WO2015001574A1 - A nicotine free synergistic polyherbal masticatory formulation and a process for the preparation thereof - Google Patents
A nicotine free synergistic polyherbal masticatory formulation and a process for the preparation thereof Download PDFInfo
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- WO2015001574A1 WO2015001574A1 PCT/IN2014/000446 IN2014000446W WO2015001574A1 WO 2015001574 A1 WO2015001574 A1 WO 2015001574A1 IN 2014000446 W IN2014000446 W IN 2014000446W WO 2015001574 A1 WO2015001574 A1 WO 2015001574A1
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- A—HUMAN NECESSITIES
- A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
- A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
- A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
- A24B15/10—Chemical features of tobacco products or tobacco substitutes
- A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
Definitions
- the present invention relates to a nicotine free synergistic polyherbal masticatory formulation and a process for the preparation thereof.
- the formulation exhibits tobacco de-addiction properties and is envisaged to replace tobacco based harmful products.
- Amla as an antioxidant has been examined by a number of authors (Kumaran et al., 2006; Rao et al., 2005; Naik et al, 2005; Bajpai et al., 2005; Bhattacharya et al, 2002, Anila et al, 2002, Scartezzini, 2000; Bandyopathyay et al., 2000, Chaudhuri, 2003).
- the studies showed that amla preparations contain high levels of free-radical scavenger, superoxide dismutase (SOD).
- SOD superoxide dismutase
- Amla besides being an antioxidant, also possesses anti-carcinogenic, antitumor, anti-genotoxic, and antiinflammatory properties. Medical studies conducted on amla fruit suggest that it has
- Menthol mint ⁇ Mentha an'ensis is generally used as a cooling agent and provides fresh breath, with antibacterial, antiseptic, antipyretic and antispasmodic activities (Farah Al- Bazaz, and Mohammed Al-Casey (201 1).
- Saunf (Foenicahim vulgare) is reported to be a digestive, blood purifier and breath freshener (Liverstrong.com. Retrieved 27 December 2012).
- Elaichi - ⁇ Elettaria cardamomum Linn. has been traditionally used for improving digestion and relieving gases. It has also been used as a stimulant, breath freshener, and aphrodisiac (Sakai et al., 1989).
- Javitri ⁇ Mace is traditionally used for diarrhoea, nausea, stomach spasms and pain, and intestinal gases (published in Natural Standard Research Collaboration, August 201 1).
- Areca nuts are traditionally chewed with betel leaf for their effect as a mild stimulant, causing a warming sensation in the body (Ashok Lingappa et al , 201 1).
- Majuphal ⁇ Quercus infectoria - Olivier also known as Gall oak/magic nut is very useful in bleeding disorders which stops bleeding from the gums (Wasim Ahmad et al, 201 1).
- Majuphal alone or in combination with other herbs is a promising remedy for dental troubles. It is also a powerful astringent and styptic agent (Basri Dayang Fredalina and Fan SH, 2005). However, none of them have been reported to exhibit tobacco deaddiction property.
- Gutkha is a powdery, granular, light brownish to white substance, which is a preparation of crushed areca nut, tobacco, catechu, paraffin, slaked lime and sweet or savory flavorings.
- Gutkha begins to dissolve and turn deep red in color. It may impart upon its user a "buzz" somewhat more intense than that of tobacco chewing, snuffing and smoking.
- the extensive use of narcotic gutkhas causes severe health hazards including oral cancer.
- India gutkha is popular among all socioeconomic groups, particularly among teenagers. Globally, 5 million deaths per annum are attributed to tobacco use in one or the other form.
- Table 1 Composition and practices of the different types of tobacco containing
- the main objective of the present invention is to provide a synergistic polyherbal tobacco/ nicotine free masticatory formulation, which obviates the drawbacks of all present forms of tobacco based formulations and exhibits positive effects on the human health along with tobacco de-addiction property.
- Yet another objective of the present invention is to provide a formulation which is more or less similar in taste and flavor to that of a traditional tobacco based formulation, minus the nicotine content, which is beneficial and safe for human health, low cost and exhibits nutraceutical effects.
- Still another objective of the present invention is to provide a formulation which acts as a strong immunity booster along with having antioxidant and anti-diarrheal activities.
- Yet another objective of the present invention is to provide a formulation which comprises of menthol mint crystal useful as a mouth freshener and in tooth care; powder of saunf seed which is a digestive, blood purifier and breath freshener; powder of Elaichi used for improved digestion and relief from gases; powder of Javitri (Mace) used for relieving diarrhea, nausea, stomach spasms, pain and intestinal gas; small chips of areca nuts useful as a mild stimulant; and powder of majuphal fruit for curing bleeding disorders of gums.
- Another objective of the present invention is to provide a process for the preparation of said nicotine free polyherbal masticatory formulation useful for tobacco de-addiction.
- the present invention provides a synergistic nicotine free polyherbal masticatory formulation which comprises Emblica officinalis, Aegle marmelos (L) Correct, Mentha arvensis, Foeniciilum vulgare - Mill, Elettaria cardamomum Linn., Myristica fragrans Linn., Areca catechu - Linn., Quercus infectoria - Olivier in the ratio of 10-15% w/w, 12-17% w/w, 0.1 -.05% w/w, 0.5-1.0% w/w, 0.5-1.0% w/w, 0.2-0.7% w/w, 0.75- 1.50% w/w and 20-35% w/w, respectively along with sugar as a binder and with optional addition of essential oil or cooling agents.
- the powder of aforesaid plant components is mixed together to obtain a mixture of powders.
- sugar paste is prepared by dissolving sugar in water and heating up to a temperature of 45 °C or till the sugar dissolves by gradually increasing the temperature by 2°C till 70°C.
- the mixture of powder is added to sugar paste under stirring while optionally adding essential oils or cooling agents to obtain the polyherbal masticatory formulation for use in tobacco de-addiction.
- the present invention provides a formulation which is useful in relief from addiction of tobacco based formulations while fulfilling the requirement of minerals, vitamins and carbohydrates.
