GB2393392A

GB2393392A - Betel nut and nicotine chewing gum

Info

Publication number: GB2393392A
Application number: GB0321238A
Authority: GB
Inventors: Abhijit De
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-09-17
Filing date: 2003-09-10
Publication date: 2004-03-31
Also published as: GB0321238D0

Abstract

A gum based chewing product, particularly a chewing or bubble gum, containing a synthetic or natural betel nut source, and nicotine. Each gum piece may contain between 1 and 12.6 mg of nicotine. The product may contain taste enhancers such as catechu and lime. A process for the preparation of the gum is also outlined.

Description

GUM BASF,D CHEWING PRODUCE' AND

PROCESS FOR PREPARING THE SAME

The present invention relates to a gum based product and a process for manufacturing 5 the same. More particularly, the invention relates to a gum based product with a synthetic or natural betel nut source, especially a chewing / bubble gum containing an alkaloid, such as nicotine, or other such alkaloids, like caffeine, theine, etc. with a natural or synthetic origin for its source, with or without taste enhancers, and a process for preparing the same.

Tobacco flavoured chewing gum or chewing gum containing tobacco, which simulates chewing tobacco are known in the art and have been described in US patent nos.

3,877,468; 5,488,976; 4,317,X37; 4,802,498; 4,093,752; 3,845,217; 865,026 and 904,521.

This tobacco-flavoured chewing gum is usually recommended for smokers as a substitute for smoking tobacco. US patent 3,877,468 and 5,488,962 disclosed chewing gum having variable amounts -1'nicotine. IJS patent 4, 317,837 and 4,802,498 describe chewing gum wherein tobacco rather than nicotine is added to chewing gum. US 20 4,093,752 employs tobacco flavourings such as 2,4,6-triisobutyl 1-1,3,5-trioxane and US 3,845,217 employs buffered nicotine in chewing gum. Further mixtures of tobacco and wax are used in US patent nos. 865,026 and 904,521. The tobacco flavourings may be employed along with non-sweet taste or flavourings such as salt, pepper, sour, bitter, meaty, with or without sweetness as desired.

In the tropical Asian countries, chewing betel nut and tobacco in the l'orm of areca quid is quite popular. -t'his type ot Areca quid mainly consists of Areca nut (betel nut), lime paste (in India known as chuna), a resinous extract from the matrix of Acacia tree (in India known as Kattha or catechti). All these are spread over betel leaf and the whole 30 quid is consumed along with the betel leaf, which is known as 'pan' in India.

The consumption of betel nut and tobacco together in the form of Areca quid has many disadvantages: i. it generates a bright thick red colored fluid which mixes with the saliva and has to be expectorated and causes pollution of the environment; ii. this type of Areca tobacco mixture mostly contains alkaline lime, which with long term use could result in oral cancer iii. long term use of such Areca / tobacco mixtures causes contraction of oral tissue which results in incapability to open the mouth filly.

To overcome these Indian Patent No. 1871 10 granted to the present applicant describes use of quimam and betel nut in chewing gum.

I'he present invention aims to improve upon Indian patent No. 187110. It delivers a 5 nicotine source, prepared by a particular method, at a level of Img to 12.6 mg per piece of chewing gum and has a better mixing capacity with the gum base. Moreover as the per chewing gum dose of nicotine is limited, and can be chewed for a longer time, a sustained effect is achieved though the overall consumption of nicotine is less.

Moreover the product smoothness is milch higher and as well saliva generation with the 20 present chewing gum is much less. Further the preferred incorporation of' taste enhancers selected from catechu and or lime along with the betel nut and nicotine source provides a better overall taste and chewing property along with improved product smoothness and feel attributes. It provides further a longer lingering effect causing reduction in intake of nicotine per day.

The present invention relates to a gum based product comprising: from 1235% by weight of a guns base in the form of dough; from 0-7.0% by weight 'f'a plasticizer.

from 0.05 to 5.75MO by weight of a nicotine source; 30 Prom 35-65% by weight of'a filler; 1.5-9% by weight of betel nut powder, having an average particle sine of between 45m and 710m;

0. I to 3.0 % by weight of one or more flavouring agents; said chewing gum based product being in the form of gum pieces adapted to deliver 1.0 to 12.6 mg of nicotine per piece.

5 According to further aspect of the present invention there is provided a process for preparing the gum based product along with nicotine source comprising: i) providing a mixture comprising 12-35% by weight of chewing gum base, 0 7.0% by weight of plasticizer, 3-30 /O by weight of dough forming medium, filler,l.5-9% by weight of betel nut powder having an average particle size of lo between 45m and 710m; ii) heating the mixture to a temperature between 45 C to 65 C to soften the gum base and form a dough; iii) adding from ().()5 to 5.75% by weight of nicotine source to the dough; iv) adding 0.1 to 3.()% by weight of one or more flavouring agent such as herein 5 described, followed by addition of a further amount of filler and mixing the mass thoroughly to obtain the chewing gum; / v) converting the said mass into chewing gum pieces containing nicotine at a level of 1.0 to 12.6 mg per piece.

20 According to another aspect of the present invention there is provided a gum based product with taste enhancers comprising: 12-35% by weight of a gum base in the form of dough; ()-7.0% by weight of a plasticizer.

0.05 to 5.75% by weight of a nicotine source; 25 35-65% by weight of a filler; 0.1 to 3.7% of taste enhancer selected Irom catechu and/or lime; 1.5-9% by weight of betel nut powder having an average particle size of between 45pm and 710,um; 0.1 to 3.0 % by weight of one or more devouring agents; 30 said chewing gum based product being in the form of gum pieces adapted to deliver 1.0 to 12.6 mg of nicotine per piece.

