Claims:1. A composition for oral hygiene, said composition comprising:
a) a fluid medium A comprising:
? sodium chloride IP;
? sodium benzoate IP;
? zinc chloride IP;
? calcium chloride IP; and
? a predetermined quantity of diluent;
b) a fluid medium B comprising:
? sodium chloride IP;
? sodium benzoate IP;
? sodium fluoride IP;
? monosodium phosphate IP;
? disodium phosphate IP; and
? a predetermined quantity of diluent;
wherein said fluid medium A and said fluid medium B are mixed in predetermined quantities prior to use, for obtaining said composition for oral hygiene.
2. A composition for oral hygiene, said composition comprising:
a) a fluid medium A comprising:
? sodium chloride IP in an amount ranging from 0.3 %w/v to 0.8 %w/v;
? sodium benzoate IP in an amount ranging from 0.001 %w/v to 0.05 %w/v;
? zinc chloride IP in an amount ranging from 0.01 %w/v to 0.1 %w/v;
? calcium chloride in an amount ranging from 0.2 %w/v to 0.8 %w/v; and
? a predetermined quantity of diluent;
b) a fluid medium B comprising:
? sodium chloride IP in an amount ranging from 0.3 %w/v to 0.8 %w/v;
? sodium benzoate IP in an amount ranging from 0.001 % w/v to 0.05 % w/v;
? sodium fluoride IP in an amount ranging from 0.01 %w/v to 0.1 %w/v;
? monosodium phosphate in an amount ranging from 0.01 %w/v to 0.03 %w/v;
? disodium phosphate in an amount ranging from 0.01 %w/v to 0.06 %w/v; and
? a predetermined quantity of diluent;
wherein said fluid medium A and said fluid medium B are mixed in predetermined quantities prior to use, for obtaining said composition for oral hygiene.
3. The composition as claimed in claim 1 or claim 2, wherein said composition is in at least one form selected from the group consisting of a solution, a liquid, a spray, a syrup, a paste, a gel, a foam, a carbonated beverage, a bottled water, a flavored water, a sports drink, a juice, a nutritional supplement, a mouthwash and combinations thereof.
4. The composition as claimed in claim 1 or claim 2, wherein said composition is in at least one form selected from the group consisting of a powder, a dental cream, a dentifrice, a toothpaste, a lozenge, a lollipop, a tablet, a flash melt composition, a gum, a candy, a coating on a teeth whitening strip, a coating on dental floss, a coating on a dental mold and combinations thereof.
5. The composition as claimed in claim 1 or claim 2, wherein said composition contains a pH adjusting agent selected from the group consisting of sodium carbonate, sodium hydroxide, acetic acid and wherein the pH of said composition is in the range of 6.4 to 7.8.
6. The composition as claimed in claim 1 or claim 2, wherein said composition contains at least one pharmaceutically acceptable flavoring agent in an amount ranging from 0.1 %w/v to 0.2 %w/v and at least one pharmaceutically acceptable coloring agent in an amount ranging from 100 mg/L to 200 mg/L.
7. The composition as claimed in claim 1 or claim 2, wherein said diluent is purified water selected from the group consisting of demineralized water, deionized water and ultra-filtered water.
8. A process for preparing a composition for oral hygiene, said process comprising the following steps:
a. a process for preparing a fluid medium A comprising the sub-steps of:
? mixing together predetermined quantities of sodium chloride IP, sodium benzoate IP and calcium chloride IP to form a first mixture;
? adding a predetermined quantity of a first diluent to said first mixture;
? heating said first mixture containing said first diluent at a temperature in the range of 60 ?C to 100 ?C with stirring for a time period in the range of 40 minutes to 80 minutes to form a first fluid reagent mix; wherein the stirring speed is maintained in the range of 40 rpm to 80 rpm;
? adjusting the pH of said first fluid reagent mix in the range of 7.2 to 7.6;
? adding a predetermined quantity of zinc chloride IP to the first fluid reagent mix and stirring for a time period in the range of 20 minutes to 40 minutes;
? cooling said first fluid reagent mix to a temperature in the range of 20 ?C to 30 ?C; and
? adding predetermined quantities of at least one pharmaceutically acceptable flavouring agent, at least one pharmaceutically acceptable coloring agent and a predetermined quantity of said first diluent to said first fluid reagent mix and adjusting the pH in the range of 6.4 to 7.8 to form said fluid medium A;
b. a process for preparing a fluid medium B comprising the sub-steps of:
? mixing together predetermined quantities of sodium chloride IP, monosodium phosphate IP, disodium phosphate IP and sodium benzoate IP to form a second mixture;
? adding a predetermined quantity of a second diluent to said second mixture;
? heating said second mixture containing the second diluent at a temperature in the range of 60 ?C to 100 ?C with stirring for a time period in the range of 40 minutes to 80 minutes to form a second fluid reagent mix; wherein the stirring speed is maintained in the range of 40 rpm to 80 rpm;
? adjusting the pH of said second fluid reagent mixing the range of 7.2 to 7.6;
? adding a predetermined quantity of sodium fluoride IP to the second fluid mix and stirring for a time period in the range of 20 minutes to 40 minutes;
? cooling said second fluid reagent mix to a temperature in the range of 20 ?C to 30 ?C; and
? adding predetermined quantities of at least one pharmaceutically acceptable flavouring agent, at least one pharmaceutically acceptable coloring agent and a second predetermined quantity of said second diluent to said second fluid reagent mix and adjusting the pH in the range of 6.4 to 7.8 to form said fluid medium B;
wherein said fluid medium A and said fluid medium B are mixed in predetermined quantities, prior to use, for obtaining said composition for oral hygiene containing a supersaturated concentration of ions.