- Emblica officinalis powder or extract used is obtained from fruits.
- Aegle marmelos (L) Corre powder or extract used is obtained from fruits or leaves.
- Mentha arvensis powder or crystals used is obtained from rhizome, leaves or stem.
- Foeniculum vulgare - Mill powder used is obtained from flowers, seeds or leaves.
- Elettaria cardamomum Linn powder used is obtained from seeds, seed covers or whole fruits.
- the powder of Myristica fragrans Linn, used is obtained from fruits or fruit coat.
- the granules of Areca catechu - Linn used is obtained from fruit or seeds.
- the chip of Quercus infectoria - Olivier used is obtained from fruits or seeds.
- the Emblica officinalis extract is used for its antioxidant and strong immune modulator activity.
- the Aegle marmelos (L)Corre powder is used for its effect on gastroduodenal disorders.
- the Mentha an>ensis powder or crystal is used for imparting cooling and freshness effect.
- the Foeniculum vulgare - Mill powder is used as a natural mouth freshener as well as for its purgative effect.
- the Elettaria cardamomum Linn powder is used for its stimulating and breathe freshening effect.
- the Myristica fragrans Linn is used for providing relief from toothache with anti-oxidant and disease preventing properties.
- the granules of Areca catechu - Linn are used for their tobacco de-addiction property and also for curing sore throat and mouth infections.
- the Quercus infectoria - Olivier powder is used for its effect against bleeding disorders which stops bleeding from the gums and for alleviating dental troubles.
- the essential oils or cooling agents are selected from the group consisting of cardamom oil, clove oil, fennel oil, menthe oil and geranium oil.
- the quantity of the essential oil or cooling agent varies from 0.05 to 1.0 % v/w of the formulation.
- water is added to sugar in a ratio of 1 :3 and heated up to a temperature of 70°C till sugar dissolves properly to obtain a sugar solution or sugar paste.
- All powdered plant parts are mixed homogenously in a separate container and the sugar solution or the sugar paste is added. The mixture is stirred while gradually adding essential oils or cooling agents.
- the present invention provides a process for the preparation of the formulation comprising the steps of:
- step (c) adding the sugar paste as obtained in step (a) under stirring while optionally adding 0.05 to 1.5 % of essential oil or cooling agent to obtain the synergistic polyherbal masticatory formulation.
- Fig. 1 The F7 shows 0.99 total phenolics content when compared to gallic acid (3.70) at dose of 100 ⁇ g.
- Fig. 2 The F7 shows 3.93 DPPH activity when compared to gallic acid (4.0) at dose of 2000 ⁇ g. F7 shows the potency as like that of gallic acid as a marker.
- Fig. 3 The F7 shows 37.08% free radical scavenging activity when compared to Vitamin E (35.39%) at dose of 3.9 ⁇ g.
- Fig. 4 The F7 shows 56.52% free radical scavenging activity when compared to Vitamin E (35.39%) at dose of 7.8 ⁇ .
- the powder of aforesaid plant components is mixed together to arrive at a mixture of powders.
- sugar is added in water and heated up to a temperature of 45°C initially and thereafter the temperature is gradually increased by 2°C till 70°C or till the sugar dissolves to obtain a sugar solution or sugar paste.
- the sugar solution or sugar paste is mixed with the prepared mixture of powders under stirring, while optionally essential oils or cooling agents are added to obtain the synergistic polyherbal masticatory formulation of the present invention.
- the polyherbal masticatory formulation of the present invention has immense application in de-addiction of tobacco for addicted individuals with no harmful side effects. Rather the formulation will exert health promoting activity.
- the present formulation is useful as a tobacco supplement or a tobacco substitute, for use in e.g. smoking cessation, tobacco chewing urge and nicotine replacement therapies, which provides the user to reduce tobacco withdrawal symptoms without causing unacceptable adverse effects along with health rejuvenation being antimicrobial and antioxidant.
- Example number 7 the formulation prepared in Example number 7 was found to be most suitable as it obviated the drawbacks of the prior art.
- Menthol (Mentha an>ensis) 0.1 %
- the powders of the aforesaid plant components were mixed together to obtain a mixture of powders. Simultaneously, sugar was added to water and heated up to a temperature of 45°C initially and thereafter the temperature was gradually increased by 2°C till the sugar dissolved. The sugar solution was mixed with the mixture of powdered components under stirring, to obtain the desired formulation.
- the formulation was distributed for testing on a limited scale. It was unable to deliver desired effects.
- Menthol (Mentha arvensis) 0.05%
- the process for the preparation of the formulation was followed as per example 1.
- the formulation showed more sweetness and less freshness.
- Menthol (Mentha ar ⁇ >ensis) 0.05%
- Menthol (Mentha arvensis) 0.05%
- Menthol (Mentha ar ⁇ >ensis) 0.05%
- Geranium oil 0.85% v/w of the prepared formulation
- the process for the preparation of the formulation was followed as per example 1.
- the formulation induced less saliva and was more sweet in nature.
- Example 7 The formulation developed in Example 7 (hereinafter referred as "F7") was able to induce the typical taste and sensation of traditional Gutkha. Samples of this formulation were distributed to 79 persons in and around Lucknow city, India belonging to different socio-economic status. The feedback received from the volunteers was satisfactory.
- Age group and The age group of the sampled population ranged between 16 to 69 years with 81 % males and 19% females [Details sex of subject
- the prepared formulation is not a mere admixture resulting in the aggregation of the properties of the individual ingredients, rather a synergistic mixture of herbs as described in the examples recited above resulting in good taste, flavour, freshness and tobacco de-addiction property.
- Total phenolic content of F7 was determined using Folin-Ciocalteu (FC) reagent.