According to further aspect of the present invention there is provided a process for preparing the gum based product with taste enhancers along with nicotine source comprlsmg: i) providing a mixture comprising 12-35% by weight of chewing gum base, 0 5 7.0% by weight of plasticizer, 3-30% by weight of dough forming medium, filler, 1.5-9% by weight of betel nut powder having an average particle size of between 45rm and 71()llm; ().1 to 3.7% of taste enhancer selected from catechu and/or lime; ii) heating the mixture to a temperature between 45 C to 65 C to soften the lo gum base and form a dough; iii) adding from 0.05 to 5.75% by weight of nicotine source to the dough; iv) adding 0.1 to 3.0 /O by weight of one or more flavouring agent such as herein described followed by addition of a I'urther amount of filler and mixing the mass thoroughly to obtain the chewing gum; 5v) converting the said mass info chewing gum pieces containing nicotine at a level of 1.0 to 12.6 mg per piece.

The gum used for the purpose of the present invention is the one for which the active components are as above and is selected from chewing gum, bubble gum and other 20guises. The invention is described with specific reference to chewing gum although other gums may be used.

25 The present invention provides a betel nut containing chewing gum with nicotine source with or without taste enhancers like catechu and/or lime, which has a lingering effect of the nicotine though the per chewing gum consumption of nicotine is limited. It also provides product smoothness. The saliva generation associated with the betel nut chewing gum with nicotine source of the present invention is also less than intake of 30 areca quid and chewing gum with quimam. It provides all tl1e attributes of intake of areca quill but without the ill effects of increased saliva formation and staining of the teeth and mouth. The present invention with taste enhancers provides added attributes of

better taste and chewing property to the product over those without such taste enhancers. Recording to a preferred aspect the said betel-nut Showing gum with or without taste 5 enhancers along with nicotine source further comprises from ().()2 to 7.5% by weight of sweetening agent wherein the sweetening agent is selected from Aspartame, mannitol, powdered sugar and the like.

I'he said chewing gum preferably comprises: 25-34% by weight ol'a chewing guts base iTI the form of dough; 1-1.5% by weight of plasticizer; 3 to 3. 5% by weight of nicotine source; 15 32.9-55% by weight of filler; 4-6% by weight of betel nut powder of average particle size ranging from 45m to 71 Opm; 0.5 to 3.0% of eateehu or 0.1 - 0.7 % lime as taste enhancer; 0. 1-6% by weight of sweetening agent; 20 0.1 to 1.5 % by weight of peppermint source and/or any other llavouring agent such as herein described; said chewing gum having shaped of sizes adapted to deliver 1.0 to 7 mg of nicotine per piece of chewing gum.

25 The amount of taste enhancer (when present) is ().1 to 3.7'lo. 'I'he said taste enhancer is selected from catechu and or lime. The amount of catechu when present as taste enhancer preferably ranges between 0.5 and 3%, while the amount of lime preferably is from 0.1 to 0.7%. According to most preferred aspect both catechu and lime are present as taste enhancers in the gum based chewing guts with nicotine source.

The plasticizer in the said product with nicotine source is preferably propylene glycol or glycerin and the dough forming medium is selected from liquid sorbitol, maltitol syrup,

liquid glucose and like while the filler in the said product is powdered D-Sorbitol or powdered sugar. The use of plasticizer may be optional in view of the use of both the taste enhancers.

5 'I'hus according to most preferred aspect the gum based product comprises: 25-34% by weight oi'a chewing gum base in the form of dough; 3 to 3.5% by weight of nicotine source; 32.'3-55% by weight of filler; 4-6% by weight ol' betel nut powder of average particle size ranging from 45pm lo to 710,um; ().5 to 3.0 % of catechu and 0.1 to 0.7 % lime as taste enhancer; 0.1-6% by weight of sweetening agent; 0.1 to 1.5 % by weight of peppermint source and/or any other flavouring agent such as herein described; 15 said chewing gum having shaped oi'si;zes adapted to deliver 1.0 to 7 mg of nicotine per piece of chewing gum.

The Pavouring agent in the said product is preferably selected from germanium oil, cardamom Llavour, sai'l'ron ilavour, clove oil, cinnamon llavour, tobacco llavour A, 20 tobacco tlavour F], tobacco ilavour (', cardamom powder, menthol powder or mentha piperita oil as a peppermint source.

I'he said flavouring agents are preferably added in the following proportions: 2s i'1avouring agent Range (% by wt) Germanium oil 0.7-0.9 Cardamom flavour 2-3 Saffron flavour 0.15-0.35 Clove oil 0. 15-0.35 30 Cinnamon flavour 0.5-0.6 Tobacco flavour A 0.5-3.5 Tobacco ilavour E3 1.0-4.5

Tobacco flavour C 0.5- 1.5 Cardamom powder 0.5-1.5 I'cppermint source 0.52.0 5 The preferred range of one or more flavouring agent added is as follows: L'lavouring agent Preferred range (% by wt Germanium oil 0.75 -0. 85 Cardamom flavour 2.0 -3.0 0 Saffron flavour 0.2 - 0.3 ('love oil 0.2 0.3 Cinnamon flavour 0.5 -0.6 Tobacco flavour A 2.2 - 3.0 Tobacco llavour B 3.0 - 3.5 5 Tobacco flavour C O X - 1.2 Cardamom powder O.X -- 1.2 Peppermint source 0.8 -- 1.2 The nicotine source used in the present invention may be prepared by conventional 20 methods. According to a prei'crred aspect of the present invention the process for preparing the nicotine source to be used in the said gum based product comprises: filling up fine scraps of tobacco in a metallic column; passing steam through the column and collecting the condensed extract of 25 tobacco at the bottom of the column; continuing the cycle till the extraction is complete; passing the collected extract through 'falling film evaporator' to concentrate the extract to 35% of the initial tobacco weight; cooling to room temperature and adding required flavouring agents as described herein.

