WO2018011470A1

WO2018011470A1 - A snuff-type composition and method and uses related thereto

Info

Publication number: WO2018011470A1
Application number: PCT/FI2017/050531
Authority: WO
Inventors: Tarmo PEKKARINEN; Joni PALMGREN
Original assignee: Pekkarinen Tarmo; Palmgren Joni
Priority date: 2016-07-12
Filing date: 2017-07-11
Publication date: 2018-01-18
Also published as: EP3484312A4; FI127620B; EP3484312A1; FI20160181A

Abstract

The present invention relates to the field of non-smokable products, more specifically snuff type compositions. Specifically, the invention relates to a snuff-type composition, wherein said snuff-type composition comprises nicotine and linseed and not tobacco. Still, the present invention relates to a method of preparing a snuff-type composition comprising nicotine and linseed and not tobacco, to use of nicotine and linseed in a snuff-type composition as well as other uses related to a snuff-type composition or nicotine and linseed but not tobacco.

Description

A snuff-type composition and method and uses related thereto

FIELD OF THE INVENTION The present invention relates to the field of non-smokable products, more specifically snuff type compositions. Specifically, the invention relates to a snuff-type composition, wherein said snuff-type composition comprises nicotine and linseed and not tobacco. Still, the present invention relates to a method of preparing a snuff-type composition comprising nicotine and linseed and not tobacco, to use of nicotine and linseed in a snuff-type composition as well as other uses related to a snuff-type composition or nicotine and linseed but not tobacco.

BACKGROUND OF THE INVENTION Worldwide, smoking causes about 5 million premature deaths each year, and in Finland smoking causes 4-6,000 deaths per year (1 ). In 2010, 23% of Finnish men and 16% of women smoke each day. Although the sale of snus is prohibited, 3% of men aged 25-34 used snuff daily and 8% occasionally. The corresponding numbers for boys and girls aged 15 to 24 were 2% and 10%, respectively. 60% of smokers would like to stop smoking and 40% of smokers have tried to quit smoking over the past year. In Finland tobacco smoke is classified as a carcinogen and according to the law the employer must protect workers from exposure to it.

Tobacco addiction fulfills the criteria for determining chronic illness and is the cause of smoking, caused by physical, psychological and social dependence syndrome. When a person stops smoking, positive health effects begin immediately. Osteoporosis, coughing and lymphatic lesions are relieved within 2-3 months after quitting smoking, lung function is significantly improved within 2-3 months, smoking cessation improves sleep quality and the risk of coronary heart disease is halved annually (2, 3). Quitting smoking reduces the risk of lung cancer, but it never returns to a completely non-smoking level.

Varenicline, Bupropion and Nortriptyline are used as medicines for the treatment of smoking cessation.

Nicotine replacement therapy plays an important role in supporting smoking cessation. Then, nicotine from tobacco is temporarily replaced by nicotine from the nicotine replacement therapy product. In this case, it is possible to avoid or significantly alleviate the nicotine withdrawal symptoms occurring during smoking cessation. Also, the use of nicotine replacement products avoids numerous health hazards caused by cigarette smoke. Blood nicotine levels stay always lower when us- ing nicotine replacement products compared to when smoking. All nicotine replacement products on the market are effective in weaning off tobacco and increase the chance of quitting smoking. Nicotine replacement therapy products are also suitable for those who want to lose weight. There are several nicotine replacement therapy products on the Finnish market under Nicorette ® (McNeil, Janssen-Cilag), Nicotinell ® (Novartis) and Nicover ® (Verman) brands. Chewing gum, patch, lozenge, inhaler and micro-tablet are available on the Nicorette ® product family. The Nicotinell product family is available with chewing gum, patch and lozenge. Nicover has the market for chewing gum. These are prescription-free products, which the consumer can buy from a pharmacy or stores. In Sweden, Denmark and Finland there is also a Zonnic® (Ni- conovum) nicotine replacement therapy product, which is a snuff-type preparation for oral cavity. E.g. EP1998748 B1 relates to a snuff composition comprising both nicotine and microcrystailine cellulose.

Still, there remains a need for more effective, healthier and more palatable snuff- type compositions and products. Also, sustained release type compositions are hoped-for in the field of snuff-type products.