- FC Folin-Ciocalteu
- the formulation in solution form (0.1 ml) was mixed with 750 ⁇ of FC reagent (previously diluted 1000-fold with distilled water) and incubated for 5 min at 22°C, then 0.06% Na 2 C0 3 solution was added. After incubation at 22°C for 90 min, the absorbance was measured at 725 nm. The phenolic content was compared to the standard concentration of gallic acid. The result obtained in provided in Figure 1.
- FC Folin-Ciocalteu
- the percentage of radical scavenging activity of the samples was evaluated by comparing with a control (100 ⁇ methanol + 200 ⁇ of 0.2mM DPPH).
- EC50 effective concentration of 50%
- mice In vivo sub-acute oral toxicity In view of potent biological activity and scope of F7, sub-acute oral toxicity of the same was carried out on Swiss albino mice. Experiment was conducted in accordance with the Organization for Economic Co-operation and Development (OECD) test Guideline No. 423. For study, 60 mice (thirty of each sex) were taken and divided into Ten groups of six mice (six male and six female mice) each weighing 18-20 gm. The animals were maintained at 22 ⁇ 5°C with 50-70% humidity and an automatic dark and light cycle of 12 h. The animals were fed with the standard rat feed and provided ad libitum drinking water. Mice of group 1-4 were considered as experimental while the group 5 was kept as control.
- OECD Organization for Economic Co-operation and Development
- test material F7 was suspended in 0.7% carboxy methyl cellulose (CMC) to be orally administered in volumes of 0.5 mL at 5, 50, 300 and 1000 mg/kg body weight to animals of groups 1-4, respectively for 28 days. Control animals received only vehicle.
- CMC carboxy methyl cellulose
- the nicotine free polyherbal masticatory formulation of the present invention is safe to be used orally as the components used in the formulation are of herbal origin and do not produce any adverse side effect on the mouth as well as other organs of the body.
- the formulation is eco-friendly and economically viable. > No harmful components like tobacco are used in the formulation which can cause oral cancer. On the contrary, the developed foiTnulation improves oral health.
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Abstract
The present invention provides a nicotine free synergistic polyherbal masticatory formulation and a process for the preparation thereof. The prepared formulation exhibits tobacco de-addiction properties and is envisaged to replace tobacco based harmful products. The formulation of the present invention is useful as a tobacco supplement or a tobacco substitute for use in smoking cessation, tobacco chewing urge and nicotine replacement therapies, which provides the user to reduce tobacco withdrawal symptoms without causing unacceptable adverse effects along with health rejuvenation being antimicrobial and antioxidant.
Description
A NICOTINE FREE SYNERGISTIC POLYHERBAL MASTICATORY
FORMULATION AND A PROCESS FOR THE PREPARATION THEREOF
FIELD OF THE INVENTION The present invention relates to a nicotine free synergistic polyherbal masticatory formulation and a process for the preparation thereof. The formulation exhibits tobacco de-addiction properties and is envisaged to replace tobacco based harmful products.
BACKGROUND OF THE INVENTION
Today, tobacco is the leading cause of preventable death. Each year tobacco kills 4,000,000 people. 2500 Indians die every day due to tobacco related diseases. Needless to mention here that smokeless tobacco including paan masala, gutkha, khaini, etc. are not any safer than cigarettes. They contain nicotine and other cancer causing chemicals just like cigarettes. Research has shown that in order to break the nicotine addiction, some form of nicotine replacement therapy must be provided to the effected individuals. These must be designed to reduce cravings for tobacco and relieve the withdrawal symptoms that people experience while trying to quit tobacco.
Many herbal formulations are available in the prior art for de-addiction of tobacco but none of them are safe and effective enough to overcome the withdrawal symptoms of nicotine containing tobacco products. In addition, none of the formulations available for deaddiction show any nutraceutical effect.
The use of Amla as an antioxidant has been examined by a number of authors (Kumaran et al., 2006; Rao et al., 2005; Naik et al, 2005; Bajpai et al., 2005; Bhattacharya et al, 2002, Anila et al, 2002, Scartezzini, 2000; Bandyopathyay et al., 2000, Chaudhuri, 2003). The studies showed that amla preparations contain high levels of free-radical scavenger, superoxide dismutase (SOD). Amla besides being an antioxidant, also possesses anti-carcinogenic, antitumor, anti-genotoxic, and antiinflammatory properties. Medical studies conducted on amla fruit suggest that it has
l
antiviral properties (Udupa, 1993) and also functions as an antibacterial and anti-fungal agent (Treadway, 1994). All of these benefits make Amla a strong immunity booster. However, the deaddiction property of amla has not been reported till date.
Anti hyperlipidaemic activity of aqueous extract of Aegle marmelos fruits was demonstrated by Marzine et al (2005). Maheshwan et al. (2009) studied ethnolic extract of dried fruit pulp of Aegle marmelos against various intestinal pathogens i.e. Shigella boydii, S. sonnei and S, flexneri and proposed that certain phytochemicals including phenols, tannins and flavonoids may be responsible for the effect. The anti E. coli property of Aegle marmelos fruit extract was also confirmed by Kaur et al, (2009). Dhuley J. N. (2007) reported that pretreatment of rats with unripe bael fruit extract produces a significant inhibition of ethanol induced gastric mucosal damage. The antidiarrhoeal effect of aqueous extract of Aegle marmelos fruit have been reported by Subramaniya et al, 2009, affecting outer membrane protein C of enteropathogenic Escherichia coli. However, the deaddiction property of beal has not been reported till date.
