Claims:We claim:

1. An effervescent tablet of terminalia chebula for mouthwash comprises citric acid in the range of 40-50 %w/w, sodium bicarbonate in the range of 20-30 %w/w, potassium carbonate in the range of 5-10 %w/w, maltodextrin in the range of 5-10 %w/w, sodium sulfate in the range of 5-10 %w/w, simethicone in the range of 0.1-0.5 %w/w, tween 80 in the range of 0.01-0.05 %w/w, iso propyl alcohol in the range of 1.0x10-6-9.0x10-6 %w/w, purified water in the range of 1.0x10-7-2.0x10-7 %w/w, terminalia chebula in the range of 0.5-3.5 %w/w, sodium benzoate in the range of 2.5-4.5 %w/w, indigo carmine in the range of 0.005-0.015 %w/w, lake indigo carmine in the range of 0.02-0.08 %w/w, sucralose in the range of 0.1-0.5 %w/w and peppermint flavor in the range of 1-5 %w/w and pharmaceutically acceptable excipients to form a mouthwash.

2. The effervescent tablet of terminalia chebula for mouthwash as claimed in claim 1, wherein the acidic source may be selected from group consisting of citric acid, tartaric acid, fumaric acid, adipic acid, maleic acid, sodium acid phosphate, ascorbic acid, acetyl salicylic acid, acid anhydrides, sodium dihydrogen citrate, disodium hydrogen citrate and salts of organic acids.

3. The effervescent tablet of terminalia chebula for mouthwash as claimed in claim 1, wherein the alkali components are selected from group consisting of potassium carbonate, potassium bicarbonate, arginine carbonate, sodium bicarbonate, sodium carbonate, sodium glycine carbonate, effersoda, L-lysine carbonate, calcium carbonate and sodium sesqui carbonate.

4. The effervescent tablet of terminalia chebula for mouthwash as claimed in claim 1, wherein the surfactant is selected from group consisting of sodium lauryl sulfate, magnesium lauryl sulfate, tween 80, tween 20, poloxamer 407 or pluronic F 127, poly ethylene glycol 1000, docusate sodium and sodium cyclamate.

5. The effervescent tablet of terminalia chebula for mouthwash as claimed
in claim 1, wherein the antifoaming agent is selected from group
consisting of polydimethyl siloxane, simethicone, simethicone-emulsion,
silicone oil emulsion and dimethicone emulsion.

6. The effervescent tablet of terminalia chebula for mouthwash as claimed
in claim 1, wherein polysaccharide is selected from group
consisting of maltodextrin, starch, dextrin, cellulose, hemicellulose,
polydextrose, pectin, acacia gum, chitosan.

7. The effervescent tablet of terminalia chebula for mouthwash as claimed
in claim 1, wherein inorganic component is selected from group
consisting of sodium sulfate, sodium chloride and sodium hydroxide.

8. The effervescent tablet of terminalia chebula for mouthwash as claimed
in claim 1, wherein solvent is selected from group consisting of Iso propyl
alcohol, purified water, ethanol, toluene, acetone and milk.

9. The effervescent tablet of terminalia chebula for mouthwash as claimed
in claim 1, wherein food preservative is selected from group
consisting of sodium stearate, methyl paraben, propyl paraben and ethyl
paraben.

10. The effervescent tablet of terminalia chebula for mouthwash as claimed
in claim 1, wherein artificial sweetner is selected from group
consisting of sucralose, acesulfame, sodium cyclamate and neotame.
Dated this 2nd day of July 2019
, Description:
FORM 2
THE PATENTS ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)

1. TITLE OF THE INVENTION:
“AN EFFERVESCENT TABLET OF TERMINALIA CHEBULA FOR MOUTHWASH”
2. APPLICANT:

1. (A) AVANCE PHYTOTHERAPIES PVT. LTD.
(B) Indian
(C) 33-34, 3rd Floor, The Chambers Building,
S.G. Highway, Ahmedabad-380 054

3. PREMABLE TO THE DESCRIPTION:
PROVISIONAL
SPECIFICATION
(See section 10 and rule 13)
The following specification describes the invention.
? COMPLETE
SPECIFICATION
The following specification particularly describes the invention and the manner in which it is to be performed.

FIELD OF INVENTION
The present invention relates to an effervescent tablet of terminalia chebula formulated as a mouthwash for the treatment of dental plaques, gingivitis, germs, cavities, mouth ulcers, bad breath and dental caries. More particularly, the present invention relates to a mouthwash obtained from an effervescent tablet having a main ingredient terminalia chebula combined with certain other pharmaceutical excipients. The disintegration time (effervescent time) for a single tablet in 200 ml of water is not more than 5 minutes.

