be effective against reduction in the count of Streptococcus mutans, Candida albicans and other bacteria and fungi found in oral cavity. The non-aqueous oral care compositions demonstrates an exceptional germicidal effect and kills 99.9% problem causing bacteria and 99.9 fungus in the oral cavity.

To use the mouthwash composition of the present invention approximately 5-20 ml of the composition is taken in mouth and swished gently in mouth for minimum of 3 minutes. After 3 minutes the mouthwash is spitted and mouth is rinsed with water.
EXAMPLES
The following examples set forth are preferred method and composition in accordance with the invention. It is to be understood, however, that these examples are provided by way of illustration and nothing therein should be taken as a limitation upon the overall scope of the invention.
Example 1: Preparation of non-aqueous oral care composition
In this example, various non-aqueous oral care compositions were prepared from the ingredients as listed in the table 1 above. The components from table 1 are taken in specific amounts and mixed together in following manner: required amount of coconut oil is taken and slightly heated at about 30 °C, the warmed coconut oil is homogenously mixed with required amount of seasame oil followed by addition of essential oil and their actives in required amount to obtain a homogenous mixture preferably for a time of 5 to 10 minutes at 100 rpm to 800 rpm.
The formulations prepared for the purpose of the present invention are illustrated in Table
2:
Table 2: Formulation of the present invention

Ingredients Formulation
1 (% wt./wt.) Formulation
2 (% wt./wt.) Formulation
3 (% wt./wt.)
Coconut Oil 0.1 5 10
Antioxidant (optional Tocopherol Acetate) 0.01 0.1 0.5

Sesame Oil 99.58 88.4 63.8
Sweetener (Saccharin optional) 0.01 0.1 0.5
Clove Oil 0.1 2.5 10
Mint oil 0.1 0.33 5.0
Cinnnamon Oil 0.1 3.0 10
Tulsi oil 0.0001 0.1 0.1
Ajwain Oil 0.0001 0.1 0.1
Example 2
Efficacy study of the non-aqueous oral care compositions of the present invention
The efficacy studies are performed in accordance with ASTM E2315-16 for measuring time kill assay of the INCI and formulations as shown in table 2. The microbial strains used in the studies are Streptococcus mutans ATCC 25175 and Candida albicans ATCC 10231. The microbes for the present invention were procured from HiMedia Laboratories Pvt. Ltd. (Address: A516, SwastikDisha Business Park, Viavadhani Indl. Est. LBS Marg, Mumbai-400086).
The microbes Streptococcus mutans ATCC 25175, Candida albicans ATCC 10231 are cultured on medium Brain Heart Infusion agar and Sabouraud dextrose agar respectively. The test suspension used for the purpose of the present invention comprises 108 cfu/ml of

microbes and neutralization challenge microbial suspension was prepared to achieve 30 to 100 colonies on plate. Diluent used in the present invention is Sodium chloride with tween 80. Inactivation medium or neutralizer used is Dey Engley Neutralizing broth.
Neutralization Validation Assay: Following tests were performed in a timely manner such that significant proliferation of the test organism did not occur:
Neutralization effectiveness Test (Test A): 0.1 ml of the neutralization challenge microbial suspension was added to sterile tube containing 8.9 ml of neutralizer further, 1.0 ml of test sample was added and mixed.
Neutralizer toxicity (TestB): 0.1 ml of the neutralization challenge microbial suspension was added to sterile tube containing 8.9 ml of neutralizer further, 1.0 ml of sterile saline was added and mixed.
Test organism viability (Test C): 0.1 ml of the neutralization challenge microbial suspension was added to sterile tube containing 9.9 ml of sterile saline and mixed.
At 0 time and 30 minutes, 1 ml from the reaction mixture of each test was plated by pour plate technique and was observed for proliferation.
The test procedure comprises preparation of initial suspension (base line) by adding 0.1 ml of test suspension (108 cfu/ml) to 10 ml of diluent (sodium chloride with tween 80), serially diluting it followed by plating through pour plate technique, incubation and observing the surviving micro-organisms in the form of colonies. The evaluation of antimicrobial activity of the test sample is done by taking 10 ml of test sample (formulations of the present invention) adding to it 0.1 ml aliquot of test suspension, mixing it, exposing test suspension to test sample for contact time of 3 minutes. It is then serially diluted and plated by pour plate technique followed by incubation at 35 °C + 2 °C for 48 hours and observing the surviving micro-organisms in form of colonies. Incubation time is selected so as to allow growth of surviving organisms, without overgrowth of colonies as it makes enumeration difficult.
Logio reduction and % reduction is calculated by using following formulas
• Average counts per ml = c / (m+0. lm) d Where,

c = sum of all colonies taken into account ni = number of plates taken in account in the lower dilution m = number of plates taken in account in the higher dilution d = dilution factor corresponding to the lower dilution
• Average counts per ml were converted to Logio.
• Logio reduction (LR) = Logio of initial suspension - Logio of test sample
• % Reduction = (Average count per ml of initial suspension - Average count per ml of test sample)/Average count per ml of initial suspension x 100
It was observed that the formulation 2 and formulation 3 as shown in table 5 shows exceptional germicidal effect and kills 99.9% problem causing bacteria S. mutans and 99.9% fungus Candida albicans in the oral cavity. Formulations 1 to 3 were found to be physically stable without any sedimentation, precipitation.
Table 3: Germicidal effect of coconut oil alone