Menthol mint {Mentha an'ensis) is generally used as a cooling agent and provides fresh breath, with antibacterial, antiseptic, antipyretic and antispasmodic activities (Farah Al- Bazaz, and Mohammed Al-Casey (201 1). Saunf (Foenicahim vulgare) is reported to be a digestive, blood purifier and breath freshener (Liverstrong.com. Retrieved 27 December 2012). Elaichi - {Elettaria cardamomum Linn.) has been traditionally used for improving digestion and relieving gases. It has also been used as a stimulant, breath freshener, and aphrodisiac (Sakai et al., 1989). Javitri {Mace) is traditionally used for diarrhoea, nausea, stomach spasms and pain, and intestinal gases (published in Natural Standard Research Collaboration, August 201 1). Areca nuts are traditionally chewed with betel leaf for their effect as a mild stimulant, causing a warming sensation in the body (Ashok Lingappa et al , 201 1). Majuphal {Quercus infectoria - Olivier) also known as Gall oak/magic nut is very useful in bleeding disorders which stops bleeding from the gums (Wasim Ahmad et al, 201 1). Majuphal alone or in combination with
other herbs is a promising remedy for dental troubles. It is also a powerful astringent and styptic agent (Basri Dayang Fredalina and Fan SH, 2005). However, none of them have been reported to exhibit tobacco deaddiction property.
Generally, traditional gutkhas are a form of smokeless tobacco formulations. Gutkha is a powdery, granular, light brownish to white substance, which is a preparation of crushed areca nut, tobacco, catechu, paraffin, slaked lime and sweet or savory flavorings. Within moments of chewing and mixing with saliva, gutkha begins to dissolve and turn deep red in color. It may impart upon its user a "buzz" somewhat more intense than that of tobacco chewing, snuffing and smoking. The extensive use of narcotic gutkhas causes severe health hazards including oral cancer. In India, gutkha is popular among all socioeconomic groups, particularly among teenagers. Globally, 5 million deaths per annum are attributed to tobacco use in one or the other form. If this tendency continues, tobacco related mortalities will reach 8 million worldwide annually by the year 2030. Chewing tobacco based formulations result in copper poisoning in humans, which is a major source of fibrosis in mouth cavities. Chewing of narcotic products may also cause metal toxicity as these products are directly consumed by the users and metals can be absorb directly through the mucosal membrane. The only chemical which causes addiction in tobacco products is nicotine. Gutkha is one type of addiction with many side effects. According to a report (Indian Express, May, 1999), chemical analysis of gutkha confirmed it's lethal potential. The aromatic hydrocarbons present in it can lead to impotency and nicotine can lead to heart disorders and oral cancer. Gutkha is more addictive than tobacco or alcohol and may be more dangerous. Some branded Gutkhas had extremely high cancer indexes. It was recommended that the Gutkha is more dangerous than tobacco taken alone due to its chemical composition.
The wave of a crackdown on Gutkha that rose in Madhya Pradesh in India has swept through 12 more states over the last couple of years. But Bengal, where 25.8% of males
and 17.8% of females (WHO report) are addicted to this deadly habit, and other remaining states have managed to maintain a distance from this wind of change.
An overview of the composition of the different types of tobacco containing chewing substances as available in the market has been provided in Table 1 along with the practices adopted for using them.
Table 1 : Composition and practices of the different types of tobacco containing
chewing substances
At present, a number of Gutkha products containing tobacco and other harmful ingredients are available in the market, causing severe health hazards. A large chunk of population is addicted to this deadly habit of chewing tobacco and other harmful ingredients, which they are unable to evade by all means. This population always looks forward to a healthy substitute which should not only be free from nicotine and other harmful ingredients, but should also have positive effects on the health along with de- addiction activity.
Thus, keeping in view the drawbacks of the hitherto reported prior art, there exists a dire need to provide a nicotine free polyherbal synergistic masticatory formulation useful for tobacco de-addiction, without any side effects and with nutraceutical benefits which will have the potential to replace tobacco based formulations.
OBJECTIVE OF THE INVENTION The main objective of the present invention is to provide a synergistic polyherbal tobacco/ nicotine free masticatory formulation, which obviates the drawbacks of all present forms of tobacco based formulations and exhibits positive effects on the human health along with tobacco de-addiction property.
Yet another objective of the present invention is to provide a formulation which is more or less similar in taste and flavor to that of a traditional tobacco based formulation, minus the nicotine content, which is beneficial and safe for human health, low cost and exhibits nutraceutical effects.
Still another objective of the present invention is to provide a formulation which acts as a strong immunity booster along with having antioxidant and anti-diarrheal activities.
Yet another objective of the present invention is to provide a formulation which comprises of menthol mint crystal useful as a mouth freshener and in tooth care; powder of saunf seed which is a digestive, blood purifier and breath freshener; powder of Elaichi used for improved digestion and relief from gases; powder of Javitri (Mace) used for relieving diarrhea, nausea, stomach spasms, pain and intestinal gas; small chips of areca nuts useful as a mild stimulant; and powder of majuphal fruit for curing bleeding disorders of gums.
Another objective of the present invention is to provide a process for the preparation of said nicotine free polyherbal masticatory formulation useful for tobacco de-addiction.
SUMMARY OF THE INVENTION
The present invention provides a synergistic nicotine free polyherbal masticatory formulation which comprises Emblica officinalis, Aegle marmelos (L) Correct, Mentha arvensis, Foeniciilum vulgare - Mill, Elettaria cardamomum Linn., Myristica fragrans Linn., Areca catechu - Linn., Quercus infectoria - Olivier in the ratio of 10-15% w/w, 12-17% w/w, 0.1 -.05% w/w, 0.5-1.0% w/w, 0.5-1.0% w/w, 0.2-0.7% w/w, 0.75- 1.50% w/w and 20-35% w/w, respectively along with sugar as a binder and with optional addition of essential oil or cooling agents.
The powder of aforesaid plant components is mixed together to obtain a mixture of powders. Simultaneously, sugar paste is prepared by dissolving sugar in water and heating up to a temperature of 45 °C or till the sugar dissolves by gradually increasing the temperature by 2°C till 70°C. The mixture of powder is added to sugar paste under stirring while optionally adding essential oils or cooling agents to obtain the polyherbal masticatory formulation for use in tobacco de-addiction. In an embodiment, the present invention provides a formulation which is useful in relief from addiction of tobacco based formulations while fulfilling the requirement of minerals, vitamins and carbohydrates.
In another embodiment of the present invention, Emblica officinalis powder or extract used is obtained from fruits.
