Classifications

• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/10—Chemical features of tobacco products or tobacco substitutes
  • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/465—Nicotine; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/55—Linaceae (Flax family), e.g. Linum
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
  • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
  • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
  • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
  • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
  • A61K9/148—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with compounds of unknown constitution, e.g. material from plants or animals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
  • A61P25/34—Tobacco-abuse

Definitions

• the present inventionrelates 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.
• Tobacco addictionfulfills the criteria for determining chronic illness and is the cause of smoking, caused by physical, psychological and social dependence syndrome.
• positive health effectsbegin 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 smokingreduces the risk of lung cancer, but it never returns to a completely non-smoking level.
• Varenicline, Bupropion and Nortriptylineare used as medicines for the treatment of smoking cessation.
• Nicotine replacement therapyplays 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-tabletare available on the Nicorette ® product family.
• the Nicotinell product familyis 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.
• EP1998748 B1relates to a snuff composition comprising both nicotine and microcrystailine cellulose.
• the objects of the inventionare achieved by utilizing specific agents in a snuff- type product.
• Defects of the prior artinclude 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 compositionmay 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 compositionstays 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.
• the present inventionsolves the problems of conventional snuff products.
• the present inventionis based on the idea of providing a specific composition without tobacco to be used in snuff-type products.
• the present inventionmakes it possible e.g. to reduce symptoms caused by nicotine addiction in an effective way and to provide a user-friendly product.
• components of the snuff-type compositionare not harmful and do not cause symptoms or side effects such as stomach cramps if unintentionally swallowed.
• An object of the present inventionis thus to provide tools and a method for effective and specific snuff-type composition.
• the present inventionrelates 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.
• the present inventionrelates 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.
• the present inventionrelates to use of a composition comprising nicotine and linseed but not tobacco in a snuff-type composition for the oral cavity.
• the present inventionrelates to use of nicotine and linseed but not tobacco for the preparation of a snuff-type composition for the oral cavity.
• the present inventionrelates 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.
• a snuff-type composition of the present inventioncomprising nicotine and linseed and not tobacco is for oral use.
• the composition of the present inventionis a smokeless product.
• a snuff-type compositionrefers to a composition, which can be used in the oral cavity, e.g. under the lip, in a similar way as snuff products.
• the snuff product of the present inventiondoes not comprise tobacco.
• tobaccorefers 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.
• the linseed of the snuff-type compositionis in a form of linseed crush (i.e. crush of flax seeds).
• the linseed crushhas 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.
• 50%, 60%, 70%, 80%, 90% or 95% by weight of the linseed crushhas 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 compositionforms an evenly blendable powder mass with nicotine and said powder mass releases nicotine in a sustained release way.
• a specific crush sizeenables 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.
• the content of nicotine and linseed of the snuff-type compositionis 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.
• the nicotine content of the snuff-type compositionis 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 nicotinemay be either powdery or liquid.
• nicotineis pure or chemically prepared nicotine, such as pharmaceutically acceptable nicotine or suitable for pharmaceutical purposes.
• Nicotineis 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.
• a derivative of nicotinehas a nicotine-like effect.
• a nicotine-like effectrefers 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.
• the snuff-type compositioncomprises a nicotine complex or salt corresponding to 1 - 5 mg or 2 - 4 mg of nicotine.
• the nicotinehas 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 resinatecomprises 15% or 20% nicotine, so the proportion of resinate is higher than when calculated based on the molecular weight.
• composition of the present inventionreleases nicotine e.g. in a sustained release way and thereby enables suitable effect of nicotine.
• linseedsenable complete or substantially complete release of nicotine from the snuff type composition e.g. in the presence of saliva.
• the compositionreleases 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.
• the compositionreleases about 20%, about 30%, about 40% or more of the total content of nicotine within 30 minutes e.g.
• in vitro dissolution testrefers 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).
• blade mixing methoda snuff-type composition in a fiber-cellulose bag is placed on a blade rotor.
• the blade-mixerrotates 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.
• composition of the present inventioncomprises at least nicotine and linseed.
• the combination of only nicotine and linseedis enough for the composition of the present invention.
• the compositionmay 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.
• one or more of said ingredients and/or agentsare acceptable in food products or are pharmaceutically acceptable constituents.
