FIELD OF THE INVENTION
The present invention relates to a herbal composition. More particularly, the present invention relates to a synergistic herbal composition for preventing or reducing the risk of cancer associated with tobacco use.
BACKGROUND OF THE INVENTION
Tobacco (Nicotiana spp.) consumption is a global dangerous health problem. Use of tobacco products either by smoking cigarette, pipe, cigar, bidis, hookah or in the form of smokeless tobacco like chewing tobacco, moist smokeless tobacco or dry snuffs; has been linked to an increased risk of various types of cancer. Cancer linked to the use of smokeless tobacco includes mouth, tongue, cheek and gum cancer (sub mucous fibrosis), cancer in the oesophagus and pancreatic cancer. Further, experimental results prove a causal association between cigarette smoking and cancer of the lung, oral cavity, pharynx, larynx, oesophagus, urinary bladder and renal pelvis. The most harmful carcinogens present in tobacco are nicotine, tobacco specific nitrosamines (TSNA’s), formaldehyde, acetaldehyde, crotonaldehyde, hydrazine, arsenic, nickel, cadmium and benzopyrene. Numerous methods and devices to reduce or remove toxic components from tobacco or tobacco smoke have been proposed and constructed.
US patent publication no. US20140088045A1 describes a smoke cessation product comprising nicotine containing material and an agent consisting of at least one anti-cancer agent, an anti-inflammatory agent or a combination thereof. For instance, the agent is a combination of a phospho-non-steroidal anti-inflammatory agent (NSAID) and curcumin.
PCT patent publication no. WO0200046A1 provides methods, devices and agents for the removal of nucleophilic toxins present in tobacco and tobacco smoke. The method comprises incorporation of suitable agent into the filter element of smoking device that will trap nucleophiles present in the tobacco or formed during burning of tobacco, for example in cigarette smoke, and do not release them when the agent itself burns. The filter element, interposed between the smoke stream and mouth, containing suitable agents, act as first line trap for harmful components. Examples of agents includes aldehydes, activated ketones, anhydrides and active esters wherein a, ß- unsaturated ketones may include 1, 2-dibenzoylethylene, curcumin and dicinnamalacetone.
PCT patent publication no. WO2014151477A1 describes a composition for inhibiting sensory irritation caused during consumption of smokeless tobacco product. Said composition contains smokeless tobacco for example- chewing tobacco and at least two active ingredients, wherein the active ingredient functions as antagonists to one or more receptor and/or channels, that play a significant role in transmission of sensations of irritation. For example-active ingredient curcumin is a potent antagonist of the TRPV1 sensory channel.
Nature has endowed us with a variety of herbs that possess numerous phytochemical compounds that can be used as an active ingredient in preparation of herbal medicines as well as chemopreventive agents. Herbs with proven beneficial effects in prevention of cancer include Curcuma longa (Turmeric) and Piper nigrum (Black pepper). Quercetin, a naturally occurring flavonoid, is also well known for its anti-cancerous and chemopreventive properties.
Quercetin, a phyotchemical (flavonoid) present in fruits, vegetables and other dietary supplements, is one of the most important naturally occurring cancer preventing agent. The anticancer property of quercetin is attributable to its ability to inhibit enzymes responsible for the activation of carcinogens. Quercetin is also known to possess the special ability of scavenging highly reactive oxygen species, that can cause oxidative damage to cellular components, such as proteins, lipids, and deoxyribonucleic acid (Molecular Targets Underlying the Anticancer Effects of Quercetin: An Update, Khan Fazlullah et al, Nutrients 2016, 8, 529, 1-19). Thus quercetin plays an important role in protecting human cells from carcinogens namely Polycyclic Aromatic Hydrocarbons (PAH), Benzopyrene (BaP) and N-nitroso compounds present in tobacco products, hence minimizing smoking-related cancer risk (Dietary Flavonoid Intake and Smoking-Related Cancer Risk: A Meta-Analysis, Woo et al, PLOS, September 2013, Vol.8(9), 1-13).
Black pepper (Piper nigrum L.) often termed as “king of spices” is known to possess useful alkaloids namely piperine and its isomers, in fruits and roots of the plant. Piperine has been reported to inhibit the proliferation and survival of many types of cancer cells. It acts by inducing cell cycle arrest, increased cell apoptosis, disruption of redox homeostasis, attenuation of CSC self-renewal, inhibition of angiogenesis, modulation of ER stress, and autophagy, influence on the Wnt/ß-catenin and inhibition of PI-3K/Akt signaling pathways (Cancer chemoprevention and piperine: Molecular mechanism and therapeutic opportunities, Frontiers in Cell and Developmental Biology, February 2018, Vol.6, Article 10, 1-12).