In yet another embodiment of the present invention, Aegle marmelos (L) Corre powder or extract used is obtained from fruits or leaves. In still another embodiment of the present invention, Mentha arvensis powder or crystals used is obtained from rhizome, leaves or stem.
In yet another embodiment of the present invention, Foeniculum vulgare - Mill powder used is obtained from flowers, seeds or leaves.
In still another embodiment of the present invention, Elettaria cardamomum Linn powder used is obtained from seeds, seed covers or whole fruits.
In yet another embodiment of the present invention, the powder of Myristica fragrans Linn, used is obtained from fruits or fruit coat.
In still another embodiment of the present invention, the granules of Areca catechu - Linn used is obtained from fruit or seeds. In yet another embodiment of the present invention, the chip of Quercus infectoria - Olivier used is obtained from fruits or seeds.
In a further embodiment of the present invention, the Emblica officinalis extract is used for its antioxidant and strong immune modulator activity.
In yet another embodiment of the present invention, the Aegle marmelos (L)Corre powder is used for its effect on gastroduodenal disorders.
In still another embodiment of the present invention, the Mentha an>ensis powder or crystal is used for imparting cooling and freshness effect.
In yet another embodiment of the present invention, the Foeniculum vulgare - Mill powder is used as a natural mouth freshener as well as for its purgative effect. In still another embodiment of the present invention, the Elettaria cardamomum Linn powder is used for its stimulating and breathe freshening effect.
In yet another embodiment of the present invention, the Myristica fragrans Linn is used for providing relief from toothache with anti-oxidant and disease preventing properties.
In still another embodiment of the present invention, the granules of Areca catechu - Linn are used for their tobacco de-addiction property and also for curing sore throat and mouth infections.
In yet another embodiment of the present invention, the Quercus infectoria - Olivier powder is used for its effect against bleeding disorders which stops bleeding from the gums and for alleviating dental troubles.
In still another embodiment of the present invention, the essential oils or cooling agents are selected from the group consisting of cardamom oil, clove oil, fennel oil, menthe oil and geranium oil.
In yet another embodiment of the present invention, the quantity of the essential oil or cooling agent varies from 0.05 to 1.0 % v/w of the formulation.
In another embodiment of the present invention, water is added to sugar in a ratio of 1 :3 and heated up to a temperature of 70°C till sugar dissolves properly to obtain a sugar solution or sugar paste. All powdered plant parts are mixed homogenously in a separate container and the sugar solution or the sugar paste is added. The mixture is stirred while gradually adding essential oils or cooling agents.
In yet another embodiment, the present invention provides a process for the preparation of the formulation comprising the steps of:
(a) adding water in sugar in the ratio of 1 :3 w/v and heating up to 70°C till the sugar dissolves to obtain a sugar paste;
(b) mixing 10-15% w/w of powder obtained from fruits of Emblica officinalis; 12- 17% w/w of powder obtained from fruits or leaves of Aegle marmelos (L) Corre; 0.05 - 0.1 % w/w of powder obtained from rhizome, leaves or stem of Mentha arvensis; 0.5 - 1.0% w/w of powder obtained from flowers, seeds or leaves of Foeniculum vulgare - Mill; 0.5 - 1.0% w/w of powder obtained from seeds or
seed cover of Elettaria cardamomum Linn; 0.2 - 0.7% w/w of powder obtained from fruits or bark of Myristica fragrans Linn. ; 0.75 - 1.50% w/w of powder obtained from fruits or seeds of Areca catechu Linn. ; and 20.0 - 35.0% w/w of powder obtained from fruits or seeds of Quercus infectoria - Olivier homogeneously in a separate container; and
(c) adding the sugar paste as obtained in step (a) under stirring while optionally adding 0.05 to 1.5 % of essential oil or cooling agent to obtain the synergistic polyherbal masticatory formulation.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 : The F7 shows 0.99 total phenolics content when compared to gallic acid (3.70) at dose of 100μg.
Fig. 2: The F7 shows 3.93 DPPH activity when compared to gallic acid (4.0) at dose of 2000 μg. F7 shows the potency as like that of gallic acid as a marker. Fig. 3: The F7 shows 37.08% free radical scavenging activity when compared to Vitamin E (35.39%) at dose of 3.9 μg.
Fig. 4: The F7 shows 56.52% free radical scavenging activity when compared to Vitamin E (35.39%) at dose of 7.8 μξ.
DETAILED DESCRIPTION OF THE INVENTION
The raw materials/biological resources used for the purposes of the present invention were procured as per the details provided in Table 2:
Table 2: Sources of biological resources
Amla (Emblica 15 kg Garden of Central Institute of Medicinal officinalis) and Aromatic Plants, Near Kukrail Picnic
Spot, Lucknow, 226015, India;
Ph.No:0522-271 8503
Beal (Aegle 4 kg Bharat Kirana Store, 86, Subhash Marg, marmelos (L) Lucknow, India; Ph No. : 09750200247, Correct) 0522-2265213
Menthol mint 500 gm Field of Central Institute of Medicinal and
{Mentha arx'ensis) Aromatic Plants, Near Kukrail Picnic Spot,
Lucknow,India; 226015 Ph.No.0522- 2718503
Saunf (Foeniciilum 1 kg Bharat Kirana Store, 86, Subhash Marg, vulgare - Mill. ) Lucknow, India. Ph No.: 09750200247,
0522-2265213
Elaichi (Elettaria 250 gm Bharat Kirana Store, 86, Subhash Marg, cardamomum Lucknow, India. Ph No.: 09750200247,
Linn.) 0522-2265213
Javitri {Myristica 100 gm Bharat Kirana Store, 86, Subhash Marg, fragrans Linn.) Lucknow, India. Ph No.: 09750200247,
0522-2265213
Areca nut (Areca 2 kg Bharat Kirana Store, 86, Subhash Marg, catechu - Linn.) Lucknow, India. Ph No.: 09750200247,
0522-2265213
Majuphal (Quercus 250 gm Bharat Kirana Store, 86, Subhash Marg, infectoria - Lucknow, Indian. Ph No.: 09750200247, Olivier) 0522-2265213
The powder of fruits of Emblica officinalis, fruits or leaves of Aegle marmelos (L) Correa, rhizome, leaves or stem of Mentha ar\>ensis, flowers, seeds or leaves of Foeniculwn vulgare - Mill, seeds or seed cover of Elettaria cardamomum Linn., fruits or bark of Myristica fragrans Linn., fruits or seeds of Areca catechu - Linn., and fruits or seeds of Quercus infectoria - Olivier were mixed in the amount 10-15% w/w, 12- 17% w/w, 0.1 -.05% w/w, 0.5-1.0% w/w, 0.5-1.0% w/w, 0.2-0.7% w/w, 0.75-1.50% w/w and 20-35% w/w respectively and made upto 100% with sugar as a binder along with optional addition of 0.05 to 1.0 % v/w of the essential oils or cooling agents. The powder of aforesaid plant components is mixed together to arrive at a mixture of powders. Simultaneously, sugar is added in water and heated up to a temperature of 45°C initially and thereafter the temperature is gradually increased by 2°C till 70°C or till the sugar dissolves to obtain a sugar solution or sugar paste. The sugar solution or sugar paste is mixed with the prepared mixture of powders under stirring, while optionally essential oils or cooling agents are added to obtain the synergistic polyherbal masticatory formulation of the present invention.
