FORM 2
THE PATENT ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
[Ref section 10 and rule 13]
1. TITLE OF THE INVENTION:
THE MOUTH (ORAL) REFRESHER / FRESHENERS COMPOSITION
2. APPLICANT (S):
Name Nationality Address
32-B, ANITA, Mount Pleasant Dr. Harshad Sanghrajka Indian Road, Mumbai 400 006, Maharashtra, India
Name Nationality Address
32-B, ANITA, Mount Pleasant Mrs. Shilpi Jay Mehta Indian Road, Mumbai 400 006, Maharashtra, India
Name Nationality Address
32-B, ANITA, Mount Pleasant Ms. Payal Sanghrajka Indian Road, Mumbai 400 006, Maharashtra, India
3. PREAMBLE TO THE DESCRIPTION:
THE FOLLOWING COMPLETE SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED

Title: The Mouth Refresher Composition Field of Invention
The present invention relates to safe herbal composition to be used as an alternative of PAN MASALA and GUTKHA, described hereinafter as "Mouth Re-freshener" or "Mouth Freshener". The composition comprising of - (A) Detoxified/Processed Afeca nuts, (B) Powder Coating Compound (CCP) selected from a group comprising Maize starch, Potato starch, Fumed Colloidal Silica (Silicon dioxide), Manitol, Sorbitol, Maltodextrin, Microcrystalline cellulose, Jingseng, CoEnzyme-QlO (Anti-Oxidant) Camphor, Menthol, Guar gum, Agar Agar, Xanthium gum, etc., (C) Liquid Coating Compound (CCL) selected from a group comprising Rice bran oil, Olive oil, Castor oil, Sweet Almond oil Diacetin, Glycerin, Organic/non-organic Spices, Food colors Essential oils and Flavoring agents.
The invention particularly provides safe alternatives to the banned, carcinogenic and harmful ingredients used in traditional mouth fresheners.
The invention further relates to a safe herbal ingredient based mouth refresher and the process of preparation thereof. Freshener
Background:
Oral cancer has been traditionally described as a critical & major form of cancer in India, although on the basis of cancer registry data it was thought that the incidence has decreased. There are several recent reports in the literature, however, predicting an increased oral cancer incidences in India. This prediction is based upon observation of an increased prevalence of oral submucous fibrosis, especially in younger individuals, caused by gutkha / pan masala, an industrially manufactured food item. A comparison of the age

distribution of recently reported oral sub-mucous fibrosis cases and incident cases reported in the past clearly establishes that the disease is now occurring at much younger ages.
In addition to a major life threatening disease mouth-cancer caused by oral use of any tobacco product, i.e. gutkha causes another serious disease: oral sub mucous fibrosis (OSF). In this disease, fibrous bands develop in the mouth, mucosae lose their elasticity, and the ability to open the mouth reduces progressively. The most serious aspect of the disease is that it has a very high potential for cancer development the relative risk is almost 400 times that of a non-user.
There have been some attempts to curb and regulate gutkha promotion and use. In one such attempt, public interest litigation to ban the substance/s was filed in a state High Court. The High Court's judgment directed the central government to find out whether gutkha was a dangerous product. The Central Committee on Food Standards duly conducted hearings and investigations and concluded that it was a dangerous food product. The committee recommended an outright ban.
The pan masala & pan masala mixed with tobacco or nicotine popularly called Gutkha are widely consumed orally in India and South East Asia. A typical pan masala consist of betel nuts which are coated with a blend of lime, Catechu (Katha), magnesium carbonate and light liquid paraffin (LLP). Menthol, Cardamom, Nutmeg, clove and other spices known to the industry are mixed with to give mouth re-freshening feeling. These are packed in small sachets and are sold widely in India. The consumption of pan masala and gutkha (betel quid/nut with tobacco) is considered most harmful to health. Therefore consumption of pan masala with and without tobacco is being discouraged on health grounds which are considered to be harmful by "World Health Organization" (WHO). The tobacco is a well-known and well established agent responsible for oral cancer and the use of gutkha is