BACKGROUND OF THE INVENTION
At present, it is well known that all mouthwashes are liquid and there are many inconveniences such as inconvenient carrying, inability to board the aircraft and easy leakage. It is been found that it is difficult for a traveler such as a tourist or a camper to carry liquid mouthwash with him because of weight, fragility or bulk. The shelf space is a problem at the retail outlet or even at the home and so the provision of a number of tablets is easily preferable to a pint of liquid or the bulky sizes greater than the pint.
In real life, people are paying more and more attention towards oral health care. Brushing their teeth after a meal has become a habit of many people. It is just that the mouthwash is not portable, and it is difficult to truly remove the oral bacteria within three minutes after a meal.
The sugar and xylitol of the chewing gum are harmful to the human body and are not beneficial, and chewing for a long time will cause the facial muscles to become bigger and affect the appearance. The use of mouthwashes in liquid form is well known and popular. However, for many years, the appropriation of a mouthwash from a dry powder had an appeal because it is freshly made instead of having been contained in a bottle for a long period of time. The application of this principle to an effervescent formula has surprisingly attracted little attention, although offering advantages of freshness, taste and effectiveness as will be set forth hereinafter.
In the present market several liquids relating to the mouthwash are available but the marketed formulations lack the effective cleaning in context to the growth of several microbes in the mouth. Moreover, the marketed formulations are sold in liquid form as a finished product whereas the present invention provides an effervescent tablet of terminalia chebula for mouthwash. On the other hand, the prepared sample of terminalia chebula mouthwash provides efficient results in context with the maintenance of salivary pH, buffering capacity and also reduces the oral microbial counts.
A tablet being formulated from powder is not subject to atmospheric changes or temperature changes and would be convenient for use by the airlines or on a ship. The tablet would be useful even where the quality of drinking water is a problem since the formula can be modified to include a water purification chemical.
Effervescent tablets for producing cleaning compositions have been formulated in the past. Oral mucositis is a complex biological process involving direct damage to the dividing cell of the oral epithelium with depletion of the basal epithelium modulated by the immune system, the inflammatory process and by super added infection by the oral bacterial flora, especially the aerobic gram negative bacteria. Oral bacteria colonize in the denuded connective tissues and their cell wall components activate macrophages to produce additional inflammatory cytokines in patients undergoing radiotherapy for Head and Neck cancers and this is the dose limiting toxicity and patients may discontinue treatment due to this. Considerable variation exists in the management of oral mucositis.

Maintaining good oral hygiene and frequently rinsing the mouth with saline and sodium bicarbonate solution is generally recommended. Following the onset of oral mucositis, the management is mainly supportive; consisting of alleviation of pain, control of secondary infection and maintaining adequate hydration and nutrition.
One such document for determination of an effervescent tablet formulated as a mouthwash has been disclosed in patent document US 3,772,431 that discloses an effervescent mouthwash tablet comprising effervescent properties combined with the astringent and desensitizing agents. The invention relates to an effervescent couple consisting of at least one each of a solid pharmaceutically acceptable acid and a solid pharmaceutically acceptable base material, wherein effervescent couple reacts to produce carbon dioxide when dissolved in water causing effervescence and an effective amount of strontium chloride, zinc chloride and mixtures thereof as an astringent-desensitizing agent. The product formed therein the reaction when dissolved in water having a pH of about 5. The problem associated in the prepared composition involves difficulties in terms of solubility in presence of carbonate and bicarbonate salts. The resulting precipitation would be undesirable due to insoluble precipitate formed during the reaction which would be objectionable in visual appearance of the prepared product and does not determine the incorporation of terminalia chebula as an ingredient in the preparation of mouthwash.
Another such document for determination of an effervescent tablet formulated as a mouthwash has been disclosed in patent document CN105982821 that determines the preparation of an herbal solid mouthwash effervescent tablet and preparation method thereof. The invention relates to incorporation of several herbal ingredients along with the acid component and an alkali component. The herbal powder involves the incorporation of mint, honeysuckle, tea tree oil, chamomile, lavender, aloe vera, witch hazel, washed, dried and crushed and further the extract was prepared and is formulated in the form of a tablet. The problem associated in the prepared composition is that the care should be taken for incorporating exact measurements of the powders of the herbal extracts used therein which further involves a constant monitoring of the formulation prepared thereunder leading to a clumsy, time consuming and a complex procedure for manufacturing of the stated composition and does not determine the usage of terminalia chebula in the preparation of mouthwash.
Hence, to overcome the above mentioned problems it is desperately needed to invent an effective and an efficient effervescent tablet pertaining to mouthwash with the incorporation of terminalia chebula as the main ingredient which is not subjected to above mentioned problems so that the finally obtained effervescent tablet of terminalia chebula for mouthwash has desired properties pertaining to oral care and which is more effective, efficient, user friendly, economical and efficacious as when compared to prior art.

