TECHNICAL FIELD
[001] The subject matter described herein in general relates to chewable compositions, and in particular relates to chewable compositions having tooth whitening effect.
BACKGROUND OF INVENTION
[002] The outermost layer of the teeth called the enamel is composed of hydroxyapatite mineral crystals. The porous nature of the enamel allows stain causing agents to permeate the enamel and cause tooth discoloration. Teeth can get stained due to stain forming agents present in certain foods and pharmaceutical products, tea, coffee and tobacco products. While some stains can be removed by mechanical action or abrasive agents, others require action of mild or strong chemical agents for their removal.
[003] For instance, conventionally available tooth whitening compositions for home use contain 1-3% by weight of peroxygen compounds, such as hydrogen peroxide, which when used effect whitening or removal of stains. However, these toothpaste compositions are not convenient to use when outside the home. Certain other tooth whitening compositions use tetrasodium pyrophosphate (TSPP) which prevent the formation and removal of stains from hydroxyapatite. For instance, US6416744B1 discloses the use of TSPP as part of tooth whitening chewing gum composition effective to remove stains from teeth.
[004] Certain other chewing gum compositions contain mineral adjuvants which act as cleaning and polishing agents. For example, US 4828820, and US 4170632 disclose the use of calcium carbonate; US 4400372 discloses the use of calcined kaolin; and US 3590120 discloses the use of zirconium silicate as polishing agents. The presence of these mineral adjuvants is problematic as such adjuvants are used in high concentrations in the order of 10-40% by weight and have been found to be unduly harsh to tooth enamel. Considering the above evidence, there exists a need to develop a tooth whitening composition which can be used at all times, within or outside the comfort of home.

SUMMARY OF THE INVENTION
[005] In an aspect of the present invention, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4.
[006] In another aspect of the present invention, there is provided a process for preparing a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4; said process: a) obtaining the at least one active ingredient; b) obtaining the at least one buffering agent; c) obtaining the at least one whitening agent; d) obtaining the at least one gum base; and e) contacting the at least one active ingredient, the at least one buffering agent, the at least one whitening agent, and the at least one gum base to obtain the composition, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4. [007] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
[008] The detailed description is described with reference to the accompanying figures. The same numbers are used throughout the drawings to reference like features and components.
[009] Figure la depicts images of films of hydroxy apatite (HA) alone and HA stained with pan masala in combination with chewing tobacco solution and treated

with different % (w/w) of tetrasodium pyrophosphate (TSPP), in accordance with
an implementation of the present subject matter.
[0010] Figure lb depicts the level of de-staining represented as percent of control
(0% active) normalized to 100%, in accordance with an implementation of the
present subject matter.
[0011] Figure 2a depicts images of films of HA alone and HA stained with black
tea solution treated with various nicotine chewing gum (NCG) extracts and TSPP,
in accordance with an implementation of the present subject matter.
[0012] Figure 2b depicts the AE* values for the HA films stained with black tea
solution treated with the various NCG extracts and TSPP, in accordance with an
implementation of the present subject matter.
[0013] Figure 2c depicts the level of de-staining represented as percent of control,
nicotine chewing gum (NCG-1) normalized to 100%, in accordance with an
implementation of the present subject matter.
[0014] Figure 3a depicts images of films of HA alone and HA stained with pan
masala in combination with chewing tobacco solution treated with the various
NCG extracts and TSPP, in accordance with an implementation of the present
subject matter.
[0015] Figure 3b depicts the AE* values for the HA films stained with pan masala
in combination with chewing tobacco solution treated with the various NCG
extracts and TSPP, in accordance with an implementation of the present subject
matter.
[0016] Figure 3c depicts the level of de-staining represented as percent of control,
NCG-1 normalized to 100%), in accordance with an implementation of the present
subject matter.
[0017] Figure 4a depicts images of films of HA alone and HA stained with
cigarette smoke condensate treated with the various NCG extracts and TSPP, in
accordance with an implementation of the present subject matter.
[0018] Figure 4b depicts the AE* values for the HA films stained with cigarette
smoke condensate treated with the various NCG extracts and TSPP, in accordance
with an implementation of the present subject matter.

[0019] Figure 4c depicts the level of de-staining represented as percent of control,
NCG-1 normalized to 100%, in accordance with an implementation of the present
subject matter.
[0020] Figure 5a depicts images of films of HA alone and HA stained with black
tea solution treated with the various NCG extracts and market product, in
accordance with an implementation of the present subject matter.
[0021] Figure 5b depicts the AE* values for the HA films stained with black tea
solution treated with the various NCG extracts and market product, in accordance
with an implementation of the present subject matter.
[0022] Figure 6a depicts images of films of HA alone and HA stained with pan
masala in combination with chewing tobacco solution treated with the various
NCG extracts and market product, in accordance with an implementation of the
present subject matter.
[0023] Figure 6b depicts the AE* values for the HA films stained with pan masala
in combination with chewing tobacco solution treated with the various NCG
extracts and market product, in accordance with an implementation of the present
subject matter.
[0024] Figure 6c depicts the level of de-staining represented as percent of control,
(stain) normalized to 100%, in accordance with an implementation of the present
subject matter.
[0025] Figure 7a depicts images of films of HA alone and HA stained with
cigarette smoke condensate treated with the various NCG extracts and market
product, in accordance with an implementation of the present subject matter.
[0026] Figure 7b depicts the AE* values for the HA films stained with cigarette
smoke condensate treated with the various NCG extracts and market product, in
accordance with an implementation of the present subject matter.
[0027] Figure 8a depicts images of films of HA alone and HA stained with black
tea solution treated with the NCG extracts, TSPP, and market product, in
accordance with an implementation of the present subject matter.