The polyherbal masticatory formulation of the present invention has immense application in de-addiction of tobacco for addicted individuals with no harmful side effects. Rather the formulation will exert health promoting activity. The present formulation is useful as a tobacco supplement or a tobacco substitute, for use in e.g. smoking cessation, tobacco chewing urge and nicotine replacement therapies, which provides the user to reduce tobacco withdrawal symptoms without causing unacceptable adverse effects along with health rejuvenation being antimicrobial and antioxidant.
EXAMPLES
In order to arrive at the final composition, initially different combinations were tried which are illustrated by the following examples. However, this should not be construed
to limit the scope of the present invention. Out of the seven examples given below, the formulation prepared in Example number 7 was found to be most suitable as it obviated the drawbacks of the prior art.
Example 1
Powder of Amla, Beal, Menthol, Elaichi, Areca nut and sugar were mixed in the following proportion by weight:
Amla (Emblica officinalis) 10%
Beal (Aegle marmelos (L) Correct) 12%
Menthol (Mentha an>ensis) 0.1 %
Elaichi (Elettaria cardamomum Linn.) 0.5%
Areca nut (Areca catechu - Linn.) 0.75%
Sugar to make 100%
Clove oil 0.05% v/w of the prepared formulation
The powders of the aforesaid plant components were mixed together to obtain a mixture of powders. Simultaneously, sugar was added to water and heated up to a temperature of 45°C initially and thereafter the temperature was gradually increased by 2°C till the sugar dissolved. The sugar solution was mixed with the mixture of powdered components under stirring, to obtain the desired formulation.
The formulation was distributed for testing on a limited scale. It was unable to deliver desired effects.
Example 2
Powder of Amla, Menthol, Saunf, Elaichi, Areca nut and sugar were mixed following proportion by weight:
Amla (Emblica officinalis) 12%
Menthol (Mentha arvensis) 0.05%
Saunf (Foeniculum vidgare - Mill) 0.5%
Elaichi (Elettaria cardamomum Linn.) 0.5%
Areca nut (Areca catechu - Linn.) 1.0%
Sugar to make 100%
Fennel oil 0.25% v/w of the prepared formulation
The process for the preparation of the formulation was followed as per example 1. The formulation showed more sweetness and less freshness.
Example 3
Powder of Amla, Menthol, Saunf, Elaichi, Areca nut, Guar gum and sugar were mixed in the following proportion by weight:
Amla (Emblica officinalis) 12%
Menthol (Mentha ar\>ensis) 0.05%
Saunf (Foeniculum vulgare - Mill.) 0.5%
Elaichi (Elettaria cardamomum Linn.) 0.5%
Guar Gum 50g
Areca nut (Areca catechu - Linn.) 1.0%
Sugar to make 100%
Clove oil 0.75% v/w of the prepared formulation
The process for the preparation of the formulation was followed as per example 1. The formulation showed less sweetness but the typical Gutkha taste was masked due the effect of guar gum.
Example 4
Powder of Amla, Beal, Menthol, Saunf, Elaichi, Areca nut, Javitri and sugar were mixed in the following proportion by weight:
Amla (Emblica officinalis) 15%
Beal (Aegle marmelos (L) Correa) 13%
Menthol (Mentha arvensis) 0.05%
Saunf (Foeniculum viilgare - Mill.) 0.5%
Elaichi (Elettaria cardamomum Linn.) 0.5%
Javitri (Myristica fragrans Linn.) 0.2%
Areca nut {Areca catechu - Linn.) 1.0%
Sugar to make 100%
Cardamom oil 0.25% v/w of the prepared formulation
The process for the preparation of the foiTnulation was followed as per example 1. The formulation showed some freshness and cooling effect but less Gutkha like sensation.
Example 5
Powder of Amla, Beal, Menthol, Saunf, Elaichi, Areca nut, Zavitri, Majuphal and were mixed in the following proportion by weight:
Amla (Emblica officinalis) 15%
Beal {Aegle marmelos (L) Correa) 17%
Menthol (Mentha ar\>ensis) 0.05%
Saunf (Foeniculum vulgare - Mill.) 0.5%
Elaichi (Elettaria cardamomum Linn.) 0.5%
Javitri (Myristica fragrans Linn.) 0.2%
Areca nut (Areca catechu - Linn. ) 1.0%
Sugar to make 100%
Geranium oil 0.85% v/w of the prepared formulation The process for the preparation of the formulation was followed as per example 1. The formulation induced less saliva and was more sweet in nature.