BRIEF DESCRIPTION OF THE INVENTION

The objects of the invention are achieved by utilizing specific agents in a snuff- type product. Defects of the prior art include but are not limited to compositions, which do not retain their consistency and form in the mouth under the lip, are not optimal or healthy to be contacted with oral mucosa and do not have sufficient sustained release characteristics. It has now been surprisingly found that with a specific combination of agents a very efficient and palatable snuff-type product has been created. The present snuff-like composition may be modified to a suitable form for use under the lip. Indeed, the consistency of the snuff-type composition is optimal for oral use. E.g. the composition stays effectively in the mouth cavity un- der the lip during use, it retains its solid form and releases nicotine from the composition in a sustained release way. Indeed, the present invention solves the problems of conventional snuff products. The present invention is based on the idea of providing a specific composition without tobacco to be used in snuff-type products. The present invention makes it possible e.g. to reduce symptoms caused by nicotine addiction in an effective way and to provide a user-friendly product. Furthermore, components of the snuff-type composition are not harmful and do not cause symptoms or side effects such as stomach cramps if unintentionally swallowed.

An object of the present invention is thus to provide tools and a method for effective and specific snuff-type composition. The present invention relates to a snuff-type composition for use (or usable) locally in the oral cavity, wherein said snuff-type composition comprises nicotine and linseed (Linum Usitatissimum) and does not comprise tobacco.

Also, the present invention relates to a method of preparing a snuff-type composi- tion usable (or for use) locally in the oral cavity, wherein said snuff-type composition comprises nicotine and linseed (Linum Usitatissimum) and does not comprise tobacco, wherein the method comprises mixing nicotine and linseed and optionally pharmaceutical constituents. Also, the present invention relates to use of nicotine and linseed in a snuff-type composition for the oral cavity, wherein said composition does not comprise tobacco.

Still, the present invention relates to use of a composition comprising nicotine and linseed but not tobacco in a snuff-type composition for the oral cavity.

Still, the present invention relates to use of nicotine and linseed but not tobacco for the preparation of a snuff-type composition for the oral cavity.

Still further, the present invention relates to a snuff-type composition comprising nicotine and linseed but not tobacco for use as a medicament. Still furthermore, the present invention relates to a snuff-type composition comprising nicotine and linseed but not tobacco for use in replacement therapy of a subject suffering from nicotine addiction. Still furthermore, the present invention relates to a method of treating a subject suffering from nicotine addiction, wherein said method comprises administering to a subject a snuff-type composition comprising nicotine and linseed but not tobacco. Other objects, details and advantages of the present invention will become apparent from the following drawings, detailed description and examples.

DETAILED DESCRIPTION OF THE INVENTION A snuff-type composition of the present invention comprising nicotine and linseed and not tobacco is for oral use. Indeed, the composition of the present invention is a smokeless product. As used herein a snuff-type composition refers to a composition, which can be used in the oral cavity, e.g. under the lip, in a similar way as snuff products. However, compared to conventional snuff products (i.e. a smoke- less tobacco comprising ground or pulverized tobacco leaves) the snuff product of the present invention does not comprise tobacco. As used herein "tobacco" refers to any part, such as leaves of a tobacco plant belonging to the genus Nicotiana and family Solanaceae. More than 70 species of tobacco are known (e.g. N. taba- cum and N. rustica) and are included within the expression "tobacco". Often in to- bacco products the leaves of the tobacco plant have been cured.

In one embodiment the linseed of the snuff-type composition is in a form of linseed crush (i.e. crush of flax seeds). In a further embodiment the linseed crush has a grain size selected from the group consisting of grain size between 0.001 - 10 mm, between 0.005 - 5 mm, between 0.01 - 4 mm, between 0.02 and 3 mm and between 0.03 - 2 mm. In a specific embodiment 50%, 60%, 70%, 80%, 90% or 95% by weight of the linseed crush has a grain size between 0.001 - 10 mm, between 0.005 - 5 mm, between 0.01 - 4 mm, between 0.02 and 3 mm and between 0.03 - 2 mm. Linseed crush of the composition forms an evenly blendable powder mass with nicotine and said powder mass releases nicotine in a sustained release way. In one embodiment of the invention a specific crush size enables mixing of nicotine to the linseed crush, and thus the most optimal powder mass and further- more the most optimal release of nicotine from the powder mass caused by the wetting of the powder mass by saliva. Therefore, the grain size of crush can be utilized for controlling the release and effect of nicotine in a subject. in one embodiment the content of nicotine and linseed of the snuff-type composition is from 50 to 100% by weight, e.g. from 60 to 99.9% by weight, from 70 to 99.9% by weight, from 80 to 99.5% by weight, or from 60 to 95% by weight.

