The present invention relates to an oral smokeless dissolvable compressed tobacco product. A number of oral smokeless non-dissolvable tobacco products that include an insoluble residual component that is disposed of by a consumer after use are known in the art. Known smokeless non-dissolvable tobacco products include: plug, twist, and loose leaf chewing tobacco; dry snuff; moist snuff, which typically contains finely cut fermented moist tobacco; loose or portioned snus, which typically contains finely ground moist tobacco; and tobacco- containing chewing gum.

A number of oral smokeless dissolvable tobacco products that dissolve in the mouth of a consumer are also known. Amongst these are smokeless dissolvable compressed tobacco products in the form of pills, tablets and lozenges, which comprise powdered or ground tobacco together with other ingredients. Raw, unprocessed tobacco may contain increased levels of viable bacteria. As smokeless dissolvable compressed tobacco products dissolve and the tobacco in such products is ingested by the consumer, it would be desirable to provide an improved method for treating a smokeless dissolvable compressed tobacco product for oral use.

According to the invention there is provided a smokeless dissolvable compressed tobacco product comprising: a pasteurised tobacco component, wherein the substantially aseptic smokeless dissolvable compressed tobacco product has a total aerobic microbial count of less than 2 log cfu/g.

According to the invention there is also provided a method of making a smokeless dissolvable compressed tobacco product having a total aerobic microbial count of less than 2 log cfu/g. The method comprises: pasteurising a tobacco component to reduce the total aerobic microbial count to less than 2 log cfu/g and the total yeast and mould count to less than 2 log cfu/g; mixing the pasteurised tobacco component with one or more non-tobacco components; and compressing the pasteurised tobacco component and one or more non- tobacco components to form a smokeless dissolvable compressed tobacco product. For the purposes of the invention, the total aerobic microbial count is measured in accordance with the Nordic Committee on Food Analysis (NMKL) method No 86, 4. Ed., 2006 and the total yeast and mould count specified is measured in accordance with NMKL method No 98, 4. Ed., 2005. The NMKL method No 86, 4. Ed., 2006 is used to determine the aerobic plate count by preparing a dilution series of sample material according to general microbiological principles, followed by pour-plating into an agar medium in Petri dishes. In this method, the samples are incubated under aerobic conditions at either 30 ⁰ C for 3 days, 20°C for 3 days, or 6.5°C for 10 days. In the NMKL method No 98, 4. Ed., 2005, the yeast and mould count is determined by surface inoculation of appropriate dilution series on dichloran rose bengal agar (DRBC), dichloran glycerol agar (DG18) or oxytetracykline glucose yeast extract agar (OGYE) dependent on which matrix are analysed. In this method, mould and yeast are counted after incubation at 22-25.0 +/- 1.0 ⁰ C for 5-7 days.

The tobacco component may be pasteurised using any suitable technique provided that the pasteuriation parameters such as temperature and time are sufficient to reduce the total aerobic microbial count of the tobacco component to less than 2 log cfu/g and the total yeast and mold count of the tobacco component to less than 2 log cfu/g to render the tobacco component substantially aseptic.

Suitable pasteurisation techniques include, but are not limited to, single hot steam injection, repeated hot steam injection and indirect heating. Preferably, the tobacco component is pasteurised by hot steam injection, more preferably by repeated hot steam injection.

Preferably, the step of pasteurising the tobacco component comprises direct heating of the tobacco by hot steam injection to a temperature of between about 100 ⁰ C and about 12O ⁰ C for a period of between about 1 minute and about 30 minutes. More preferably, the step of pasteurising the tobacco component comprises direct heating of the tobacco component by repeated hot steam injection to temperatures of at least about 100 ⁰ C.

As well as reducing the total aerobic microbial count and the total yeast and mould count of the tobacco component, the heat treament of the tobacco component during pasteurisation advantageously results in the formation of tobacco-derived flavourings.

The tobacco component may be pasteurised together with water. Alternatively, or in addition, the tobacco component may be pasteurised with one or more other additives approved for use in the food industry, including, but not limited to, sodium chloride, sodium carbonate, potassium carbonate, propylene glycol, glycerol and combinations thereof.

The pH of the pasteurised tobacco component may be adjusted prior to compressing the pasteurised tobacco component and one or more non-tobacco components to form the smokeless dissolvable compressed tobacco product.