Turmeric (Curcuma longa L.) is a widely used, popular Indian medicinal plant belonging to the family of Zingiberaceae. Curcumin (diferuloylmethane), a polyphenolic compound, extracted from the roots of turmeric, is well known for its anti-inflammatory, anti-oxidant, anti-bacterial and anti-cancer activities. It inhibits cell proliferation and induces apoptosis in human leukaemia, prostate cancer and non-small cell lung cancer. Curcumin affects cancers associated with tobacco use by absorbing nitric oxide, a chemical produced in the lungs when they are exposed to tobacco. This prevents nitric-oxide-induced reactions associated with cancer and inflammation. Curcumin also stops the cellular reaction in both the lungs and the mouth that activates cancer-causing agents in both cigarette smoke and smokeless tobacco (Understanding herbal healing, Phyllis A Balch, Part-I-pp: 137)
Turmeric oil is secondary metabolite of turmeric and obtained by steam distillation of its rhizomes. Turmeric oil chiefly comprises ar-turmerone and ß-turmerone (Curlone). (Pharmacological profile of Turmeric oil: A Review, Verma et al., LEK. SIROV. Vol. XXXV, No. 35, Page 3-21, Belgrade 2015). Experimental results confirmed that turmerone supports curcumin absorption and also significantly increases the amount of curcumin inside the cell (The role of turmerones on curcumin transportation and P-glycoprotein activities in intestinal caco-2 cells, J Med Food (2012) Mar; 15(3):242-252).
Although the methods, compositions and devices disclosed in the aforementioned prior arts endeavour to prevent or reduce the risk of developing cancer or cancers associated with tobacco by using natural anti-cancer agents, there are no reports on the combined effects, particularly synergistic effect, of the aforestated natural anti-cancer agents. A synergistic effect occurs when two or more components with or without the same overt effect, are used together to yield a combined effect that has an outcome greater than the sum of the single components alone. Synergistic effect may also occur, when only one component exerts an action that is made greater by the presence of a second component.
Chemoprevention or reduction of the risk of cancer is an emerging highly promising approach to cancer prevention or reduction of the risk of. Thus, there exists a need to provide a novel synergistic herbal composition that will prevent or reduce the risk of developing cancer or lowers the chances of its recurrence among tobacco users without affecting the taste, flavor or enjoyment of the product.
OBJECT OF THE INVENTION
The main object of the present invention is to provide a composition that overcomes limitations of the prior art.
It is an object of the present invention to provide a novel synergistic herbal composition that will prevent or reduce the risk of developing cancer or lowers the chances of its recurrence among tobacco users.
Another objective of the present invention is to provide the novel synergistic herbal composition administered in combination with smoking and/or smokeless tobacco without affecting the taste, flavor or enjoyment of the product.
Yet another objective of the present invention is to provide a filter element of a tobacco smoking device capable of delivering the herbal synergistic composition.
SUMMARY OF THE INVENTION
The present invention relates to a novel synergistic herbal composition that will prevent or reduce the risk of developing cancer or lowers the chances of its recurrence among tobacco users comprising Curcuma longa extract, turmeric oil, Piper nigrum extract, and Quercetin.
In accordance with an embodiment of the invention, there is provided a novel synergistic herbal composition comprising Curcuma longa extract comprising curcumin, turmeric oil comprising turmerone, Piper nigrum extract comprising piperine, and Quercetin wherein the composition ameliorates the carcinogenic effect and oxidative stress produced by the nucleophilic toxins produced from smokeless or smoking tobacco product.
In accordance with another embodiment of the invention, the novel synergistic herbal composition comprises Curcuma longa extract comprising curcumin is in range of 10 to 60% w/w.
In accordance with yet another embodiment of the invention, the novel synergistic herbal composition comprises turmeric oil comprising turmerone is in a range of 2.5 to 15% w/w.
In accordance with yet another embodiment of the invention, the novel synergistic herbal composition comprises Piper nigrum extract comprising piperine is in a range of 0.5 to 2% w/w.
In accordance with another embodiment of the invention, the novel synergistic herbal composition comprises Quercetin in a range of 5 to 20% w/w.
In accordance with yet another embodiment of the invention, the novel synergistic herbal composition is administered along with tobacco product, i.e. smokeless or smoking tobacco product.
In accordance with yet another embodiment of the invention, the novel synergistic herbal composition is incorporated in the filter element of tobacco smoking device, so that it can be inhaled along with tobacco smoke thus entering the lungs and mouth of smoker.
In accordance with yet another embodiment of the invention, the novel synergistic herbal composition wherein the herbal composition is from 0.1 to 10%w/w of filter element of tobacco smoking device.
In accordance with yet another embodiment of the invention, the filter element of the tobacco smoking device is a cigarette filter wherein, the filter traps the nucleophilic toxins present in tobacco or tobacco smoke.