!n one embodiment the nicotine content of the snuff-type composition is from 0.01 to 20% by weight of the composition, from 0.05 to 15% by weight, from 0.1 to 10% by weight or from 0.05 to 5% by weight. The nicotine may be either powdery or liquid. In a specific embodiment nicotine is pure or chemically prepared nicotine, such as pharmaceutically acceptable nicotine or suitable for pharmaceutical purposes.

Nicotine is released from the composition of the present invention into the oral cavity by the action of saliva and thereafter absorbed into the bloodstream, !n a very specific embodiment nicotine of the snuff-type composition is nicotine (Nico- tinium) ((S)-3-(1 -methylpyrrolidin-2-y!)pyridine), any derivative of nicotine, nicotine as a free base, salt or other complex form of nicotine such as nicotine resinate, solvate or adduct of nicotine or any combination thereof. In one embodiment of the invention a derivative of nicotine has a nicotine-like effect. As used herein "a nicotine-like effect" refers to e.g. including but not limited to a strong mood altering effect, a stimulant of the brain and/or a relaxant of the brain.

In one embodiment the snuff-type composition comprises a nicotine complex or salt corresponding to 1 - 5 mg or 2 - 4 mg of nicotine. In some embodiments the nicotine has molecular weight (Mw) of 162.23 and/or the actual molecular weight of nicotine resinate (calculated Mw 380.529) varies according to the resinate struc- ture and is determined by the structure used. Theoretically, 9.38 mg of nicotine resinate corresponds to 4 mg of pure nicotine and 4.69 mg of nicotine resinate corresponds to 2 mg of pure nicotine, respectively. Commercial nicotine resinate comprises 15% or 20% nicotine, so the proportion of resinate is higher than when calculated based on the molecular weight. Nicotine absorption into the blood and pharmacokinetics of nicotine of the present invention follow the ADME parameters known in literature (absorption, distribution, metabolism and excretion). (5) Composition of the present invention releases nicotine e.g. in a sustained release way and thereby enables suitable effect of nicotine. Also, in specific embodiments linseeds enable complete or substantially complete release of nicotine from the snuff type composition e.g. in the presence of saliva. In one embodiment, the composition releases about 20%, about 30%, about 40% or more of the total content of nicotine within 30 minutes e.g. in the oral cavity of a subject. In another embodiment, the composition releases about 20%, about 30%, about 40% or more of the total content of nicotine within 30 minutes e.g. when subjected to an in vitro dissolution test. As used herein "in vitro dissolution test" refers to an in vitro test e.g. described in the European Pharmacopoeia. A person skilled in the art knows which tests to use and how to carry out said tests. Suitable in vitro dissolution tests include but are not limited to so-called "blade-mixing" or "basket mixing" methods (4). In the blade mixing method a snuff-type composition in a fiber-cellulose bag is placed on a blade rotor. The blade-mixer rotates in a suitable container comprising water (37°C) and the composition releases nicotine into the water. Samples of the resulting liquid are collected for determination at specific time points. In this way the dissolution function of the product may be studied. (4) In the basket mixing method a snuff-type composition in a fiber-cellulose bag is placed in an basket and rotated in water (37°C). Samples of the resulting liquid are collected for determina- tion at specific time points. In this way the dissolution function of the product may be studied. (4)