[0028] Figure 8b depicts the AE* values for the HA films stained with black tea
solution treated with the NCG extracts, TSPP, and market product, in accordance
with an implementation of the present subject matter.
[0029] Figure 8c depicts the level of de-staining represented as percent of control
(NCG-3) normalized to 100%, in accordance with an implementation of the present
subject matter.
[0030] Figure 9a depicts a comparative analysis of films of HA alone, and HA
stained with pan masala in combination with chewing tobacco solution treated with
the NCG extracts, TSPP, and market product, in accordance with an
implementation of the present subject matter.
[0031] Figure 9b depicts AE* values for the HA films stained with pan masala in
combination with chewing tobacco solution treated with the NCG extracts, TSPP,
and market product, in accordance with an implementation of the present subject
matter.
[0032] Figure 9c depicts the level of de-staining represented as percent of control
(NCG-3), for various the NCG extracts, TSPP, and market product, normalized to
100%, in accordance with an implementation of the present subject matter.
[0033] Figure 10a depicts a comparative analysis of films of HA alone, and HA
stained with cigarette smoke condensate treated with various NCG extracts, TSPP,
and market product, in accordance with an implementation of the present subject
matter.
[0034] Figure 10b depicts AE* values for the HA films stained with cigarette
smoke condensate and treated with the NCG extracts, TSPP, and market product, in
accordance with an implementation of the present subject matter.
[0035] Figure 10c depicts the level of de-staining represented as percent of control
(NCG-3), for various the NCG extracts, TSPP, and market product, normalized to
100%), in accordance with an implementation of the present subject matter.
DETAILED DESCRIPTION OF THE INVENTION
[0036] Those skilled in the art will be aware that the present disclosure is subject to variations and modifications other than those specifically described. It is to be

understood that the present disclosure includes all such variations and
modifications. The disclosure also includes all such steps, features, compositions,
and compounds referred to or indicated in this specification, individually or
collectively, and any and all combinations of any or more of such steps or features.
Definitions
[0037] For convenience, before further description of the present disclosure,
certain terms employed in the specification, and examples are delineated here.
These definitions should be read in the light of the remainder of the disclosure and
understood as by a person of skill in the art. The terms used herein have the
meanings recognized and known to those of skill in the art, however, for
convenience and completeness, particular terms and their meanings are set forth
below.
[0038] The articles "a", "an" and "the" are used to refer to one or to more than one
(i.e., to at least one) of the grammatical object of the article.
[0039] The terms "comprise" and "comprising" are used in the inclusive, open
sense, meaning that additional elements may be included. It is not intended to be
construed as "consists of only".
[0040] Throughout this specification, unless the context requires otherwise the
word "comprise", and variations such as "comprises" and "comprising", will be
understood to imply the inclusion of a stated element or step or group of element or
steps but not the exclusion of any other element or step or group of element or
steps.
[0041] The term "including" is used to mean "including but not limited to".
"Including" and "including but not limited to" are used interchangeably.
[0042] Ratios, concentrations, amounts, and other numerical data may be presented
herein in a range format. It is to be understood that such range format is used
merely for convenience and brevity and should be interpreted flexibly to include
not only the numerical values explicitly recited as the limits of the range, but also
to include all the individual numerical values or sub-ranges encompassed within
that range as if each numerical value and sub-range is explicitly recited. For

example, a range 01 1.110 i.^t, snoum oe construed as including suo-ranges 01 1.1
to 1:3, 1:1.5 to 1:3, 1:1.25 to 1:3.75, and so on.
[0043] The term "at least one" is used to mean one or more and thus includes
individual components as well as mixtures/combinations.
[0044] For the purposes of the present disclosure, the terms "humectants",
"binding agent", "hydrating agent", "coloring agent", "polishing agent", "fillers",
and "coating syrup" refer to the generally known components used in the art. The
specific components of the above-described categories have been mentioned in the
present disclosure wherever applicable. Wherever not mentioned, it can be
construed that any component falling under the categories can be used as part of
the composition.
[0045] Unless defined otherwise, all technical and scientific terms used herein have
the same meaning as commonly understood by one of ordinary skill in the art to
which this disclosure belongs. Although any methods and materials similar or
equivalent to those described herein can be used in the practice or testing of the
disclosure, the preferred methods, and materials are now described. All
publications mentioned herein are incorporated herein by reference.
[0046] The present disclosure is not to be limited in scope by the specific
embodiments described herein, which are intended for the purposes of
exemplification only. Functionally-equivalent products, compositions, and methods
are clearly within the scope of the disclosure, as described herein.
[0047] Conventionally used tooth whitening compositions involve the use of harsh
chemical agents like peroxide which when applied in a tooth brushing regimen
effect whitening or removal of stains. However, these compositions cannot be used
outside the comfort of the home. Certain other chewable compositions which can
be used at all times involve the use of mineral adjuvants as polishing agents which
can cause damage to the tooth enamel on prolonged usage. Therefore, there still
exists a need to develop novel chewable tooth whitening compositions which can
overcome the drawbacks associated with the prior art.
[0048] An important aspect of oral care is teeth stains since it has both social and
psychological implications. Dental stain originates from many sources, including