correlated with increasing oral cancer in India and worldwide. The magnesium carbonate in pan masala is correlated with hyper magnesia and is also correlated with promoting cancer. The presence of magnesium, arsenic and lead in pan masala is a big risk to human health. The LLP is carcinogenic too and not permitted in food items and as per the Supreme Court of India and FOOD CODEX, pan masala and gutkha are covered under food category.
Commercially available pan masala or gutkha is prepared using betel nuts
with 3 to 5% of Katha, 2-2.5% slaked lime and 8-10% magnesium
carbonate along with spices like cardamom, clove, etc., flavouring agents.
The coating of the dry mixture of Katha, lime and magnesium carbonate and other
ingredient is produced using 6-9% light liquid paraffin (LLP) (petroleum).
The material is packed in the range of 1.7 to 2 g in plastic pouches (currently banned) & is ready for oral human consumption with toxic magnesium carbonate and LLP.
Position Paper on Pan Masala / Guthka Alternatives
Definitions: Pan Masala is a blend of areca catechu, catechu, lime, flavouring agents. Guthka is a combination of tobacco with the above.
Spread Of Usage: Across Asia and Asian immigrants in Europe and Americas across all societal classes.
Reasons For Consumption: Stimulant, Euphoric, Appetite suppressant, Heightened concentration, Increased energy, Sedation, Fresh breath etc.
Estimated Users: 60 crores.
Estimated Potential: 900 crore sachets per annum.

Estimated Incidence of Fibrosis: 33 CR.
Estimated Incidence of Cancer: 3.4 CR.
Medical Consequence: Leukopia, Oral sub-mucous fibroses, Dysplasia, Oral quamous cell carcinoma, esophagus carcinoma, Scleroderma, Tachycardia, Arrhythmia, Cardia vascular disorders, Diabetes.
Ingredients Involved: Areca Catechu, Catechu, Calcium Hydroxide, Nicotine, Heavy
metals.
Chemicals Involved: Alkaloids, Catechins, Calcium Hydroxide, Heavy Metals.
Mechanism of Action: The alkaloids are cholinergic agonists and affect the central nervous system functions via acetyl choline release and act as stimulants. Some alkaloids interact with muscarinic receptors and cause excess salivation. Some alkaloids combine with n-nitroso compounds in vivo and cause cytogenic damage. Up regulation of heavy metal dependant extracellular enzyme lysyl oxidase by fibroblasts result in oral sub-mucous fibrosis by causing excessive cross linking and accumulation of collagen thereby causing tumour formation. Collectively they are cytotoxic, genotoxic, mutagenic and teratogenic. Calcium hydroxide enhances the bioavailability of the Alkaloids and their transfer to the blood stream there by heightening the psychoactive effects.
The Solution: There is a tremendous potential for a clinically safe alternative to the above that can provide the stimulant effect without the carcinogenicity. For this the areca catechu has to be detoxified and some ingredients like lime, catechu, heavy metals are eliminated and replaced by safer alternatives without affecting the organoleptic properties. There are natural ingredients which can negate the reactive oxygen species formation potential of the ingredients as well as activate acetyl choline release without carcinogenic side effects to

reinforce the stimulant activity, the main reason for usage of pan masala/guthka.
Methodology: This would involve the following activities;
1 Desk Research: To identify the harmful ingredients.
2 Method Development: To isolate, characterize such ingredients and devise analytical methods for their identification and quantification. To create working standards for future analysis.
3 Protocol Development: For detoxification of ingredients, identifying safe alternatives, making a Formulation and getting it tested for absence of cytotoxicity, genotoxicity, mutagenecity and teratogenecity.
4 Clinical Testing: Getting the product tested In-Vitro on cell lines, then In-Vivo on animals and finally on human volunteers as per WHO protocols.
5 FDA And Patent Filing: Based on the generated evidence we would need to file for a FDA registration of HERBAL PAN MASALA/GUTHKA and patent.
Objects of the invention:
Pan masala and Gutkha being the products of human consumption and the use of magnesium carbonate and light liquid petroleum in food items are not permitted. An important object of the present invention is to avoid use of and to provide safe alternatives to the banned, carcinogenic and harmful ingredients used in traditional mouth fresheners.
Another object of the invention is to provide a safe pan masala and gutkha alternative with DETOXIFIED areca nut and other food additives and to