The composition of the present invention comprises at least nicotine and linseed. In one embodiment the combination of only nicotine and linseed is enough for the composition of the present invention. However, in addition the composition may also comprise any other ingredients and/or agents, such as one or more selected from the group consisting of a pharmaceutical additive, alcohol, solvent, diluent, carrier, buffer, excipient, filling agent, stabilising agent, thickening agent, humec- tant, salts, dye, coloring agent, aroma, sweetener, flavor, flavor additive and any component normally found in corresponding products, and any combination thereof. In a specific embodiment one or more of said ingredients and/or agents are acceptable in food products or are pharmaceutically acceptable constituents. In a specific embodiment, in addition to nicotine and linseed the snuff-type composition of the present invention further comprises a solvent, diluent, carrier, buffer, excipi- ent, filling agent, stabilising agent, thickening agent, humectant, salts, dye, colouring agent, sweetener, flavor, flavor additive or any combination thereof. In one embodiment the snuff-type composition of the present invention further comprises one or more ingredients selected from the following groups:

a. Aromas and sweeteners

i) tobacco aroma, menthol aroma, smoke aroma, licorice aroma, and/or fruit aroma (e.g. strawberry) b. Pharmaceutical additives (e.g. as Quantum satis, QS)

i) ethanol

ii) water

iii) sodium bicarbonate

iv) sodium carbonate

v) sodium triphosphate

vi) sodium chloride e.g. as a solution (e.g. 0.9%), and/or

vii) hydrogen chloride

In one embodiment in addition to nicotine and linseed the snuff-type composition further comprises one or more ingredients in any suitable amount. Said ingredients) may be present quantum satis (QS). As used herein "quantum satis" for an ingredient refers to "add as much of this ingredient as is needed to achieve the desired result, but not more." In food safety regulations in the EU it is a catch-all restriction for artificial food ingredients (especially food additives) which are harmless enough to have no specific quantity restriction. In some embodiments said ingredients (e.g. pharmaceutical agents) may help in releasing nicotine from the composition.

In one embodiment the snuff-type composition comprises water in an amount from approximately 0.1 to 50 w/w %, 0.5 to 40 w/w %, 0.5 to 30 w/w % or 0.5 to 10 w/w % of the weight of the composition. Any ingredients suitable for snuff-type compositions may be utilized in the present invention and are well known to a person skilled in the art. In a specific embodiment said ingredients comply with food regulations and/or are pharmaceutically acceptable.

The composition may be in any form suitable for snuff-like products, such as in a solid or semisolid form, suitable for local use in the cavity of the mouth, e.g. under the lip between the lip and teeth. In one embodiment a formulation is a powdery mixture. Semisolid mass forms when this powdery mixture is wetted by saliva. In one embodiment the composition is a moist snuff-type composition.

The snuff-type composition of the present invention may be utilized as such in the mouth or alternatively may be enclosed in a bag, pouch or membrane. In one embodiment said composition forms a solid mixture enclosed in a semipermeable membrane bag. In another embodiment said composition is enclosed in a porous membrane material that penetrates saliva and nicotine of the composition. In a further embodiment said composition is to be administered to the mucosa of the mouth in or from a cellulose-containing membrane bag or directly e.g. from the applicator. In a very specific embodiment a membrane bag material, e.g. semipermeable fiber cellulose (e.g. commercially produced), is utilized for enclosing the snuff-type composition. Other suitable membrane materials for the present invention include but are not limited to synthetically produced semi-permeable mem- brane materials. The total length of the enclosed snuff-type product is 10-30 mm, width 10-15 mm and thickness 3-8 mm, depending on the mass of the snuff-type composition.

The pharmaceutical compositions may be produced by any conventional methods known in the art. In one embodiment the methods of the present invention follow the standards of the field (4). The manufacturing process may be carried out by using pharmaceutical technology and optionally raw materials according to the European Pharmacopoeia (4). The preparation of the composition may be made by hand or, as appropriate, mechanically (e.g. mechanically in part) in appropriate sterile conditions. The equipment suitable for manufacturing includes but is not limited to, for example, a sieve for allowing the right grain size and/or a mixer. In the present invention nicotine is mixed with linseed (e.g. ground to a suitable size) and optionally with other ingredients. In one embodiment of the invention and in addition to mixing nicotine with linseed and optionally with other ingredients the method further comprises grinding linseed or alternatively the linseed is in a form of linseed crush.

