AU2021104022A4 - A Novel Polyherbal Formulation for Cessation of Pan masala - Google Patents

Abstract

Manufacture of herbal gutka is a new concept. Chewing of beetle (popularly known as Paan) is an age-old Indian tradition. Since last few years, many types of gutkas have been introduced in the market and they have become very popular. Many varieties of paan or gutka are available in the market with many ingredients including chewing tobacco. Excessive consumption of tobacco is dangerous as it may cause cancer. Even non-tobacco varieties are harmful in the long run with many side effects. As a matter of fact, this is a kind of addiction. Many variants are available in the market but herbal gutka is yet to be seen.

Description

Title of the Invention

A Novel Polyherbal Formulation for Cessation of Pan Masala

Background of the Invention

Pan masala (PM) is a mixture of areca nut with slaked lime, catechu and other flavoring agents. It is widely available and used by all the sections of the sub Asian countries. It is genotoxic as it increases sister chromatin exchange and chromatin aberrations. Among humans, it is a leading cause of oral submucous fibrosis that often progresses to oral cancer. Among experimental animals, it leads to neoplastic lesions in lung, liver and stomach. It is hepatotoxic leading to increased level of enzymes, deranged carbohydrate and lipid metabolism. It is harmful to kidneys and testes leading to increased creatinine and sperm deformities respectively. PM is a very harmful substance affecting almost all organ systems, and there is immediate need for a national policy on complete ban on the production, storage, sale and marketing of PM.6More and more people these days are walking into hospital OPDs complaining that they're increasingly unable to open their mouths. Almost all of them complain of a soreness of the mouth and constant burning in the oral cavity. Some have a nasal voice and find they can't blowout the cheeks and extend the tongue. Others complain of difficulty in swallowing. All these patients suffer from oral submucousfibrosis(SMF).

Description of the invention

As presently, there is no alternate available for gutkha,which is non toxic for healthy and also help to reduce the cravings for gutkha.There is a necessity to develop an alternate,similar in taste of gutkhas,basically fulfilling the criteria of having astringent taste,as well as having mouth freshening property too.The formulation should be easilyavailable and it should be cheaper in cost.It should act as a herbal substitute for gutkhas,pan masala and also nicotine in various forms.Another alternates such as mouth fresheners only freshen the breath,but are unable to stop the cravings for the gutkhas,which is mainly due to the presence of astringent taste containing herbal constituents.With increasing health awareness, people at large have started disliking such hazardousproducts. Thus, this is the most appropriate time to come out with an alternate productwhich is not harmful, helps reduce addiction and may prove useful. Proper understanding ofconsumer needs, attractive packaging and adequate and strategic placement are the keyfactors.Likewise, many mouth fresheners are available in the market as harmless alternatives. But herbal gukta is a new concept and would amount to concept selling. Market for gutkas is very large and scattered and it is growing very rapidly. Consumption of tobacco in any form is discouraged with restrictions like non-use at public places, no sales to children below 18 years of age and so on.

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.

Ingredients and herbs Used in developing formulation.

Kava-Kava

For centuries, people throughout the world have used the Pacific herb kava-kava as both a recreational drug and a treatment for psychiatric disturbances. Like nicotine, kava-kava creates a temporary sense of well-being. The NIH reports that kava, which works in a manner similar to prescription benzodiazepines such as Xanax and Valium, may help to curb symptoms of anxiety, stress and agitation. Although no studies have investigated its efficacy as a nicotine substitute, it may theoretically ease "nicotine fits," or episodes of anxiety related to nicotine withdrawal. The NIH warns that kava-kava has caused liver damage, including fatal liver failure, in some individuals. Consult your health care provider before using kava-kava, especially if you have a history of liver disease.

Passionflower

Anxiety, restlessness, insomnia and agitation are among the most common and troublesome symptoms associated with nicotine withdrawal, according to the NIH. Fortunately, natural supplements made from passionflower may help to reduce these frustrating problems. The University ofMaryland Medical Center reports that passionflower may help to ease anxiety and insomnia, particularly in people with diagnosed psychiatric problems. However, these uses are based primarily based in tradition, with only limited scientific evidence to support these uses. Passionflower has a sweet fragrance and may be consumed as a tea, tincture, capsule or liquid extract.

