Field of invention
The present invention relates to composition for smokeless tobacco product. Particularly,
the present invention relates to a composition for manufacture of smokeless tobacco
product, which does not require spitting/discarding/expulsion during consumption and does
not leave any residue after consumption. More particularly the present invention relates to
a solid smokeless tobacco product, preferably in the form of tablet, stick and the like.
Background and prior art of the invention
Tobacco is used in the form of smokable as well as smokeless tobacco products. The
conventional smokeless tobacco products like Gutka, Zarda, Khaini, Snus, Quimam etc.
are made of tobacco in cuVshreddedlflake form and other ingredients like areca nut,
catechu, spices and permitted flavours as required.
684/MUM/2005 discloses an element containing nicotine and aromatic flavorings, where
each element is shaped like a small flat disc, which is suitable to be placed sub-labially or
sub-lingually. The process involved for making such product comprises soaking of tobacco,
purification of extracts and sheet formation with remaining tobacco. The achieved material
are sUbsequently infused with nicotine and divided into portion pieces. Moreover, the said
discs comprises fibers which individual elements to be held together and includes a binding
agent. The discs contain tobacco. However, the process is more closer to sheet formation
and not compressed tablet formation. The product thus made is unlikely to be dissolvable
due to the presence of long fiber, and tobacco in the form of sheet.
IN 221428 is related to buccal drug delivery device and composition for unidirectional
release of nicotine. The composition involves utilization of pure nicotine as active ingredient
along with silicon dioxide and HPMC. More partiCUlarly, the composition is directed to
smoking cessation which comprises hydrophilic polymers, nicotine, starch, colloidal carriers
and excipients such that the excipients having the property of controlling the release of
nicotine, the resulting composition being provided a backing membrane to facilitate
unidirectional release of nicotine.
2281/KOLNP/2007 relates to a method of relieVing nicotine craving comprising the steps of
providing at least one chewing gum comprising tobacco alkaloid to a user,
providing relief of nicotine craving to said user by transferring of tobacco alkaloid
from the chewing gum to the human body of said user by cheWing of said chewing
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gum, said chewing of said chewing gum compnslng a chewing process involving a
transfer of tobacco alkaloid from said chewing gum above a threshold transfer rate in
the period of about Y2 minute to about 2% minutes from initiation of said chewing
process.
7851/DELNP/2008 relates to a composition that provides a rapid release of nicotine and
thus, provides a rapid increase in the plasma concentration of nicotine upon in vivo use.
The composition is in the form of a tablet for buccal absorption (Le. in the form of a
lozenge) and it has a shelf life of 24 months or more. The composition may be used as a
pharmaceutical composition and/or as a tobacco substitute composition. Thus, the
invention relates to the use of a nicotine-cellulose combination and one or more
pharmaceutically acceptable excipients for the preparation of lozenge composition for
achievement of a fast onset of action of nicotine after application of the composition to the
oral cavity of a subject. This invention uses pure nicotine in cellulose combination and thus
caters to the need of nicotine per se rather than tobacco.
3838/CHENP/2009 relates to a solid oral transmucosal dosage form compnslng the
following ingredients: nicotine or nicotine derivative as an active ingredient; an effervescent
couple; and a pH adjusting substance; the dosage form being formulated for static resident
placement within a recipient's oral cavity for transmucosal delivery of the nicotine or
nicotine derivative across said recipient's oral mucosal tissue. In a preferred embodiment,
the dosage form is in the form of a buccal tablet. The pH adjusting agent used herein is to
maintain the pH of the micro environment at the point of transport of the nicotine from the
product to the buccal mucosa. Moreover, this invention uses pure nicotine in cellulose
combination and thus caters to the need of nicotine per se rather than tobacco.
US 6834654 discloses smokeless tobacco product comprising powdered tobacco and
other ingredients like binders, eucalyptus, propolis, peppermint, spearmint and/or other
f1avorants. The powdered tobacco has very low level of TSNA (tobacco specific
nitrosamine). The product preferably contains primarily water-soluble (or saliva-soluble)
components, permitting transdermal or transmucosal delivery of nicotine and other
components. The powder is preferably milled fine enough so that even insoluble
components can be easily swallowed. However, the invention is more particularly related to
the use of specially cured tobacco in compressed form and does not describe about any
specific binder and any other ingredient.
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US 2004/0020503 describes an alterative to cigarettes and traditional smokeless products.
The smokeless tobacco product contains powdered tobacco and optionally other
ingredients like binder. In addition the smokeless tobacco product contains suitable
quantities of flavorants. The product has very low, food safe level of nitrosamine content.