Example 6
Powder of Amla, Beal, Menthol, Saunf, Elaichi, Areca nut, Zavitri, Majuphal and sugar were mixed in the following proportion by weight:
Amla (Emblica officinalis) 14%
Beal (Aegle marmelos (L) Correa) 16%
Menthol {Mentha an>ensis) 0.05%
Saunf (Foeniculum vulgare— Mill.) 0.5% Elaichi (Elettaria cardamomum Linn.) 0.5%
Javitri (Myristica fragrans Linn.) 0.2%
Areca nut (Areca catechu - Linn.) 1.0%
Majuphal (Quercus infectoria - Olivier) 20%
Sugar to make 100% Fennel oil 1.0% v/w of the prepared formulation
The process for the preparation of the formulation was followed as per example 1. The formulation prepared as above was observed to be better than the formulations prepared in examples 1 to 5, but still some improvement was required in terms of its comparison to the typical taste and sensation of a traditional Gutkha.
Example 7
Powder of Amla, Beal, Menthol, Saunf, Elaichi, Areca nut, Zavitri, Majuphal and sugar were mixed in the following proportion by weight:
Amla (Emblica officinalis) 15% Beal {Aegle marmelos (L) Correa) 17%
Menthol {Mentha arvensis) 0.05%
Saunf (Foeniculum vulgare - Mill.) 0.5%
Elaichi (Elettaria cardamomum Linn.) 0.5%
Javitri {Myristica fragrans Linn.) 0.2% Areca nut {Areca catechu - Linn.) 1.0%
Majuphal (Quercus infectoria - Olivier) 25%
Sugar to make 100%
Mentha oil 0.55% v/w of the prepared
The process for the preparation of the fomiulation was followed as per example 1. The formulation developed in Example 7 (hereinafter referred as "F7") was able to induce the typical taste and sensation of traditional Gutkha. Samples of this formulation were distributed to 79 persons in and around Lucknow city, India belonging to different socio-economic status. The feedback received from the volunteers was satisfactory.
Example 8
The statistical analysis of the survey is provided in Table 3.
Table 3: Statistical Analysis of Survey
Sample size 79 People
Area covered Lucknow - 93% Outside Lucknow- 7%
Methodology Direct contact questionnaire methods
Precisions 1. Subjects were asked to return the questionnaire after using the product
2. Questionnaire contained instructions of use
Age group and The age group of the sampled population ranged between 16 to 69 years with 81 % males and 19% females [Details sex of subject
provided in Table 4]
Effectiveness in terms 38% people reported the taste as very good, 41 % reported as of TASTE good in taste and 15% reported as satisfactory and acceptable.
Only 6% people suggested improvement in taste as they observed it to be more pungent to the tongue. [Details provided in Table-5]
Effectiveness in terms 32% people 6reported the flavor as very good, 38% reported of FLAVOUR as good in flavor and pleasant while 19% reported that the flavour is satisfactory. Only 1 1 % mentioned that improvement in flavor is needed [Details provided in Table- 6]
Effectiveness in terms 52% reported that the product in the form of chewing of LOOK/TEXTURE granules is good while 48% people reported that the texture of the product should be just like traditional Gutkha available in the market [Details provided in Table 7]
Problem for which the 60% people used the product for tobacco de-addiction, 21%
product was used used for indigestion related problems, 16% used the product for Gas/acidity related problems and only 3% used it for its nutritional value.
Relief Observed About 70% of the tobacco addicted volunteers reported that the product has moderate tobacco de-addiction property, while 27% reported that product is less effective and only 3% people did not found any positive result against tobacco addiction [Details provided in Table-8]
None of the volunteers reported any adverse effect of the product as prepared and described above.
It is pertinent to mention here that the prepared formulation is not a mere admixture resulting in the aggregation of the properties of the individual ingredients, rather a synergistic mixture of herbs as described in the examples recited above resulting in good taste, flavour, freshness and tobacco de-addiction property.
Table 4: Age group & sex of volunteers
Table 5: Taste of the product
Taste of the product No. of Users Percentage
Very Good 30 38
Good 32 41
Satisfactory 12 15
Need to Improve 05 06
Total 79 100%
Table 6: Flavour of the product
Flavour of the product No. of Users Percentage
Very Good 25 32
Good 30 38
Satisfactory 15 19
Need to Improve 09 1 1
Total 79 100%
Table 7: Look/Texture of the product
Look/Texture of the product No. of Users Percentage
Very Good 10 13
Good 16 20
Satisfactory 15 19
Need to Improve 38 48
Total 79 100%
Table 8: Tobacco deaddiction activity
Example 9: Analysis of the Polyherbal formulation (F7)
Determination of Total Phenolics
Total phenolic content of F7 was determined using Folin-Ciocalteu (FC) reagent. The formulation in solution form (0.1 ml) was mixed with 750 μΐ of FC reagent (previously diluted 1000-fold with distilled water) and incubated for 5 min at 22°C, then 0.06% Na2C03 solution was added. After incubation at 22°C for 90 min, the absorbance was measured at 725 nm. The phenolic content was compared to the standard concentration of gallic acid. The result obtained in provided in Figure 1. DPPH assay
Samples of F7 processed previously as described above were considered for the assay. 1 ΟΟμΙ of each sample was pipetted into 96-well plates and serial dilution was made with filtered deionized water. Subsequently, 200 μΐ of 0.2mM DPPH solution in methanol was pipetted into each well and incubated at room temperature (24-26°C) for 30 min. The absorbance of the mixture was measured using a microplate reader (Molecular Devices) at 517nm against blank. The result obtained is provided in Figure 2.
The percentage of radical scavenging activity of the samples was evaluated by comparing with a control (100 μΐ methanol + 200 μΐ of 0.2mM DPPH). The radical scavenging activity was calculated using the following formula: RSA = [(AO -Al)/A0]x l00, where RSA is the radical scavenging activity, AO is the
absorbance of the control and Al is the absorbance of the sample after 30 min. EC50 (effective concentration of 50%) was determined from radical scavenging curve. The result obtained is provided in Figure 3 and 4.