OBJECT OF THE INVENTION
The principle object of the present invention is to provide an effervescent tablet of terminalia chebula for mouthwash.
Further, object of the present invention is to provide an effervescent tablet of terminalia chebula which is been formulated as a mouthwash and is easily sold over the counter.
Another object of the present invention is to provide an effervescent tablet for mouthwash with improved and convenient treatment of dental plaques, gingivitis, germs, cavities, mouth ulcers, bad breath and dental caries.

Another object of the present invention is to provide an effervescent tablet for mouthwash provides a better significance in the salivary pH, buffering capacity and reduction in the microbial counts.
Another object of the present invention is to provide an effervescent tablet for mouthwash which is user friendly, economical and more importantly easy to administer by the patient.
Yet another object of the present invention is to provide an effervescent tablet for mouthwash with disintegration time (effervescent time) of a single tablet in 200 ml of water is not more than 5 minutes.
Still another object of the present invention is to provide an effervescent tablet for mouthwash with the moisture content not more than 0.15% w/w.

SUMMARY OF THE INVENTION
The present invention relates to an effervescent tablet of terminalia chebula for mouthwash. More particularly, it relates to a mouthwash prepared from a effervescent tablet of terminalia chebula which provides an improved and convenient treatment in dental plaques, gingivitis, germs, cavities, mouth ulcers, bad breath and dental caries. The present invention involves a series of steps being followed over to result in the formation of an effervescent tablet of terminalia chebula which is been formulated as a mouthwash therein. The effervescent tablet of terminalia chebula is buff in color, round in shape, having plain and flat faced beveled edge with peppermint odor. The prepared effervescent tablet for mouthwash is formulated from terminalia chebula and may sold over the counter. The disintegration time (effervescent time) of a single terminalia chebula effervescent tablet in 200 ml of water is not more than 5 minutes. An effervescent tablet of terminalia chebula for mouthwash provides a better significance in the salivary pH, buffering capacity and reduction in the microbial counts.

DETAILED DESCRIPTION
Before explaining the present invention in detail, it is to be understood that the invention is not limited in its application to the details. The invention is capable of other embodiment and of being practiced or carried out in a variety of ways. It is to be understood that the phraseology and terminology employed herein is for the purpose of description and not of limitation.
Terminalia Chebula is commonly known as black or chebulic myrobalan which is a species of Terminalia, which is a native to South Asia from India and Nepal east to southwest China and south to Sri Lanka, Malaysia and Vietnam. The Termianalia Chebula is a fruit of a series of Terminalia species. The Terminalia Chebula species has a dull white to yellow flowers which are monoecious and have a strong, unpleasant odor. The fruits are smooth ellipsoid to ovoid drupes, yellow to orange-brown in color with single angled stone.
It is to be understood that the effervescent tablet involving main ingredient as terminalia chebula which is combined with certain other pharmaceutically acceptable excipients. The effervescent tablet is been formulated as a mouthwash providing the effective results in consideration to treat the dental problems. Besides being a natural standardized extract from an Indian native plant it has shown efficacy as an antimicrobial agent, which has ability to reduce plaque, anticaries, anti gingivitis and mouth ulcers.
The terminalia chebula effervescent tablet being formulated as a mouthwash has a strong anti oxidant property which contains highest amount of tannins and polyphenols compared to any other extract available in the market (more than 90% polyphenols) which shows efficacy equivalent to chlorhexidine formulated mouhwash. The prepared terminalia chebula effervescent tablet formulated as a mouthwash is effective over all microbes present in the oral cavity.
Acidic source of the present invention is selected but not limited to citric acid, tartaric acid, fumaric acid, adipic acid, maleic acid, sodium acid phosphate, ascorbic acid, acetyl salicylic acid, acid anhydrides, sodium dihydrogen citrate, disodium hydrogen citrate and salts of organic acids are used as an organic acid. More preferably citric acid is used as an acidic source.
Alkali components of the present invention is selected but not limited to potassium carbonate, potassium bicarbonate, arginine carbonate, sodium bicarbonate, sodium carbonate, sodium glycine carbonate, effersoda, L-lysine carbonate, calcium carbonate and sodium sesqui carbonate. More preferably sodium bicarbonate is used as an alkali component.
Polysaccharides of the present invention is selected but not limited to maltodextrin, starch, dextrin, cellulose, hemicellulose, polydextrose, pectin, acacia gum, chitosan.
Inorganic components of the present invention is selected but not limited to sodium sulfate, sodium chloride and sodium hydroxide.
Surfactants of the present invention is selected but not limited to sodium lauryl sulfate, magnesium lauryl sulfate, tween 80, tween 20, poloxamer 407 or pluronic F 127, poly ethylene glycol 1000, docusate sodium and sodium cyclamate. More preferably tween 80 is used as a surfactant.
Antifoaming agents of the present invention is selected but not limited to polydimethyl siloxane, simethicone, simethicone-emulsion, silicone oil emulsion and dimethicone emulsion. More preferably simethicone is used as an antifoaming agent.