tobacco, dietary chromogens, metal ions and medications such as chlorohexidine (Vogel et al., J. Oral. Med. 1975, 30, 99-104). It is widely accepted that the acquired salivary pellicle is the main site of stain uptake. However, mineral surface, calculus or deposits of calcium phosphate within the pellicle are also sites for chromogen binding (Leach SA 1977, London: Academic Press; p. 105-28). Due to the wide variety of substances that can potentially stain teeth and the dynamic nature of the organic and inorganic composition of the tooth enamel, the staining process is complex and involves a variety of physical and chemical interactions. While other mechanisms cannot be excluded, electrostatic interactions are widely considered to be important in adhesion of proteins to both hydroxyapatite (HA) and enamel (Bernardi et al., Biochim. Biophys. Acta. 1972; Luo et al., J. Colloid Interface Sci. 1998, 200, 104-13). Modifications of such interactions through application of suitable ionic agents therefore is a logical approach to stain prevention.
[0049] The condensed phosphates, such as tetrasodium pyrophosphate (TSPP) and sodium tripolyphosphate (STP) are polyanionic surface active agents which have found many applications in colloid stabilization and detergency. Due to their ability to prevent mineralization, such condensed phosphates have been incorporated in oral care products such as anti-tartar dentrifices (White DJ. Tartar; Oxford: Oxford University Press; 1992; 277-91). Several condensed phosphates can desorb salivary proteins from HA or enamel surface and can even inhibit protein adsorption on such surfaces (Pruitt et al., Nature. 1970; Rykke et al., Scand. J. Dent. Res. 1988; Rykke et al., Scand. J. Dent. Res. 1990, 98, 211-214).
[0050] Sodium tripolyphosphate (STP) is a condensed phosphate used in whitening dentrifice such as Aquafresh Whitening (GlaxoSmithKline, UK) has been shown to be effective in removing stains in vitro (Sharif et al., Br. Dent. J. 2000, 188, 620-4). Tetrasodium pyrophosphate (TSPP) is a condensed phosphate used in whitening oral care products such as Colgate Visible White (Colgate-Palmolive, USA). TSPP is also reported to prevent the formation and removal of stains from hydroxyapatite (Shellis et al., J. Dent. 2005, 33, 313-324).

[0051] The present disclosure provides a chewing gum containing nicotine polacrilex as the active ingredient along with TSPP which provides a tooth whitening effect. The composition also comprises buffering agent, and gum base. [0052] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4. In another embodiment, the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:2.
[0053] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate, and combinations thereof. In another embodiment, the at least one active ingredient is nicotine polacrilex. [0054] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine

salicylate, nicotine benzoate, nicotine lactate, nicotine citrate, and combinations thereof.
[0055] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the at least one active ingredient is nicotine polacrilex. [0056] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is nicotine polacrilex.
[0057] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof. In another embodiment of the present disclosure, the at least one buffering agent is selected from a group consisting of sodium carbonate, sodium hydrogen carbonate, and combinations thereof.
[0058] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof. In another embodiment of the present disclosure, the at least one buffering agent is a combination of sodium carbonate, and sodium hydrogen carbonate.
[0059] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said

composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate and combinations thereof, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof.
[0060] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the at least one whitening agent is selected from the group consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof. In another embodiment, the at least one whitening agent is TSPP.
[0061] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one whitening agent is selected from the group consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof.
[0062] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco

alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate and combinations thereof, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof, and wherein the at least one whitening agent is selected from the group consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof. [0063] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the at least one whitening agent is TSPP. [0064] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one whitening agent is TSPP.
[0065] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is nicotine polacrilex, and wherein the at least one whitening agent is TSPP.
[0066] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said

composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is nicotine polacrilex, and wherein the at least one whitening agent is TSPP, and wherein the at least one buffering agent is a combination of sodium carbonate, and sodium hydrogen carbonate.
[0067] In an embodiment of the present disclosure, there is provided a chewable composition as described herein, wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof.
[0068] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof. [0069] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate and combinations thereof, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof, and wherein the at least one whitening agent is selected from the group

consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof and wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof.
[0070] In an embodiment of the present disclosure, there is provided a chewable composition as described herein, wherein the composition comprises: a) at least one buffering agent having a weight percentage in the range of 0.5% - 2.0% with respect to the composition; b) at least one whitening agent having a weight percentage in the range of 0.5% - 2.0% with respect to the composition; and c) at least one gum base having a weight percentage in the range of 20% - 35% with respect to the composition.
[0071] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one buffering agent has a weight percentage in the range of 0.5% - 2.0% with respect to the composition; the at least one whitening agent has a weight percentage in the range of 0.5%) - 2.0%) with respect to the composition; and the at least one gum base has a weight percentage in the range of 20% - 35% with respect to the composition. [0072] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof, and wherein the at least one whitening agent is selected from the group consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium

hexametaphosphate, and combinations thereof, and wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof, and wherein the at least one buffering agent has a weight percentage in the range of 0.5% - 2.0% with respect to the composition; the at least one whitening agent has a weight percentage in the range of 0.5% - 2.0%> with respect to the composition; and the at least one gum base has a weight percentage in the range of 20% - 35% with respect to the composition.
[0073] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is in form of a pellet, and the at least one active ingredient is having an amount in a range of 1.5 mg to 6.0 mg with respect to the pellet. In another embodiment, the at least one active ingredient is having an amount in a range of 1.5mg to 4.0mg with respect to the pellet. [0074] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one buffering agent has a weight percentage in the range of 0.5% - 2.0% with respect to the composition; the at least one whitening agent has a weight percentage in the range of 0.5%) - 2.0%) with respect to the composition; and the at least one gum base has a weight percentage in the range of 20% - 35% with respect to the composition, and wherein the composition is in form of a pellet, and the at least one active ingredient is having an amount in a range of 1.5 mg to 6.0 mg with respect to the pellet. [0075] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation

exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate, and combinations thereof, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof, and wherein the at least one whitening agent is selected from the group consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof, and wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof, and wherein the at least one buffering agent has a weight percentage in the range of 0.5% - 2.0% with respect to the composition; the at least one whitening agent has a weight percentage in the range of 0.5% - 2.0% with respect to the composition; and the at least one gum base has a weight percentage in the range of 20% - 35% with respect to the composition, and wherein the composition is in form of a pellet, and the at least one active ingredient is having an amount in a range of 1.5 mg to 6.0 mg with respect to the pellet. [0076] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein wherein the composition further comprises: (a) at least one sweetener; and (b) at least one additive. In another embodiment of the present disclosure, the at least one additive is selected from the group consisting of humectants, binding agent, hydrating agent, coloring agent, polishing agent, fillers, coating syrup, and combinations thereof; and the at least one additive has a weight percentage in the range of 3%-5% with respect to the composition. In yet another embodiment of the present disclosure, the additive is humectant, wherein the humectant is glycerin. In yet another embodiment, the at least one additive is binding agent, wherein the binding agent is gum acacia or gum arabic. In an alternate embodiment of the present disclosure, the hydrating agent is liquid

maltitol, the polishing agent is carnauba wax, and the coloring agent is titanium dioxide.
[0077] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; d) at least one gum base; e) at least one sweetener; and f) at least one additive, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4.
[0078] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the at least one sweetener is selected from the group consisting of sucralose, mannitol, sorbitol, maltitol, xylitol, lactitol, erythritol, isomalt, aspartame, acesulfame K, neotame, stevia, high fructose syrup, honey, and combinations thereof; and the at least one sweetener has a weight percentage in the range of 45%-65% with respect to the composition. In another embodiment, the at least one sweetener is selected from a group consisting of sucralose, mannitol, maltitol, D-sorbitol, and combinations thereof. In another embodiment, the at least one sweetener has a weight percentage in the range of 50% - 60% with respect to the composition.
[0079] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; d) at least one gum base; e) at least one sweetener; and f) at least one additive, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one sweetener is selected from the group consisting of sucralose, mannitol, sorbitol, maltitol, xylitol, lactitol, erythritol, isomalt, aspartame, acesulfame K, neotame, stevia, high fructose syrup, honey, and combinations thereof; and wherein the at least one additive is glycerin, and wherein the at least one sweetener has a weight percentage in the range of 45%-65% with respect to the composition.
[0080] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering

agent; c) at least one whitening agent; d) at least one gum base; e) at least one sweetener; and f) at least one additive, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate, and combinations thereof, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof, and wherein the at least one whitening agent is selected from the group consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof, and wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof, and wherein the at least one sweetener is selected from the group consisting of sucralose, mannitol, sorbitol, maltitol, xylitol, lactitol, erythritol, isomalt, aspartame, acesulfame K, neotame, stevia, high fructose syrup, honey, and combinations thereof, and the at least one additive is selected from the group consisting of humectants, binding agent, hydrating agent, coloring agent, polishing agent, fillers, coating syrup, and combinations thereof.
[0081] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; d) at least one gum base; e) at least one sweetener; and f) at least one additive, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one buffering agent has a weight percentage in the

range of 0.5% - 2.0% with respect to the composition; the at least one whitening agent has a weight percentage in the range of 0.5% - 2.0% with respect to the composition; and the at least one gum base has a weight percentage in the range of 20%) - 35%) with respect to the composition, d) the at least one sweetener has a weight percentage in the range of 45%>-65%> with respect to the composition, and wherein the composition is in form of a pellet, and the at least one active ingredient is having an amount in a range of 1.5 mg to 6.0 mg with respect to the pellet. [0082] In an embodiment of the present disclosure, there is provided a a chewable composition as described herein, wherein the composition optionally comprises at least one flavoring agent selected from the group consisting of natural flavors, artificial flavors, and combinations thereof; and wherein the at least one flavoring agent has a weight percentage in the range of 1% to 3% with respect to the composition. In another embodiment, the at least one flavoring agent is mint, and wherein the at least one flavoring agent has a weight percentage of 1.5% to 2.5% with respect to the composition. In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; d) at least one gum base; e) at least one sweetener; f) at least one additive, and g) at least one flavoring agent, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate, and combinations thereof, and wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof, and wherein the at least one whitening agent is selected from the group

consisting of TSPP, sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof, and wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof, and wherein the at least one sweetener is selected from the group consisting of sucralose, mannitol, sorbitol, maltitol, xylitol, lactitol, erythritol, isomalt, aspartame, acesulfame K, neotame, stevia, high fructose syrup, honey, and combinations thereof; the at least one additive is selected from the group consisting of humectants, binding agent, hydrating agent, coloring agent, polishing agent, fillers, coating syrup, and combinations thereof and the at least one flavoring agent is selected from the group consisting of natural flavors, artificial flavors, and combinations thereof.
[0083] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; d) at least one gum base; e) at least one sweetener; f) at least one additive, and g) at least one flavoring agent; and wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, and wherein the at least one buffering agent has a weight percentage in the range of 0.5% - 2.0% with respect to the composition; the at least one whitening agent has a weight percentage in the range of 0.5%) - 2.0%) with respect to the composition; and the at least one gum base has a weight percentage in the range of 20% - 35% with respect to the composition; the at least one sweetener has a weight percentage in the range of 45%>-65%> with respect to the composition; the at least one additive has a weight percentage in the range of 3%>-5%> with respect to the composition; the at least one flavoring agent has a weight percentage in the range of 1% to 3% with respect to the composition, and wherein the composition is in form of a pellet, and the at least one active ingredient is having an amount in a range of 1.5 mg to 6.0 mg with respect to the pellet.
[0084] In an embodiment of the present disclosure, there is provided a chewable composition comprising: a) at least one active ingredient; b) at least one buffering

