TECHNICAL FIELD

[0001] The present disclosure generally relates to the field of composition for external application for oral care. More particularly, the present disclosure relates to the use of therapeutically formulated herbal dentifrice.

BACKGROUND

[0002] Oral pharmaceutical compositions serve dual purpose of cosmetic use and therapeutic effect. The compositions intended for oral hygiene are formulated to cater to oral health like plaque, tartar, gingivitis, bleeding gums, premature loss of tooth, chipping of tooth enamel etc. Formulations comprising of chemicals and synthetic products have long been found to have adverse effect. Traditional medicinal systems like Ayurveda and Unani have been promoting the use of herbal ingredients in formulations. These ingredients are preferably plant extracts which are obtained from various parts of the medicinal plants. For example: the clove oil obtained from clove is the bud of the plant, mint is a leaf, neem twigs have been used as a natural tooth brush etc.

[0003] The nature of herbal ingredients utilised for oral hygiene purposes have been limited. There stand many of the ingredients available in the nature whose therapeutic and cosmetic effects need to be harnessed.

[0004] In the light of aforementioned discussion there exists a need to explicitly harness the use of berries, fruits and other special herbal ingredients for dental therapy and cosmetic purposes.

BRIEF SUMMARY

[0005] The following presents a simplified summary of the disclosure in order to provide a basic understanding to the reader. This summary is not an extensive overview of the disclosure and it does not identify key/critical elements of the invention or delineate the scope of the invention. Its sole purpose is to present some concepts disclosed herein in a simplified form as a prelude to the more detailed description that is presented later.

[0006] Exemplary embodiments of the present disclosure are directed towards a composite herbal formulation for oral care.

[0007] An exemplary object of the present subject matter is directed towards a composite herbal formulation for oral care preferably in a paste form for easy application.

[0008] Another exemplary object of the present subject matter is directed towards the use of herbal components to have little or no side effects.

[0009] Another exemplary object of the present subject matter is directed towards the use of abrasives to remove food particles from in between the teeth.

[00010] Yet another exemplary object of the present subject matter is directed towards the prevention of bacterial growth and gum weakening.

[00011] Exemplary aspects of the present disclosure are directed towards a herbal active ingredient inclusive of at least one of: Ocimum filamentosum , Ocimum minimum, Ocimum kilimandscharicum,Eugenia aromatica (L.), Mentha spicata L.Mentha piperita, Mentha vagans, Mentha suaveolens, whereby the amount of active ingredient incorporated ranges between 0.25% to 2% weight by weight of the total composition.

[00012] An exemplary aspect of the present subject matter is directed towards an herbal active ingredient having Salvadora persica; Oscimum Bascillicum; Syzygium aromaticum; Ziziphus mauritiana; Mentha Longifolia; Olea europaea and Azardichta Indica with the amount of active ingredient being incorporated in ranges between 1.0 % to 1.5% weight by weight of the total composition.

[00013] Another exemplary aspect of the disclosure is directed towards an anti-carries agent incorporated as 1 % weight by weight of the total composition.

[00014] Another exemplary aspect of the disclosure is directed towards a thickening agent incorporated in the ranges between 1 % to 2.5% weight by weight of the total composition;

[00015] Another exemplary aspect of the disclosure are directed towards a surfactant incorporated ranges between 0.01% to 10% weight by weight of the total composition; and

[00016] Yet another exemplary aspect of the disclosure is directed towards an aqueous phase comprising at least one of; glycerin and water incorporated ranges between 7.5% to 24% weight by weight of the total composition.

BRIEF DESCRIPTION OF DRAWINGS

[00017] Other objects and advantages of the present invention will become apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments, in conjunction with the accompanying drawings, wherein like reference numerals have been used to designate like elements, and wherein:

[00018] FIG 1 is a flow diagram illustrating the method employed for the preparation of a composite herbal formulation for oral care, according to an exemplary embodiment of the present disclosure.