Preferably, the pH of the pasteurised tobacco component is adjusted to between about 7.5 and about 8.9. The pH of the pasteurised tobacco component may be adjusted through the addition of one or more acidity regulators. Suitable acidity regulators approved for use in the food industry are known in the art and include, but are not limited to: alkali carbonates, such as sodium carbonate and potassium carbonate; calcium carbonate; alkali hydroxides, such as sodium hydroxide and potassium hydroxide; calcium hydroxide; magnesium hydroxide; and combinations thereof. Preferably the pH of the pasteurised tobacco component is adjusted prior to mixing the pasteurised tobacco component with the one or more non-tobacco components.

However, alternatively or in addition, the pH of the pasteurised tobacco component may be adjusted by mixing the pasteurised tobacco component with one or more non-tobacco components comprising at least one acidity regulator or buffering agent.

The tobacco component may comprise one or more of tobacco lamina, tobacco stem, expanded tobacco and reconstituted tobacco.

The tobacco component may comprise a blend of two or more different types of tobacco. For example, the tobacco component may comprise a blend of two or more of different types of tobacco selected from the group consisting of Virginia, Burley, Maryland, Nicotiana rustica and oriental tobacco. Alternatively, the tobacco component may comprise a single type of tobacco.

The tobacco component may comprise tobacco that has been one or more of dried, aged, flue-cured, air-cured, fire-cured, sun-cured, shredded, powdered and ground.

Preferably, the tobacco component comprises air-cured tobacco, sun-cured tobacco, dark air-cured tobacco or a combination thereof.

Preferably, the tobacco component comprises particulate tobacco. More preferably, the tobacco component comprises powdered tobacco, ground tobacco or a combination thereof.

The particulate tobacco may have any suitable average particle size. For example, the particulate tobacco may have an average particle size of less than about 1 mm, less than about 0.5 mm or less than about 0.1 mm. Preferably, the particulate tobacco has an average particle size of between about 100 nm and about 1 mm, more preferably of between about 100 nm and about 0.5 mm. The tobacco may be ground and sieved in a typical manner in order to obtain a desired particle size.

As well as the tobacco component, to obtain desired mechanical and organoleptic properties, the smokeless dissolvable compressed tobacco product further comprises one or more non-tobacco components. For example, smokeless dissolvable compressed tobacco products according to the invention may further comprise one or more non-tobacco components approved for use in the food industry selected from the group consisting of: acidity regulators, buffering agents, fillers, binders, gelling agents, lubricants, anti-adherents, glidants, disintegration agents, sweeteners, flavourants, taste enhancers and colourants.

The tobacco component may be dry blended or otherwise mixed with the one or more non-tobacco components. For example, the tobacco component and one or more non-tobacco components may be ground together or mixed in a twisting powder mixer.

The tobacco component may be present in the smokeless dissolvable compressed tobacco product in an amount of between about 0.5% to about 60% of the dry weight of the compressed tobacco product. The amount of the tobacco component may be selected as a function of, for example, the desired nicotine content or the desired flavour or other organoleptic properties of the smokeless dissolvable compressed tobacco product.

In a particularly preferred embodiment of the invention, the smokeless dissolvable compressed tobacco product comprises: at least one binder or filler; at least one lubricant, anti- adherent or glidant; at least one acidity regulator; at least one flavourant; and at least one sweetener. Preferably, the smokeless dissolvable compressed tobacco product also comprises one or more of a gelling agent, a taste enhancer, a colourant and a disintegration agent.

Preferably, the smokeless dissolvable compressed tobacco product comprises at least one binder or filler. Throughout the specification, the terms "binder" and "filler" are used to refer to any component that increases the disintegration time of the dissolvable compressed tobacco product, maintains the integrity of the dissolvable compressed tobacco product, increases the hardness of the dissolvable compressed tobacco product, reduces the friability of the dissolvable compressed tobacco product or adds bulk to the smokeless dissolvable compressed tobacco product. It will be appreciated that a single non-tobacco component may perform the functions of a binder and a filler.