In accordance with yet another embodiment of the invention, the novel synergistic herbal composition is incorporated in the matrix of filter element of a tobacco smoking device by dissolving in solvent.
In accordance with yet another embodiment of the invention, wherein the solvent is selected from the group comprising of water, methanol, ethanol, 1,3-propylene glycol, glycerol or a mixture thereof.
In accordance with an embodiment of the invention, the novel synergistic herbal composition is in oral form like tablets, capsules, syrup, suspension, oral film, filter and sachets.
In accordance with yet another embodiment of the invention, there is provided a process for preparing a novel synergistic herbal composition, comprising the steps of adding and mixing in a mixing vessel Curcuma longa extract comprising Curcumin; Turmeric oil comprising Turmerone; Piper nigrum extract comprising Piperine and Quercetin in a pre-determined ratio.
DESCRIPTION OF THE INVENTION
Discussed below are some representative embodiments of the current invention. The invention in its broader aspects is not limited to the specific details and representative methods. The illustrative examples are described in this section in connection with the embodiments and methods provided. The invention according to its various aspects is particularly pointed out and distinctly claimed in the attached claims read in view of this specification, and appropriate equivalents.
It is to be noted, as used in the specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a composition containing “a compound” includes a mixture of two or more compounds. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. The expression of various quantities in terms of “%w/w” means the percentage by weight, relative to the weight of the total composition unless otherwise specified.
The expression of quantity in terms of "% w/w" or “%” means the percentage by weight, relative to the weight of the total solution or composition, unless otherwise specified.
The present invention describes a novel synergistic herbal composition, process for preparation and incorporation of herbal composition into the filter element of a tobacco smoking device.
The novel synergistic herbal composition comprises of Curcuma longa extract comprising curcumin in range of about 10 to 60% w/w, turmeric oil comprising turmerone in range of 2.5 to 15% w/w, Piper nigrum extract comprising piperine in range of about 0.5 to 2% w/w and Quercetin in range of 5 to 20% w/w.
The filter element of a tobacco smoking device is a component of a cigarette, along with cigarette paper, capsules and adhesives. The filter may be made from cellulose acetate fibre, paper or activated charcoal (either as a cavity filter or embedded into the cellulose acetate). The acetate and paper modify the particulate smoke phase by particle retention (filtration), and finely divided carbon modifies the gaseous phase (adsorption). Filters can reduce "tar" and nicotine smoke yields up to 50%, with a greater removal rate for other classes of compounds (e.g., phenols), but are ineffective in filtering toxins such as carbon monoxide.
Smokeless tobacco includes tobacco products which are used by methods other than smoking, for instance, as snuff and chewing tobacco. Toxic products present in tobacco also enter the body by these methods of using tobacco which do not involve combustion, and these products are also associated with numerous adverse affects of tobacco use.
Nucleophilic toxins are the toxic compounds present in tobacco and volatilized during its combustion, as well as those formed as a result of combustion. These include gaseous compounds, such as carbon monoxide, hydrogen cyanide, ammonia, and formaldehyde, and others that are volatilized in tobacco smoke, such as benzene, acrolein, hydrazine, and aniline. Collectively, the solid material which may be condensed from tobacco smoke is known as tar. Several compounds in smoke and tar are classified as carcinogens: benzene, 2-naphthylamine, 4-aminobiphenyl, and the radioactive element polonium-210. Others are considered probably human carcinogens, such as formaldehyde, hydrazine, N-nitrosodimethylamine, N-nitrosodiethylamine, N-nitrosopyrrolidine, benzo[a]pyrene, N-nitrosodiethanolamine, and cadmium.
In one preferred embodiment, the novel synergistic herbal composition is incorporated in the filter element of tobacco smoking device for example cigarette filter, so that it can be inhaled along with tobacco smoke thus entering the lungs and mouth of smoker, said filter element of the tobacco smoking device is a cigarette filter and it is used to trap nucleophilic toxins present in tobacco or tobacco smoke.
The solvent used for incorporating the herbal composition in the material of filter element of tobacco smoking device is selected from the group consisting of water, methanol, ethanol, 1,3-propylene glycol, glycerol or a mixture thereof.
The novel synergistic herbal composition of the present invention prevent or reduce the risk of developing cancer or lowers the chances of its recurrence among tobacco users. The composition will ameliorate the carcinogenic effect and oxidative stress produced by the nucleophilic toxins produced from cigarette smoke.
The present invention is more particularly described in the following non-limiting examples that are intended as illustrations only since numerous modifications and variations within the scope of the present invention will be apparent to a skilled artisan. Unless otherwise noted, all parts, percentages, and ratios reported in the following examples are on a weight basis, and all reagents used in the examples were obtained or made available from the chemical suppliers.