Solvents of the present invention is selected but not limited to Iso propyl alcohol, purified water, ethanol, toluene, acetone and milk.
Food preservatives of the present invention is selected but not limited to sodium stearate, methyl paraben, propyl paraben and ethyl paraben.
Artificial sweetners of the present invention is selected but not limited to sucralose, acesulfame, sodium cyclamate and neotame.
The present invention contains a coloring agent. Any water soluble or insoluble coloring agent is used in pharmaceuticals which are approved by the FDA. More preferably indigo carmine and lake indigo carmine is used as a coloring agent.
The present invention contains a flavoring agent. More preferably peppermint flavor is used as a flavoring agent. Any flavoring agent used in pharmaceuticals which are approved by FDA.
It should be appreciated that there is considerable overlap between the above-listed additives in common usage, since a given additive is often classified differently by different practitioners in the field, or is commonly used for any of several different functions. Thus, the above-listed additives should be taken as merely exemplary, and not limiting, of the types of additives that can be included in composition of the present invention. One or more of these additives can be selected and used by the skilled artisan having regard to the particular desired properties of the dosage form by routine experimentation without any undue burden.
The present invention provides a terminalia chebula effervescent tablet formulated as a mouthwash which comprises following stages and steps:
Stage I: Dispensing
Before starting the operation ensure that all manufacturing and primary packing area has a temperature less than 25°C and humidity less than 25%. Record the temperature and humidity at each stage of manufacturing area at specified time.
The present invention includes a composition of a terminalia chebula effervescent tablet which comprises 40-50 %w/w citric acid, 20-30 %w/w sodium bicarbonate, 5-10 %w/w potassium carbonate, 5-10 %w/w maltodextrin, 5-10 %w/w sodium sulfate, 0.1-0.5 %w/w simethicone, 0.01-0.05 %w/w tween 80, 1.0x10-6-9.0x10-6 %w/w iso propyl alcohol, 1.0x10-7-2.0x10-7 %w/w purified water, 0.5-3.5 %w/w terminalia chebula, 2.5-4.5 %w/w sodium benzoate, 0.005-0.015 %w/w indigo carmine, 0.02-0.08 %w/w lake indigo carmine, 0.1-0.5 %w/w sucralose and 1-5 % w/w peppermint flavor.
(i) Accurately dispense the raw materials through a stainless steel scoop and weigh them through a weighing balance accurately.
Stage II: Sizing and Binder preparation
(A) Sizing
(ii) Transfer the dispensed materials from the staging area to the sifting area through vibratory shifters after verification.
(iii) Sift all the dispensed materials through the respective sieve sizes (#) of 30, 60 or with a lint free cloth respectively as mentioned in table 2 through a multimill.
(iv) Keep the dispensed materials tightly closed in polythene bags.
(B) Binder preparation
(v) Binder solution 1: Mix 1.4x10-7 %w/w purified water and 2.5x10-6 %w/w isopropyl alcohol
(vi) Binder solution 2: Dissolve simethicone and tween 80 in 2.6x10-5 %w/w isopropyl alcohol

Stage III: Granulation
(vii) Accurately weigh citric acid anhydrous, sodium bicarbonate, potassium carbonate, maltodextrin, sodium sulfate, simethicone and transfer the weighed materials into a rapid mixture granulator. Mix all the raw materials for 15 minutes at a slow speed.
(viii) Add necessary quantity of binder solution 1 at slow speed for proper granulation and with a slow speed of rapid mixture granulator.
(ix) Prepared granules are checked visually. If granulation is achieved stop adding binder solution 1 and mix materials for 5 minutes at high speed.
(x) Add necessary quantity of binder solution 2 at slow speed for proper granulation and to attain proper granulation the rapid mixture granulator is allowed to rotate at the slow speed.
(xi) Continue the mixing for further 10 minutes at slow speed and start the chopper during slow speed of rapid mixture granulator if necessary.
(xii) Visually check the end point of granulation process and unload the wet mass into the tray and start drying.
Stage IV: Drying of granules
(xiii) Dry the prepared granules at temperature 60°C with intermediate racking if required. Intermediately check the Loss Of Drying and if required continue drying till Loss Of Drying is achieved below 0.2% w/w.
Stage V: Sizing of dried granules
(xiv) Pass the dried granules through 24 mesh (#) stainless steel sieve. Collect the sized granules in a polythene bag and label it appropriately and check the weight properly.