The invention is more particularly related to the use of specially cured tobacco in
compressed form and does not describe about any specific binder or any other ingredients.
US 6668839 discloses a smokeless tobacco product made from an extract of cured
tobacco with low level of TSNA (tobacco specific nitrosamine) content. The invention is
directed to a smokeless tobacco product made from an extract of cured tobacco. According
to one aspect of the invention, a smokeless tobacco product suitable for human
consumption comprises a solid tablet having at least 50 wt %, preferably at least 60 wt %,
more preferably at least 75 wt %, powdered tobacco, based on the total dry weight of the
tablet. The powdered tobacco thus made mixed with sufficient amount of eucalyptus oil.
The product thus made is very less in TSNA content. However, the invention does not
teach the use of any other essential ingredients essentially required to extract, drying of
excess solvent and then make powder of the extract thus obtained is very time consuming.
US 3368567 describes a tablet having tobacco concentrate and which is intended to be for
oral use. In preparing the tablet, nicotine and other active ingredients are extracted from
cured tobacco that has been ground into fine particles. The tobacco is steeped in water
and then concentrated mineral acid is added. The resulting liquid is applied to an
absorbent, inert, edible base to the extent that it constitutes less than 10% of the base.
After the liquid is dried, the resultant material is compressed into a tablet. The invention
does not teach the use of tobacco embedded in a carrier. The invention uses acid which
is harmful and moreover the process of extraction and drying is cumbersome and tedious
and involves high cost and labour.
EP 2062484 relates to the manufacturing of a smokeless tobacco articles on a rod-making
device. The paper type reconstituted tobacco web after increasing moisture content or a
slurry type reconstituted tobacco web was fed into a rod making machine equipped with a
funnel shaped entry zone and suitable format parts to obtain a rod like tobacco product.
This composition uses recon form of tobacco dust which made into sheets and finally
formed into rods.
US 2008/0196730 is related to a three layered smokeless dissolvable tobacco product,
where one layer comprising water soluble matrix and concentrated tobacco extract
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followed by another layer of different types of flavours, additives and other drugs such as
nicotine. The invention is characterized in that the outermost layer comprises a
mucoadhesive substance. This uses tobacco extract from which the ultimate active in the
product is less and large amount of raw materials/labour/cost is involved to achieve
ultimate product.
1305/DELNP/2009 relates to a smokeless tobacco formulation includng particles or pieces
of tobacco, and many other ingredients, such as salts, sweeteners, binders, colorants, pH
adjusters, fillers, flavoring agents, disintegration aids, antioxidants, humectants, and
preservatives. Certain smokeless tobacco products have the form of tobacco compositions
or formulations that result from casting or otherwise forming a mixture incorporating
tobacco material and their components into a desired shape. The foregoing tobacco
products can be sealed in outer packaging materials that are virtually impervious to oxygen
and/or moisture, and those packaging materials can be vacuum sealed, such that the
atmosphere therewithin is essentially inert. This invention teaches a snus-type tobacco
containing water permeable pouch and tapeifilm like form as well processed tobacco in
form of tobacco pellets with or without coating The composition is prepared involving slurry
formation.
As mentioned above, all the popularly available smokeless tobacco products, which are in
use, require spitting/expulsion during use and/or have to be discarded the left over after
intended consumption of the product. The above form of smokeless tobacco creates
unpleasant experience to the consumer and non-consumers during and after consumption
of the product. Further such products cause direct and continued reaction at the site of
application
Additionally there is no product which provides tobacco per se in dissolvable form to be
totally dissolved in buccal cavity within a given time span without leaving any residue or
need to discard.
Further, there is no teaching in the prior art to provide a dissolvable tobacco product, which
can achieve a desired dissolution time and disintegration rate of the product thus made and
yet provide the required tobacco taste and flavour to the consumer.
Thus there is a need to provide a smokeless dissolvable solid tobacco product resulting in
improved consumer satisfaction and high productivity with a desired dissolution time and
disintegration rate and providing tobacco per se to the consumers for define amount of
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time. There is further need to provide a process using dry form of components without
involvement of slurry formation yet having adequate release of tobacco from the end
product
Objects of the invention
It is an object of the present invention to overcome the drawbacks of the prior arts.
It is another object of the present invention to provide a composition for smokeless tobacco
product.
It is another object of the present invention to provide a composition for solid smokeless
dissolvable tobacco product.