agent; c) at least one whitening agent; d) at least one gum base; e) at least one sweetener; f) at least one additive, and g) at least one flavoring agent, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4; and wherein the at least one active ingredient is nicotine polacrilex; and wherein the at least one buffering agent is a combination of sodium hydrogen carbonate, and sodium carbonate; the at least one whitening agent is selected from the group consisting of TSPP, titanium dioxide, and combinations thereof; the at least one additive is one or more of a glycerin, gum acacia, carnauba wax, liquid maltitol, titanium dioxide, and combinations thereof; the at least one sweetening agent is selected from a group consisting of sucralose, mannitol, D-sorbitol, maltitol, and combinations thereof; and wherein the at least one flavoring agent is mint.
[0085] In an embodiment of the present disclosure, there is provided a process for preparing a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, said composition prepared by a process comprising: a) obtaining the at least one active ingredient; b) obtaining the at least one buffering agent; c) obtaining the at least one whitening agent; d) obtaining the at least one gum base; and e) contacting the at least one active ingredient, the at least one buffering agent, the at least one whitening agent, and the at least one gum base to obtain the composition.
[0086] In an embodiment of the present disclosure, there is provided a process for preparing a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; d) at least one gum base, e) at least one sweetener; and f) at least one additive, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, said composition prepared by a process comprising: a) heating the at least one gum base to obtain a soft gum base; b) contacting the at least one active ingredient, the at least one buffering agent, the at least one whitening agent, the at least one sweetener, and the at least one additive to the soft

gum base to obtain a dough; c) processing the dough to obtain a processed dough; d) extruding the processed dough to obtain gum strip; e) cutting the gum strip to obtain gum pellets; and f) curing and coating the gum pellet with the at least one additive, to obtain the chewable composition.
[0087] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein heating is at a temperature in the range of 45°C to 60°C for a time period of 45 to 60 minutes. In another embodiment of the present disclosure, heating is at a temperature in the range of 50°C to 55°C for a time period of 50 to 55 minutes.
[0088] In an embodiment of the present disclosure, there is provided a process for preparing a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; d) at least one gum base, e) at least one sweetener; and f) at least one additive, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, said composition prepared by a process comprising: a) heating the at least one gum base to obtain a soft gum base, wherein heating is at a temperature in the range of 45°C to 60°C for a time period of 45 to 60 minutes; b) contacting the at least one active ingredient, the at least one buffering agent, the at least one whitening agent, the at least one sweetener, and the at least one additive to the soft gum base to obtain a dough; c) processing the dough to obtain a processed dough; d) extruding the processed dough to obtain gum strip; e) cutting the gum strip to obtain gum pellets; and f) curing and coating the gum pellet with the at least one additive, to obtain the chewable composition. [0089] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is used as a tooth whitener. [0090] In an embodiment of the present disclosure, there is provided a process for preparing a chewable composition comprising: a) at least one active ingredient; b) at least one buffering agent; c) at least one whitening agent; and d) at least one gum base, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, wherein the composition is used as a tooth whitener.

as described herein, wherein the composition is in the form of a chewing gum. In another embodiment of the present disclosure, the chewing gum is in form of a pellet. In yet another embodiment of the present disclosure, the chewing gum is in form of a strip.
[0092] Although the subject matter has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the subject matter, will become apparent to persons skilled in the art upon reference to the description of the subject matter. It is therefore contemplated that such modifications can be made without departing from the spirit or scope of the present subject matter as defined. EXAMPLES
[0093] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may apply. [0094] The working examples described herein clearly depict the potential of tetrasodium pyrophosphate (TSPP) to remove stains caused by black tea, pan masala in combination with tobacco, and cigarette smoke condensate from hydroxyapatite (HA). The present disclosure is directed to a chewing gum-based composition comprising at least one whitening agent (TSPP) and at least one buffering agent, wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4, which

when used is effective in removal of stains caused by black tea, pan masala, tobacco stains, and cigarette condensate.
[0095] In the present method, hydroxyapatite (HA) film was used as a model for the tooth enamel, wherein the effect of TSPP on the interaction of stains with hydroxyapatite (HA) was quantified to determine its stain removal efficacy. One of the chosen staining solution as discussed above was black tea. The colour of black tea is due to a variety of polyphenols, substances which bind to various salivary proteins, particularly proline rich proteins and histatins (McArthur et al., J. Chem. Ecol. 1995, 21, 663-91). Tea polyphenols has been shown to bind to salivary pellicle (Joiner et al., Eur. J. Oral Sci.2003, 111, 417-22) and black tea has already been used successfully in previous in vitro and in vivo studies on staining (Sharif et al., Br. Dent. J. 2000, 188, 620-4). MATERIALS AND METHODS Example 1: Formulation
[0096] Nicotine gum was prepared by heating a gum base at a temperature in the range of 45°C to 60°C for a period of 45 to 60 minutes to obtain a soft gum base. Further, the soft gum base is blended in a sigma mixer with at least one active ingredient, at least one buffering agent, at least one whitening agent, at least one sweetener, and at least one additive, to obtain a dough. The dough thus obtained was further processed to obtain a processed dough. The processed dough was further extruded to long strips of defined thickness using an extruder and fed into a rolling-scoring machine to obtain a gum strip. The gum strip was further cut to get the desired shape and size of gum pellets. The gum pellets were further subjected to curing and coating with the at least one additive to obtain the formulation. The Table 1 enlists the ingredients used in the formulation of the nicotine gum. [0097] The product is a nicotine chewing gum with nicotine polacrilex USP being the active ingredient. The product in addition to the active ingredient has the active tetrasodium pyrophosphate (TSPP) for teeth whitening and/or stain reduction. Nicotine chewing gum is a commonly used in nicotine replacement therapy (NRT) as a substitute for people who wish to quit their habit of using any form of nicotine/tobacco. The primary purpose of any NRT product is to gradually replace