prohibit the use of Catechu (Kattha), Lime, Magnesium Carbonate (MgCo3) and light liquid (petroleum) paraffin (LLP) in a pan masala and gutkha mix but still provide the identical effects and feel of chewing a pan masala with refreshing and euphoric properties.
Further object of the invention is to formulate the mouth Refresher composition with naturally occurring plant products that are Generally Recognized as Safe (GRAS) and are permitted under food safety and safe for human consumption.
Summary of the Invention:
The present invention is directed to a mouth refresher composition and the process of preparing thereof, containing (A) processed areca nuts, (B) powder coating compound (CCP), (C) liquid coating compound (CCL) and optionally flavouring, menthol and spices, thus completely avoiding use of any kind of ingredients that may be harmful for human consumption.
The invention relates to a mouth Refresher composition comprising 75 to 80% by wt. Areca nuts, 0.5 to 1.5% by wt. liquid coating compound (CCL), 03 to 10% by wt. Starch, 2.0 to 6% by wt. Guar gum, 2.0 to 6% by wt. Manitol, 2.0-3.0% by wt. Maltodextrin and optionally 0.5 to 2% by wt sorbitol, micro crystalline cellulose, spices and flavouring agent.
Powder Coating Compound (CCP) is selected from a group comprising Maize starch, Potato starch, Fumed Colloidal Silica (Silicon dioxide), Manitol, Sorbitol, Maltodextrin, Microcrystalline cellulose, JINGSENG, CoEnzyme-QlO (Anti-Oxidant) Camphor, Menthol, Guar gum, Agar Agar, Xanthium gum, etc., whereas Liquid Coating Compound (CCL) is selected from a group comprising Rice bran oil, Olive oil, Castor oil, Sweet Almond oil Diacetin, Glycerine, Organic/non-organic Spices, Food colours Essential oils and Flavouring agents.

Description of the Invention:
The present invention relates to a safe ingredient based mouth Refresher and the process of preparing thereof.
Pan masala and Gutkha are the products of human consumption and contain magnesium carbonate and light liquid petroleum which are not permitted in food items. Magnesium carbonate consumed in certain forms and quantities is considered harmful for human health. It is therefore, an objective of the present invention to develop a safe pan masala and gutkha alternative with DETOXIFIED areca nut and other food additives. The embodiment of the present invention includes only permitted food and chemicals that are "Generally Recognized as Safe" (GRAS). The Necessary permissions - FDA and FSSAI - have been obtained for manufacturing and marketing such safe products.
In order to confer a slow and sustained presence of mouth refresher, it is
necessary that gums should be included which bind the entire component
together and make it slow release. The carbohydrate polymers such as starch and
cellulose block the release of spices from the betel nuts. The mouth cavity must
have a cool feel during and after the process of chewing and it should have a thirst
neutralizing effect.