9. The composition as claimed in anyone of the preceding claims, wherein said composition optionally comprises at least one pharmaceutically effective amount of an additive wherein said additive is at least one selected from the group of therapeutic agents, surface adherents, diluents, glidants, propellants, thickeners, emulsifiers, breath fresheners, anti-plaque agents, sweeteners, preservatives, antimicrobial agents, surfactants, gums, whitening agents, vitamins, vehicles, antibiotics, antifungal agents, antiseptics, immunomodulators, taste-enhancing components, organic and inorganic acids, foaming agents, demulcents, astringents, analgesics, alkalizers, wound healing agents, anti-inflammatory steroids, hydrocolloids, chelating agents, pH-buffers, coloring agent and combinations thereof.
10. A portable oral hygiene composition kit (100) comprising:
at least two containers, wherein a first container contains a fluid medium A and a second container contains a fluid medium B;
wherein said fluid medium A in the first container (12) comprises:
? sodium chloride IP in the range of 0.3 %w/v to 0.8 %w/v;
? sodium benzoate IP in the range of 0.001 %w/v to 0.05 %w/v;
? zinc chloride IP in the range of 0.01 %w/v to 0.1 %w/v;
? calcium chloride in the range of 0.2 %w/v to 0.8 %w/v;
? pharmaceutically acceptable flavoring agents in the range of 0.1 % w/v to 0.2 %w/v;
? pharmaceutically acceptable coloring agents in the range of 100 mg/L to 200 mg/L; and
? predetermined quantity of purified water;

and wherein said fluid medium B in the second container (14) comprises:
? sodium chloride IP in the range of 0.3 %w/v to 0.8 %w/v;
? sodium benzoate IP in the range of 0.001 %w/v to 0.05 %w/v;
? sodium fluoride IP in the range of 0.01 %w/v to 0.1 %w/v;
? monosodium phosphate in the range of 0.01 %w/v to 0.03 %w/v;
? disodium phosphate in the range of 0.01 %w/v to 0.6 %w/v;
? pharmaceutically acceptable flavoring agents in the range of 0.1 %w/v to 0.2 %w/v;
? pharmaceutically acceptable coloring agents in the range of 100 mg/L to 200 mg/L; and
? predetermined quantity of purified water;

wherein said fluid medium A and said fluid medium B are mixed in predetermined quantities prior to use for obtaining said oral hygiene composition. , Description:FIELD
The present disclosure relates to the field of compositions for oral hygiene.
BACKGROUND
Oral hygiene is considered to be one of the best means for the prevention of dental cavities (dental caries), gingivitis, periodontitis, and it also helps to prevent bad breath (halitosis). Dental plaque, which is also known as microbial plaque, oral biofilm, dental biofilm, dental plaque biofilm or bacterial plaque biofilm, is a biofilm or mass of bacteria that grows on surfaces within the mouth. Plaque is a microbial coating on tooth surfaces formed by microbial action on the cell debris, food remnants, sugars and starches in the mouth. It appears as a white/pale yellow "slime layer” that is commonly found between the teeth and along the cervical margins, which is commonly associated with oral diseases such as caries and periodontal diseases (gum diseases).