the nicotine formally obtained from tobacco. It provides small and sustained quantities of nicotine without causing teeth stains usually associated with both smoking or chewing tobacco and pan masala. Furthermore, it helps to reduce the severity of withdrawal symptoms and cravings.
Example 2: In Vitro Studies
[0098] Hydroxyapatite (HA) coated tissue culture treated polystyrene well plates: The quantification of staining and de-staining of hydroxyapatite is carried out using the method described in Indian Pat. No. 1856/CHE/2015. Commercially available HA suspension was used to drop cast films of HA using layer by layer method into wells of a 48-well tissue culture treated polystyrene well plate. The dry drop casted HA films were then used for the staining and de-staining studies. Example 3: Staining and de-Staining of HA coated films

[0099] The HA films were stained using the staining solutions namely black tea, pan masala in combination with chewing tobacco, and cigarette smoke condensate. The freshly stained HA films were de-stained using solution of actives or masticated (simulated) extracts of chewing gum in buffer. The color of the dry stained and de-stained HA films was measured using a chromameter. Example 4: Chromameter measurements
[00100] Konica Minolta Chromameter (CR-400, Konica Minolta Inc., Japan)
was used for color measurements of the unstained, stained and de-stained hydroxyapatite films in the 48-well plate. The L*, a* and b* values of the films were measured, and these values were used to compute the AE* (total difference in color) as described by Hunter et ah; John Wiley & Sons Inc.; 1987; p 432 relative to unstained HA. The de-staining was quantified and represented as percent (%) of control. AE* value for the stain/control chewing gum was normalized to 100% and the formula [(AE*test/ (AE*controi)] X 100, was used to calculate the percent (%) stain remaining when the TSPP/product chewing gum was used. RESULTS AND DISCUSSION Dose response study
[00101] Dose response for TSPP against pan masala in combination with
chewing tobacco was established. For this purpose, the pan masala in combination with chewing tobacco formed on HA films were treated with varying concentrations of the active (TSPP) corresponding to that present in the chewing compositions of the present disclosure. The various concentrations of TSPP used were 1%, 1.5%, 2% and 3%. The images of the films after treatment with TSPP are shown in Figure la. From the Figure la, it can be observed that no significant efficacy of TSPP was observed beyond a concentration of 1.5%. The results were found to be comparable for the concentration 2.0% as well. Figure lb graphically depicts the level of de-staining represented as percent of control (0% active) normalized to 100%). From the figure lb it can be observed that chewing gum compositions comprising 1.5% and 2% of TSPP were found to exhibit maximum de-staining effect, which is 4.7% and 4.98% respectively, in comparison to the control. Chewing gum compositions comprising 2% TSPP were further formulated

based on the results observed from the Figure lb. The Table 2 mentioned below discloses composition of Nicotine Chewing Gum (NCG) with the amount of each ingredient represented as % (w/w) in the chewing gum.
Removal of black stains form hydroxyapatite (HA)
[00102] The efficacy of the chewing gum composition comprising 2% TSPP
was further evaluated for its de-staining capacity of black tea stains from HA. For this purpose, the black tea stains formed on HA films were treated with nicotine chewing gum extracts NCG -1 and NCG-2, and TSPP. The results of the HA films after treatment are presented in Figure 2a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 2b. From the figure 2b it can be understood that HA films exposed to black tea solution were least stained on treatment with TSPP. The level of de-staining was further quantified by comparing the AE* values of the samples relative to control (NCG-1). The results are presented in Figure 2c. The level of de-staining with NCG-1 was normalized to

100%. From the figure 2c, it can be observed that TSPP and NCG-2 can remove
stains caused by black tea up to 69 ± 3% and 56 ± 2% respectively.
Removal of pan masala and chewing tobacco stains from HA
[00103] The efficacy of the chewing gum composition comprising 2% TSPP
was further evaluated for its de-staining capacity of pan masala in combination with chewing tobacco from HA. For this purpose, the pan masala combined with chewing tobacco stains formed on HA films were treated with nicotine chewing gum extracts NCG -1 and NCG-2, and TSPP. The results of the HA films after treatment are presented in Figure 3a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 3b. From the figure 3b it can be understood that HA films exposed to pan masala in combination with chewing tobacco were least stained on treatment with TSPP. The level of de-staining was further quantified by comparing the AE* values of the samples relative to control (NCG-1). The results are presented in Figure 3 c. The level of de-staining with NCG-1 was normalized to 100%. From the figure 3c, it can be observed that TSPP and NCG-2 can remove stains caused by pan masala combined with chewing tobacco up to 89 ± 5% and 87 ± 2% respectively. Removal of cigarette smoke condensate stains from HA
[00104] The efficacy of the chewing gum composition comprising 2% TSPP
was further evaluated for its de-staining capacity of stains caused by cigarette smoke condensate from HA. For this purpose, the cigarette smoke condensate stains formed on HA films were treated with nicotine chewing gum extracts NCG -1 and NCG-2, and TSPP. The results of the HA films after treatment are presented in Figure 4a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 4b. From the figure 4b it can be understood that HA films exposed to cigarette smoke condensate were least stained on treatment with TSPP. The level of de-staining was further quantified by comparing the AE* values of the samples relative to control (NCG-1). The results are presented in Figure 4c. The level of de-staining with NCG-1 was normalized to 100%. From the figure 4c, it