[00019] FIG. 2 is a flow diagram illustrating a method employed for the preparation of a composite herbal formulation by the addition of Salvadora persica for oral care, according to an exemplary embodiment of the present disclosure.

DETAILED DESCRIPTION

[00020] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[00021] The use of "including", "comprising" or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms "a" and "an" herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms "first", "second", and "third", and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

[00022] The present disclosure provides a composite herbal formulation for oral care comprising of herbal active components;

[00023] Raihaan (Habaq), as in Tibbi, and/or Oscimum Bascillicum as the botanical name, and/or Basil as the conventional name.

[00024] Qaranful(Kuboosh) as in Tibbi, and/or Syzygium aromaticum as the botanical name, and/or Clove as the conventional name.

[00025] Unnab as in Tibbi, and/or Ziziphus mauritiana as the botanical name, and/or Indian Plum as the conventional name. Unnab is also referred to as Ber in colloquial lingo.

[00026] Nana Al- Fulfuli as in Tibbi, and/or Mentha Longifolia as the botanical name, and/or Mint as the conventional name.

[00027] Zaitoon as in Tibbi, and/or Olea europaea as the botanical name, and/or Olive as the conventional name.

[00028] Yavan Priya as in Tibbi, and/or Azardichta Indica as the botanical name, and/or Neem as the conventional name.

[00029] The present disclosure provides a composite herbal formulation for oral care comprising of excipients which are configured to have requisite therapeutic effect when a part of the formulation;

• Aerosil

• Calcium Carbonate

• Carbopol

• Glycerine

• Sodium Mono Fluro Phosphate

• Chlorophyll

• Sodium Carboxy Methylcellulose

• Sodium Saccharin

• Sodium Lauryl Sulphate

• Sorbitol

• Water

[00030] Raihaan (Habaq), as in Tibbi, and/or Oscimum Bascillicum as the botanical name, and/or Basil as the conventional name is used, not limiting to, the herbal formulation for oral care. Basil is a phenolic derivative. Basil is incorporated in the formulation for oral care as the chemical components in Basil aid the user in keeping oneself away from many mouth diseases such as gums diseases, pyorrhoea, and other dental infections.

[00031] Qaranful(Kuboosh) as in Tibbi, and/or Syzygium aromaticum as the botanical name, and/or Clove as the conventional name. Eugenol is an active ingredient in clove oil. Eugenol acts as an analgesic in the mouth, owing to its ability to temporarily block pain by numbing tissues. This leads to an anti-inflammatory action of clove.

[00032] Unnab as in Tibbi, and/or Ziziphus mauritiana as the botanical name, and/or Indian Plum as the conventional name. Unnab is also referred to as Ber in colloquial lingo. Ziziphus species contain several phytochemicals not limited to saponins, pectin, fatty acids, triterpenoic acids, cyclopeptide alkaloids and the like without limiting the scope of the disclosure. The property of Indian plum may not be limited to: an analgesic, an antiinflammatory, an antibacterial and the like, thus making it an essential ingredient for composite herbal oral care formulation.

[00033] Nana Al- Fulfuli as in Tibbi, and/or Mentha Longifolia as the botanical name, and/or Mint as the conventional name. Mint possesses germicidal qualities and rapidly freshens the breath. The mechanism of action of mint involves the suppression of harmful bacterial growth within the oral cavity by cleansing the tongue and/or teeth.

[00034] Zaitoon as in Tibbi, and/or Olea europaea as the botanical name, and/or Olive as the conventional name. Olive oil is configured to act upon the soft, sticky and colourless film of bacteria deposited in the gums and teeth, when left untreated may lead to gingivitis which may be a precursor to chronic gum ailments. The presence of anti-oxidants and monounsaturated fats aid in reduction of building up of plaque and exhibit antiinflammatory properties.