Plaque formation is a normal process that cannot be prevented, but its progression and build up leads to oral diseases. Thus, the removal and control of dental plaque is important as it may become acidic, causing demineralization of the teeth leading to tooth decay. The accumulation of bacteria in the oral cavity of mammals, such as on the teeth or tongue or in the tissue area between the teeth and gums can contribute to plaque formation, tooth decay and periodontal disease. Hence, it is important to disrupt the mass of bacteria and remove it periodically.
Teeth are naturally protected in the mouth from decay by saliva. When saliva is removed from the teeth, the tooth enamel is more susceptible to destruction by naturally occurring acids, which are produced by the bacteria occurring in the mouth that demineralize the tooth enamel causing cavities. Additionally, with the decreased saliva there is an increase in bacteria, which causes an increase in the plaque formation. Antibodies which are present in the saliva are absent in people suffering from dry mouth which can cause dental problems.
Patients with compromised immune systems, such as those suffering from Acquired Immune Deficiency (AIDS) or those undergoing chemotherapeutic treatments, individuals having compromised or non-functioning salivary glands (such as certain radiation therapy patients and people with diabetes and vitamin deficiencies) as well as individuals taking certain medications including, some anti-depressives, anti-hypertensives, diuretics and anti-histamines, are particularly susceptible to mouth ulcers and irritations. Such individuals are in need of a dental composition that can be used to thoroughly rinse their teeth and mouth thereby stimulating and healing the lesions, alleviating pain in the pre-existing conditions.
Generally, antibiotics are used for treating diseases related to the oral cavity and to reduce or eliminate the effects of microorganisms. Even though, such use is systemic, it can result in various undesirable side effects, including the threat or danger of building allergies or immunity to the antibiotic, overgrowth of opportunistic microorganisms and intestinal disturbances. Hence, there exists need to provide an oral hygiene composition that ameliorates the drawbacks mentioned hereinabove.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
An object of the present disclosure is to provide a composition for oral hygiene.
Another object of the present disclosure is to provide a process for preparing the composition for oral hygiene.
Still another object of the present disclosure is to provide a portable oral hygiene composition kit.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY
The present disclosure envisages a composition for oral hygiene. The composition for oral hygiene comprises a fluid medium A and a fluid medium B, which are to be mixed prior to use. The fluid medium A comprises sodium chloride IP in an amount ranging from 0.3 % w/v to 0.8 %w/v; sodium benzoate IP in an amount ranging from 0.001 % w/v to 0.05 % w/v; zinc chloride IP in an amount ranging from 0.01 % w/v to 0.1 % w/v; calcium chloride IP in an amount ranging from 0.2 % w/v to 0.8 % w/v; and a diluent. The fluid medium B comprises sodium chloride IP in an amount ranging from 0.3 % w/v to 0.8 % w/v; sodium benzoate IP in an amount ranging from 0.001 % w/v to 0.05 % w/v; sodium fluoride IP in an amount ranging from 0.01 % w/v to 0.1 % w/v; monosodium phosphate IP in an amount ranging from 0.01 %w/v to 0.03 %w/v; disodium phosphate IP in an amount ranging from 0.01 %w/v to 0.06 %w/v ; and a diluent.
A process for preparing a composition for oral hygiene is also provided in the present disclosure. The process comprises preparing a fluid medium A and a fluid medium B. The process for preparing the fluid medium A comprises mixing together sodium chloride IP, sodium benzoate IP and calcium chloride IP to form a first mixture; adding a first diluent to the first mixture; heating the first mixture containing the first diluent at a temperature in the range of 60 °C to 100 °C with stirring for a time period in the range of 40 minutes to 80 minutes to form a first fluid reagent mix; wherein the stirring speed is maintained in the range of 40 rpm to 80 rpm; adjusting the pH of the first fluid reagent mix in the range of 7.2 to 7.6; adding zinc chloride IP to the first fluid reagent mix and stirring for a time period in the range of 20 minutes to 40 minutes; cooling the first fluid reagent mix to a temperature in the range of 20 °C to 30 °C; and adding at least one pharmaceutically acceptable flavouring agents, at least one pharmaceutically acceptable coloring agent, first diluent to the first fluid reagent mix and adjusting the pH in the range of 6.4 to 7.8 to form the fluid medium A. The process for preparing the fluid medium B comprises mixing together sodium chloride IP, monosodium phosphate IP, disodium phosphate IP and sodium benzoate IP to form a second mixture; adding a second diluent to the second mixture; heating the second mixture containing the second diluent at a temperature in the range of 60 °C to 100 °C with stirring for a time period in the range of 40 minutes to 80 minutes to form a second fluid reagent mix; wherein the stirring speed is maintained in the range of 40 rpm to 80 rpm; adjusting the pH of the second fluid reagent mix in the range of 7.2 to 7.6; adding sodium fluoride IP to the second fluid mix and stirring for a time period in the range of 20 minutes to 40 minutes; cooling the second fluid reagent mix to a temperature in the range of 20 °C to 30 °C; and adding at least one pharmaceutically acceptable flavouring agent, at least one pharmaceutically acceptable coloring agent, the second diluent to the second fluid reagent mix and adjusting the pH in the range of 6.4 to 7.8 to form the fluid medium B. The fluid medium A and fluid medium B are mixed prior to use.