• the snuff-type composition of the present inventionfurther 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.
• the snuff-type composition of the present inventionfurther comprises one or more ingredients selected from the following groups:
• sodium chloridee.g. as a solution (e.g. 0.9%), and/or
• the snuff-type compositionfurther comprises one or more ingredients in any suitable amount.
• Said ingredientsmay be present quantum satis (QS).
• QSquantum satis
• Quantum satisfor an ingredient refers to "add as much of this ingredient as is needed to achieve the desired result, but not more.”
• said ingredientse.g. pharmaceutical agents
• the snuff-type compositioncomprises 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 compositionsmay 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 compositionmay 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.
• a formulationis a powdery mixture. Semisolid mass forms when this powdery mixture is wetted by saliva.
• the compositionis a moist snuff-type composition.
• the snuff-type composition of the present inventionmay be utilized as such in the mouth or alternatively may be enclosed in a bag, pouch or membrane.
• said compositionforms a solid mixture enclosed in a semipermeable membrane bag.
• said compositionis enclosed in a porous membrane material that penetrates saliva and nicotine of the composition.
• said compositionis to be administered to the mucosa of the mouth in or from a cellulose-containing membrane bag or directly e.g. from the applicator.
• a membrane bag materiale.g. semipermeable fiber cellulose (e.g. commercially produced), is utilized for enclosing the snuff-type composition.
• Suitable membrane materials for the present inventioninclude but are not limited to synthetically produced semi-permeable mem- brane materials.
• the total length of the enclosed snuff-type productis 10-30 mm, width 10-15 mm and thickness 3-8 mm, depending on the mass of the snuff-type composition.
• the pharmaceutical compositionsmay 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 manufacturingincludes but is not limited to, for example, a sieve for allowing the right grain size and/or a mixer.
• nicotineis mixed with linseed (e.g. ground to a suitable size) and optionally with other ingredients.
• the methodfurther comprises grinding linseed or alternatively the linseed is in a form of linseed crush.
• a method for preparing or manufacturing a snuff-type compositioncomprises 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 grindingmay take place either before or after providing linseed and nicotine.
• Watermay be added before, after or both before and after grinding.
• the preparation of the compositionis made by utilizing a geometric set.
• nicotineor a derivative, free base, salt, complex, solvate or adduct thereof or any combination thereof
• linseed crushhaving a suitable grain size.
• This mixture having weight Xis further mixed with linseed crush having the same weight X resulting in a mixture having weight Y.
• Mixture Yis 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.
• the other ingredientse.g.
• linseedsare ground or crushed with pharmaceutically acceptable methods or methods acceptable in food industry.
• linseed or linseed crushis 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.
• sievingis utilized after grinding. Said sieving can be carried out e.g. by sieving the crushed material through a sieve having suitable grain size.
• one or several method steps selected from the following groupmay 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.
• heating of the snuff-type compositionis utilized to kill harmful germs or pathogens.
• the temperaturemay 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 compositionis followed by a cooling step.
• the methodcomprises a cooling step wherein the tern- perature is cooled down to 15-30° C, e.g. about 20-25° C.
• flavors and/or possibly additional additivesare added to the cooled blend.
• heating and cooling stepsare not needed in the method of preparing a snuff-type composition.
• the method of the present inventionis 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 membranecan be determined readily by those skilled in the art.
• the desired amount of the snuff-type compositionmay be applied to the bag, pouch, membrane or can so that the snuff-type composition dosed contains the desired amount of nicotine.
• the snuff-type dose to be applied to the oral cavityvaries 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.
• a bag, pouch or membrane comprising the enclosed snuff type compositionis closed, for example, with hot iron using either machine or hand.
• Example 1A method of preparing a snuff-type composition
• linseedwas ground by a suitable grinding mill or by hand utilizing e.g. mortar.
• Sievingwas carried out by sieving the crushed material through a sieve to obtain crush having a suitable grain size 0.001 - 10 mm.
• a dose of a snuff-type compositioncomprising 4 mg nicotine was prepared by utilizing the geometric series:
• 9.38 mg nicotine resinatewas mixed with 9.38 mg linseed crush of example 1A having a suitable grain size.
• This mixture having weight 18.76 mgwas 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 mgwas 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 ingredientse.g. excipients
• a dose of a snuff-type compositioncomprising 2 mg nicotine was prepared by utilizing the geometric series:
• the snuff-type composition prepared in example 1 B or 1 Cwas applied to the membrane bag.
• Membrane bag materialwas 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 compositionwas 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 bagwas closed, for example, with hot iron using either machine or hand.
• the total length of the cellulose bag containing the snuff-type compositionmay 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 2In vitro dissolution test of a snuff-type composition of the present invention
• composition in a fiber-cellulose bagreleased 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 3Use of a snuff-type composition of the present invention
• Example 1The 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.

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