Stage VI: Lubrication and final blending
(xv) Load the above sifted dried granules, terminalia chebula, sodium benzoate, indigo carmine, lake indigo carmine color, sucralose and peppermint flavor into a blender. Properly mix the materials for 30 minutes and check the weight and Loss Of Drying of the lubricated granules.
Stage VII: Compression of tablet
(xvi) Transfer the lubricated granules to the required punch set from the punch storage room to the compression crucible. Physically verify the lower and upper punches for avoidance of any damages. If any punch is damaged then stop the operation and affix it before starting the compression process.
(xvii) Transfer the prepared blend from the store area to the compression area. Load the prepared powder into the hopper.
(xviii) Set the compression machine and adjust the tablet parameters and record the readings. Put a fresh container under the discharge of each metal detector with a plastic bag and with an appropriate label affixed on it. Check and record the physical parameters of initial checks. After setting up of compression parameters, run the compression machine.
Stage VIII: Drying of tablet
(xix) Prepared compressed tablets have been dried removing the water content in a control condition (Relative Humidity: NMT 25% and Temperature: 25°C). The compressed tablets are dried till moisture content is not more than 0.15%w/w.

The invention is illustrated more in detail in the following example. The example describes and demonstrates embodiment within the scope of the present invention. This example is given solely for the purpose of illustration and is not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope.

Example 1:
One accomplishment of the present invention may be illustrated by preparation of a terminalia chebula effervescent tablet and its preferred excipients ratios and sieve sizes are described in Table 1 and Table 2 below:
Composition of the terminalia chebula effervescent tablet
Table 1: Ingredients utilized in the termianlia chebula effervescent tablet
Sr. No. Ingredients Qty/tab (%w/w)
1. Citric acid anhydrous 44.4
2. Sodium bicarbonate 24.3
3. Potassium carbonate 7.4
4. Maltodextrin 7.4
5. Sodium Sulfate 7.4
6. Simethicone 0.3
7. Tween 80 0.03
8. Iso Propyl Alcohol 5.1x10-6
9. Purified Water 1.4x10-7
10. Terminalia chebula 1.8
11. Sodium Benzoate 3.7
12. Indigo Carmine 0.01
13. Lake Indigo Carmine 0.05
14. Sucralose 0.3
15. Peppermint Flavor 2.5

Table 2: Respective sieve sizes used to sift the ingredients
Sr. No. Ingredients Sieve size (#)
1. Citric acid anhydrous 30
2. Sodium bicarbonate 30
3. Potassium carbonate 30
4. Maltodextrin 30
5. Sodium Sulfate 30
6. Simethicone Lint free cloth
7. Tween 80 Lint free cloth
8. Iso Propyl Alcohol Lint free cloth
9. Purified Water Lint free cloth
10. Terminalia chebula 60
11. Sodium Benzoate 60
12. Indigo Carmine 60
13. Lake Indigo Carmine 60
14. Sucralose 60
15. Peppermint Flavor 60