The preferred process for preparing betel-nut containing chewing gum with nicotine source with or without taste enhancers like catechu and or lime as described herein

further comprising of gradually adding 0.02-7.5 %by weight of sweetening agent selected from Aspartame, mannitol powdered sugar and the like. The preferred aspect of the said process l'or preparing chewing guns comprises: 5 i) providing a mixture comprising 25-34% by weight of chewing gum base, 0 1.5'Mo by weight of plasticizer, 6-22 % by weight of dough forming medium, a filler, from 0.5 to 3% of catechu and/or 0.1 -0. 7% of lime as taste enhancer, 4-6% by weight of betel nut powder of average particle size ranging from 45m to 71(),um, 0.1-6% by weight of sweetening agent, lo ii) heating to a temperature between 45 C to 60 C to soften the gum base to form a dough; iii) adding 3 to 3.5% by weight of nicotine source of a type obtained by a process such as herein described to the dough; iv) adding 0.1 to 1.5 % by weight of peppermint source or any other flavouring 5 agent such as herein described followed by addition of further amount of filler and mixing it thoroughly to obtain the chewing gum; v) converting the said mass into chewing gum pieces so as to deliver 1.0 to 7mg of nicotine per piece of chewing gum.

20 Preferably both the taste enhancers may be used in the said process and in such process the plasticizer is not used. Thus the said process comprises: i) providing a mixture comprising 25-34% by weight of chewing gum base, 6 22 % by weight of dough forming medium, a filler, 0.5 to 3.0 % of catechu and 0.1 to 0.7 % of lime as taste enhancers, 4-6% by weight of betel nut 25 powder of average particle size ranging from 451lm to 710pm,0.1-6% by weight of sweetening agent, ii) heating to a temperature between 45 C to 60 C to soften the gum base to Norm a dough; iii) adding 3 to 3.5% by weight of nicotine source of a type obtained by a 30 process such as herein described to the dough;

iv) adding 0.1 to 1.5 % by weight of peppermint source or any other flavouring agent such as herein described followed by addition of further amount of filler and mixing it thoroughly to obtain the chewing gum; converting the said mass into chewing gum pieces so as to deliver 1.0 to 7mg of 5 nicotine per piece of chewing gum.

After addition of the nicotine source the mass is preferably reheated for uniform mixing of the nicotine source in the dough.

lo The filler is preferably incorporated in the mix at a level ol' between 15-80% of the total filler to be present in the chewing gum and at a subsequent stage adding the balance filler in an amount of between 20-85%.

I'he formation of the said chewing gum pieces is prel'erably done by spreading the said 5 chewing gum mass obtained at the step (iv) of the process of preparation in the form of a sheet of uniform thickness and cut into shaped pieces of sizes adapted to deliver 1.0 to 12.6 ma, preferably 1-7mg of nicotine per dose of chewing gum.

Tile dough forming medium used in the said process is preferably selected Prom liquid 20 sorbitol, maltitol syrup, liquid glucose and like, while the filler used is powdered D Sorbitol, powdered sugar and the plasticizer used is propylene glycol or glycerin.

I'he flavouring agent used in the nicotine source is preferably selected from germanium oil, cardamom flavcur, saffron Devour, clove oil, cinnamon flavour, tobacco flavour A, 25 tobacco flavour B. tobacco flavour C, cardamom powder, menthol powder or mentha piperita oil as peppermint source.

The one or more [lavouring agent used are added in the following proportions: 30 I:'lavouring agent Range (% by wt) Germanium oil 0.7-0.9 Cardamom flavour 2.0-3.0

Saffron flavour 0.15-0.35 Clove oil 0.15-0.35 Cinnamon flavour 0.5-0.6 I'obacco flavour A 0.5-3.5 5 Tobacco flavour 1.0-4. 5 Tobacco flavour C 0. 5- 1.5 Cardamom powder 0.5-1.5 T'eppennint source 0.5-2.0 o The preferred range of one or more flavouring agent used is as follows: Flavouring agent l'reherred range (% by wt (germanium oil 0.75 -O.X5 Cardamom llavour 2.0 -3.0 l 5 Saffron flavour 0.2 - 0.3 Clove oil 0.2 -0.3 Cinnamon flavour 0.5 -0.6 Tobacco flavour A 2.2 - 3.0 Tobacco llavour B 3. 0 - 3.5 20 Tobacco flavour C O.X - 1.2 Cardamom powder 0.8 - 1.2 Peppermint source O.X - 1.2 The invention shall now be described with reference to non restrictive exemplary 25 illustrations Example 1

CHEWING GUM COlVlPOSITlON: so The composition of chewing gum is as follows: Gum base 30% by weight Plasticizer (propylene glycol or glycerin) 1.0% by weight

Dough forming medium (liquid sorbitol 70%)] 3.0% by weight Nicotine source 3.2% by weight Filler (powdered D-Sorbitol) 47.7% by weight Betel nut powder (45lm to 710m) 4.5% by weight 5 Sweetening agent (lispartamc or any other material providing required sweetness) 0.] % by weight Pepper mint 0.5% by weight and/or any other flavouring agents and mixing it thoroughly. 0 PREPARATION OF CHEWING GUM:

To prepare the chewing gum of this composition the following process is followed: i) mixing chewhlg gum base, plasticizer, dough forming medium, a portion of filler, betel mat powder and sweetening agent; ii) heating the above mixture at 45 C to soften the gum base to form a dough; 5 iii) adding the nicotine source prepared by the method as described above to the dough and reheating the dough for wlit'onn mixing of the nicotine source in the dough; iv) adding peppermint and any other flavouring agent and mixing thoroughly; 20 v) gradually adding the remaining portion of the filler to obtain the tobacco chewing gum mass; vi) spreading the said chewing gum mass in the form of a sheet of uniform thickness and cut into rectangular or any other shaped pieces. 'I'he cut pieces are wrapped in wax paper / aluminum foil for airtight packing. 'l'hc nicotine source used will 25 deliver 1.0 mg to]2.6 mg of nicotine per dose i.e. per piece of chewing gum.

Example 2

COMPOSITION OF CHEWIN('(.UM:

30 The composition of chewing gum is as follows: Gum base 32.5% by weight Plasticizer (propylene glycol or glycerin) 1.0% by weight

Dough forming medium (Maltitol syrup) 6.5% by weight Nicotine source 3.2% by weight l'iller ( powdered D-Sorbitol) 50.8'Mo by weight Betel nut powder (45m to 710pm) 5.0% by weight 5 Pepper mint].0% by weight and / or any other flavouring agents and mixing it thoroughly. PREPARl\TIOIS OF CIIEW1NG GUM: I'o prepare the chewing ol'this composition the following process is l'ollowed: ]0 i) mixing chewing gum base, plasticizer, dough forming medium, a portion of filler and betel nut powder; ii) heating the above mixture at 55 C to soften the gum base to forth a dough; iii) adding the nicotine source prepared by the method as described above to the dough and reheating the dough for uniform mixing of the nicotine source in the 5 dough; iv) adding peppermint and any other flavouring agent and mixing thoroughly; v) gradually adding the remaining portion of filler to obtain the chewing gum mass; vi) spreading the said chewing gum mass in the form of a sheet of uniform thickness and cut into rectangular or any other shaped pieces. 'I'he cut pieces are wrapped 20 in wax paper / aluminum foil for airtight packing. The nicotine source used will deliver 1.0 mg to 12.6 mg of nicotine per dose i.e. per piece of chewing gun1.

Example 3

25 COMPOSlrl'ION OF CHEWING GUM: The composition of chewing gum is as follows: Gum base 34 % by weight Plasticizer (propylene glycol or glycerin) 1.5% by weight Dough forming medium (maltitol syrup) 15.0% by weight 30 Nicotine source 3.2% by weight l'iller ( powdered D-Sorbitol) 35% by weight Betel nut powder (45pm to 710pm) 5% by weight

]3 Swcetcning agent (Mannitol or any other material providing required sweetness) 5.55% by weight Pepper mint 0.75% by weight and / or other flavouring.

5 PREPARATION OF CHEWING ('SUM:

To prepare the chewing of this composition the following process is followed: i) mixing chewing gum base, plasticizer, dough forming medium, a portion of filler. betel nut powder and sweetening agent: ii) heating the above mixture at 55 C to soften the gum base to form a dougl1; lo iii) adding the nicotine source prepared by the method as described above to the dough and reheating the dough for uniform mixing of the nicotine source in the dough; iv) adding peppermint and any other flavouring agent and mixing thoroughly; v) gradually adding the remaining portion of filler to obtain the chewing gum mass; 5 vi) spreading the said chewing gum mass in the form of a sheet of uniform thickness and cut into rectangular:'r any other shaped pieces. The cut pieces are wrapped in wax paper / aluminum l'oil l'or airtight packing. The nicotine source used will deliver 1.0 mg to l 2.6 mg of nicotine per dose i.e. per piece of chewing gum.

Example 4

COMPOSITION OF CHEWING GUM:

I'he composition of chewing gum is as follows: 25 Gum base 25.1% by weight Plasticizer (propylene glycol or glycerin) 1.0% by weight Dough fonning medium (liquid glucose) 20.8% by weight Nicotine source 3.2'Yo by weight Filler (powdered sugar) 45.()% by weight 30 Betel nut powder (45pm to 710m) 4.4% by weight Peppermint 0.5% by weight. and / or any other flavouring agents and mixing it thorougllly.

PREPARATION OF CHEWING GUM:

l'o prepare the chewing gum of this composition the following process is followed: i) mixing chewing gum base, plasticizer, dough forming medium, a portion of s filler ? betel nut powder; ii) heating the above mixture at 50 C to sol'ten the gum base to form a dough; iii) adding the nicotine source prepared by the method as described above to the dough and reheating the dough l'or uniform mixing of the nicotine source in the dough; lo iv) adding peppermint and any other flavouring agent and mixing thoroughly; v) gradually adding the remaining portion ol'the filler to obtain the chewing gum mass; vi) spreading the said chewing gum mass in the form of a sheet of uniform thickness and cut into rectangular or any other shaped pieces. The cut pieces are wrapped 5 in wax paper / aluminum foil for airtight packing. The nicotine source used will deliver 1.0mg to l 2.6 mg of nicotine per dose i.e. per piece of chewing gum.

Example 5

20 CHEWIN(, GUM COMPOSITION:

l'he composition ol chewing gum is as follows: Gum base 25.1% by weight Plasticizer (propylene glycol or glycerin) 0.5 % by weight Dough forming medium (liquid glucose 20.8 % by weight 25 Nicotine source 3.2% by weight Filler ( powdered sugar) 44.4 % by weight Betel nut powder (mom to 7101lm) 4.4 /0 by weight Taste en}1anccr no. 1 (catechu) 1.0% by weight Sweetening agent (Aspartame or any other material providing required sweetness) 0. 1% so by weight.