The present disclosure also provides a portable, easy to operate oral hygiene composition kit.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWING
The present disclosure will now be described with the help of the accompanying drawing in which:
Figure 1(a) illustrates a portable oral hygiene composition kit (100) comprising two removable containers (12 and 14), separated by a separator (16); and
Figure 1(b) illustrates a portable oral hygiene composition kit (100) comprising two separate containers (12 and 14).

DETAILED DESCRIPTION
Oral hygiene is the practice of keeping the mouth and teeth clean to prevent dental problems, most commonly, tooth decay, dental cavities, gingivitis, periodontal (gum) diseases and bad breath. Tooth decay is the result of tooth demineralization, the key feature of which is an increase of bacteria within the dental plaque. Demineralization is a process where an acidic environment leaches some of the mineral content out of a tooth's calcified tissues. This mineral loss can be recovered, i.e. remineralisation by use of ions dissolved in the saliva. Cavities result when the rate of demineralisation exceeds the rate of remineralisation. Due to the numerous reasons as stated above, individuals who are unable to produce enough saliva tend to suffer from several oral diseases.
Therefore, in accordance with the present disclosure there is provided a composition for oral hygiene comprising a supersaturated concentration of ions for treating the oral diseases and to reduce or eliminate the effects of microorganisms while simultaneously lubricating and moistening the oral cavity and aiding in ulcer healing.
In accordance with one aspect of the present disclosure, there is provided a composition for oral hygiene. The composition for oral hygiene of the present disclosure comprises a fluid medium A and a fluid medium B.
In accordance with the embodiments of the present disclosure, the fluid medium A comprises sodium chloride IP in an amount ranging from 0.3 %w/v to 0.8 %w/v, sodium benzoate IP in an amount ranging from 0.001 %w/v to 0.05 %w/v, zinc chloride IP in an amount ranging from 0.01 %w/v to 0.1 %w/v, calcium chloride IP in an amount ranging from 0.2 %w/v to 0.8 %w/v, at least one pharmaceutically acceptable flavoring agent in an amount ranging from 0.1 % w/v to 0.2 %w/v, at least one pharmaceutically acceptable coloring agent in an amount ranging from 100 mg/l to 200 mg/l and a predetermined quantity of a diluent.
In an embodiment of the present disclosure the diluent is purified water selected from the group consisting of, but not limited to, demineralized water, deionized water and ultra-filtered water.
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable flavouring agent is selected from the group consisting of, but not limited to, Garden Mint, Strawberry and Lemon.
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable coloring agent is selected from the group consisting of, but not limited to, Sunset Yellow and Green 5.
In accordance with the embodiments of the present disclosure, the fluid medium B comprises sodium chloride IP in an amount ranging from 0.3 %w/v to 0.8 %w/v, sodium benzoate IP in an amount ranging from 0.001 %w/v to 0.0 5%w/v, sodium fluoride IP in an amount ranging from 0.01 %w/v to 0.1 %w/v, monosodium phosphate IP in an amount ranging from 0.01 %w/v to 0.03 %w/v, disodium phosphate IP in an amount ranging from 0.01 %w/v to 0.06 %w/v, at least one pharmaceutically acceptable flavoring agent in an amount ranging from 0.1 %w/v to 0.2 %w/v, at least one pharmaceutically acceptable coloring agent in an amount ranging from 100 mg/l to 200 mg/l and a predetermined quantity of a diluent.
In an embodiment of the present disclosure the diluent is purified water selected from the group consisting of, but not limited to, demineralized water, deionized water and ultra-filtered water.
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable flavouring agent is selected from the group consisting of, but not limited to, Garden Mint, Strawberry and Lemon
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable coloring agent is selected from the group consisting of, but not limited to, Sunset Yellow and Green 5
In an embodiment of the present disclosure the fluid medium A and the fluid medium B are mixed in predetermined quantities prior to use for obtaining the composition for oral hygiene.