In one embodiment of the invention a method for preparing or manufacturing a snuff-type composition comprises the following steps: providing linseed and nicotine, grinding linseed, adding water to linseed or nicotine or a mixture thereof e.g. under stirring to form a mixture comprising linseed, nicotine and water. The steps of grinding may take place either before or after providing linseed and nicotine. Water may be added before, after or both before and after grinding.

In a specific embodiment of the invention the preparation of the composition is made by utilizing a geometric set. In a specific embodiment of the invention nicotine (or a derivative, free base, salt, complex, solvate or adduct thereof or any combination thereof) is mixed with linseed crush having a suitable grain size. This mixture having weight X is further mixed with linseed crush having the same weight X resulting in a mixture having weight Y. Mixture Y is further mixed with lin- seed crush having the same weight Y and the geometric series is continued until the final dose e.g. ad 300 mg to 1300 mg of bag or sachet is reached. In some embodiments the other ingredients (e.g. excipients) are mixed in the initial phase of the geometric series and the actual batch size is scaled to the desired size. Grinding may be carried out by utilizing any methods or means known to a person skilled in the art including but not limited to grinding by a suitable grinding mill or by hand utilizing e.g. mortar. In one embodiment the linseeds are ground or crushed with pharmaceutically acceptable methods or methods acceptable in food industry. In a specific embodiment linseed or linseed crush is ground to a grain size selected from the group consisting of grain size between 0.001 - 10 mm, between 0.005 - 5 mm, between 0.01 - 4 mm, between 0.02 and 3 mm and between 0.03 - 2 mm. In one embodiment sieving is utilized after grinding. Said sieving can be carried out e.g. by sieving the crushed material through a sieve having suitable grain size.

In one embodiment one or several method steps selected from the following group may be further comprised in the method of the present invention: optionally mixing two or more groups of linseed having different grain size distributions, optionally further sieving ground linseed, optionally adding further ingredients, optionally packing e.g. in a bag, pouch, membrane or can, or any combination of said method steps.

In one embodiment of the invention heating of the snuff-type composition is utilized to kill harmful germs or pathogens. In a specific embodiment the temperature may be held at about 70-100° C, in another embodiment about 1 to 30 hours, e.g. about 8-15 hours. Heating of the snuff-type composition is followed by a cooling step. In one embodiment the method comprises a cooling step wherein the tern- perature is cooled down to 15-30° C, e.g. about 20-25° C. In some embodiments flavors and/or possibly additional additives are added to the cooled blend. In a very specific embodiment heating and cooling steps are not needed in the method of preparing a snuff-type composition.

In one embodiment the method of the present invention is carried out in an open system or in a closed system to minimize the risk of contamination.

Amounts of the snuff type composition of the present invention for administration as such or in a bag, pouch or membrane can be determined readily by those skilled in the art. The desired amount of the snuff-type composition may be applied to the bag, pouch, membrane or can so that the snuff-type composition dosed contains the desired amount of nicotine. Generally, the snuff-type dose to be applied to the oral cavity varies in the range of 300 mg to 1300 mg of the total weight, more specifically in the range of 500 to 900 mg or 600 to 800 mg of the total weight.

In specific embodiments a bag, pouch or membrane comprising the enclosed snuff type composition is closed, for example, with hot iron using either machine or hand.

It will be obvious to a person skilled in the art that, as the technology advances, the inventive concept can be implemented in various ways. The invention and its embodiments are not limited to the examples described below but may vary within the scope of the claims.

EXAMPLES

Example 1. A method of preparing a snuff-type composition

A)

In the present example linseed was ground by a suitable grinding mill or by hand utilizing e.g. mortar. Sieving was carried out by sieving the crushed material through a sieve to obtain crush having a suitable grain size 0.001 - 10 mm. B)

In the present example a dose of a snuff-type composition comprising 4 mg nicotine was prepared by utilizing the geometric series: In a specific embodiment of the invention 9.38 mg nicotine resinate was mixed with 9.38 mg linseed crush of example 1A having a suitable grain size. This mixture having weight 18.76 mg was further mixed with linseed crush having the same weight 18.76 mg resulting in a mixture having weight 37.52 mg. This mixture with weight 37.52 mg was further mixed with linseed crush having the same weight 37.52 mg and the geometric series was continued until the final dose, e.g. 600 mg to 1300 mg of bag or sachet, was reached. Other ingredients (e.g. excipients) were mixed in the initial phase of the geometric series and the actual batch size was scaled to the desired size. C)