It is yet another object of the present invention to provide a composition for solid smokeless
tobacco product which disintegrates completely in the mouth of the user with no leftover
remains.
A further object of the present invention is to prOVide a composition for solid smokeless
tobacco product which delivers adequate tobacco taste and flavour to the consumer.
Another object of the present invention is to provide a composition for solid smokeless
tobacco product which substantially dissolve and disintegrate in the user's mouth and
delivers adequate tobacco and does not leave any residue which requires to be expulsed.
It is yet another object of the present invention to provide a manufacturing process to
provide solid smokeless tobacco product having desired dissolution time and disintegration
rate.
It is another object of the present invention is to provide a process which is user friendly
and cost-effective.
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Summary of the invention
According to an aspect of the present invention there is provided a composition for
dissolvable smokeless tobacco product, comprising tobacco in amount of 10 wt% to 40
wt% and a binder adhesive in amount of 5 wt% to 50 wt%.
It is a further aspect of the present invention to provide a process for manufacturing a
dissolvable smokeless tobacco product comprising the steps of grinding the tobacco
followed by sieving and blending and compressing the blend into solid product forms of
appropriate size and shape, preferably tablets etc.
Description of invention
According to one aspect the present invention provides novel composition for smokeless
dissolvable tobacco product comprising processed or raw tobacco and at least one binder
(gum :natural and/or synthetic origin or its combination), desired flavor, releasing agent and
filler.
According to another aspect, the smokeless dissolvable tobacco product contains tobacco
preferably in amount of about 5 wt % to about 70 wt % of the dry wt of the smokeless
dissolvable tobacco product, more preferably about 10 wt % to about 40 wt % of the dry
weight of the smokeless dissolvable tobacco product.
Preferably, the tobacco component may include at least one type of tobacco and / or blend
of two or more different types of tobaccos. For example, the tobacco and tobacco materials
that can be used in the smokeless dissolvable tobacco product include, but are not limited
to, flue cured tobacco, air-cured tobacco, Burley tobacco, Maryland tobacco, Oriental
tobacco, rare tobacco, specialty tobacco, blends thereof and the like.
In the preferred embodiment, the tobacco can be ground to produce a fine powder and lor
extracted for incorporation in the smokeless dissolvable tobacco product. As used herein,
the term "tobacco powder" describes dust, fines, colloidal dispersions, granules and the like
having dimension of less than about 500 micron, more preferably less than 250 micron and
the most preferably about less than 150 micron.
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In the preferred embodiment, the terms "Binder" and "Filler" are used to refer to any
component that increase the hardness, increases the disintegration time of the smokeless
dissolvable tobacco product, maintains the integrity, reduces the friability and / or adds bulk
to the smokeless dissolvable tobacco product. It will be preferred to use single nontobacco
component which may perform the functions of Binder and a Filler.
According to another aspect, the smokeless dissolvable tobacco product contains at least
one binder (Gum : natural and/or synthetic origin or its combination thereof) preferably in
amount of about 5 wt % to about 50 wt % of the dry wt of the smokeless dissolvable
tobacco product, more preferably about 10 wt % to about 40 wt % of the dry wt of the
smokeless dissolvable tobacco product.
The suitable gum includes, without limitation, maize gum, guar gum, xanthan gum,
carboxymethyl cellulose (CMC), agar gum, accacia/arabic gum, gum ghatti, tamarind gum,
carrageenan gum, algel, karaya gum, locust bean gum, alginate, gellan gum, konjac gum,
modified starch, pectin, etc and' or combinations thereof. Preferably maize gum, guar
gum, CMC and or its combinations.
Suitable Fillers are known in the art and include, without limitation, non tobacco plant fiber,
starches, natural gums, calcium carbonate, and / or other popular betel quid ingredients
like areca nut, catechu, mineral slaked lime, etc.
In the preferred embodiment, the terms "releasing agent" is used to refer to any component
that facilitates manufacturing of the smokeless dissolvable tobacco product by reducing
friction, reducing adhesion and / or improving flow properties.
Suitable releasing agents are known in the art and without limitation includes stearates,
including magnesium stearates, calcium stearates, zinc stearates, sodium stearates and'
or combinations thereof.
In the preferred embodiment, the smokeless dissolvable tobacco product include preferably
the one or more releasing agents or combinations thereof in amount of about 0.1 wt % to
about 5.0 wt % of the dry wt of the smokeless dissolvable tobacco product, more preferably
about 0.5 wt % to about 3.0 wt % of the dry wt of the smokeless dissolvable tobacco
product.
