DESC:Field of Invention
The present invention provides a novel chewable composition substantially free of the deleterious effects of tobacco, tobacco based products such as cigarettes, areca nut and areca nut-based products like pan masala, or combinations of tobacco and supari, like gutka etc. The composition of the invention being chewable for a substantially long period acts as a substitute for an areca nut- or tobacco-based products and serves as substitute thereof. The invention also provides a process for preparing the said chewable composition.

Background of the Invention and Related Prior Art
It is a common practice in India to chew areca nut, either by itself, or in combination with betel leaf, tobacco and other ingredients. The ingredients may include catechu paste or mukhwas to freshen the breath. It is also a practice to include ingredients such as coconut, catechu, saffron, cardamom, permitted natural colours, menthol etc. along with the betel leaf prior to chewing. It is a common practice to add a slaked line paste to bind the ingredients, roll up the betel leaf and chew the betel leaf with composition for a long time.

Several studies have now revealed that both areca nut and tobacco based compositions used for chewing are probably addictive, euphoria-inducing formulation and may have adverse health effects. Pan masala, a product created by the Indian tobacco industry, consists of area nut, catechu, lime, cardamom, and flavouring agents. When tobacco is included, it is called gutkha. Its availability in convenient sachets, and high-profile advertising campaigns have resulted in increasing use by certain sector. Research by Indian scientists suggests that long-term use of pan masala, a form of betel quid either by itself or containing the tobacco material, may cause tumours in different parts of the body and not just the oral cavity as previously thought. On account of these and such other studies, several governments have imposed a ban on the sale of compositions comprising areca nut and/ or tobacco based products.

Accordingly, several studies have been undertaken by the industry to develop formulation that are substantially areca nut and tobacco free, capable of being chewed by itself and which can also be used for chewing with a betel leaf. As an example, Indian Patent Application No. 153/MUM/2009 discloses a herbal based mouth freshener and the process of preparing thereof, comprising, tapioca taken in the range of 400 gm to 800 gm 30% to 62% by weight of the composition, potato taken in the range of 150 gm to 800 gm 14 to 48% by weight of the composition, a herbal products comprising of dalchini 3 to 10 gm, lavang (clove) 3 to 10 gm, Elaichi 2 to 8 gm, KapurKachari 4 to 12 gm, SungandhMantri 3 to 10 gm, Balchad 2 to 7 gm, Akalkara 2 to 7 gm, SaffedMulsi 2 to 7 gm Kulingin 8 to 16 gin, Kababchini 3 to 10 gm, Mulethi 3 to 10 gm, Javantri Leaves 2 to 8 gm, Black pepper 2 to 7 gm, Lindi pepper 2 to 7 gm, along with a Liquid base compounds of liquid material having ingredients of propylene glycol 3 to 10 gm. Honey 3 to 10 gm, glycerine 1 to 4 gm, Sugar Syrup 7 to 18 gm, Menthol 1 to 6 gm. Saffron 0.05 to 0.40 gm. Natural and synthetic perfumes 2 to 7gm, Katha Powder 75 to 200 gm used as anti caking agent, Calcium carbonate 15 to 40 gm, manually mixed all above ingredients and preserving the resultant mixture in a closed room temperature for 24 hours.

Indian Application No. 2347/MUM/2009 discloses a chewable mouth freshener comprising boiled and roasted areca nuts, catechu, lime, and at least one of the special agents selected from a group of substances comprising milk calcium, corn fiber, rice starch, wheat fiber, wheat starch, oat fiber, arrow root powder, tapioca, wheat protein, and apple fiber, or any combination thereof. Similar compositions comprising salted gooseberry, cardamomum, Carom seeds, Clove, and Licorice has been proposed in US Application no.2006/137702. This product is primarily a medicinal product and is proposed as an alternative to gutkha.
In the recent times, K.K. Sales has proposed a mouth freshener composition comprising dry dates (chuara), Fennel seeds (Saunf), Muretthi, natural and synthetic perfume and also eatable catechu (Katha) in a particular ratio. This composition is proposed as an alternative to avoid the deleterious effect of areca nut. This composition, however, suffers from the main drawback that it does not have the crispness, chewability and mouth feel of areca nut nor is the composition is capable of being chewed and residing in the mouth for a substantially long period. The shelf life of this composition is also very limited, thereby restricting its wide spread use.

Taking into account, the drawbacks of the prior art, the present invention proposes a composition which is capable of being chewed for a long time, gives the mouth feel and effect of a areca nut-based product, but is substantially free of all the deleterious effects and consequence of a areca nut-based product.

Object of the Invention
An object of the present invention is to provide a novel chewable composition substantially free of the deleterious effects of tobacco, tobacco based products such as cigarettes, areca nut and areca nut-based products like pan masala, or combinations of tobacco and supari, like gutka etc and a process for preparing the same.