Test Organism Contact Time Test count (cfu/ml) Test Log Log Reduction % Reduction
Streptococcus mutans 3 minutes 2.3xl06 6.36 0.05 11.54
Candida albicans 3 minutes 1.3xl06 6.11 0.34 53.57
Table 4: Germicidal effect of seasame oil alone

Test Organism Contact Time Test count (cfu/ml) Test Log Log Reduction % Reduction
Streptococcus mutans 3 minutes 2.3xl06 6.36 0.05 11.54
Candida albicans 3 minutes 1.9xl06 6.28 0.17 32.14
Table 5: Germicidal effect of the formulations of the present invention

Test Organism Contact Time Test
count
(cfu/ml) Test Log Log Reduction % Reduction

Formulation 1 Streptococcus mutans 3 minutes 1.93xl06 6.29 0.05 9.33

Candida albicans 3 minutes 1.60xl06 6.20 0.01 3.13
Formulation
2 Streptococcus mutans 3 minutes 7.3xl06 6.86 >5.86 99.99

Candida albicans 3 minutes 1.5xl06 6.18 3.07 99.9
Formulation 3 Streptococcus mutans 3 minutes 1.93xl06 6.29 >5.29 99.9

Candida albicans 3 minutes 1.60xl06 6.20 >5.20 99.9
The non-aqueous oral care compositions of the present invention are natural, economical and are without any side effects. The compositions of the present invention have the following advantages: it reduces total oral bacterial count and plaque and gingival scores and also diminishes the susceptibility to dental caries and are physically stable at room temperature and below room temperature without any solidification or sedimentation. The product of the present invention is organoleptically suitable for use.
While particular embodiments of the present invention have been illustrated and described, it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of the invention.
The essential oils like clove oil, cinnamon bark oil, mint oil, tulsi oil, ajwain oil, seasame oil and coconut oil for the purpose of the present invention were obtained from Dabur International Ltd., Dubai, United Arab Emirates.

We claim:

1. A non-aqueous oral care composition comprising edible oils, essential oils or their
actives and additives wherein the edible oils are coconut oil present in a range from 0.1
to 10.0% wt./wt. and seasame oil present in a range from 50 to 99.9% wt./wt; and
wherein essential oils selected from the group comprising of clove oil, mint oil, cinnamon oil, tulsi oil and ajwain oil.
2. The non-aqueous oral care composition as claimed in claim 1, wherein clove oil is present in a range from 0.1 to 10% wt./wt.
3. The non-aqueous oral care composition as claimed in claim 1, wherein mint oil is present in a range from 0.1 to 5.0% wt./wt.
4. The non-aqueous oral care composition as claimed in claim 1, wherein cinnamon oil is present in a range from 0.1 to 10% wt./wt.
5. The non-aqueous oral care composition as claimed in claim 1, wherein tulsi oil is present in a range from 0.0001 to 0.1% wt./wt.
6. The non-aqueous oral care composition as claimed in claim 1, wherein ajwain oil is present in a range from 0.0001 to 0.1% wt./wt.
7. The non-aqueous oral care composition as claimed in claim 1, wherein additive is saccharin present in a range from 0.01 to 0.5% wt./wt.
8. The non-aqueous oral care composition as claimed in claim 1, wherein the additive is antioxidant tocopherol acetate (Vitamin E) present in a range from 0.01 to 0.5% wt./wt.

Documents

Application Documents

# Name Date
1 202011036435-PROVISIONAL SPECIFICATION [24-08-2020(online)].pdf 2020-08-24
2 202011036435-FORM 1 [24-08-2020(online)].pdf 2020-08-24
3 202011036435-FORM-26 [25-08-2020(online)].pdf 2020-08-25
4 202011036435-Proof of Right [03-09-2020(online)].pdf 2020-09-03
5 202011036435-APPLICATIONFORPOSTDATING [20-08-2021(online)].pdf 2021-08-20
6 202011036435-APPLICATIONFORPOSTDATING [24-11-2021(online)].pdf 2021-11-24
7 202011036435-CORRESPONDENCE-OTHERS [19-02-2022(online)].pdf 2022-02-19
8 202011036435-COMPLETE SPECIFICATION [19-02-2022(online)].pdf 2022-02-19
9 202011036435-FORM 18 [10-11-2022(online)].pdf 2022-11-10
10 202011036435-FER.pdf 2023-03-31
11 202011036435-FER_SER_REPLY [15-09-2023(online)].pdf 2023-09-15
12 202011036435-COMPLETE SPECIFICATION [15-09-2023(online)].pdf 2023-09-15
13 202011036435-CLAIMS [15-09-2023(online)].pdf 2023-09-15
14 202011036435-US(14)-HearingNotice-(HearingDate-15-12-2023).pdf 2023-11-17
15 202011036435-FORM-26 [12-12-2023(online)].pdf 2023-12-12
16 202011036435-Correspondence to notify the Controller [12-12-2023(online)].pdf 2023-12-12
17 202011036435-Written submissions and relevant documents [30-12-2023(online)].pdf 2023-12-30
18 202011036435-Response to office action [30-12-2023(online)].pdf 2023-12-30
19 202011036435-Proof of Right [30-12-2023(online)].pdf 2023-12-30
20 202011036435-FORM 3 [30-12-2023(online)].pdf 2023-12-30
21 202011036435-ENDORSEMENT BY INVENTORS [30-12-2023(online)].pdf 2023-12-30
22 202011036435-FORM-26 [31-12-2023(online)].pdf 2023-12-31
23 202011036435-PatentCertificate01-01-2024.pdf 2024-01-01
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