[00035] Yavan Priya as in Tibbi, and/or Azardichta Indica as the botanical name, and/or Neem as the conventional name. The use of neem for not limiting to strong teeth has been a part of oral health practices since time immemorial. The neem leaves, neem bark and neem twig and the like have been used as a part of composite herbal formulation for oral care. The incorporation of neem may be attributed to prevention and healing of gum diseases, prevention of cavities, elimination of bacteria causing cavities and inflammation of the gums, preventing bacteria from adhering to the user's teeth (reduce plaque), enhance mouth immunity in general, breath freshener and the like without limiting the scope of the disclosure.

[00036] The present disclosure provides a composite herbal formulation for oral care comprising of excipients which are configured to have requisite therapeutic effect when a part of the formulation. The excipients comprise of; thickening agents not limited to Aerosil and Sodium CMC (Carboxy methyl cellulose) and carbapol 934. An abrasive not limited to Calcium carbonate configured to impart shine and cleanliness to the enamel of the teeth by polishing and grinding effect. Glycerin, a humectant is configured to impart a pasty texture to the toothpaste and keeps it from drying out and also, coats the teeth to prevent remineralisation. Sodium monofluorophosphate acts with the insoluble compound produced after the consumption of high sugary meal to resist the attack degradation of apatite by loss of OH ^" (hydroxide ion) which would enable the dissolution of the enamel. Sweeteners not limiting to Sodium Saccharin and Sorbitol may be incorporated for enhancing the palatability and masking the strong taste generated due to incorporation of various components in the composite herbal formulation for oral care. Sodium lauryl sulphate acts as a surfactant which is involved in the creation of the foaming action. Sodium lauryl sulphate is an anionic surfactant which combines with the debris in the oral cavity, chelates them and ensures that they are pulled out. Chlorophyll, a natural ingredient may be found in green leafy vegetables, green vegetables, algae and the like. Chlorophyll imparts colour. A colorant incorporated may not be limited to green. Glycerine along with water may be utilised as an aqueous base for incorporation and dissolution of both the active components and excipients.

[00037] An exemplary embodiment for the composition for the composite herbal formulation for oral care is represented in the following table:

10. Sodium 1 20

monofluorophosphate

Sl.No Ingredient Percentage Quantity of ingredient(gm) per batch of 2 kg

Aerosil

1. 1 20

Basil

2. 1.5 30

3. Calcium Carbonate 40

800

4. Carbopol 1.5 30

5. Syzygium aromaticum 1.5 30

Glycerine 7.5 150

6.

