EP4527213A2 - Nikotinzusammensetzung - Google Patents

Nikotinzusammensetzung Download PDF

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Publication number
EP4527213A2
EP4527213A2 EP24209645.1A EP24209645A EP4527213A2 EP 4527213 A2 EP4527213 A2 EP 4527213A2 EP 24209645 A EP24209645 A EP 24209645A EP 4527213 A2 EP4527213 A2 EP 4527213A2
Authority
EP
European Patent Office
Prior art keywords
amount
agar
nicotine
composition
water
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24209645.1A
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English (en)
French (fr)
Other versions
EP4527213A3 (de
Inventor
Ara ABRAHAMIAN
Vahid NOURI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Habit Factory In Sweden AB
Original Assignee
Habit Factory In Sweden AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Habit Factory In Sweden AB filed Critical Habit Factory In Sweden AB
Priority to EP24209645.1A priority Critical patent/EP4527213A3/de
Publication of EP4527213A2 publication Critical patent/EP4527213A2/de
Publication of EP4527213A3 publication Critical patent/EP4527213A3/de
Pending legal-status Critical Current

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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
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/24—Treatment of tobacco products or tobacco substitutes by extraction; Tobacco extracts
    • A24B15/241—Extraction of specific substances
    • A24B15/243—Nicotine
    • 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
    • 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
    • A24B15/12—Chemical features of tobacco products or tobacco substitutes of reconstituted tobacco
    • 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
    • A24B15/165—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes comprising as heat source a carbon fuel or an oxidized or thermally degraded carbonaceous fuel, e.g. carbohydrates, cellulosic material
    • 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
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A24B15/32—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances by acyclic compounds
    • 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
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A24B15/36—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a heterocyclic ring
    • A24B15/365—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a heterocyclic ring having nitrogen and sulfur as hetero atoms in the same ring
    • 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
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A24B15/36—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a heterocyclic ring
    • A24B15/40—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a heterocyclic ring having only oxygen or sulfur as hetero atoms
    • A24B15/403—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a heterocyclic ring having only oxygen or sulfur as hetero atoms having only oxygen as hetero atoms
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F23/00—Cases for tobacco, snuff, or chewing tobacco
    • A24F23/02—Tobacco pouches