Summary of the Invention
The present invention describes a chewable composition substantially free of the deleterious effects of tobacco, tobacco based products. The chewable composition comprises of phoenix dactylefera together with starch or starch derivatives. The composition further comprises atleast one or more cellulose derivatives, a binder and optionally other pharmaceutically acceptable ingredients.

Description of the Invention
Accordingly the present invention provides a novel chewable composition comprising phoenix dactylefera substantially free of sugar together with granules of starch and starch derivatives and other excipients selected from or all of cellulose derivatives, binder, lime, dried coconut flakes, catechu, saffron, cardamom, dry fruits, mulethi, sabnermusa, other aromatic herbs and spices, sugar, glycerine, glucose, permitted natural colours, menthol and non prohibited flavours.

The phoenix dactylefera used in the composition specifically processed so as to ensure that it is substantially water free and has moisture content of less than 5%. Further, the phoenix dactylefera used in the invention is also subjected to a process whereby the sugar therein is substantially removed and substantially sugar free product is used in the composition of the invention. In order to achieve this objective, phoenix dactylefera is deseeded. In the alternative, seedless phoenix dactylefera may be used. The said phoenix dactylefera is cleaned and subjected to repeated washing with sodium bicarbonate solution, whereby the resultant product contains not more than 5% sugar, followed by drying in a hot-air oven, or a fluid-bed drier, or any other type of drier involving The product may then be used as a whole or preferably in the form of fine pieces that passes through a 8 mm screen. The amount of such phoenix dactylefera that may be used will vary between 50% to 90% by weight of the composition. Further, the phoenix dactylefera used in the composition is crisp so as to give a mouth feel of an areca-nut like product.

The composition may further comprise granules composed of starch, starch derivatives, cellulose and cellulose derivatives. The starch and starch derivatives include purified starch, pre-gelatinised starch and partially pre-gelatinised starch from a food source including but not limited to rice, maize, potato, pea or tapioca. In addition, the composition comprises Cellulose and cellulose derivatives including but not limited to as methyl cellulose, hydroxyl propyl cellulose, hydroxyethyl cellulose, hydroxyl propyl methyl cellulose, carboxymethyl cellulose.

Further, the composition may comprise and include binders, lime, coconut, catechu, saffron, cardamom, dry fruits, mulethi, sabnermusa, other aromatic herbs and spices, sugar, glycerine, glucose, permitted natural colours, menthol and non prohibited flavours. The composition is free from areca nut or tobacco.

By way of summary, the invention involves a process which includes preparation of the chewable composition. The invention is illustrated in more details by the following examples which are not to be construed as limitations on the concept embodied in the present invention.

Example 1
1000 grams of phoenix dactylefera pieces (Chuara) was washed in saturated sodium bicarbonate solutiontill the sugar level of the product is less than 5%. The washed product was dried in an air oven at a temperature of 80º C to 105º C degree for 30 to 60 minutes.The dried product had dark-reddish brown colour, appearance and texture of cut areca-nuts.

Example 2 – Preparation of Composition
The dried product resulting from Example 1 is mixed with other excipients in the following ratio:
(i) Dried and de-sugared phoenix dactylefera pieces: 53.5%.
(ii) Granules of starch, starch derivatives, cellulose, and cellulose derivative15%;
(iii) Starch, starch derivative and cellulose powder 4.5%
(iv) lime 2.5%;
(v) catechu powder7.5%;
(vi) cardamom2%
(vii) menthol and non-prohibited flavours15%.

Additional advantages and modification will readily occur to those skilled in art. Therefore, the invention in its broader aspect is not limited to specific details and representative embodiments shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general invention concept as defined by the appended claims and their equivalents.

CLAIMS:1.A chewable composition comprising phoenix dactylefera; substantially free of sugar along with granules of starch and starch derivatives and other excipients selected from cellulose derivatives, binder, lime, dried coconut flakes, catechu, saffron, cardamom, dry fruits, mulethi, sabnermusa, and other aromatic herbs and spices.
2.The composition as claimed in Claim 1 wherein, the phoenix dactylefera is substantially water free having moisture content in the range of less than 5%.
3.The composition as claimed in Claim 1 wherein, the amount of phoenix dactylefera is in the range of 50% to 90% w/w.
4.The composition as claimed in Claim 1 wherein, the starch and starch derivatives include purified starch, pre-gelatinised starch and partially pre-gelatinised starch and is present in the range of 12 to 15%.
5.The composition as claimed in Claim 1 wherein, the said chewable composition is free from areca nut or tobacco.
6.The composition as claimed in Claim 1 wherein, the composition comprises 53.5% dried and de-sugared phoenix dactylefera pieces, 15% granules of starch, starch derivatives, cellulose and cellulose derivative, 4.5% starch, starch derivatives and cellulose powder, 2.5% lime, 7.5% catechu powder, 2% cardamom, 15% menthol and non-prohibited flavours.
7.The use of composition as claimed in claim 1 wherein, the composition is used as an alternative to areca nut or tobacco based products and is capable of being chewed for a long time.