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According to another aspect, the smokeless dissolvable tobacco product has pH of about 5
to about 10, more preferably about 7.5 to about 8.5. The pH of the smokeless dissolvable
tobacco product may be modified through the addition of one or more pH modifiers. The
suitable pH modifiers approved for use in the food industry are known in the art and
include, without limitation, CaC03, NaHC03, Na2C03, K3P04, K3HP04, Citric acid and
combinations thereof.
Suitable flavors include any flavor commonly used in foods, confections, oral product and /
or tobacco product. The flavor can be incorporated in the matrix applied to the smokeless
dissolvable tobacco product by spring, coating, immersing, embossing, and / or dispersing
them into or onto the smokeless dissolvable tobacco product.
In addition, the smokeless dissolvable tobacco product may preferably include one or more
taste enhancers (such as sodium chloride) and salivation agents. Suitable salivation agents
are known in the art and include, without limitation, one or more salt and / or sweeteners.
The smokeless dissolvable tobacco product may include natural sweeteners, artificial
sweeteners and / or combinations thereof.
In the preferred embodiment, the smokeless dissolvable tobacco product may optionally
include one or more colorants.
According to one more aspect, the smokeless dissolvable tobacco product may optionally
includes multilayers products. Such additional layers may be used to employ for various
purposes like varying dissolution rates, deliver specific ingredients, provide different taste,
flavors and / or colour etc. The resultants products preferably subjected to the coating with
suitable coating material and or color to indicate or reflect or brand or otherwise enhance
the aesthetic appearance.
According to another aspect the present invention provides a process for manufacturing
the dissolvable smokeless tobacco product wherein the said process achieves desired
dissolution time and disintegration rate.
The typical manufacturing process to make the dissolvable smokeless tobacco product
involves drying and grinding of tobacco and other raw materials and sieved to the desired
particle size. Preparation of formulation by blending with suitable mixing machine, such as,
for example, ribbon mixer. Optionally, The formulation thus prepared is then converted into
granules with the help of suitable roller machine, such as, for example, roller compactor. The
granules are dried to desired moisture content with the help of tray dryer. The dry granules
are further converted into the desired particle size and mixed with flavoring and specialty
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ingredients. Preferably, the compression forces used to form the dissolvable smokeless
tobacco product from the above formulation. The dissolvable smokeless tobacco product
thus obtained generally weigh from 0.1 to 3.0 gm.
In the preferred embodiment, the smokeless dissolvable tobacco product dissolves in the
mouth of an average consumer within about 5 minutes to about 60 minutes. The
dissolution time and hardness of the smokeless dissolvable tobacco product may be
achieved as desired by appropriate choice of the one or more non tobacco components
and I or appropriate choice of compression force.
Alternatively, the formulation is converted directly into dough with suitable dough maker,
such as, for example, sigma mixer, which is then extruded into appropriate size and
shape for conventional packing.
According to the present invention, the product thus obtained from the said composition is
dissolvable when placed in mouth with no leftover.
The present invention further offers reduction in production time and thereby results in
higher productivity. Further the manufacturing process of the present invention achieves
product which has desired dissolution time and disintegration rate.
The present invention is now disclosed by way of non-restrictive illustrative example. The
components as provided in the following table are taken. They are exposed to grinding
followed by sieving and blending as applicable. The blend is formed into tablets.