A process for preparation of a terminalia chebula effervescent tablet comprises following stages and steps:
Stage I: Dispensing
(i) Freshly prepared 44.4 %w/w citric acid, 24.3 %w/w sodium bicarbonate, 7.4 %w/w potassium carbonate, 7.4 %w/w maltodextrin, 7.4 %w/w sodium sulfate, 0.3 %w/w simethicone, 0.03 %w/w tween 80, 5.1x10-6 %w/w iso propyl alcohol, 1.4x10-7 %w/w purified water, 1.8 %w/w terminalia chebula, 3.7 %w/w sodium benzoate, 0.01 %w/w indigo carmine, 0.05 %w/w lake indigo carmine, 0.3 %w/w sucralose and 2.5 %w/w peppermint flavor were dispensed through a stainless steel scoop and the dispensed materials were weighed through weighing balance.
Stage II: Sizing and Binder preparation
(A) Sizing
(ii) The above dispensed materials were transferred from the staging area to the sifting area after verification.
(iii) All the dispensed materials were sifted through the respective sieves through a multimill as mentioned in the above Table 2.
(iv) The dispensed materials were kept tightly closed in polythene bags.
(B) Binder preparation
(v) 1.4x10-7 %w/w purified water was mixed with 2.5x10-6 %w/w isopropyl alcohol termed as Binder solution 1.
(vi) 0.3 %w/w simethicone and 0.03 %w/w tween 80 were dissolved in 2.6x10-6 %w/w isopropyl alcohol termed as Binder solution 2.
Stage III: Granulation
(vii) Accurately weighed 44.4 %w/w citric acid, 24.3 %w/w sodium bicarbonate, 7.4 %w/w potassium carbonate, 7.4 %w/w maltodextrin, 7.4 %w/w sodium sulfate, 0.3 %w/w simethicone were transfered into a rapid mixture granulator and all the raw materials were mixed for 15 minutes at a slow speed.
(viii) The necessary quantity of binder solution 1 was added to achieve proper granulation and with the slow speed of rapid mixture granulator.
(ix) The prepared granules were visually checked and binder solution 1 was not added if the prepared granules were of appropriate size and shape and further the prepared granules were mixed for 5 minutes at high speed of rapid mixture granulator.
(x) Freshly prepared binder solution 2 was added at a slow speed for proper granulation and to achieve proper granulation the rapid mixture granulator was rotated at slow speed.
(xi) The prepared wet mass was mixed for 10 minutes more at slow speed and the chopper was started during the slow speed of rapid mixture granulator if necessary.
(xii) The end point of granulation process was visually checked and the wet mass was unloaded into the tray and drying was started.
Stage IV: Drying of granules
(xiii) The prepared granules were dried at temperature 60°C with intermediate racking if required. Intermediately Loss Of Drying was checked and the drying of the prepared granules was continued till the granules achieve Loss Of Drying below 0.2%w/w.
Stage V: Sizing of dried granules
(xiv) The above dried granules were passed through 24 mesh (#) stainless steel sieve. The sized granules were collected in a polythene bag and were properly labeled and the weight was checked properly.
Stage VI: Lubrication and final blending
(xv) The sifted granules were loaded alongwith 1.8 %w/w terminalia chebula, 3.7 %w/w sodium benzoate, 0.01 %w/w indigo carmine, 0.05 % w/w Lake indigo carmine color, 0.3 % w/w sucralose and 2.5 %w/w peppermint flavor into a blender. The loaded materials were properly mixed for 30 minutes and the weight was checked alongwith the Loss Of Drying of the lubricated granules.
Stage VII: Compression of tablet
(xvi) The lubricated granules were transferred to the required punch set from the punch storage room to the compression crucible. The lower and upper punches were verified physically for avoidance of any damages and if any punch was found to be damaged then the operation was stopped and the problem should be affixed before starting the compression process.
(xvii) The prepared blend was transferred from the store area to the compression area and the prepared powder was loaded into the hopper.
(xviii) The compression machine was set and the tablet parameters were adjusted and the readings were recorded. The fresh container was kept under the discharge of each metal detector with a plastic bag and an appropriate label was affixed on it. The physical parameters of initial checks were recorded and checked.
Stage VIII: Drying of tablet
(xix) Prepared compressed tablets were dried by removing the water content in a control condition (Relative Humidity: NMT 25% and Temperature: 25°C). The compressed tablets were dried till moisture content was not more than 0.15%w/w.

Evaluation study:
The final product was evaluated through various parameters. The final product i.e. terminalia chebula effervescent tablet formulated as a mouthwash was used as a sample and was evaluated through various parameters. An evaluation study was based on the available form of the standard marketed formulation of mouthwash which was compared to the prepared terminalia chebula effervescent tablet for mouthwash from the present claimed process. The parameters for evaluation study are as follows:

i) Description:
The visual examination of prepared sample of terminalia chebula effervescent tablet for mouthwash was done.
ii) Solubility:
The solubility of prepared sample of effervescent tablet of terminalia chebula for mouthwash was checked in water and other common solvent. The prepared sample of effervescent tablet of terminalia chebula for mouthwash was soluble in alcohol and practically insoluble in water.
iii) Determination of the baseline characteristics of the volunteers:
The conduction of the test of the prepared sample mouthwash involves selection of 34 volunteers in total upon whom the test of the prepared mouthwash was conducted which thereby involves following inclusion and exclusion criteria for the selection of the volunteers:
Inclusion criteria
1. Male and female patients were selected in the age group of 18-25 years,
2. Willing to participate by providing written informed consent which was approved by EC,
3. Patients with high caries-risk,
4. Good general health with 110 clinically significant and relevant abnormalities of medical history and/or major oral disease on oral/ dental examination (in the opinion of the investigator),
5. Patient with at least 12 gradable teeth,
6. Patient willing to delay elective dental treatment including oral prophylaxis for the duration of the study,
7. Patient's ability to understand and provide voluntary consent to participate in this clinical study through a signed consent form,
8. Patients who were willing to comply with the study-visits,
Exclusion criteria
1. History of systemic diseases
2. History of oral prophylaxis 6 months prior to the study
3. Known or suspected intolerance or hypersensitlvity to chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients,
4. Patients with mouth breathing habit,
5. Patient using orthodontic and prosthodontic appliances.