Calamus

The calamus plant, more commonly known as bitterroot or sweet flag, contains psychoactive constituents which may be used as nicotine substitutes. When chewed, bitterroot releases a combination of chemicals which, like nicotine, exert both a stimulant and depressant effect. Herbalist Jim McDonald notes that calamus is classified as a known carcinogen by the Food and Drug Administration, but he recommends it as a helpful adjunct for relieving anxiety caused by nicotine withdrawal.

Mullein

Also known as Verbascum, mullein features in many tobacco blends as an active herbal ingredient. It acts as a great base, producing a light smoke, a subtle flavour, and a slow bum. It has been used for a very long time as a herbal remedy, and smoking it can help clear out the lungs (in smokers), encourage lymph circulation, and even sooth a sore throat.

PRODUCTS

Chewing of paan or gutka is one type of addiction with many side effects. Hence a new

concept of herbal gutka, which will not have side effects but may even help the digestive

system, is discussed in this note. The product may also result in de-addiction to some

extent. This product can be manufactured in many states like UP,Bihar, Jharkhand,Orissa

etc and this note considers Bihar as a preferred location.

Demand and Supply

After-mints are very popular throughout the country, with chewing of tobacco or non-tobacco

paan, beetle-nuts or gutka being the most popular varieties. Over a period of time, they

become addiction and it becomes extremely difficult to get rid of such habits even though

they are harmful in the long run. Likewise, many mouth fresheners are available in the market as harmless alternatives. But herbal gukta is a new concept and would amount to

concept selling. Market for gutkas is very large and scattered and it is growing very rapidly.

Consumption of tobacco in any form is discouraged with restrictions like non-use at public

places, no sales to children below 18 years of age and so on.

Need of Invention

With increasing health awareness, people at large have started disliking such hazardous

products. Thus, this is the most appropriate time to come out with an alternate product

which is not harmful, helps reduce addiction and may prove useful. Proper understanding of

consumer needs, attractive packaging and adequate and strategic placement are the key factors.

MANUFACTURING PROCESS

The process of manufacture is simple. All the ingredients are cleaned and passed through

sieves to remove impurities. They are then ground individually in roller grinder. Then all of

them are blended in a blender to obtain a homogenous mix. Finally, the desired quantity is

packed in printed pouches on form, fill and seal machine.

Raw Materials (Constituents)

Kava-Kava in between 10-15 %

Saufin between 15-20 %

Calamus 10-15 %

Passionflower 10-15 %

Kava-Kava 5-15 %

Sandalwood Powder 4-10 %

Mulethiin between 3-10 %

Sunthiin between 5-10 %

Mullien in between 5-10 %

Kala Namakin between 3-5 %

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.

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.

Novelty

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.

Summary

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.Our formulation Does not cause bad smell from mouth, and Helps in caring mouth ulcers and cuts caused due to eating pan masala and gutkha.After eating this, the person feels refreshing and does not feel the urge to eat/take things contain nicotine, pan masala and gutkha. It Can be eaten as a mouth freshener after meals as digestive supplement. No need for spitting.It will keep away from you Cancer, COPD, Chronic Bronchitis, Emphysema, and Ulcer Etc.We all know pan masala that causes a number of health problems due to its tobacco content.Our formulation will give you the same feeling and taste of pan masala but it is free from tobacco and areca-nut (supari).

Claims (5)

Claims

1. 1.We claim to form a formulations overcome the withdrawal symptoms of nicotine containing tobacco products.

2. We also claim that in this invention none of the formulations available for deaddiction show any nutraceutical effect.

3. We claim, it Does not cause bad smell from mouth, and Helps in caring mouth ulcers and cuts caused due to eating pan masala

4. We Claim it It Can be eaten as a mouth freshener after meals as digestive supplement

5. WE claims the constituents

Kava-Kava in between 10-15 %

Saufin between 15-20 %

Calamus 10-15 %

Passionflower 10-15 %

Kava-Kava 5-15 %

Sandalwood Powder 4-10 %

Mulethiin between 3-10 %

Sunthiin between 5-10 %

Mullien in between 5-10 %

Kala Namakin between 3-5 %