The use of magnesium carbonate as an anti-caking agent is totally avoided in the present invention. In the present invention herbal compositions are used for coating betel nuts instead of banned magnesium carbonate in coating betel nuts to make pan masala and Gutkha.
In the process of the present invention, a blend of oils extracted from spices, known to the industry and flavouring agents are imbibed onto betel nut followed by covering it with CCL. This provides freshening effect as well cooling sensation

to mouth cavity. The flavouring material can be of wide range and by way of example; it may be a mint flavour such as peppermint, oil. Also usable are fruit flavours or other flavouring such as vanillin, menthol, eucalyptus oil or combinations of flavourings. The flavours are used in the range of 0.5 to 1%.
Manitol, another ingredient of the present composition, an anti stimulator in blood glucose, is used as a sweetener. It also has a low glycemic index, making it a low carbohydrate. Manitol also has a very low hygroscopic property therefore it does not pick up moisture from the air until the humidity level is 98%. Thus it acts as an anti-caking agent. In the present invention manitol is used as an anti-caking agent in place of harmful magnesium carbonate. The pleasant taste and mouth feel of manitol also makes it a popular excipient for chewable tablets. In oral doses larger than 20 g, manitol acts as an osmotic laxative, and is sometimes sold as a laxative for children.
Sorbitol or glucitol, is a sugar alcohol that occurs naturally in fruits and berries. However, the content of sorbitol varies and some fruits have a higher content than others. Sorbitol is often used as an artificial sweetener in sugar-free candies, soft drinks and chewing gums. It has about one-third less calories than sucrose or common table sugar, making it a popular choice. Maltodextrin, a thickening agent, is a food additive approved by the U.S. Food and Drug Administration for its "Generally Recognized as Safe" (GRAS) list. The additive is mixed with a number of foods as a thickening agent, as an agent to create bulk in foods and a viscosity builder. Maltodextrin is used in food to create bulk in foods that have a liquid or gelatin-like texture. When added to foods such as salad dressings or instant pudding, maltodextrin helps to reduce their viscosity, making them thicker. Other foods that may contain maltodextrin for this purpose include canned fruits, desserts, protein shakes, instant pudding and sauces. The use of maltodextrin in the present invention makes the composition thick and is safe for use for longer time. Because Maltodextrin is derived from real foods, it does contain calories however vary low about 4

calories per gram.
Starch is a carbohydrate consisting of a large number of glucose units joined by glycosidic bonds. This polysaccharide is produced by all green plants as an energy store. Starch is the most common carbohydrate in the human diet and is contained in many staple foods. The major sources of starch intake worldwide are the cereals (rice, wheat, and maize) and the root vegetables (potatoes and cassava). Many other starchy foods are grown, some only in specific climates, including acorns, arrowroot, arracacha, bananas, barley, breadfruit, buckwheat, canna, colacasia, katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potatoes, rye, taro, chestnuts, water chestnuts and yams, and many kinds of beans, such as favas, lentils, mung beans, peas, and chickpeas. Pure starch is a white, tasteless and odourless powder that is insoluble in cold water or alcohol. It consists of two types of molecules: the linear and helical amylose and the branched amylopectin. As an additive for food processing, food starches are typically used as thickeners and stabilizers in foods such as puddings, custards, soups, sauces, gravies, pie fillings, and salad dressings, and to make noodles and pastas. Mean intake of dietary microcrystalline cellulose in the USA has been estimated to range from 2.7 g/person per day (children 2 years of age) to 5.1 g/person per day (young adult males). For heavy consumer intake of microcrystalline cellulose (90th percentile) the values are 5.4 to 10.2 g/person per day for the same age groups. The mean intake of dietary microcrystalline cellulose in the United Kingdom has been estimated as 0.65 g/person per day. The highest mean intake, 0.90 gm / person per day, was for children aged 10-11 (the youngest group for which data were available). For heavy consumer intake of microcrystalline cellulose (90th percentile) the values ranged from 1.13 gm/person per day for adults age 16-24 to 1.83 gm/ person per day for males age 10-11.
The present invention is hereinafter described with the help of various

examples. The base of present mouth freshener composition is betel nut. The pre-perfumed betel nut is then coated with a mixture of powder as described in the following examples.
EXAMPLE I
In one of the embodiment of the present invention, betel nuts were imbibed with a blend of spices and permitted flavours and olive oil and glycerine. A dry powder whose composition is given in Table I was added 12% (w/w) over the betel nuts and mixed.
TABLE I: Ingredient of coating dry powder in gm per cent