7. Ziziphus mauritiana 1.5 30

Mentha Longifolia

8. 1 20

9. Olea europaea 1.5 30

10. Sodium 1 20

monofluorophosphate

[00038] Referring to FIG. 1 is a flow diagram 100, illustrating the method employed for the preparation of a composite herbal formulation for oral care, according to an exemplary embodiment of the present disclosure. The method involves both dry phase and aqueous phase which are subjected to step by step procedures to obtain the requisite composite herbal formulation for oral care. The method starts at step 102, where the sifting of Calcium Carbonate, Xanthan Gum, Sodium Carboxy Methyl Cellulose and Carbapol 934 is done by passing them through sieve #40. The sifted Calcium Carbonate, Xanthan Gum, Sodium Carboxy Methyl Cellulose and Carbapol 934 are placed in a planetary mixer with a vaccum provision and a capacity not limiting to 5000ml and subjected to mixing resulting in the formation of a dry mixture at step 104.The process at step 104 was carried out at not limiting to 60% of relative humidity (RH) and at a temperature of not limiting to 20°C -25 °C. The principle of geometrical dilution may be applied during the addition and mixing of the components. Further, at step 106 predetermined quantities sorbitol and water are added preferably in a stainless steel container not limiting to 2000 ml capacity to form an aqueous mixture. Placing the aqueous mixture in water bath to increase the temperature to 50°C - 60 °C is done at step 108. Pre-determined quantity of colorant (chlorophyll) is dissolved in a pre-determined quantity of glycerin and the mixture of chlorophyll dissolved in glycerin is added to the aqueous mixture at step 110. Pre-determined quantities of aerosil sifted through a mesh # 80, Sodium Saccharin and Sodium mono fluoro phosphate were added to the aqueous solution with continuous stirring using propeller type agitator not limiting to 30 minutes to form a homogenous aqueous dispersion at step 112 which facilitates the formation of a homogenous dispersion. Pre-determined quantities of Sodium Lauryl Sulphate were added to homogenous dispersion at step 114. Adding the homogenous aqueous dispersion to the dry sifted components into a planetary mixer for not limiting to 15 minutes to form a wet mass at step 116. The forms of basil oil (Oscimum BasciUicum), clove oil (Syzygium aromaticum), Unnab (Ziziphus mauritiana), Zaitoon (Olea europaea), and extract of Neem (Azardicta Indica) were de aerated at step 118. The deaerated basil oil (Oscimum BasciUicum), clove oil (Syzygium aromaticum), Unnab (Ziziphus mauritiana), Zaitoon (Olea europaea), and extract of Neem (Azardicta Indica) were added to the wet mass obtained at step 116 by continuous agitation for not limiting to 60 minutes to form a homogenous mass at step 120. Adequate controls may be kept in assessing the homogeneity of mass for the oil levels. Further, at step 122, a pre-determined quantity of Mentha Longifolia (Nana-al - Fulfuli) was added to the homogenous mass obtained at step 120. Finally, mixing the contents of step 122 for 30 minutes at lOOrpm under vacuum to obtain the requisite composite herbal formulation for oral care at step 124.

[00038] The present disclosure provides a composite herbal formulation for oral care comprising of herbal active components:

[00039] Meswak known with the botanical name Salvadora persica available at a percentage, not limiting to, 1.5 % of the composition.

[00040] Raihaan known with the botanical name Oscimum BasciUicum as the botanical name, and/or Basil as the conventional name available at a percentage, not limiting to, 1.5 % of the composition.

[00041] Qaranful with the botanical name Syzygium aromaticum as the botanical name, and/or Clove as the conventional name available at a percentage, not limiting to, 1.5 % of the composition.

[00042] Unnab with the botanical name Ziziphus mauritiana as the botanical name, and/or Indian Plum as the conventional name. Unnab is also referred to as Ber in colloquial lingo available at a percentage, not limiting to, 1.5 % of the composition.

[00043] Peppermint oil with the botanical name Mentha longifolia as the botanical name, and/or Mint as the conventional name available at a percentage, not limiting to, 1 % of the composition.

[00044] Olea europaea as the botanical name, and/or Olive as the conventional name available at a percentage, not limiting to, 1.5 % of the composition.

[00045] Yavan Priya as in Tibbi, and/or Azardirachta indica as the botanical name, and/or Neem as the conventional name available at a percentage, not limiting to, 1 % of the composition.

[00046] The present disclosure provides a composite herbal formulation for oral care comprising of excipients which are configured to have requisite therapeutic effect when a part of the formulation;

• Aerosil

• Calcium Carbonate

• Sodium silicate

• Carbopol

• Glycerine

• Sodium Mono Fluro Phosphate

• Chlorophyll

• Xanthan Gum

• Coca amido propyl betaine

• Sodium Carboxy Methylcellulose

• Sodium Saccharin

• Sodium Lauryl Sulphate • Sorbitol

• Water

[00047] Meswak known with the botanical name Salvadora persica was used erstwhile as a teeth whitener and polishing agent. Meswak is known to have antimicrobial properties especially against oral bacteria and exhibits minimal and/or no mammalian toxicity. The cleansing efficacy of Meswak is normally by leaching out in saliva, and for their antifungal properties which is attributed to active chemical constituents, not limited to, sodium chloride, potassium chloride, salvadourea, alkaloids, oleic acid and linoleic acids.