Table 3: Number of volunteers selected for study of the prepared sample mouthwash and the standard marketed formulation of mouthwash
Characteristics Prepared sample mouthwash Standard marketed formulation of mouthwash peak –value (p)
Age-(18-25) mean 15 19 0.08
Race (White, Asian, Black, Others) Asian Asian 0.01

After fulfilling of the above mentioned criterias the volunteers were selected to participate in the study of the prepared sample mouthwash and the standard marketed formulation of mouthwash.
(iv) Efficacious study of the prepared sample:
The study evolves pertaining to the several criterias which are to be tested relating to the objectives therein for the selected 34 volunteers which are as follows:
• Salivary pH
• Salivary buffer capacity
• Microbial count of saliva
There are primary objectives of the conducted study which are as follows:
• Change in the pH of saliva
• Change in the buffering capacity of saliva
• Change in the microbial count of saliva
There are secondary objectives of the conducted study which are as follows:
• Relative assesment of dysguesia
• Relative assesment of transient burning/stinging of mucous membrane secondary to use of the mouth rinse
The above mentioned inclusion and exclusion criteria are been followed on the initial stage and thereafter the screening is been conducted which involves parameters to be tested which are as follows:
1. Informed consent was obtained before initiating any study procedure.
2. Patient medical history was documented, including the use of concomitant medications. All patients underwent the screening procedure by inclusion and exclusion criteria.
3. Details with regard to Demography, physical examination were completed and relevant dates recorded.
4. Patient's saliva samples were collected for checking pH, buffer capacity and microbial count.
Thereafter the screening; the volunteers are enrolled for the conduction of the study which involves certain parameters to be followed which are as follows:
1. Patients who meet all of the inclusion and none of the exclusion criteria received the study treatments.
2. Patients were asked to take 20ml of the assigned mouthwash in their mouth and rinse.
3. The pH and buffer tests were repeated after 10, 30, 60 and 90 minutes post rinsing. The microbial analysis was done at 90 minutes post rinsing.
Post preliminary assessment, 34 volunteers were selected with high caries-risk were assigned to prepared sample mouthwash or the standard marketed formulation in this single center, open label, randomized, active controlled, parallel grouping to take part in the study and their response/feedback were captured in the CRF for the test and comparator.
The volunteers were allowed to use the prepared sample mouthwash for the duration of 3 days and after that the below mentioned results were obtained.
Table 4: SALIVARY pH
Number of sample: 15
For Prepared sample:
Time (min) Pre-rinse 10 30 60 90
Mean 6.733 6.633 6.666 6.800 6.733
SD 0.454 0.480 0.487 0.368 0.416

Number of sample: 19
For Standard marketed formulation
Time
(min) Pre-rinse 10 30 60 90
Mean 6.815 6.710 6.684 6.789 6.921
SD 0.381 0.418 0.447 0.384 0.250

Table 5: BUFFERING CAPACITY
Number of sample: 15
For Prepared sample:
Time (min) Pre-rinse 10 30 60 90
Mean 6.500 6.566 6.533 6.266 6.366
SD 0.510 0.457 0.480 0.416 0.611

Number of sample: 19
For Standard marketed formulation
Time
(min) Pre-rinse 10 30 60 90
Mean 6.315 6.552 6.526 6.500 6.368
SD 0.478 0.466 0.512 0.577 0.879

Table 6: MICROBIAL COUNT
Number of sample: 15
For Prepared sample:
% reduction (S) SD% % reduction (L) SD%
81 78 92 82

Number of sample: 19
For Standard marketed formulation
% reduction (S) SD% % reduction (L) SD%
64 50 83 69