The smokeless dissolvable compressed tobacco product may optionally comprise one or more gelling agents. Throughout the specification, the term "gelling agent" is used to refer to any component that affects the mouth feel of the smokeless dissolvable compressed tobacco product when dissolved in the mouth of a consumer. Suitable binders, fillers and gelling agents are known in the art and include, but are not limited to: non-tobacco plant fibres; starches, including pre-gelatinized starch; gums, including natural gums, such as xanthan gum, gum, acacia, gum arabic, guar gum, locust bean gum and sodium alginate; pectins: gelatine: agar: carrageenan; pullulan; microcrystalline cellulose; methyl cellulose; carboxymethyl cellulose; dextrins, including maltodextrin; sugar alcohols, such as erythritol, xylitol mannitol, sorbitol, isomalt, maltitol and lactitol; glucose; lactose; sucrose; polyvidone; calcium sulfate dihydrate; and combinations thereof.

In a preferred embodiment, the smokeless dissolvable compressed tobacco product comprises microcrystalline cellulose, which functions as a binder and a filler.

The smokeless dissolvable compressed tobacco product may optionally comprise one or more lubricants, anti-adherents, glidants or combinations thereof. Throughout the specification, the terms "lubricant" "anti-adherent" and "glidant" are used to refer to any component that facilitates manufacturing of the smokeless dissolvable compressed tobacco product by reducing friction, reducing adhesion, or otherwise improving flow properties. It will be appreciated that a single non-tobacco component may perform the functions of one or more of a lubricant, an anti- adherent and a glidant.

Suitable lubricants, anti-adherents and glidants are known in the art and include, but are not limited to: stearates, including magnesium stearate, calcium stearate, sodium stearate, zinc stearate, and derivatives thereof, including sodium stearyl fumarate; fatty acids, including stearic acid; silicates, including magnesium silicates and calcium silicates; starch; lauryl sulfates, including magnesium lauryl sulfate and sodium lauryl sulfate; polyethylene glycol; and silica aerogels, including colloidal fumed silica.

The one or more lubricants, anti-adherents, glidants or combinations thereof may be present in the smokeless dissolvable compressed tobacco product in an amount of, for example, between about 0.1% to about 5% of the dry weight of the compressed tobacco product. Preferably, the one or more lubricants, anti-adherents, glidants or combinations thereof are present in the smokeless dissolvable compressed tobacco product in an amount of less than about 1% of the dry weight of the compressed tobacco product, more preferably in an amount of about 0.2% of the dry weight of the compressed tobacco product.

The smokeless dissolvable compressed tobacco product may optionally comprise one or more disintegrants. Throughout the specification, the term "disintegrant" is used to refer to any component that facilitates breakup or disintegration of the smokeless dissolvable compressed tobacco product when placed in a consumer's mouth.

Suitable disintegrants are known in the art and include, but are not limited to: starches, including pregelatinised starch; sodium starch glycolate; sodium alginate; croscarmellose sodium; crosslinked polyvinylpyrrolidone, including crospovidone; sodium carboxymethyl cellulose; calcium carboxymethyl cellulose; sodium bicarbonate; and calcium carbonate.

Depending on the nature thereof, the one or more disintegrants maybe present in the smokeless dissolvable compressed tobacco product in an amount of, for example, between about 1% to about 15% of the dry weight of the compressed tobacco product.

The smokeless dissolvable compressed tobacco product may optionally comprise one or more sweeteners. Smokeless dissolvable compressed tobacco products according to the invention may include natural sweeteners, artificial sweeteners or combinations thereof. Suitable natural and artificial sweeteners are known in the art and include, but are not limited to: monosaccharides, such as glucose, fructose, ribose xylose and invert sugar; disaccharides, such as lactose, maltose and sucrose; sugar alcohols, such as erythritol, xylitol mannitol, sorbitol, isomalt, maltitol and lactitol; and artificial sweeteners, such as sucralose, aspartame, saccharin, acesulfame K, and cyclamate,

The smokeless dissolvable compressed tobacco product may optionally comprise one or more flavourants. Smokeless dissolvable compressed tobacco products according to the invention may include natural flavourants, artificial flavourants or combinations thereof. The one or more flavourants may be added in encapsulated or non-encapsulated form. Suitable natural and artificial flavourants are known in the art and include, but are not limited to, peppermint, spearmint, wintergreen, menthol, eucalyptus oil, angelica, anise, anethole, carvone, vanillin, vanilla, basil oil, cardamom, cassia, cinnamon, clove, cocoa, coriander oil, fennel oil, fenugreek, ginger, lemon grass, liquorice, nutmeg, palmarosa oil, sage oil, acacia, amber, clary, geranium, jasmine, juniper berry, lavender oil, magnolia, oak moss, orris root, osmanthus, rose oil, sandalwood, bergamot oil, lemon oil, lime oil, orange oil, fruit extracts, fruit flavouring, almond, coconut, chocolate, coffee, tea, arrack, rum, cognac, whisky, and gin.