In the present example a dose of a snuff-type composition comprising 2 mg nicotine was prepared by utilizing the geometric series:

In a specific embodiment of the invention 4.69 mg nicotine resinate was mixed with 4.69 mg linseed crush of example 1A having a suitable grain size. This mixture having weight 9.38 mg was further mixed with linseed crush having the same weight 9.38 mg resulting in a mixture having weight 18.76 mg. This mixture with weight 18.76 mg was further mixed with linseed crush having the same weight 18.76 mg and the geometric series was continued until the final dose, e.g. 600 mg to 1300 mg of bag or sachet, was reached. Other ingredients (e.g. excipients and/or flavors) were mixed in the initial phase of the geometric series and the actual batch size was scaled to the desired size.

D)

In the present example a bag comprising a snuff-type composition of the present invention was prepared:

The snuff-type composition prepared in example 1 B or 1 C was applied to the membrane bag. Membrane bag material was a commercially produced semi- permeable fiber cellulose, which allows the release of nicotine to saliva and into the oral cavity. The desired amount of the snuff-type composition was applied to the fiber cellulose bag so that the snuff-type composition dosed in the membrane bag contained either 2 or 4 milligrams of nicotine. The cellulose fiber bag was closed, for example, with hot iron using either machine or hand.

The total length of the cellulose bag containing the snuff-type composition may vary, for example, from 10 to 30 mm, a width from 10 to 15 mm, and a thickness from 3 to 8 mm depending on the desired final bag size and nicotine content.

Example 2. In vitro dissolution test of a snuff-type composition of the present invention

In the "basket mixing" method a snuff-type composition in a fiber-cellulose bag of Example 1 was placed in a basket and rotated in a suitable container in water (37°C). Samples of the resulting liquid were collected at specific time points. In this way the dissolution function of the product was studied. (4)

The composition in a fiber-cellulose bag released at least about 20%, at least about 30%, at least about 40% or more of the total content of nicotine within 30 minutes when subjected to said in vitro dissolution test. Example 3. Use of a snuff-type composition of the present invention

The products of Example 1 were tested. It was found out that the feeling of the composition in the mouth was pleasant, palatability was good, and the product was appropriately solid under the influence of saliva. The product was of the right size and the taste with different flavors was pleasant. According to the tobacco smokers (subjects smoking tobacco regularly) the snuff-type product was able to eliminate craving for a cigarette, prevent nicotine addiction and furthermore the snuff-type product committed to nicotine substitution treatment instead of smoking.

References:

1 ) Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006;3:e442

2) Willemse BW, Postma DS, Timens W ym. The impact of smoking cessation on respiratory symptoms, lung function, airway hyperresponsiveness and inflammation. Eur Respir J 2004;23:464-76 3) Fagerstrom K. The epidemiology of smoking: health consequences and benefits of cessation. Drugs 2002;62 Suppl 2:1 -9

4) European Pharmacopeia, Edition 8, 2014 5) Martindale: The Complete Drug reference, Edition 38, 2014. Edited by Alison Brayfield

Claims

1 . A snuff-type composition for use locally in the oral cavity, wherein said snuff- type composition comprises nicotine and linseed (Linum Usitatissimum) and does not comprise tobacco.

2. The snuff-type composition of claim 1 , wherein the linseed is in a form of linseed crush.

3. The snuff-type composition of claim 1 or 2, wherein the linseed crush has a grain size selected from the group consisting of grain size between 0.001 - 10 mm, between 0.005 - 5 mm, between 0.01 - 4 mm, between 0.02 and 3 mm and between 0.03 - 2 mm.

4. The snuff-type composition of any one of claims 1 -3, wherein the content of nic- otine and linseed of the composition is 80 to 99.5% by weight.

5. The snuff-type composition of any one of claims 1 -4, wherein the nicotine content of the composition is 0.01 - 20% by weight, 0.05 - 15% by weight, 0.1 - 10% by weight or 0.05 - 5% by weight.