can be observed that TSPP and NCG-2 can remove stains caused by cigarette smoke condensate up to 32 ± 9% and 29 ± 9% respectively. Comparative studies and non-working examples Removal of black stains
[00105] The HA films with black tea stains were further treated with other
NCG's (NCG-1, NCG-3 and NCG-5), and commercially available products, herein referred to as a market product to evaluate their ability to remove stains from the HA films, in comparison to TSPP. The results are presented in Figure 5a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 5b. From a combined reading of Figure 5a, and Figure 5b, it can be observed that NCG-1, NCG-3, NCG-5, and the market product were unable to remove stains from HA.
Removal of pan masala combined with chewing tobacco stain
[00106] The efficacy of NCG-1, NCG-3, NCG-5, and the market product in
their ability to remove stains caused by pan masala combined with chewing tobacco from HA was further evaluated. For this purpose, the pan masala combined with chewing tobacco stains formed on HA films were treated with nicotine chewing gum extracts NCG-1, NCG-3, NCG-5, and the market product. The results of the HA films after treatment are presented in Figure 6a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 6b. Further, the level of de-staining was further quantified by comparing the AE* values of the samples relative to control (stain). The results are presented in Figure 6c. From the Figure 6c it can be observed that only NCG-5 and NCG-3 exhibited around 34 ± 6% and 21 ± 11% removal of pan masala combined with chewing tobacco stains from HA respectively. NCG-1 and the market product did not exhibit any stain removal. It can be appreciated that although NCG-5 and NCG-3 exhibited stain removal it was very less as compared to NCG-2 as observed previously. Removal of cigarette smoke condensate stains

[00107] The efficacy of NCG-1, NCG-3, NCG-5, and the market product in
their ability to remove stains caused by cigarette smoke condensate from HA was further evaluated. For this purpose, the cigarette smoke condensate stains formed on HA films were treated with nicotine chewing gum extracts NCG-1, NCG-3, NCG-5, and the market product. The results of the HA films after treatment are presented in Figure 7a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 7b. From a combined reading of the Figure 7a, and Figure 7b, it can be observed that NCG-5, NCG-3, NCG-1 and the market product were unable to remove the cigarette smoke condensate stain from HA. Removal of black stains
[00108] The efficacy of NCG-2, NCG-3, NCG-4, and the market product in
their ability to remove stains caused by black tea from HA was further evaluated. For this purpose, the black tea stains formed on HA films were treated with nicotine chewing gum extracts NCG-2, NCG-3, NCG-4, the market product, and compared to TSPP. The results of the HA films after treatment are presented in Figure 8a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 8b. Further, the level of de-staining was further quantified by comparing the AE* values of the samples relative to control (NCG-3). The results are presented in Figure 8c. From the Figure 8c, it can be observed that NCG-4, NCG-2 and TSPP exhibited around 60 ± 5%, 66 ± 7% and 68 ± 1% removal of black tea stains respectively. The market product was unable to remove the black tea stain, unlike TSPP and NCG-2 and NCG-4. Removal of pan masala stain combined with chewing tobacco stain The efficacy of NCG-2, NCG-3, NCG-4, and the market product in their ability to remove stains caused by pan masala combined with chewing tobacco from HA was further evaluated. For this purpose, the black tea stains formed on HA films were treated with nicotine chewing gum extracts NCG-2, NCG-3, NCG-4, the market product, and compared to TSPP. The results of the HA films after treatment are presented in Figure 9a. The colour of the HA films was then measured on the

chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 9b. Further, the level of de-staining was further quantified by comparing the AE* values of the samples relative to control (NCG-3). The results are presented in Figure 9c. From the Figure 9c, it can be observed that NCG-4, NCG-2 and TSPP exhibited around 83 ± 4%, 83 ± 6% and 82 ± 2% removal of stains caused by pan masala combined with chewing tobacco, respectively. The market product did not offer any reduction in stain, and instead exhibited an enhancement of the stain. Removal of cigarette smoke condensate stains
[00109] The efficacy of NCG-2, NCG-3, NCG-4, and the market product in
their ability to remove stains caused by cigarette smoke condensate from HA was further evaluated. For this purpose, the cigarette smoke condensate stains formed on HA films were treated with nicotine chewing gum extracts NCG-2, NCG-3, NCG-4, the market product, and compared to TSPP. The results of the HA films after treatment are presented in Figure 10a. The colour of the HA films was then measured on the chromameter CR-400 to determine the AE* values relative to the unstained HA. The results are presented in Figure 10b. Further, the level of de-staining was further quantified by comparing the AE* values of the samples relative to control (NCG-3). The results are presented in Figure 10c. From the Figure 10c, it can be observed that none of the nicotine chewing gums NCG-3, NCG-4, NCG-2, and the market product could remove stains caused by cigarette smoke condensate.
[00110] It can be observed from Figures 5 to Figure 10 that not all chewing
gum compositions are effective in removal of stains caused by black tea, pan masala combined with chewing tobacco, and cigarette smoke condensate. In the absence of the ability to remove all the stains tested on HA films, NCG-1, NCG-3, NCG-5, and the market product, can be considered as a non-working example of the present disclosure. Although, the compositions of the present disclosure -NCG-2, and NCG-4 were not able to remove the stains caused by cigarette smoke condensate but they were efficiently able to remove stains caused by black tea, pan masala combined with chewing tobacco stain. Therefore, the composition of the