Definitions

  • the present invention relates to tobacco-free or low-tobacco nicotine compositions.
  • the compositions are preferably for human consumption, such as may be delivered orally by means of placing a permeable pouch filled with the compositions in the mouth of a user.
  • Nicotine-loaded tobacco-free or low-tobacco pouches are replacement products that can help to alleviate cravings associated with smoking cigarettes, cigars, or other nicotine delivery products.
  • nicotine-delivery systems based on inhalation i.e., so-called vaping
  • nicotine vapor is quickly absorbed through the lungs into the blood stream, reaching the brain within ten seconds of inhalation. The latter produces a feeling of almost instantaneous satisfaction, that lasts also some time after smoking/inhalation.
  • Nicotine-loaded tobacco-free or low-tobacco pouches are intended for use in the mouth by placing the pouch under the lip, thereby enabling the release and absorption of nicotine through oral mucosa.
  • the pouches typically comprise a saliva permeable membrane material and contain particulate filler materials, nicotine or nicotine derivatives and other ingredients such as flavourings.
  • the particulate materials may comprise inter alia polysaccharide or cellulose materials.
  • Nicotine is an alkaloid, which was traditionally derived from tobacco leaves but may now also be provided in a fully synthetic form. It is available both as a free-base nicotine and in the form of different nicotine salts that are produced from the interaction between nicotine and an acid. Common nicotine salts include chloride, sulfate, benzoate, tartrate salts.
  • the formulations contain significant quantities of buffering salts to increase the alkalinity of the formulation. Increased alkalinity shifts the dissociation constant of the nicotine such that the free base form is made in solution (such as in the mouth of the user) from the ionic form of nicotine in the salts.
  • the uncharged free-base nicotine exhibits enhanced permeability across the oral mucosa into the blood stream compared to its ionic form, which is critical for consumer use.
  • the pH of nicotine-loaded tobacco-free pouches ranges typically between 6.9 and 10.1, which translates into undissociated free-base nicotine levels between 7.7 to 99.2 %, respectively ( Stanfil et al. Nicotine & Tobacco Research, 2021, 1590-1596 ).
  • nicotine salt formulations tend to feature a low moisture content, i.e. less than 10wt%. (such as 1-8 wt%). This is because higher moisture content would stimulate the formation of free base nicotine in situ, which would in turn reduce the stability of the product because free base nicotine is volatile and labile to oxidative degradation.
  • free base nicotine is volatile and labile to oxidative degradation.
  • some formulations involve large quantities of sweetener (such as maltitol) to stimulate salivation.
  • sweetener such as maltitol
  • salivation the overproduction of saliva tends to result in users spitting or swallowing, impacting nicotine uptake.
  • degradation of the product is indicative of reactivity in the system which may result in the presence of undesired (and potentially toxic) compounds.
  • WO 2010/104464 and WO 2010/0114445 disclose compositions of free-base nicotine that can be stabilized using a salt of alginic acid, such as sodium alginate (e.g., Protanal LFR 5/60).
  • a salt of alginic acid such as sodium alginate (e.g., Protanal LFR 5/60).
  • the amount of sodium alginate used as a stabilizer is substantial, typically corresponding to nicotine:Protanal 1:2 ratio (wt).
  • WO2020244721 discloses a composition of free-base nicotine wherein the latter is stabilized using an ion exchange resin, e.g., polacrilex resin, such as Amberlite IRP64 (methacrylic acid polymer with divinylbenzene, or potassium salt of the latter).
  • the amount of polacrilex resin used as a nicotine stabilizer is in a nicotine-to-resin ratio which may vary between 1:1.19 and 1:4. It is to be understood that polymers having some carboxylate groups are typically used to stabilise free-base nicotine.
  • the moisture present in the product poses significant challenges for formulation.
  • Moisture acts not only as a nicotine solvent that facilitates diffusive transport from formulation to the oral mucosa but also a medium for chemical reactions that can significantly accelerate the rate of chemical degradation and product spoilage.
  • high moisture content nicotine formulations may still be unstable, especially if the moisture content exceeds 30% wt.
  • degradation of nicotine causes discoloration of the product.
  • the physical and chemical instability may lead to accumulation of toxic by-products of nicotine degradation as well as negative product experiences due to color changes (white product turning yellow, brown, or pink), dusting due to drying and leakage through pouch, product hardening and deteriorated mouthfeel as well as altered nicotine release profile.