Example 1
Process for preparation of herbal composition
Curcuma longa extract comprising curcumin (Sanat Products, 95%), turmeric oil comprising turmerone (Sanat Products), Piper nigrum extract comprising piperine (Sanat Products) and Quercetin (Kuber Impex) were commercially obtained from the market. Curcuma longa extract comprising curcumin, turmeric oil comprising turmerone, Piper nigrum extract comprising piperine and Quercetin were taken in required quantities as illustrated in Table 1 below were weighed and transferred in a mixing vessel. The active ingredients were mixed under normal conditions of temperature and pressure to obtain a homogenous mixture.
Table 1 below illustrates the various concentration ranges of the components of the synergistic herbal composition

Synergistic herbal components Composition
Components Example 1
(w/w) Example 2
(w/w) Example 3
(w/w) Example 4
(w/w)
Curcumin 10% 20% 40% 60%
Turmeric oil/Turmerones 2.5% 5% 10% 15%
Piper nigrum 0.5% 1% 1.5% 2%
Quercetin 5% 10% 15% 20%

The composition of the present invention can be used in all oral dosage forms and includes tablets, capsule, syrup, suspension, oral film, filter and sachets, etc. The composition of the present invention can be incorporated in tablets, capsule, syrup, suspension, oral film, filter and sachets in a manner known per se. It will thus be seen that there is provided compositions which achieve the various objects of the invention and are well adapted to meet the conditions of practical use.
The present invention also provides a filter element of a tobacco smoking device preferably a cigarette filter, capable of delivering the herbal synergistic composition.

Example 2
Process for incorporation herbal composition in filter element of tobacco smoking device and smokeless tobacco product
The herbal composition of the present invention as obtained from Example 1 is dissolved in sufficient amount of solvent e.g. ethanol. This solvent containing dissolved active ingredients of the composition is incorporated in the material of filter element of tobacco smoking device. The filter element being used in the present invention is the conventional one that is normally being used in cigarette and is well known to a person skilled in art. The herbal composition is in the range of 0.1 – 10% w/w of filter plug or element of the tobacco smoking device.
The herbal composition of the present invention as obtained from Example 1 is admixed with the smokeless tobacco product in a manner known per se.
While particular embodiments of the present invention are illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is thereof intended to cover in the appended claims such changes and modifications that are within the scope of the invention.

CLAIMS
1. A novel synergistic herbal composition for reducing the risk of cancer comprising:
- Curcuma longa extract comprising curcumin;
- Turmeric oil comprising turmerone;
- Piper nigrum extract comprising Piperine; and
- Quercetin
wherein, the composition ameliorates the carcinogenic effect and oxidative stress produced by the nucleophilic toxins produced from smokeless or smoking tobacco product.
2. The novel synergistic herbal composition as claimed in claim 1, wherein the Curcuma longa extract comprising curcumin is in range of 10 to 60% (w/w).
3. The novel synergistic herbal composition as claimed in claim 1, wherein the Turmeric oil comprising turmerone is in range of 2.5 to 15% (w/w).
4. The novel synergistic herbal composition as claimed in claim 1, wherein the Piper nigrum extract comprising Piperine is in range of 0.5 to 2% (w/w).
5. The novel synergistic herbal composition as claimed in claim 1, wherein the Quercetin is in range of 5 to 20% (w/w).
6. The novel synergistic herbal composition as claimed in claim 1, wherein the composition is administered along with tobacco product, i.e. smokeless or smoking tobacco product.
7. The novel synergistic herbal composition as claimed in claim 1, wherein the composition is incorporated in the filter element of tobacco smoking device, so that it can be inhaled along with tobacco smoke thus entering the lungs and mouth of smoker.
8. The novel synergistic herbal composition as claimed in claim 7, wherein the composition is from 0.1-10% w/w of filter element of tobacco smoking device.
9. The filter element of the tobacco smoking device as claimed in claim 7, wherein the filter traps the nucleophilic toxins present in tobacco or tobacco smoke.
10. The novel synergistic herbal composition as claimed in claim 7, wherein the herbal composition is incorporated in the matrix of filter element of a tobacco smoking device by dissolving in solvent.
11. The novel synergistic herbal composition as claimed in claim 10, wherein solvent is selected from the group consisting of water, methanol, ethanol, 1,3-propylene glycol, glycerol or a mixture thereof.
12. The novel synergistic herbal composition as claimed in claim 1 is in oral form like tablets, capsules, syrup, suspension, oral film, filter and sachets.
13. A method for the novel synergistic herbal composition comprising, adding and mixing Curcuma longa extract comprising Curcumin; Turmeric oil comprising Turmerone; Piper nigrum extract comprising Piperine and Quercetin to obtain a homogenous mixture.