In an exemplary embodiment of the present disclosure, equal quantities of the fluid medium A and fluid medium B are mixed together, prior to use.
In an embodiment of the present disclosure, the composition for oral hygiene is in a dosage form selected from the group consisting of, but not limited to, a solution, a liquid, a spray, a syrup, a paste, a gel, a foam, a carbonated beverage, a bottled water, a flavoured water, a sports drink, a juice, a nutritional supplement, a mouthwash and combinations thereof.
In another embodiment of the present disclosure, the composition for oral hygiene is in a dosage form selected from the group consisting of, but not limited to, a powder, a dental cream, a dentifrice, a toothpaste, a lozenge, a lollipop, a tablet, a flash melt composition, a gum, a candy, a coating on a teeth whitening strip, a coating on dental floss, a coating on a dental mold and combinations thereof.
In an exemplary embodiment of the present disclosure, the composition for oral hygiene is in the form of a mouthwash.
In an embodiment of the present disclosure, the pH of the composition for oral hygiene is in the range of 6.4 to 7.8.
In accordance with an embodiment of the present disclosure, the composition for oral hygiene comprises a pH adjusting agent. The pH adjusting agent is selected from the group consisting of, but not limited to, sodium carbonate, sodium hydroxide, acetic acid and alum.
In accordance with a non-limiting example, the composition for oral hygiene of the present disclosure alleviates the symptoms of oral diseases, gingivitis, periodontal disease, stomatitis, halitosis, plaque, tartar, calculus and oral infections.
In one embodiment of the present disclosure, the composition for oral hygiene alleviates the symptoms of mucositis, which is one of the side effects of chemotherapy or radiotherapy. The composition for oral hygiene mimics the function of saliva and heals the ulcers by permeating into the intracellular spaces in the oral lining, thus lubricating and disinfecting it. The composition for oral hygiene of the present disclosure contains supersaturated levels of ions that promote healing at the cellular level thereby providing palliative care to the patients. The absence of alcohol in the composition for oral hygiene of the present disclosure obviates the pain associated with the use of alcohol-based mouthwashes by patients suffering from mucositis.
In accordance with another aspect of the present disclosure there is provided a process for preparing the composition for oral hygiene. The process of the present disclosure comprises preparing the fluid medium A and fluid medium B separately, and mixing them in a predetermined quantity prior to use. The process for preparing the composition for oral hygiene is hereinafter described in detail.
The process for preparing the fluid medium A comprises mixing together predetermined quantities of sodium chloride IP, sodium benzoate IP and calcium chloride IP to form a first mixture and adding a predetermined quantity of a first diluent to the first mixture.
In accordance with the embodiments of the present disclosure, the amount of sodium chloride IP in the composition for oral hygiene is in the range of 0.3 %w/v to 0.8 %w/v.
In accordance with the embodiments of the present disclosure, the amount of sodium benzoate IP in the composition for oral hygiene is in the range of 0.001 %w/v to 0.05 %w/v.
In accordance with the embodiments of the present disclosure, the amount of calcium chloride IP in the composition for oral hygiene is in the range of 0.2 %w/v to 0.8 %w/v.
In an embodiment of the present disclosure the first diluent is purified water selected from the group consisting of, but not limited to, demineralized water, deionized water and ultra-filtered water.
The first mixture containing the first diluent is then heated at a temperature in the range of 60 °C to 100 °C with stirring for a time period in the range of 40 minutes to 80 minutes to form a first fluid reagent mix.
In accordance with the embodiments of the present disclosure, the stirring speed is maintained in the range of 40 rpm to 80 rpm.
The pH of the first fluid reagent mix is adjusted to lie in the range of 7.2 to 7.6 and a predetermined quantity of zinc chloride IP is added to the first fluid reagent mix and stirred for a time period in the range of 20 minutes to 40 minutes and then cooled to a temperature in the range of 20 °C to 30 °C. After cooling, predetermined quantities of at least one pharmaceutically acceptable flavouring agent, at least one pharmaceutically acceptable coloring agent and a predetermined quantity of the first diluent is added to the first fluid reagent mix; and the pH is adjusted to lie in the range of 6.4 to 7.8 to form the fluid medium A.
In accordance with the embodiments of the present disclosure, the amount of zinc chloride IP in the composition for oral hygiene is in the range of 0.01 %w/v to 0.1 %w/v.