[00049] An exemplary embodiment for the composition for the composite herbal formulation for oral care is represented in the following table:

11. Sodium Mono fluro 1 20.0

phosphate

12. Azardirachta indica 1 20.0

(Neem Bark)

13. Chlorophyll 0.5 10.0

14. Xanthan Gum 1 20.0

15. Sodium Saccharin 0.5 10.0

16. Sodium Lauryl 2.5 50.0

Sulphate

17. Sorbitol 12 240.0

18. Coca amido Propyl 0.5 10.0

Betaine

19. Water 23.5 470.0

100 2000

[00050] Referring FIG. 2 is a flow diagram 200, illustrating a method employed for the preparation of a composite herbal formulation by the addition of Salvadora persica for oral care, according to an exemplary embodiment of the present disclosure. The method involves both dry phase and aqueous phase which are subjected to step by step procedures to obtain the requisite composite herbal formulation for oral care. The method starts at step 202, where the presifted Calcium Carbonate, Xanthan Gum, and sodium silicate are passed them through sieve #40. The presifted Calcium Carbonate, Xanthan Gum, and sodium silicate are placed in a high shear mixer with a vacuum provision and a capacity not limiting to 5000ml step 204. The process at step 204 was carried out at not limiting to 60% of relative humidity (RH) and at a temperature of not limiting to 20°C -25 °C. The principle of geometrical dilution may be applied during the addition and mixing of the components. Further, at step 206 predetermined quantities sorbitol was added to water preferably in a stainless steel container not limiting to 2000 ml capacity to form an aqueous mixture. Placing the aqueous mixture in a water batch to increase the temperature to 50°C -60 °C is done at step 208. Pre-determined quantity of colorant (chlorophyll) is dissolved in a pre-determined quantity of glycerin and the mixture of chlorophyll dissolved in glycerin is added to the aqueous mixture at step 210. Pre-determined quantities of aerosil sifted through a mesh # 80, Sodium Saccharin and Sodium mono fluoro phosphate and Coca amido propyl betaine were added to the aqueous solution with continuous stirring using propeller type agitator not limiting to 30 minutes to form a homogenous aqueous dispersion at step 212. Pre-determined quantities of Sodium Lauryl Sulphate were added to aqueous homogenous dispersion at step 214. Adding the homogenous aqueous dispersion to the dry sifted components into a planetary mixer for not limiting to 15 minutes to form a wet mass at step 216. At step 218, the wet mass obtained is subjected to an agitation speed of lOOrpm for 60 min under vacuum to prevent the formation of foam. The deaerated basil oil (Oscimum Bascillicum), clove oil (Syzygium aromaticum), Unnab (Ziziphus mauritiana), Zaitoon (Olea europaea), and extract of Neem (Azardirachta Indica) and Salvadora persica were added to the wet mass obtained at step 216 by continuous agitation for not limiting to 60 minutes to form a homogenous mass at step 220. Adequate controls may be kept in assessing the homogeneity of mass for the herbal components. Further, at step 222, a pre-determined quantity of Mentha Longifolia (Nana-al -Fulfuli) was added to the wet mass obtained at step 220 into a planetary mixer. Finally, mixing the contents of step 222 for 30 minutes at lOOrpm under vacuum to obtain the requisite composite herbal formulation for oral care at step 224.

[00051] Although the present disclosure has been described in terms of certain preferred embodiments and illustrations thereof, other embodiments and modifications to preferred embodiments may be possible that are within the principles and spirit of the invention. The above descriptions and figures are therefore to be regarded as illustrative and not restrictive.

[00052] Thus the scope of the present disclosure is defined by the appended claims and includes both combinations and sub combinations of the various features described herein above as well as variations and modifications thereof, which would occur to persons skilled in the art upon reading the foregoing description.