  • the present invention provides A composition comprising:
  • the invention provides the use as a nicotine release control agent of agar agar in a composition comprising:
  • the invention provides the use as a nicotine stabilising agent of agar agar in a composition comprising:
  • the composition further comprises additional ingredients, in an amount from about 1 wt% to about 10 wt% or more preferably in an amount from about 1 wt% to about 8 wt%.
  • additional ingredients may comprise one or more additives selected from flavourings, flavour enhancers, sweeteners and preservatives.
  • Sweeteners are preferably present in an amount from about 1wt% to about 3 wt %.
  • the sweeteners may comprise compounds selected from sugars (such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose), sugar alcohols (such as xylitol, maltitol, sorbitol, erythritol) and/or sugar substitutes (such as aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate or steviol glycosides).
  • sugars such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose
  • sugar alcohols such as xylitol, maltitol, sorbitol, erythritol
  • sugar substitutes such as aspartame, saccharin, sucralose, allulose, acesulfame K,
  • the sweeteners include a sugar alcohol in an amount less than 3 wt%, preferably less than 2 wt%, such as between 1 wt% and 2 wt%. Additionally or alternatively, the sweetener may comprise a sugar substitute in an amount less than 1 wt%, preferably less than 0.5 wt%, such as between 0.05 wt% and 0.3 wt%.
  • Preferred sweeteners include xylitol and/or acesulfame K.
  • Preservatives may comprise one or more preservatives selected from calcium chloride, salts of sorbic acid (such as potassium sorbate), salts of benzoic acid (such as sodium benzoate), nitrate salts, nitrite salts, sulfate salts, sulfite salts and proponiate salts.
  • preservatives are in an amount less than about 1wt%, preferably between 0.1wt% and 0.5wt%, such as between about 0.25wt% and about 0.35wt%.
  • the pH control salts may comprise buffering salts such as carbonate or sesquicarbonate salts; acetate salts, glycinate, acetate, glycinate, gluconate, borate, glycerophosphate or citrate salts; phosphate salts.
  • buffering salts such as carbonate or sesquicarbonate salts; acetate salts, glycinate, acetate, glycinate, gluconate, borate, glycerophosphate or citrate salts; phosphate salts.
  • Preferred is a combination of ammonium chloride and sodium bicarbonate.
  • ammonium chloride may be in an amount between 0.05 wt% and 1wt%, preferably between 0.1wt% and 0.5 wt%, for example between 0.15 wt% and 0.25 wt%.
  • sodium bicarbonate is present it may be in an amount between less than 1wt%, preferably between 0.1wt% and 0.5 wt%
  • the composition contains greater than 40wt% water, for example between 40 wt% and 50 wt% water, preferably between about 44 wt% and about 48 wt% water.
  • the native cellulose material comprises powdered cellulose and/or microcrystalline cellulose (MCC), with MCC being preferred.
  • MCC microcrystalline cellulose
  • the release control agent preferably comprises agar agar in an amount less than about 1wt%, preferably less than 0.7wt% of the composition.
  • the release control agent may comprise agar agar in an amount from about 0.2 wt% to about 0.7wt%, preferably in an amount from about 0.2wt% to about 0.5wt%.
  • the ratio of agar agar to nicotine is preferably less than about 1.3:1. In further preferred embodiments, the ratio of agar agar to nicotine is from about 0.1:1 to about 1.2:1, preferably from about 0.1:1 to about 1:1, more preferably from about 0.1:1 to about 0.8:1.
  • Some embodiments may include tobacco leaf in an amount less than 5 wt%, preferably about 1 wt% to 3 wt%.
  • the pH of the composition is from 6 to 9, preferably from 7 to 9 and more preferably from 7 to 8.5.
  • any flavour enhancers present are selected from the group comprising sodium chloride, glutamate salts, glycine salts, inosinic acid salts and 5'-ribonucleotide salts.
  • sodium chloride it is preferred to be in an amount less than 8 wt%, preferably between 1 wt% and 7 wt% by weight of the composition.
  • the composition preferably includes flavouring compounds in an amount less than about 5 wt% of the total composition, for example less than 3 wt% of the composition or between 0.5 wt% and 3 wt% of the composition.
  • Preferred quantities of nicotine in the composition are between 0.2wt% and 3 wt%, or between 0.2wt% and 2wt%.
  • the composition may consist essentially of the components described above.
  • the invention provides a water or saliva permeable pouch containing a composition as described above. In a still further aspect, the invention provides a package containing a plurality of those pouches.
  • the invention provides a process for forming a nicotine containing composition, such as that which is described above, the process comprising:
  • the mixing of the precursor is at a temperature greater than about 60°C, preferably above about 70°C, preferably above 80°C.
  • step (b) the water may be provided to the precursor at a temperature above about 70°C, preferably above about 80°C. Indeed, in step (b) the water may be provided to the precursor is in the form of steam or vapour.
  • steps (c) and (d) may be at a temperature greater than about 70°C, preferably above about 80°C. Indeed, it may be in the form of steam or vapour.
  • the precursor mixture is heated while in the mixer, for example during step (b) and/or (c) and or during or after any addition of water following step (c).
  • further water is added to the composition after step (d).
  • any of the following components may be added to the precursor mixture prior to step (b):
  • Agar agar is a dried, hydrophilic, colloidal polysaccharide complex extracted from red algae (Rhodophyceae). The structure is believed to be a complex range of polysaccharide chains having alternating ⁇ -(1 ⁇ 3) and ⁇ -(1 ⁇ 4) linkages.
  • Agar agar can be separated into a natural gelling fraction, agarose, and a sulphated nongelling fraction, agaropectin.
  • Agar agar is soluble in hot water to form a viscous solution but has poor solubility in cold water and ethanol (95%). A 1% w/v aqueous solution forms a stiff jelly on cooling.
  • tobacco any part, such as leaves, stems, and stalks, of any member of the genus Nicotiana.
  • the tobacco may be whole, shredded, threshed, cut, ground, cured, aged, fermented, or treated otherwise, e.g., granulated or encapsulated.
  • a tobacco free (or in some instances low tobacco) nicotine formulation for use in pouches for oral use.
  • the formulation has a high water content and contains nicotine in its free base form.
  • the composition involves a cellulosic filler and also the use of agar agar as a nicotine release agent to promote the release of nicotine from the composition when it is placed (e.g. in a pouch) in the oral cavity of a user.
  • the composition has a general formulation as described below:
  • All wt% are based on the total weight of the composition.
  • the quantity of nicotine in the composition varies by the desired strength of the product. In some embodiments the quantity of nicotine is between 0.2wt% and 3 wt%, or between 0.2wt% and 2wt%.
  • the native cellulose useful in the present invention may comprise powdered cellulose and/or microcrystalline cellulose.
  • powdered cellulose which may be used in te invention include Arbocel(RTM) as supplied by J. Rettenmaier & Söhne GmbH; Elcema; KC Flock(RTM) supplied by Nippon Paper Industries Co. Ltd.; Microcel 3E-150 supplied by Roquette Frées; Sanacel (RTM) supplied by CFF GmbH; Sanacel Pharma (RTM) supplied by CFF GmbH; Sancel-W supplied by NB Entrepreneurs Company; or Solka-Floc (RTM) supplied by J. Rettenmaier USA LP.
  • microcrystalline cellulose examples include Avicel (RTM) PH supplied by Dupont Nutrition and Biosciences, Inc.; Cellets (RTM) supplied by Pharmatrans Sanaq AG; Celphere (TM) supplied by Asahi Kasei Corporation; Ceolus (TM) KG supplied by Asahi Kasei Corporation; Emcocel (RTM) supplied by JRS Pharma GmbH; MCC Sanaq (RTM) supplied by Pharmatrans Sanaq AG; Pharmacel (RTM) supplied by DFE Pharma GmbH; Tabulose (RTM) supplied by Roquette Fromme; Vivapur (RTM) supplied by JRS Pharma GmbH.
  • Avicel RTM PH supplied by Dupont Nutrition and Biosciences, Inc.
  • Cellets supplied by Pharmatrans Sanaq AG
  • Celphere (TM) supplied by Asahi Kasei Corporation Celphere supplied by Asahi Kasei Corporation
  • Ceolus (TM) KG supplied by Asahi Kasei Corporation
  • the water content of the composition should be at least 35wt%, it is preferred that a greater proportion of water is contained in the composition. Greater palatability for the user, including greater softness, tends to be found when the water content of the composition is greater than 40 wt%.
  • Preferred compositions have a water content greater than 42 wt%, for example between 44 wt% and 48 wt% water.
  • the composition contains pH control salts to provide optimum pH of the composition while in use in the mouth of a user. It is preferred that the pH of the composition, when measured according to the Coresta Method No.69, 2017, is from 6 to 9, preferably from 7 to 9 and more preferably from 7 to 8.5. This can be achieved by providing pH adjusting agents such as sodium bicarbonate or buffering salts such as a combination of a ammonium chloride and sodium bicarbonate. Typical quantities of pH control salts are between 0.2wt% and 2wt%, preferably between 0.2 wt% and 1 wt%.
  • Alternative buffering salts may be selected from e.g. carbonate or sesquicarbonate salts; acetate salts, glycinate, acetate, glycinate, gluconate, borate, glycerophosphate or citrate salts; phosphate salts.
  • Flavourings contained within the composition are not limited but preferably include flavonoid compounds to stimulate the olefactory system of the user, typically in an amount of less than about 3wt% of the total composition. Such compounds are commercially available and are well known to those skilled in the art.