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable flavouring agent is selected from the group consisting of, but not limited to, Garden Mint, Strawberry and Lemon
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable coloring agent is selected from the group consisting of, but not limited to, Sunset Yellow and Green 5
The process for preparing the fluid medium B comprises mixing together predetermined quantities of sodium chloride IP, monosodium phosphate IP, disodium phosphate IP and sodium benzoate IP to form a second mixture and adding a predetermined quantity of a second diluent to the second mixture.
In accordance with the embodiments of the present disclosure, the amount of sodium chloride IP in the composition for oral hygiene is in the range of 0.01 %w/v to 0.1 %w/v.
In accordance with the embodiments of the present disclosure, the amount of monosodium phosphate IP in the composition for oral hygiene is in the range of 0.01 %w/v to 0.03 %w/v.
In accordance with the embodiments of the present disclosure, the amount of disodium phosphate IP in the composition for oral hygiene is in the range of 0.01 %w/v to 0.06 %w/v.
In accordance with the embodiments of the present disclosure, the amount of sodium benzoate IP in the composition for oral hygiene is in the range of 0.001 % w/v to 0.05 % w/v.
In an embodiment of the present disclosure the second diluent is purified water selected from the group consisting of demineralized water, deionized water and ultra-filtered water.
The second mixture containing the second diluent is then heated at a temperature in the range of 60 °C to 100 °C with stirring for a time period in the range of 40 minutes to 80 minutes to form a second fluid reagent mix. The pH of the second fluid reagent mix is adjusted to lie in the range of 7.2 to 7.6 and a predetermined quantity of sodium fluoride IP is added to the second fluid reagent mix and stirred for a time period in the range of 20 minutes to 40 minutes and then cooled to a temperature in the range of 20 °C to 30 °C. After cooling, predetermined quantities of at least one pharmaceutically acceptable flavouring agent, at least pharmaceutically acceptable coloring agent and a predetermined quantity of the second diluent is added to the second fluid reagent mix; and the pH is adjusted to lie in the range of 6.4 to 7.8 to form the fluid medium B.
In accordance with the embodiments of the present disclosure, the stirring speed is maintained in the range of 40 rpm to 80 rpm.
In accordance with the embodiments of the present disclosure, the amount of sodium fluoride IP in the composition for oral hygiene is in the range of 0.01 % w/v to 0.1 % w/v.
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable flavouring agent is selected from the group consisting of, but not limited to, Garden Mint, Strawberry and Lemon
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable coloring agent is selected from the group consisting of, but not limited to, Sunset Yellow and Green 5
In an embodiment of the present disclosure, a pH adjusting agent is used to adjust the pH of the fluid medium A and the fluid medium B. The pH adjusting agent is selected from the group consisting of sodium carbonate, sodium hydroxide, acetic acid and alum.
The fluid medium A and the fluid medium B are mixed in predetermined quantities prior to use for obtaining the composition for oral hygiene containing a supersaturated concentration of ions.
In an exemplary embodiment, the fluid medium A and fluid medium B are mixed in equal quantities to obtain the composition of the oral hygiene of the present disclosure.
In an embodiment of the present disclosure, the composition includes at least one pharmaceutically effective amount of an additive which is selected from the group consisting of, but not limited to, therapeutic agents, surface adherents, diluents, glidants, propellants, thickeners, emulsifiers, breath fresheners, anti-plaque agents, sweeteners, preservatives, antimicrobial agents, surfactants, gums, whitening agents, vitamins, vehicles, antibiotics, antifungal agents, antiseptics, immunomodulators, taste-enhancing components, organic and inorganic acids, foaming agents, demulcents, astringents, analgesics, alkalizers, wound healing agents, anti-inflammatory steroids, hydrocolloids, chelating agents, pH-buffers, coloring agent and combinations thereof.
In accordance with another aspect of the present disclosure, there is provided a portable oral hygiene composition kit (100). The kit (100) illustrated in Figure 1(a) comprises at least two containers which are detachably connected and are separated from each other by means of a separator (16). The container 12 contains a pre-determined concentration of the fluid medium A and the container 14 contains a pre-determined concentration of the fluid medium B, respectively. The fluid medium A and the fluid medium B are to be mixed prior to use for obtaining the oral hygiene composition containing a supersaturated concentration of ions.
In accordance with another embodiment of the present disclosure, the portable oral hygiene composition kit (100) as disclosed in figure 1(b) is devoid of a separator.