Table 7: Parameter test of the selected volunteers
Parameter Prepared sample (PS) or Standard formulation (SF) Mean Score Standard error p-value
Taste of the product PS 4.3 0.12 0.03
SF 1.3 0.11
Feel of comfort in the mouth PS 3.9 0.15 0.02
SF 1.6 0.19
Does it sooth the mouth/ oral cavity? PS 3.5 0.15 0.03
SF 2.2 0.19
Does it effectively moisten the mouth? PS 4.0 0.17 0.01
SF 2.3 0.27
Does it help to freshen breath? PS 4.2 0.19 0.05
SF 3.0 0.23
Does it effectively lubricate mouth? PS 3.8 0.26 0.02
SF 2.3 0.24
Does it relieve the discomfort of dry mouth? PS 3.3 0.20 0.07
SF 2.3 0.20
Does it provides whole mouth comfort? PS 3.6 0.21 0.00
SF 2.0 0.19
Rate the long-lasting lubricating effect PS 3.2 0.17 0.06
SF 2.12 0.25
Rate the long-lasting moisturizing effect PS 3.1 0.16 0.05
SF 2.4 0.28
Rate the changes in the sense of taste PS 3.5 0.23 0.02
SF 2.3 0.27
Rate the convenience of mouth rinse PS 3.8 0.13 0.07
SF 2.1 0.23
Does it help mouth feel “normal”? PS 4.2 0.13 0.01
SF 2.1 0.21

Result:
A study was conducted to evaluate and compare the efficacy and safety of the prepared sample mouthwash and the standard marketed mouthwash for evaluation; 34 volunteers were selected from both male and female gender of different age group and the study results were tabulated above.
Out of the total study population of 34 volunteers it was found that:
• 29 (85.5%) patients were female and 5 were male
• the average age of female patients was 18 years and
• 19. 27% of the patients were 20 years old.
From Table 4, for prepared sample mouthwash it was observed that the pH increases to a peak value of 6.80 at 60 min and then decreases gradually, at 90 min, it reaches its lowest value of 6.733 with p-0.02.
For the standard formulated mouthwash it was observed that the pH decreases at 30 minutes and gradually increases to a peak value of 6.92 at 90min with p-0.03.

Saliva has a buffer capacity which neutralizes acids in the mouth. This capacity was based on several systems such as the phosphate system and the carbonic acid/bicarbonate system.
From Table 5, prepared sample mouthwash reveals that the buffering capacity increased to a peak value of 6.5 at 10 minutes and then decreased gradually up till 60 min and then increased slightly at 90 min, when it reached a low of 6.3 with p-0.02. For standard formulated mouthwash the buffering capacity increased to a peak value of 6.5 at 10 minutes and then decreased gradually until at 90 min, it reached a low of 6.3 with p-0.03. The buffering capacity was seen to be higher in the prepared sample mouthwash. The results of microbial analysis revealed that there was an 81% decrease ill the microbial count for Streptococcus mutans and a 92% decrease for Lactobacilli in the prepared sample mouthwash with p-0.02 and 64% decrease in the microbial count for Streptococcus mutans and a 83% decrease for Lactobacilli in the standard marketed formulation of mouthwash with p- 0.03.
Further, it was observed that 13 parameters were compared between the prepared sample mouthwash and the standard marketed formulation of mouthwash in which the prepared sample of mouthwash showed excellent product acceptance from volunteers with average mean of 3.7 and p-0.02,
Whereas the standard marketed formulation of mouthwash showed few mild adverse effects with average mean of 2.2 and p-0.03.

Observation:
1. The prepared sample mouthwash has shown marginally better significance in salivary pH and buffering capacity when compared to the standard marketed formulation of mouthwash. (p-0.02)
2. The prepared sample mouthwash has shown higher significance with respect to microbial count in comparison to standard marketed formulation of mouthwash. (p-0.03)
3. Considerable superiority was observed in participant's acceptance and compliance towards prepared sample with average mean of 3.7 compared to standard marketed formulation with average mean of 2.2.
4. The prepared sample mouthwash has superior safety profile compared to standard marketed formulation of mouthwash with 0 adverse events in the prepared sample of mouthwash whereas it was observed that 5 adverse events were recorded in the standard marketed formulation of mouthwash.
5. Both standard marketed formulation and prepared sample were assessed for burning/Stinging Sensation of mucosal membrane of the mouth during and after mouthwash, which showed favorable results for test formulation with mean average of 2 compare to mean average of 4 for standard marketed formulation.
Although the example as well as the process of preparation and use has been specifically described, it should be understood that variations in the preferred embodiment could be achieved by a person skilled in the art without departing from the spirit of the invention. It is also to be understood that the present invention is given with the understanding that this invention is intended only to be illustrations without serving as a limitation on the scope of the invention as defined in the claims.