The one or more flavourants may be present in the smokeless dissolvable compressed tobacco product in an amount of, for example, between about 0.1% to about 4% of the dry weight of the compressed tobacco product.

The smokeless dissolvable compressed tobacco product may optionally comprise one or more taste enhancers such as, for example, sodium chloride or ammonium chloride.

The smokeless dissolvable compressed tobacco product may optionally comprise one or more colourants to, for example, indicate or reflect the flavour or brand of the compressed tobacco product or otherwise enhance its aesthetic appearance.

It will be appreciated that smokeless dissolvable compressed tobacco products according to the invention may comprise multifunctional non-tobacco components that perform two or more of the functions previously described above. For example, the smokeless dissolvable compressed tobacco product may comprise a multifunctional non-tobacco component that functions as at least two of: (i) a binder or filler; (ii) a lubricant, anti-adherent or glidant; and (iii) a disintegrant. In one embodiment, the smokeless dissolvable compressed tobacco product may comprise pre-gelatinised starch that functions as a binder, lubricant and disintegrant. Smokeless dissolvable compressed tobacco products according to the invention may also comprise mutlifunctional non-tobacco components that perform two or more other functions. For example, the smokeless dissolvable compressed tobacco product may comprise a sugar alcohol that acts as a binder and a sweetner, or colloidal fumed silica that acts as a glidant and a desiccant. Other suitable known desiccants such as, for example, magnesium sulfate may also be included in smokeless dissolvable compressed tobacco products according to the invention to control the moisture content thereof.

The pasteurised tobacco component may be dry blended with one or more non-tobacco components and then directly compressed in a typical manner to form the smokeless dissolvable compressed tobacco product. The pasteurised tobacco component and one or more non-tobacco components maybe be directly compressed using, for example, a tablet press having a single die and punch arrangement or a rotary tablet press having multiple dies. Prior to being dry blended with one or more non-tobacco components, the pasteurised tobacco component may optionally be wet granulated in a typical manner using, for example, a fluid bed granulator.

The compression forces used to form the smokeless dissolvable compressed tobacco product may be selected based on a number of factors. These factors include: the type of apparatus employed to compress the tobacco component and one or more non-tobacco components; the size of the smokeless dissolvable compressed tobacco product; the desired physical and mechanical properties of the smokeless dissolvable compressed tobacco product, including but not limited to the hardness, friability, disintegration or dissolution characteristics; and the desired appearance of the compressed smokeless dissolvable compressed tobacco product. For example, through an appropriate choice of compression force and the tobacco and non-tobacco components thereof, smokeless dissolvable compressed tobacco products according to the invention may be produced having a hardness of between about 2 N and about 300 N. Furthermore, through an appropriate choice of compression force and the tobacco and non-tobacco components thereof, smokeless dissolvable compressed tobacco products according to the invention may be produced that dissolve in the mouth of an average consumer within about 5 minutes to about 45 minutes.

In a preferred embodiment, through an appropriate choice of the one or more non- tobacco components therein, smokeless dissolvable compressed tobacco products according to the invention dissolve in the mouth of an average consumer within about 5 minutes to about 15 minutes.

Through another appropriate choice of the one or more non-tobacco components, smokeless dissolvable compressed tobacco products according to the invention which dissolve in the mouth of an average consumer within about 30 minutes to about 45 minutes and which can be sucked by a consumer and then "parked" between their cheek and gum may be advantageously produced.

If desired, one or more surfaces of the formed smokeless dissolvable compressed tobacco product may be embossed or debossed. Alternatively the formed smokeless dissolvable compressed tobacco product may be at least partially coated in a typical manner using, for example, a pan coater.

Smokeless dissolvable compressed tobacco products according to the invention may be produced in a variety of different shapes. Figs. 1-12 show: (a) perspective views; (b) side views; and (c) top views of examples of different shaped smokeless dissolvable compressed tobacco products according to the invention.

Smokeless dissolvable compressed tobacco products according to the invention may also be produced in a variety of different sizes. For example, smokeless dissolvable compressed tobacco products according to the invention may have a diameter of from about 2 mm to about 30 mm and a weight of from about 0.1 g to about 3.0 g.