S.No. Tobacco Binder (%) Filler Others Wt (g) Moisture Nicotine pH Hardness Dissolution
(%) (%) (%) (%) (mg) (kg) (Min)
Exp.l 25 Maize - 40 25 10 0.340 7.6 1.99 7.4 4.1 > 30
Exp.2 25 CMC- 40 25 10 0.364 6.2 - - 7.9 > 30
Exp.3 25 Guar - 40 25 10 0.378 7.3 2.26 7.7 4.0 3
Exp.4 25 Xanthan - 40 25 10 0.351 7.3 - - 7.6 > 30
Exp.5 25 Accacia- 40 25 10 0.439 7 - - 8.8 > 30
Exp.6 25 Agar - 40 25 10 0.347 12 - - 2.0 10
Exp.8 25 Tamarind - 40 25 10 0.355 6.4 - - 2.6 5
Exp.9 23 Maize 30 + Guar 10 25 12 0.332 6.6 1.00 8.2 4.8 > 30
Exp.1O 23 CMC-30 + Guar-10 25 12 0.449 6.6 1.24 8.4 11.2 > 30
Exp.11 23 Guar-30 + CMe-10 25 12 0.395 7.3 - - 6.6 3
Exp.12 23 Xanthan-30 + Guar-10 25 12 0.423 7.3 - - 12.8 > 30
Exp.13 23 Accacia-30 + Guar-10 25 12 0.420 7.8 - - 7.6 > 30
Exp. 14 23 Agar-30 + Guar-10 25 12 0.306 11 - - 1.1 2
Exp. 16 23 Tamarind-40 + Guar-10 25 12 0.397 6.7 - - 1.5 2
Exp.17 20 Maize 30 + CMC10 29 11 0.363 6.9 2.32 7.8 8.9 > 30
Exp. 18 20 Maiz-30+Guar-5+CMC-5 29 11 0.356 7.1 2.29 7.7 7.4 > 30
Exp. 19 20 Guar-30 + CMC-lO 29 11 0.362 7.4 - - 7.3 3
Exp.20 20 Xanthan-30 + CMC-lO 29 11 0.456 7.1 - - 17.9 > 30
Exp.21 20 Accacia-30 + CMC-lO 29 11 0.471 7.8 - - 11.7 >30
Exp.22 20 Agar-30 + CMC-lO 29 11 0.402 10.4 - - 2.8 8
Exp.24 20 Tamarind-40 + CMC-lO 29 11 0.390 6.6 - - 3.9 5
We claim:
1. A composition for dissolvable smokeless tobacco product, comprising tobacco in
amount of 10 wt% to 40 wt% and a binder adhesive in amount of 5 wt% to 50 wt%.
2. The composition for dissolvable smokeless tobacco product as claimed in claim 1
wherein the composition for dissolvable smokeless tobacco product further
comprises at least one of a filler, a pH adjusting agent, a releasing agent, a
sweetener, a flavour, and a combination thereof.
3. The composition for dissolvable smokeless tobacco product as claimed in claim 1
wherein the tobacco includes at least one tobacco selected from flue cured
tobacco, air-cured tobacco, Burley tobacco, Maryland tobacco, Oriental tobacco,
rare tobacco, specialty tobacco, and a combination thereof.
4. The composition for dissolvable smokeless tobacco product as claimed in claim 1
wherein the tobacco is a fine powder having dimension of less than about 500
micron, more preferably less than 250 micron and most preferably about less than
150 micron.
5. The composition for dissolvable smokeless tobacco product as claimed in claim 1
wherein the binder adhesive is selected from at least one of maize gum, guar gum,
xanthan gum, carboxymethyl cellulose (CMC), agar gum, accacia/arabic gum, gum
ghatti, tamarind gum, carrageenan gum, algel, karaya gum, locust bean gum,
alginate, gellan gum, konjac gum, modified starch, pectin, and a combination
thereof. Preferably maize gum, guar gum, CMC and or its combinations thereof.
6. The composition for dissolvable smokeless tobacco product as claimed in claim 2
wherein the filler is selected from at least one of non tobacco plant fiber, starches,
natural gums, calcium carbonate, popular ingredients of betel quid such as areca
nut, catechu, mineral slaked lime, and a combination thereof.
7. The composition for dissolvable smokeless tobacco product as claimed in claim 2
wherein the releasing agent is selected from at least one of magnesium stearates,
calcium stearates, zincs stearates, sodium stearates and a combination thereof in
amount up to 0.1 wt % to 5.0 wt %.
8. The composition for dissolvable smokeless tobacco product as claimed in claim 2
wherein the pH adjusting agent is selected from at least one of CaCOs, NaHC03,
Na2COS, K3P04, KsHP04,citric acid, and a combination thereof.
9. The composition for dissolvable smokeless tobacco product as claimed in claim 1,
wherein the dissolvable smokeless tobacco product has pH of 7.0 to 9.0.
10. The composition for dissolvable smokeless tobacco product as claimed in claim 1,
wherein the dissolvable smokeless tobacco product weighs from 0.1g to 3.0g.
11. The composition for dissolvable smokeless tobacco product as claimed in claim 1,
wherein the dissolvable smokeless tobacco product comprises a multilayer.
12. A process for manufacturing a dissolvable smokeless tobacco product comprising
the steps of grinding the tobacco followed by sieving and blending and compressing
the blend into solid product forms of appropriate size and shape, preferably tablets
etc.
13. The process as claimed in claim 12, wherein the said formulation is optionally,
converted into dough, which then is extruded into appropriate size and shape.
14. The process as claimed in claim 12, wherein the dissolution time of the smokeless
tobacco product is 5 minutes to 60 minutes.