Ingredients Weight (gm per cent)
Starch 30.0%
Guar Gum 15.0%
Sorbitol 03.0%
Mannitol 06.0%
Matodextrin 03.0%
Colloidal Silica 30.0%
Xanthum gum 03.0%
EXAMPLE II
In another embodiment of the present invention, betel nuts were imbibed with a blend of spices and permitted flavours and olive oil and glycerin. A dry powder whose composition is given in Table II was added 12% (w/w) over the betel nuts and mixed.

TABLE II: Ingredient of coating dry powder in gm per cent

Ingredients Weight (gm per cent)
Starch 30.0%
Guar Gum 30.0%
Sorbitol 10.0%
Matodextrin 10.0%
Cellulose 10.0% (microcrystalline cellulose)
Colloidal Silica 10.0%
EXAMPLE III
In yet another embodiment of the present invention, betel nuts were imbibed with a blend of spices and permitted flavours and olive oil and glycerin. A dry powder whose composition is given in Table III was added 14% (w/w) over the betel nuts and mixed.
TABLE III: Ingredient of coating dry powder in gm per cent

Ingredients Weight (gm per cent)
Starch 40.0%
Guar Gum 20.0%

Sorbitol 10.0%
Matodextrin 10.0%
Colloidal Silica 20.0%
EXAMPLE IV
In yet another embodiment of the present invention, betel nuts were imbibed with a blend of spices and permitted flavours and olive oil and glycerin. A dry powder of the composition given in Table IV was added 14% (w/w) over the betel nuts previously imbibed with spice blends, olive oil and glycerin and mixed. The composition of Mouth Re-freshener was as given in Table IV.
TABLE IV: Composition of Mouth Re-freshener and its Ingredient in gm per cent

Ingredients Weight (gin per cent)
Betel nuts 80.00%
Starch 04.0%
Guar Gum 02.0%
Sorbitol 01.0%
Manitol 01.0%
Matodextrin 02.0%
CCL 09.0%

WE CLAIM:
1. The mouth Refresher composition comprising:
- 75 to 80% by wt. Areca nuts,
- 0.5 to 1.5% by wt. Vegetable oils,
- 0.5 to 1.5% by wt. Glycerin,
- 03 to 10% by wt. Starch,
- 2.0 to 6% by wt. Guar gum,
- 2.0 to 6% by wt. Manitol
- 2.0-3.0% by wt. Maltodextrin
- Optionally 0.5 to 2% by wt sorbitol, Micro crystalline cellulose, spices and flavouring agent.

2. The composition as claimed in claim 1, wherein Areca nut (supari) is in the range of 80 to 87% by weight.
3. The composition as claimed in claim 1, wherein starch is in the range of 2% to 5 % by weight.
4. The composition as claimed in claim 1, wherein manitol is in the range of 0.5 to 1% by weight.
5. The composition as claimed in claim 1, wherein sorbitol and microcrystalline
cellulose are in the range of 0.5 to 1% by weight.
6. The composition as claimed in claim 1, wherein guar gum is in the range of 0.5% to 3% by weight.
7. The composition as claimed in claim 1, wherein maltodextrin is in the range of 0.5% to 1% by weight.

8. The composition as claimed in claim 1, wherein olive oil is in the range of 0.5% to 1% by weight.
9. The composition as claimed in claim 1, wherein glycerin is in the range of 0.5 to 1% by weight.
10. The process of preparing the said mouth Refresher composition
comprising steps of:
- activating the areca nut by blending with the mixture of olive oil, glycerol and spices;
- mixing starch, manitol, guar gum, sorbitol, maltodextrin, and flavoring agent to obtain a powdered mixture;
- adding the predetermined amount of activated areca nut to the said powdered mixture and blending the entire mixture so as to obtain the granules of the mouth freshener composition.