In an embodiment of the present disclosure, the container (12) comprises sodium chloride IP in the range of 0.3 % w/v to 0.8 %w/v, sodium benzoate IP in the range of 0.001 %w/v to 0.05 %w/v, zinc chloride IP in the range of 0.01 %w/v to 0.1 %w/v, calcium chloride IP in the range of 0.2 %w/v to 0.8 %w/v, at least one pharmaceutically acceptable flavoring agent in the range of 0.1 %w/v to 0.2 %w/v, a least one pharmaceutically acceptable coloring agent in an amount ranging from 100 mg/l to 200 mg/l and a predetermined quantity of a diluent.
In accordance with the embodiments of the present disclosure, the diluent is purified water selected from the group consisting of, but not limited to, demineralized water, deionized water and ultra-filtered water.
The container (14) comprises sodium chloride IP in the range of 0.3 %w/v to 0.8 %w/v, sodium benzoate IP in the range of 0.001 %w/v to 0.05 %w/v, sodium fluoride IP in the range of 0.01 %w/v to 0.1 %w/v, monosodium phosphate IP in the range of 0.01 %w/v to 0.03 %w/v, disodium phosphate IP in the range of 0.01 %w/v to 0.06 %w/v, at least one pharmaceutically acceptable flavoring agent in the range of 0.1 %w/v to 0.2 %w/v, at least one pharmaceutically acceptable coloring agent in an amount ranging from 100 mg/l to 200 mg/l and a predetermined quantity of a diluent.
In accordance with the embodiments of the present disclosure, the diluent is purified water selected from the group consisting of, but not limited to, demineralized water, deionized water and ultra-filtered water.
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable flavouring agent is selected from the group consisting of, but not limited to, Garden Mint, Strawberry and Lemon
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable coloring agent is selected from the group consisting of, but not limited to, Sunset Yellow and Green 5
The present disclosure is further illustrated herein below with the help of the following experiments. The experiments used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the experiments should not be construed as limiting the scope of embodiments herein. These laboratory scale experiments can be scaled up to industrial/commercial scale and the results obtained can be extrapolated to industrial/commercial scale.
Experiment 1: Preparation of the composition for oral hygiene
Step-1: Preparation of fluid medium A
150 mM sodium chloride IP, 1.00 g/l sodium benzoate IP and 15 mM calcium chloride IP were added to 500 ml purified water to obtain a first mixture. The first mixture was then heated at a temperature of 80 °C with stirring for a time period of 60 minutes to form a first fluid reagent mix. The stirring speed was maintained at 60 rpm.
The pH of the first fluid reagent mix was adjusted to 7.4 and 0.1 mM zinc chloride IP was added to the first fluid reagent mix and stirred for a time period of 30 minutes. After completion of 30 minutes, the first fluid reagent mix was cooled to 25 °C.
After cooling, 2.0 ml/l of a strawberry flavour, 1.5 ml/l of Green 5 as the coloring agent and purified water was added to make up the volume to 1000 ml and the pH was adjusted to 7 to obtain the fluid medium A.
Step-2: Preparation of fluid medium B
95 mM sodium chloride IP and 2.1 mM monosodium phosphate IP, 5.0 mM disodium phosphate IP and 1.00 g/l sodium benzoate IP were added to 550 ml of purified water to obtain a second mixture. The second mixture was then heated at a temperature of 80 °C with stirring for a time period of 60 minutes to form a second fluid reagent mix. The stirring speed was maintained at 60 rpm.
The pH of the second fluid reagent mix was adjusted to 7.4 and 0.05 mM sodium fluoride IP was added to the second fluid reagent mix and stirred for a time period of 30 minutes. After completion of 30 minutes, the second fluid reagent mix was cooled to 25 °C.
After cooling, 2.0 ml/l a lemon flavour, 1.5 ml/l of Sunset yellow as the coloring agent was added, then purified water was added to make up the volume to 1000 ml and the pH was adjusted to 7 to obtain the fluid medium B.
Experiment 2: Saliva substitute composition.
In this experiment, the following composition of the present disclosure was used for patients/individuals having a decreased salivary output (i.e. to moisten and lubricate the oral cavity and to act as a salivary substitute).
The composition for oral hygiene comprised two separate concentrate fluid mediums, A and B and stored separately. Equal volumes of the two fluid mediums were mixed prior to use.
Fluid medium A comprised:
10 mM of, calcium chloride IP, 100 mM of sodium chloride IP, 1.0 g/l of sodium benzoate IP, 2.0 ml/l of Garden mint as the flavoring agent, 0.1mM zinc chloride IP, 1.5 ml/l of Sunset Yellow as the coloring agent and purified water for dilution upto 1000 ml.