  • flavour of the composition may be improved by the inclusion of sweeteners or flavour enhancers.
  • Sweeteners may include sugar based sweeteners such as sucrose, fructose, glucose, dextrose, maltose, lactose, galactose; sugar alcohols such as xylitol, maltitol, sorbitol, erythritol; or other sugar substitutes such as aspartame, saccharin, sucralose, allulose, acesulfame K, cyclamate or steviol glycosides.
  • the sweeteners may be present alone though are preferably used in combination (for example a sugar alcohol and a sugar substitute). A preferred combination is xylitol and acesulfame K. Quantities of the sweetener present in the composition depend on the properties of the sweeteners chosen, as would be understood by a person skilled in the art but typically range between 1 wt% and 3 wt% in total.
  • Flavour enhancers may include sodium chloride, salts of glutamic acid (such as sodium glutamate), glycine salts, inosinic acid salts and 5'-ribonucleotide salts (such as on or more disodium ribonucleotides). Quantities of the flavour enhancer present in the composition depend on the properties of the flavour enhancer chosen, as would be understood by a person skilled in the art but typically range between 1 wt% and 8 wt% in total.
  • Preservatives may include antimicrobial preservatives such as sorbic acid salts (such as sodium or potassium sorbate), benzoic acid salts, nitrate salts, nitrite salts, sulfate salts, sulfite salts and proponiate salts. Salts such as calcium chloride may also be used as preservatives.
  • antimicrobial preservatives such as sorbic acid salts (such as sodium or potassium sorbate), benzoic acid salts, nitrate salts, nitrite salts, sulfate salts, sulfite salts and proponiate salts. Salts such as calcium chloride may also be used as preservatives.
  • compositions may contain a small quantity of tobacco, such as between 1 wt% and 5 wt%, especially when contained in a pouch.
  • agar agar in the composition acts as an effective nicotine stabilizer and release control agent.
  • the nicotine may be partially bound within an agar agar gel which may be formed during manufacture. This appears to provide both a highly stable nicotine composition, which despite the use of free base nicotine and high levels of moisture is able to maintain a long shelf life.
  • the nicotine release profile of the composition is fast and consistent, providing excellent product performance.
  • the agar agar is preferably present in an amount from 0.1wt% to about 1.2 wt%. It is preferably present in a ratio of agar agar to nicotine of 0.1:1 to about 1.2:1, preferably from about 0.1:1 to about 1:1, more preferably from about 0.1:1 to about 0.8:1. This is a significantly lower ratio than would be required for prior art stabilizing agents.
  • Any food or pharmaceutical grade agar agar may be utilized in the present invention.
  • Specific examples include Rokoagar (RTM) RGM 600 and RGM 800, as supplied by Industrias Roko, S.A..
  • the composition may have a general composition as follows:
  • a process for the manufacture of tobacco-free or low-tobacco nicotine compositions involves the mixing in a vessel (such as an autoclave) the native cellulose in a portion of from 30 wt% to 60 wt% of the intended final composition and agar agar in a portion of from 0.1 wt% to 2 wt% of the final composition, each in powder or granular form.
  • a vessel such as an autoclave
  • the native cellulose in a portion of from 30 wt% to 60 wt% of the intended final composition and agar agar in a portion of from 0.1 wt% to 2 wt% of the final composition, each in powder or granular form.
  • agar agar in a portion of from 0.1 wt% to 2 wt% of the final composition, each in powder or granular form.
  • One or more of the other solid components of the composition such as pH control salts, flavour enhancers, sweeteners or preservatives may also be added
  • At least a portion of the water (preferably at least 10wt% of the intended final composition) is then added to the composition and the composition is heated.
  • the heating may take place in a number of ways.
  • the mixing vessel may be heated, for example by use of a heating manifold.
  • the water may be heated prior to its introduction to the mixing vessel or some or all of the water may be added as steam.
  • the precursor is then allowed to cool, preferably while mixing is continued.
  • the resulting composition may be set aside.
  • the agar agar forms a gel which at least partially encapsulates the nicotine which is present, stabilizing it and also providing excellent release properties.
  • Nicotine Nicotine content 17 mg/g MCC Moisture content: 8.31% Maltitol Shelf-life: 10 months Chewing gum base Color (storage): Creamy white Sodium bicarbonate Lumping: Moderate Glycerol Palatability: Poor Propylene Glycol Release: Slow Aromas Dusting: Yes pH: 9.61