Pepper mint 0.5% by weight and/or any other flavouring agents and mixing it thoroughly.

PREPARATION OF CHEWING GUM:

To prepare the chewing gum of this composition the following process is followed: i) mixing chewing gum base, plasticizer, dough forming medium, taste enhancer s no. I i.e catechu,a portion of filler, betel nut powder and sweetening agent ii) heating the above mixture at 45 C to soften the gum base to form a dough; iii) adding the nicotine source prepared by the method as described above to the dougl1 and reheating the dough for uniform mixing of the nicotine source in the dough; 0 iv) adding peppermint and any other flavouring agent and mixing thoroughly; v) gradually adding the remaining portion of the filler to obtain the tobacco chewing gum mass; vi) spreading the said chewing gum mass in the lone of a sheet ot'uniform thickness and cut into rectangular or any other shaped pieces. The cut pieces are wrapped 5 in wax paper / aluminum foil for airtight packing. The nicotine source used will deliver 1.() mg tol2.6 mg ol'nicotine per dose i.e. per piece ol'chewing gum.

Example 6

20 COMPOSITION OF CHEWING GUM:

The composition of chewing gum is as follows: Gum base 25.1 % by weight Plasticizer (propylene glycol or glycerin) 0.5% by weight Dough forming medium (Maltitol syrup) 20.8 % by weight 25 Nicotine source 3.5% by weight Filler ( powdered sugar) 44.5% by weight Betel nut powder (45pm to 710m) 4.4% by weight Taste enhancer no. 2 (lime) 0.5 % by weight Pepper mint 1.()% by weight and / or any other flavouring agents and mixing it 30 thoroughly. PREPARATION OF CHEWING GUM:

To prepare the chewing gum of this composition the following process is followed: i) mixing chewing gum base, plasticizer, dough forming medium, taste enhancer no. 2 i.e. lime, a portion of filler and betel nut powder; ii) heating the above mixture at 55 (1 to soften the gum base to form a dough; s iii) adding the nicotine source prepared by the method as described above to the dough and reheating the dough for uniR'nn mixing of the nicotine source in the dough; iv) adding peppermint and any other llavouring agent and mixing thoroughly; v) gradually adding the remaining portion of filler to obtain the chewing gum mass; 0 vi) spreading the said chewing gum mass in the form ol a sheet of uniform thickness and cut into rectangular or any other shaped pieces. The cut pieces are wrapped in wax paper / aluminum foil for airtight packing. The nicotine source used will deliver 1.0 mg to 12.6 mg of nicotine per dose i.e. per piece of chewing gum.

5 Example 7

COMPOSITION OF CHEWING (FILM:

The composition of chewing gum is as follows: Gum base 34.0 % by weight 20 Dough terming medium (liquid glucose) I X.2% by weight Nicotine source 3.2% by weight Filler ( powdered sugar) 32.9 % by weight Betel nut powder (45pm to 710m) 4.4% by weight Taste enhancer no. 1 (catechu) 1.0% by weight 25 Taste enhancer no. 2(1ime) 0.5% by weight Sweetening agent (Mannitol or any other material providing required sweetness) 5.55% by weight Pepper mint 0.5 % by weight and / or other flav-'uring.

30 PREPARATION OF CHF,WING GUM:

To prepare the chewing of this composition the following process is followed:

i) mixing chewing gum base,, dough forming medium, taste enhancer no. I i. e. catechu and taste enhancer no. 2 i.e. lime, a portion of filler, betel nut powder and sweetening agent.

ii) heating the above mixture at 55 C to soften the gum base to form a dough; s iii) adding the nicotine source prepared by the method as described above to the dough and reheating the dough l'->r uniform mixing of the nicotine source in the dough; iv) adding peppermint and any other flavouring agent and mixing thoroughly; v) gradually adding the remaining portion of filler to obtain the chewing gum mass; lo vi) spreading the said chewing gum mass in the form of a sheet of uniform thickness and cut into rectangular or any other shaped pieces. The cut pieces are wrapped in wax paper / aluminum foil for airtight packing. The nicotine source used will deliver 1.0 mg tol2.6 mg ol'nicotine per dose i.e. per piece of chewing gum.

s EVALUATION - To make an evaluation of the product according to thc present invention chewing gum prepared by the process of examples 1,2,3, 4,5,6 and 7 a control sample A was prepared by the method as follows.

20 20.8 Em of chewing gum base, 20.8 gm of liquid glucose, 24.55 gm of powdered sugar and 4.4 gm of betel nut powder are mixed together. The mixture is heated at 65 C to soften the gum base to l'orm dough; 4.4gm of quimam is added to the dough and reheating the dough for uniform mixing of 25 the quimam and dough; ().5 gm of peppermint is added and mixed thoroughly, A t'urther amount ol'24.55 gm of powdered sugar is added gradually to the mixture to 30 obtain the chewing gum mass

The chewing gum mass in the form ova sheet of uniform thickness is cut into rectangular or any other shaped pieces. The cut pieces are wrapped in wax paper / aluminum foil for air tight packing I'he evaluation was made taking the factors of product smoothness, saliva generation per dose, lingering ef'i'ect, nicotine intake /day, chewing property, overall taste. A panel of 10 nicotine consumers with intake of nicotine between 70 to] 05 mg of nicotine per day divided into 10 to] 2 doses through various nicotine containing products other than 0 smoking, were used for the purpose of evaluation.