In vivo sub-acute oral toxicity In view of potent biological activity and scope of F7, sub-acute oral toxicity of the same was carried out on Swiss albino mice. Experiment was conducted in accordance with the Organization for Economic Co-operation and Development (OECD) test Guideline No. 423. For study, 60 mice (thirty of each sex) were taken and divided into Ten groups of six mice (six male and six female mice) each weighing 18-20 gm. The animals were maintained at 22 ± 5°C with 50-70% humidity and an automatic dark and light cycle of 12 h. The animals were fed with the standard rat feed and provided ad libitum drinking water. Mice of group 1-4 were considered as experimental while the group 5 was kept as control. The animals were acclimatized for 7 days in experimental environment prior to actual experimentation. The test material (F7) was suspended in 0.7% carboxy methyl cellulose (CMC) to be orally administered in volumes of 0.5 mL at 5, 50, 300 and 1000 mg/kg body weight to animals of groups 1-4, respectively for 28 days. Control animals received only vehicle.
Results
No mortality and observational changes were observed throughout the experimental period of 28 days in all the groups of animals studied. Blood samples collected at the end of the experiment showed non-significant changes in all parameters studied such as SGPT, SGOT, AL P, Bilirubin (liver function), Cholesterol, triglycerides (lipid metabolism) and creatinine as kidney function test. The results obtained for such biochemical studies are provided in Table 9. Animals on gross pathological study showed no changes in any of the organs studied including their absolute weight. Therefore, the experiment concluded that the formulation (F7) was well tolerated by the Swiss albino mice up to the dose level of 1000 mg/kg body once orally for 28 days in the sub acute oral toxicity study.
Table 9: The effect of F7 on the biochemical levels of in vivo sub-acute toxicity studies
ADVANTAGES OF THE INVENTION
> The nicotine free polyherbal masticatory formulation of the present invention is safe to be used orally as the components used in the formulation are of herbal origin and do not produce any adverse side effect on the mouth as well as other organs of the body.
> The formulation is eco-friendly and economically viable.
> No harmful components like tobacco are used in the formulation which can cause oral cancer. On the contrary, the developed foiTnulation improves oral health.
> Besides being an alternate of health affecting Gutkha, it is a source of many minerals, vitamins, carbohydrates and possesses anti-oxidant property, while improving digestion and boosting immunity.
Claims
1. A nicotine free synergistic polyherbal masticatory formulation comprising:
(i) 10-15% w/w of powder or an extract obtained from fruits of Emblica officinalis;
(ii) 12-17% w/w of powder or an extract obtained from fruits or leaves of Aegle marmelos (L) Co e;
(iii) 0.05 - 0.1% w/w of powder or a crystal obtained from the rhizome, leaves or stem of Mentha an>ensis;
(iv) 0.5 - 1.0% w/w of powder obtained from flowers, seeds or leaves of Foeniculum vulgare - Mill;
(v) 0.5 - 1.0% w/w of powder obtained from seeds or seed cover of Elettaria cardamomum Linn;
(vi) 0.2 - 0.7% w/w of powder obtained from fruits or bark of Myristica fragrans Linn. ;
(vii) 0.75 - 1.50% w/w of powder obtained from fruits or seeds of Areca catechu Linn. ;
(viii) 20.0 - 35.0% w/w of powder obtained from fruits or seeds of Quercus infectoria - Olivier; and
(ix) sugar as a binder to make the total quantity 100%, optionally along with 0.05 to 1.0% v/w of an essential oil or a cooling agent.
2. The formulation as claimed in claim 1 for use in de-addiction of tobacco from tobacco addicted individuals.
3. The formulation as claimed in claim 1 , wherein said essential oil or said cooling agent is selected from the group consisting of cardamom oil, clove oil, fennel oil, menthe oil and geranium oil.
4. A process for the preparation of the formulation as claimed in claim 1, wherein said process comprising the steps of:
(a) . adding water in sugar in the ratio of 1 :3 v/w and heating up to 70° C till the sugar dissolves to obtain a sugar paste;
(b) mixing 10-15% w/w of powder obtained from fruits of Emblica officinalis; 12-17% w/w of powder obtained from fruits or leaves of Aegle marmelos (L) Corre; 0.05 - 0.1 % w/w of powder obtained from rhizome, leaves or stem of Mentha an>ensis; 0.5 - 1.0% w/w of powder obtained from flowers, seeds or leaves of Foeniculum vulgare - Mill; 0.5 - 1.0% w/w of powder obtained from seeds or seed cover of Elettaria cardamomum Linn; 0.2 - 0.7% w/w of powder obtained from fruits or bark of Myristica fragrans Linn. ; 0.75 - 1.50% w/w of powder obtained from fruits or seeds of Areca catechu Linn. ; and 20.0 - 35.0% w/w of powder obtained from fruits or seeds of Quercus infectoria - Olivier homogeneously in a separate container to obtain a mixture; and
adding the sugar paste of step (a) to the mixture obtained in step (b) under stirring while optionally adding 0.05 to 1.0 % of an essential oil or a cooling agent to obtain the synergistic polyherbal masticatory formulation.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017145056A1 (en) * | 2016-02-23 | 2017-08-31 | SINGH, Gurseet | Nicotine free herbal composition for smoking de-addiction and treatment of side-effects and/or ailments from smoking |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060137702A1 (en) * | 2004-12-28 | 2006-06-29 | Council Of Scientific & Industrial Research | Anti-cigarette herbal formulation as an antidote to tobacco |
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| US20060137702A1 (en) * | 2004-12-28 | 2006-06-29 | Council Of Scientific & Industrial Research | Anti-cigarette herbal formulation as an antidote to tobacco |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017145056A1 (en) * | 2016-02-23 | 2017-08-31 | SINGH, Gurseet | Nicotine free herbal composition for smoking de-addiction and treatment of side-effects and/or ailments from smoking |
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