present disclosure displays a loom wmiening eneci/ de-siaining eneci in me disclosed w/w ratio range and the same has been established experimentally as described herein.
Advantages of the present disclosure:
[00111] The present disclosure reveals that chewing gum compositions are
effective in removing stains caused by black tea, cigarette smoke condensate and pan masala combined with chewing tobacco. Further, the composition is formulated in the form of a gum because of which, the chewing gum compositions of the present disclosure could be consumed at any time of the day, even outside the comfort of the home. One of the embodiment also discloses that the chewing gum can be extruded in form of pellets which can be easily packaged, transported, and consumed. Also, due to the presence of active ingredient - nicotine, the gum compositions of the present disclosure can significantly reduce withdrawal symptoms or even eliminate them. Therefore, the gum compositions of the present disclosure would be beneficial in terms of providing tooth whitening and for nicotine replacement therapy.

I/We Claim:
1. A chewable composition comprising:
a) at least one active ingredient;
b) at least one buffering agent;
c) at least one whitening agent; and
d) at least one gum base,
wherein the at least one whitening agent to the at least one buffering agent w/w ratio in said composition is in the range of 1:1 to 1:4.
2. The composition as claimed in claim 1, wherein the at least one active ingredient is selected from the group consisting of nicotine polacrilex, tobacco alkaloids, nicotine, nicotine salt, free base form of nicotine, nicotine cation exchanger, nicotine inclusion complex, nicotine bound to zeolites, nicotine bound to cellulose microspheres, nicotine bound to starch microspheres, nicotine mimicking agents, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulphate, nicotine zinc chloride, nicotine salicylate, nicotine benzoate, nicotine lactate, nicotine citrate, and combinations thereof.
3. The composition as claimed in claim 2, wherein the at least one active ingredient is nicotine polacrilex.
4. The composition as claimed in claim 1, wherein the at least one buffering agent is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium phosphate, monocalcium phosphate, calcium carbonate, calcium phosphate and combinations thereof.
5. The composition as claimed in claim 1, wherein the at least one whitening agent is selected from the group consisting of tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate, sodium percarbonate, sodium pyrophosphate, sodium hexametaphosphate, and combinations thereof.
6. The composition as claimed in claim 5, wherein the at least one whitening agent is tetrasodium pyrophosphate (TSPP).

7. The composition as claimed in claim 1, wherein the at least one gum base is selected from the group consisting of chicle latex, jelutong latex, crepelatex, synthetic rubber, polyvinyl acetate, and combinations thereof.
8. The composition as claimed in claim 1, wherein the composition comprises:

a) at least one buffering agent having a weight percentage in the range of 0.5% - 2.0% with respect to the composition;
b) at least one whitening agent having a weight percentage in the range of 0.5%) - 2.0%) with respect to the composition; and
c) at least one gum base having a weight percentage in the range of 20%) - 35%o with respect to the composition

9. The composition as claimed in claim 8, wherein the composition is in form of a pellet, and the at least one active ingredient is having an amount in a range of 1.5 mg to 6.0 mg with respect to the pellet.
10. The composition as claimed in claim 1, wherein the composition further comprises: (a) at least one sweetener; and (b) at least one additive.
11. The composition as claimed in claim 10, wherein the at least one sweetener is selected from the group consisting of sucralose, mannitol, sorbitol, maltitol, xylitol, lactitol, erythritol, isomalt, aspartame, acesulfame K, neotame, stevia, high fructose syrup, honey, and combinations thereof; and the at least one sweetener has a weight percentage in the range of 45% -65%o with respect to the composition.
12. The composition as claimed in claim 10, wherein the composition optionally comprises at least one flavoring agent selected from the group consisting of natural flavors, artificial flavors, and combinations thereof; and wherein the at least one flavoring agent has a weight percentage in the range of 1-3 % with respect to the composition.
13. A process for preparing a composition as claimed in claim 1, said process comprising:

a) obtaining at least one active ingredient;
b) obtaining at least one buffering agent;
c) obtaining at least one whitening agent;

d) obtaining at least one gum base; and
e) contacting the at least one active ingredient, the at least one buffering agent, the at least one whitening agent, and the at least one gum base to obtain the composition.
14. A process for preparing a composition as claimed in claims 1 to 12, said
process comprising:
a) heating the at least one gum base to obtain a soft gum base;
b) contacting the at least one active ingredient, the at least one buffering agent, the at least one whitening agent, the at least one sweetener, and the at least one additive to the soft gum base to obtain a dough;
c) processing the dough to obtain a processed dough;
d) extruding the processed dough to obtain gum strip
e) cutting the gum strip to obtain gum pellets
f) curing and coating the gum pellet with the at least one additive, to obtain the chewable composition.

15. The process as claimed in claim 14, wherein heating is at a temperature in the range of 45°C to 60°C for a period of 45 to 60 minutes.
16. The composition as claimed in any of the claims 1 to 12, wherein the composition is used as a tooth whitener.