The chewing gum ot' the present invention as in examples 1, 2, 3, 4, 5, 6 and 7 are compared with the control example A for the following attributes: _ ATTRJBUTES EXAMPLE 1 EXAMPLE 2 EXAMPLE 3 EXAMPLE 4 EXAMPLE 5 EXAMPLE 6 EXAMPLE 7 EXAMPLE A

1 PRODUCT

= SMOOTHNESS 90 78 87 84 92 75 92 60

2 SALIVA

= GENERATION 8.0 cc 9.0 cc 10.0cc 10.0 cc 7 5cc 6.8 cc 7.0 cc 15.0 cc 3 LINGERING = EFFECT 120 MINUTES 95 MINUTES 110 MINUTES 110 MINUTE' 125 MINUTES 125

MINUTES 135 MINUTE' 90 MINUTES

4 NICOTINE

= INTAKE / DAY 52.5 mg 61.9 mg 57.3 mg 58.7mg 49.9 mg 49.9 mg 46.2 mg 70. 0 mg 5 CHEWING

= PROPERTY 8.3 7.95 8.1 8.15 8.8 8.2 8.5 7.9

6 OVERALL

15 = TASTE 8.2 8.4 8.6 8.75 9.0 7.9 9.2 8.15

PRODUCT SMOOTHNESS

1- Product Smootlmess is an attribute that is related to the degree at which the nicotine 20 is absorbed into the system giving the user the feel. In a scale of 100 example I delivers a smoothness of 90, example 2 a smoothness of 78, example 3,4,5,6 and 7delivers a smoothness of 87,84, 92,75 and 92 respectively which is much higher than that delivered by control example A which is 6().'1'hus the gum based product

with nicotine source without taste enhancer is better in respect of this attribute to that with quimam while that with both taste enhancers gives the best result.

SALIVA GENERATION

5 2- Saliva (generation is the saliva formed during intake of the chewing gum. Example I leads to saliva generation ol' 8.0cc, examples 2 to 7 saliva generate 9 cc,10 cc,]0 cc 7.5 cc,6.8 cc and 7.0 cc, which are much lower than that by control example A which is 15.0 cc. Ilence there is less saliva generation in the product with nicotine source without taste enhancer while those with both taste enhancers lead to least lo saliva generation.

LINGERING EFFECT

3- The lingering effect is the time interval when the user feels the urge to take another dose of nicotine product. The effect of' the chewing gum lingers for 120 minutes in is example 1, 95 minutes for example 2, 110 minutes for example 3 and 4,125 minutes for examples 5 and 6 whereas 135 minutes for example 7 which are much higher than the control example A where effect lingers for only 90 minutes.

The lingering effect being higher for the examples 1, 2, 3,4,5,6 and 7 the intake of 20 chewing gum and in the effect nicotine intake per day is lesser than the control example A. The values of nicotine intake/day being 52.5 mg in example 1, 61.9mg in examples, 57.3 mg in examples, 58.7 mg in example 4, 49.9mg in examples 5 and 6, 46.2 mg in example 7 while it is 70 mg in example A. 25 CHF,WING PROPERTY & OVERALL TASTE

Chewing property and overall taste were determined in a scale of 10. Example Ito 7 revealed values 8.3, 7.95, 8.1, X.15, 8.8, 8.2 and 8.5 respectively as against 7.9 for example A with respect to Chewing property whereas for Overall Taste the values were 8.2, 8.4, 8.6, 8.75, 9. 0,7.9 and 9.2 for Example I to 7 as against 8.15 for Example A. Thus considering all aspects of the experiments done, it is found that betel nut containing chewing gum with nicotine source of the present invention is superior to the

control sample A while the chewing gum with nicotine source along with both taste enhancers namely catechu and lime, gives better result than the gum without taste enhancers with respect of the attributes tested.

5 The gum based product of the present invention may be used for other applications by incorporating appropriate actives such as caffeine and other alkaloids together with suitable additives.

Claims

CLAIMS:

1. A gum based product comprising: from 12-35% by weight ol'a gum base in the form of dough; 5 from 0-7.0% by weight of a plasticizer.

Prom 0.05 to 5.75% by weight of a nicotine source; I'rom 35-65% by weight of a filler; from 1.5-9% by weight of betel nut powder having average particle size of between 45rm to 7]0lm; lo from 0.1 to 3.() % by weight of one or more flavouring agent; said gum based product being in the form of gum pieces adapted to deliver 1.0 to 12.6 mg of nicotine per piece.

2. A gum product as claimed in claim 1, further comprising 0.1 to 3.7% of taste 15 enhancer selected 1'r-,m catechu and/or lime.

3. A awn product as claimed in claim I or claim 2, further comprising t'rom 0.02 to7.5% by weight of sweetening agent.

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4. A gum product as claimed in any one of claims I to 3, comprising: I'rom 25-34% by weight of a awn base in the form of dough; from I -1.5% by weight of plasticizer; from 3 to 3.5% by weight of nicotine source; from 35-55% by weight of filler; 25 from 4-6"/o by weight of betel nut powder of average particle size ranging from 45,um to 710rm; from 0.5 to 3.0% of'catechu; from 0. 1-6% by weight of sweetening agent; from 0.1 to 1.5 % by weight of peppermint source and any other flavouring 30 agent such as herein described; said gum based product being in the form ol gum pieces adapted to deliver 1.0 to 7 mg of nicotine per piece.