8. The snuff-type composition of any one of claims 1 -5, wherein nicotine is powdery or liquid.

7. The snuff-type composition of any one of claims 1 -6, wherein nicotine is pure or chemically prepared nicotine.

8. The snuff-type composition of any one of claims 1 -7, wherein nicotine is nicotine (Nicotinium) ((S)-3-(1 -methy!pyrrol id in-2-yi )pyrid i ne), any derivative of nicotine, nicotine as a free base, salt or other complex form of nicotine such as nicotine res- inate, solvate or adduct of nicotine or any combination thereof.

9. The snuff-type composition of any one of claims 1 -8, wherein said composition further comprises one or more ingredients selected from the following groups: a. Aromas and sweeteners

i) tobacco aroma, menthol aroma, smoke aroma, licorice aroma, and/or fruit aroma b. Pharmaceutical additives

i) ethanol

ii) water

iii) sodium bicarbonate

iv) sodium carbonate

v) sodium triphosphate

vi) sodium chloride e.g. as a solution (e.g. 0.9%), and/or

vii) hydrogen chloride

10. The snuff-type composition of any one of claims 1 -9, wherein said composition further comprises a solvent, diluent, carrier, buffer, excipient, filling agent, stabilising agent, thickening agent, humectant, salts, dye, colouring agent, sweetener, flavor, flavor additive or any combination thereof.

1 1 . The snuff-type composition of any one of claims 1 -10, wherein said composition forms a solid mixture enclosed in a semipermeable membrane bag.

12. The snuff-type composition of any one of claims 1 -1 1 , wherein said composition is enclosed in a porous membrane material that penetrates saliva and nicotine of the composition.

13. The snuff-type composition of any one of claims 1 -12, wherein said composition is to be administered to the mucosa of the mouth in or from a cellulose- containing membrane bag or directly from the applicator.

14. A method of preparing a snuff-type composition usable locally in the oral cavity, wherein said snuff-type composition comprises nicotine and linseed (Linum Usi- tatissimum) and does not comprise tobacco, wherein the method comprises mixing nicotine and linseed and optionally pharmaceutical constituents.

15. The method of claim 14, wherein the method further comprises grinding linseed or the linseed is in a form of linseed crush.

16. The method of claim 15, wherein the linseed crush has a grain size selected from the group consisting of grain size between 0.001 - 10 mm, between 0.005 -

5 mm, between 0.01 - 4 mm, between 0.02 and 3 mm and between 0.03 - 2 mm.

17. The method of any one of claims 14-16, wherein the content of nicotine and linseed of the composition is 80 to 99.5% by weight.

18. The method of any one of claims 14-17, wherein the nicotine content of the composition is 0.01 - 20% by weight, 0.05 - 15% by weight, 0.1 - 10% by weight or

0.05 - 5% by weight.

19. The method of any one of claims 14-18, wherein nicotine is powdery or liquid.

20. The method of any one of claims 14-19, wherein nicotine is pure or chemically prepared nicotine.

21 . The method of any one of claims 14-20, wherein nicotine is nicotine {Nicotin- ium) ((S)-3-(1 -methylpyrroiidin-2-yl)pyridine), any derivative of nicotine, nicotine as a free base, salt or other complex form of nicotine such as nicotine resinate, solvate or adduct of nicotine or any combination thereof.

22. The method of any one of claims 14-21 , wherein said snuff-type composition further comprises one or more ingredients selected from the following groups: a. Aromas and sweeteners

i) ethanol

ii) wafer

iii) sodium bicarbonate

iv) sodium carbonate

v) sodium triphosphate

vi) sodium chloride e.g. as a solution (e.g. 0.9%), and/or

via) hydrogen chloride

23. The method of any one of claims 14-22, wherein said snuff-type composition further comprises a solvent, diluent, carrier, buffer, excipient, filling agent, stabilis- ing agent, thickening agent, humectant, salts, dye, colouring agent, sweetener, flavor, flavor additive or any combination thereof.

24. The method of any one of claims 14-23, wherein the method further comprises enclosing the snuff-type composition in a semipermeable membrane bag.

25. Use of nicotine and linseed in a snuff-type composition for the oral cavity, wherein said composition does not comprise tobacco.