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Toxicology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Manufacture Of Tobacco Products (AREA)
EP24209645.1A 2022-03-15 2022-03-15 Nikotinzusammensetzung Pending EP4527213A3 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24209645.1A EP4527213A3 (de) 2022-03-15 2022-03-15 Nikotinzusammensetzung

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP22715985.2A EP4322772B1 (de) 2022-03-15 2022-03-15 Verwendung eines freisetzungskontrollmittels in einer nicotin-zusammensetzung
EP24209645.1A EP4527213A3 (de) 2022-03-15 2022-03-15 Nikotinzusammensetzung
PCT/EP2022/056762 WO2023174523A1 (en) 2022-03-15 2022-03-15 Nicotine composition

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP22715985.2A Division EP4322772B1 (de) 2022-03-15 2022-03-15 Verwendung eines freisetzungskontrollmittels in einer nicotin-zusammensetzung

Publications (2)

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EP4527213A2 true EP4527213A2 (de) 2025-03-26
EP4527213A3 EP4527213A3 (de) 2025-06-11

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Family Applications (2)

Application Number Title Priority Date Filing Date
EP22715985.2A Active EP4322772B1 (de) 2022-03-15 2022-03-15 Verwendung eines freisetzungskontrollmittels in einer nicotin-zusammensetzung
EP24209645.1A Pending EP4527213A3 (de) 2022-03-15 2022-03-15 Nikotinzusammensetzung

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP22715985.2A Active EP4322772B1 (de) 2022-03-15 2022-03-15 Verwendung eines freisetzungskontrollmittels in einer nicotin-zusammensetzung

Country Status (9)

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US (1) US20250194662A1 (de)
EP (2) EP4322772B1 (de)
JP (1) JP2025509580A (de)
CA (1) CA3245742A1 (de)
ES (1) ES3010302T3 (de)
HU (1) HUE070143T2 (de)
MX (1) MX2024011331A (de)
PL (1) PL4322772T3 (de)
WO (1) WO2023174523A1 (de)

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Publication number Priority date Publication date Assignee Title
US20230049343A1 (en) * 2021-07-30 2023-02-16 Nicoventures Trading Limited Shaped pouched products

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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WO2023174523A1 (en) 2023-09-21
HUE070143T2 (hu) 2025-05-28
US20250194662A1 (en) 2025-06-19
JP2025509580A (ja) 2025-04-11
EP4527213A3 (de) 2025-06-11
EP4322772A1 (de) 2024-02-21
MX2024011331A (es) 2025-03-07
ES3010302T3 (en) 2025-04-02
CA3245742A1 (en) 2023-09-21
PL4322772T3 (pl) 2025-03-10

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