5. A gum based product as claimed in any one of claims 1 to 3, comprising: from 25-34% by weight of a gum base in the form of dough; from 1-1.5% by weight of' plasticizer; 5 from 3 to 3.5% by weight of nicotine source; trom 35-55% by weight of filler; from 4-6% by weight of betel nut powder of average particle size ranging from 45lm to 71()m; from 0.1 to 0.7 % of lime; 0 from 0.1-6% by weight of sweetening agent; from 0.1 to 1.5 % by weight of peppermint source and any other flavouring agent such as herein described; said gum basecl product being in the form of gum pieces adapted to deliver 1.0 to 7 mg of nicotine per piece.

6. A gum product as claimed in any one of claims I to 3, comprising: from 25-34% by weight oi'a gum base in the form of dough; from 3 to 3.5% by weight ot'nicotine source; From 35-55% by weight of filler; 20 from 46'/o by weight of betel nut powder of average particle size ranging from 45m to 710lm; from 0.5 to 3.0 % of catechu and 0.1 to 0.7 % oi'lime from 0.1-6% by weight of sweetening agent; from 0.1 to 1.5 % by weight of peppermint source and any other 25 flavouring agent such as herein described; said gum based product being in the form of gum pieces adapted to deliver 1.0 to 7 mg of nicotine per piece.

7. A gum based product as claimed in any of the preceding claims wherein the 30 plasticizer when present is propylene glycol or glycerin.

8. A gum based product as claimed in any of the preceding claims wherein the filler is powdered D-Sorbitol or powdered sugar.

9. A gum based product as claimed in any of claims 3 to 8, wherein the sweetening 5 agent is selected from Aspartame, mannitol, powdered sugar and the like.

10. A gum based product as claimed in any of the preceding claims, wherein the flavouring agent is selected from gennaninn1 oil, cardamom navour, saffron ilavour, clove oil, cinnamon flavour, tobacco llavour A, tobacco llavour B. lo tobacco flavour C, cardamom powder, menthol powder or mentha piperita oil as peppermint source.

11. A gum based product as claimed in claim 10, wherein one or more flavouring agent(s) are selected from: 15 Flavouring agent flange (% by wt Germanium oil 0.7-0.9 Cardamom flavour 2-3 Saffron flavour 0.15-0.35 Clove oil 0.1 5-0.3 5 20 cinnamon flavour 0.5-0.( Tobacco flavour A 0.5-3. 5 Tobacco flavour B 1.0-4.5 Tobacco flavour C 0.5- 1.5 Cardamom powder 0. 5-1.5 25 Peppermint source ().5-2.0

12. A gum based product as claimed in claim 11, wherein one or more flavouring agent(s) are selected from: 30 Flavouring agent Preferred range ( /0 by wt) (germanium oil 0.75 -0.85 Cardamom Bavour 2.0 -3.0

Saffron flavour 0.2 - 0.3 Clove oil 0.2 -0.3 Cinnamon flavour 0.5 -0.6 Tobacco flavour A 2.2 - 3.0 5 'tobacco flavour B 3.0 - 3.5 Tobacco flavour C O.X - 1.2 Cardamom powder 0. X -- 1.2 Peppermint source 0.8 - 1. 2 lo

13. A gum based product as claimed in any one of claims 1 to 12, wherein the gum based product is a chewing gum, bubble gum and the like.

14. /t gum based product as claimed in claim 13, wherein the gum based product is a chewing gum.

15. A process liar preparing gum based product comprising: i) providing a mixture comprising 12-35% by weight of gum base, 0-7.0% by weight of plasticizer, 3-30% by weight of dough Forming medium, a filler,l.5-9% by weight of betel nut powder average particular size ranging 20 loons 45lm to 710m; ii) heating the mixture to a temperature between 45 C to 65 C to soften the gum base and form a dough; iii) adding from 0.05 to 5.75% by weight of nicotine source to the dough; iv) adding 0.1 to 3.0% by weight of one or more flavouring agent such as 25 herein described followed by addition of a further amount of filler and mixing the mass thoroughly to obtain the gum; v) converting the said mass into gum pieces containing nicotine at a level of 1.0 to 12.6 mg per piece.

30 1 G. A process for preparing gum based product as claimed in claim 15 comprising: i) providing a mixture comprising 12-35% by weight of gum base, 0-7.0% by weight of plasticizer, 3-30% by weight of dough forming medium, a

fller,].5-9% by weight of' betel nut powder average particular size ranging from 45pm to 710m; 0.1 to 3.7% of taste enhancer selected from catechu and or lime; ii) heating the mixture to a temperature between 45 C to 65 (2 lo soften the 5 gum base and form a Lough; iii) adding from 0.05 to 5.75% by weight of nicotine source to the dougll; iv) adding 0.1 to 3.0% by weight of one or more ilavouring agent such as herein described followed by addition of a further amount of filler and mixing the mass thoroughly to obtain the gum; lo v) converting the said mass into guns pieces containing nicotine at a level of 1.0 to 12.6 mg per piece.

17. A process for preparing gum based product as claimed in claim 14 further comprising gradually adding 0.()2-7.5% by weight of sweetening agent selected 5 from Aspartame, mannitol, powdered sugar and the like.

18. A process t'or preparing gum based product as claimed in claims 15 to 17 comprising: i) providing a mixture comprising 25-34% by weight of gum base,l-1.5% 20 by weight ot'plasticizer,6-22% by weight of dough forming medium, a filler,4-6% by weight of betel nut powder of average particle size ranging t'rom 45,um to 710rm, 0.5 to 3.0% of catechu, 0.1-6% by weight of sweetening agent; ii) heating to a temperature between 45 C to 60 C to soften the gum base to 25 t'orm a dough; iii) adding 3 to 3.5% by weight ol'nicotine source to the dough; iv) adding 0.1 to 1.5 % by weight of peppermint source or any other flavouring agent such as herein described followed by addition of' a further amount of filler and mixing the mass thoroughly to obtain the 30 gum; v) converting the said mass into gum pieces containing nic-,line at a level of 1.() to 7 mg per piece.