Fluid medium B comprised:
5.2 mM of disodium phosphate IP, 2.2 mM of monosodium phosphate IP, 0.05mM sodium fluoride IP, 100mM of sodium chloride IP, 1.0 g/l of sodium benzoate IP, 2.0 ml/l of a Garden Mint as the flavoring agent, 1.5 ml/l of Green 5 as the coloring agent and purified water for dilution upto 1000 ml.
Each of these two fluid mediums A and B which, were filled in two sterilized containers of high density polyethylene were mixed in equal quantities in a graduated measuring cup to form the composition of the present disclosure.
Experiment 3: Ulcer healing composition.
In this experiment, the following composition of the present disclosure was used for patients/individuals suffering from Mucositis with symptoms of painful mouth ulcers or lesions. The composition for oral hygiene comprised of two separate concentrate fluid mediums, A and B and stored separately. Equal volumes of the two fluid mediums were mixed prior to use.
Fluid medium A comprised:
10mM of calcium chloride IP, 100 mM of sodium chloride IP, 5.1 mM of zinc chloride IP, 1.0 g/l of sodium benzoate IP, 2.0 ml/l of lemon as the flavoring agent, 1.5 ml/l of Sunset Yellow as the coloring agent and purified water for dilution upto 1000 ml.
Fluid medium B comprised:
5.2 mM of disodium phosphate IP, 2.2 mM of monosodium phosphate IP, 100mM of sodium chloride IP, 3.5mM of sodium fluoride IP, 1.0 g/l of sodium benzoate IP, 2.0 ml/l of a lemon flavour, 1.5 ml/l of Sunset Yellow coloring agent and purified water for dilution upto 1000 ml.
Each of these two fluid mediums A and B, which were filled in two sterilized containers of high density polyethylene, were mixed in equal quantities in a graduated measuring cup to form the composition of the present disclosure.
Anecdotal studies: The present disclosure would be now explained with the following anecdotal examples.
Anecdote 1: A 40 years old female suffering from bad breath was started on the oral hygiene composition of the present disclosure. 5 ml of fluid medium A and 5 ml of fluid medium B were mixed and used for rinsing the mouth, after breakfast, after lunch and after dinner for 30 days. On the 31st day the individual was checked for bad breath – no bad breath was reported. Also, the individual did not have any side effects, such as, unacceptable taste, burning sensation in the mouth, and the like.
Anecdote 2: A 20 years old male suffering from bad breath was started on the oral hygiene composition of the present disclosure. Fluid medium A (5 ml) and fluid medium B (5 ml) were mixed before use. The oral hygiene composition was used to rinse the mouth after every meal. A significant decrease in the bad breath was observed after 15 days of using the oral hygiene composition. The individual has continued with the use of the oral hygiene composition and further improvement is awaited.
Anecdote 3: A 33 year old male complaining of mouth ulcer was prescribed the oral hygiene composition of the present disclosure. Fluid medium A (10 ml) and fluid medium B (10 ml) were mixed and used for rinsing mouth twice every day for 3 minutes. On the 31st day no ulcer was observed in the patient. There were no side effects reported by the individual.
Anecdote 4: A 50 years old female suffering from mouth ulcers was prescribed the oral hygiene composition of the present disclosure. Fluid medium A (15 ml) and fluid medium B (15 ml) were mixed and used for rinsing mouth three times a day for 3 minutes. Complete healing of the ulcers was observed on the 33rd day. There were no side effects reported by the individual.
Anecdote 5: A 66 years old male complaining of bad breath was prescribed the oral hygiene composition of the present disclosure. 10 ml of fluid medium A and 10 ml of fluid medium B were mixed and were used to rinse the mouth after every meal. A substantial reduction in the bad breath was observed on the 10th day, further results are awaited.
The composition lubricated and healed the ulcerative lesions in the mouth. The calcium and phosphate ions penetrated the interstitial spaces in the oral mucosa thus soothing the damaged epithelium. Healing of the ulcers without any infections was observed as the fluoride ions have a remineralising effect and the zinc ions have antimicrobial activity.
TECHNICAL ADVANCES AND ECONOMICAL SIGNIFICANCE
The composition of the present disclosure described herein above has several technical advantages including, but not limited to, the realization of:
? a composition for oral hygiene being devoid of alcohol;
? a simple composition to alleviate the effects of oral diseases;
? a simple portable kit for oral hygiene; and
? a simple process for preparing the composition for oral hygiene.
The foregoing description of the specific embodiments fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.
Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.
The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values ten percent higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.
While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.