19. A proeFss for preparing gum based product as claimed in claims 15 to 17 comprlsmg: i) providing a mixture comprising 25-34% by weight of gum base,l-].5% 5 by weight of p]asticizer,6-22% by weight of dough forming medium, a filler,4-6% by weight of betel nut powder oi average particle size ranging from 45m to 7]0rm, 0.1 to 0.7% of dime, 0.1-6% by weight of sweetening agent; ii) heating to a temperature between 45 C' to 60 C to soften the gum base to 0 form a dough; iii) adding 3 to 3.5% by weight of nicotine source to the dough; iv) adding 0.] to 1.5 % by weight of peppermint source or any other flavouring agent such as herein described followed by addition of a further amount oi ii]]er and mixing the mass thoroughly to obtain the s gum; v) converting the said mass into gum pieces containing nicotine at a]eve] of 1.0 to 7 mg per piece.

20. A process for preparing gum based product as claimed in claims 15 to 17 20 comprising: i) providing a mixture comprising 25-34% by weight of gum base, 6-22% by weight Cal dough forming medium, a filler,4-6% by weight of betel nut powder of average particle size ranging from 45m to 710,um, 0.5 to 3.0 % of catechu and 0.1 to 0.7 % lime, 0.1-6% by weight of sweetening 25 agent; ii) heating to a temperature between 45 C to 6() C to soften the gum base to form a dough; iii) adding 3 to 3.5% by weight of nicotine source to the dough; iv) adding 0.1 to 1.5 % by weight of peppermint source or any other 30 ilavouring agent such as herein described followed by addition of a further amount of filler and mixing the mass thoroughly to obtain the gum;

v) converting the said mass into gum pieces containing nicotine at a level of 1.0 to 7 mg per piece.

21. A process for preparing gum based product as claimed in any one of claims 15 5 to 2O, wherein the gum based product is chewing gum, bubble gum and the like.

22. A process for preparing gum based product as claimed in claim 21, wherein the gum based product is chewing gum.

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23. A process for preparing gum based product as claimed in any one oi'claims 15 to 22, wherein the dough is reheated following addition of nicotine source for uniform mixing of the nicotine source with the dough.

24. A process for preparing gum based product as claimed in any one of claims 15 5 to 23, wherein the filler is incorporated in the mix at a level of between 1 5-X0% of the total filler to be present in the chewing gum and at a subsequent stage adding the balance filler in an amount of between 20-85%.

25. A process for preparing gum based product as claimed in any one of claims 15 20 to 24, wherein the said gum pieces are formed by spreading the mass obtained in step iv) of the process in the form of a sheet of uniform thickness and cut into shaped pieces of size adapted to deliver the said amount ol nicotine per piece of chewing gum.

2s

26. A process for preparing gum based product as claimed in any one of claims 15 to 25, wherein the flavouring agent is selected from germanium oil, cardamom llavour, saffron flavour, clove oil, cinnamon flavour, tobacco flavour A, tobacco flavour 13, tobacco Devour C. cardamom powder, menthol powder or mentha piperita oil as peppermint source.

3()

27. A process for preparing gum based product as claimed in claim 26, wherein one or more flavouring agent are selected l'rom:

Flavouring agent Range (% by wt Germanium oil 0.7-0.9 Cardamom llavour 2. 0-3.0 Saffron flavour 0.15-0.35 s Clove oil 0.15-0.35 Cinnamon flavour 0. 5-0 6 Tobacco flavour A 0.5-3.5 Tobacco flavour B 1.0-4.5 Tobacco llavour C 0.5- 1.5 ]0 Cardamom powder 0.5-1.5 Peppermint source 0.5-2.()

28. A process for preparing gum based product as claimed in claim 27, wherein one or more flavouring agent are selected l'rom: llavourinc agent Preferred range (TO by wt) Germanium oil 0.75 -0.85 Cardamom flavour 2.0 -3.0 Saffron flavour 0.2 - 0.3 20 Clove oil 0.2 -0.3 Cinnamon flavour 0.5 -0.6 Tobacco flavour A 2.2 - 3.0 Tobacco flavour E3 3.0 - 3.5 Tobacco ilavour C 0.8 - 1.2 25 Cardamom powder 0.8 -1.2 Peppermint source 0.8 1.2

29. A process for preparing guns based product as claimed in claims 15-28, wherein the plasticizer, when present is propylene glycol or glycerin.

30. A process for preparing gum based product as claimed in any one of claims 15 to 29, wherein the dough forming medium is selected from liquid sorbitol, maltitol syrup, liquid glucose and like.

5

31. A process for preparing gum based product as claimed in any one of claims 15 to 30, wherein the filler is selected from powdered D-Sorbitol, powdered sugar and the like.

32. A gum based product and a process for preparing the same as claimed in any of lo the preceding claims, wherein the said nicotine source is prepared by a process comprising: filling up fine scrap of tobacco in a metallic column; passing stream through the column and collecting the condensed extract of tohaecc' at the bottom of the column; 15 continuing the cycle till the extraction is complete; passing the collected extract through a falling film evaporator to concentrate the extract to 35% ofthe initial tobacco weight; cooling to room temperature; and adding said ilavouring agents.

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33. A gum based product substantially as herein described with reference to the description and the examples.

34. A process for preparing gum based product substantially as herein described with reference to the description and the examples