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WO2003053175A2 - Composition de substitut de tabac et/ou de tabac ameliore s'utilisant comme tabac a priser dans la cavite buccale - Google Patents

Composition de substitut de tabac et/ou de tabac ameliore s'utilisant comme tabac a priser dans la cavite buccale Download PDF

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Publication number
WO2003053175A2
WO2003053175A2 PCT/EP2002/014853 EP0214853W WO03053175A2 WO 2003053175 A2 WO2003053175 A2 WO 2003053175A2 EP 0214853 W EP0214853 W EP 0214853W WO 03053175 A2 WO03053175 A2 WO 03053175A2
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WO
WIPO (PCT)
Prior art keywords
nicotine
tobacco
composition according
release
membrane
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.)
Ceased
Application number
PCT/EP2002/014853
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English (en)
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WO2003053175A3 (fr
Inventor
Henri Hansson
Lars Hovgaard
Christer Spegel
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.)
Galenica AB
Original Assignee
Galenica 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 Galenica AB filed Critical Galenica AB
Priority to DK02795287T priority Critical patent/DK1458252T3/da
Priority to US10/499,552 priority patent/US20050061339A1/en
Priority to EP02795287A priority patent/EP1458252B1/fr
Priority to AU2002360097A priority patent/AU2002360097A1/en
Priority to DE60224832T priority patent/DE60224832T2/de
Publication of WO2003053175A2 publication Critical patent/WO2003053175A2/fr
Publication of WO2003053175A3 publication Critical patent/WO2003053175A3/fr
Anticipated expiration legal-status Critical
Ceased 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
    • 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
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes

Definitions

  • the present invention relates to a novel composition for the use as snuff in the oral cavity, the composition comprising tobacco and/or a tobacco substitute encapsulated in a membrane material comprising one or more membranes at least one of which being water permeable and water-insoluble.
  • a novel composition enables a selective release of e.g. nicotine while it at the same time reduces the release of substances, which normally lead to unwanted side effects.
  • the novel compositions may be used as a healthier alternative to snuff and other tobacco products such as, e.g., cigarettes, cigars and pipe.
  • the invention also relates to methods for giving up smoking, reducing nicotine craving, reducing side effects normally related to smoking and snuffing of tobacco as well to a method for the preparation of a composition according to the invention.
  • various buffer systems may be added, e.g. carbonates.
  • the moist snuff is either packed loosely, as bulk in a box or as single doses in small non- woven bags. A number of the filled and sealed bags are then packed in a box.
  • the moist snuff as a single dose has become popular due to the ease of use compared to the bulk product.
  • the popularity of moist snuff is most probably due to its pharmacological nicotine absorption profile.
  • the dose of nicotine and speed of absorption is approximately 10 ng per ml over 10 minutes.
  • Plasma nicotine concentrations rapidly increase within the first few minutes of the use of snuff and reach levels comparable to those obtained from smoking cigarettes within 30 min of use. Measurements of plasma nicotine concentrations after a single day of moist snuff consumption also yielded levels similar to cigarette use.
  • the kinetics is slightly slower compared to the kinetics when smoking tobacco, such as e.g. cigarettes and cigars; however, the overall amount of nicotine absorbed is higher when snuff is employed.
  • snuff is the vast number of compounds, more or less harmful to the body, e.g. different tobacco-specific nitrosamines, which are compounds known to cause different diseases such as, e.g., gastro-intestinal disorders and cancer.
  • US 4,141 ,369 describes a method of inhaling the nicotine from tobacco without combustion of the tobacco.
  • Another way of avoiding the harmful substances contained in tobacco is to substitute tobacco with nicotine.
  • Various devices have also be constructed in order to deliver nicotine from a tobacco composition placed in the oral cavity:
  • US 5,346,734 describes a perforated latex oral pouch for loose, moist snuff, the pouch serving as a barrier to avoid direct physical contact between the tobacco product and the gum.
  • the pouch has to be filled by the user, cut to fit the mouth cavity of the user and is re-usable.
  • US 6,162,516 describes a shield, which also has to be filled with snuff by the user, the shield acting as a barrier to reduce tobacco contact with the sensitive inner cheek lining and gum surfaces while using snuff.
  • the present invention provides a composition wherein the release of nicotine from snuff can be designed freely, even though the release of unwanted and harmful substances from the tobacco is dramatically reduced.
  • the present invention provides a composition for use in the oral cavity comprising tobacco and/or a tobacco substitute encapsulated in a membrane material comprising one or more membranes at least one of which being water permeable and water-insoluble.
  • the gist of the invention is the employment of a membrane material which makes it possible to deliver nicotine and/or a nicotine derivative, analog, salt, solvate or a mixture thereof in a predetermined manner and - at the same time - has the properties of withholding the substances which are unwanted to such a degree that the side-effects normally observed in connection with the use of snuff in the oral cavity are dramatically reduced.
  • the tobacco used in the novel snuff composition according to the invention may be natural tobacco leaves in order to preserve the authentic taste and feeling of tobacco.
  • the tobacco plant belongs to the family Solanaceae and the genus Nicotiana. More than 60 tobacco species exists, the most commonly used in smoking or snuffing tobacco products being Nicotiana tabacum and Nicotiana rustica.
  • To manufacture moist snuff the tobacco, which typically has a content of from about 1% to 8% nicotine, is dried, milled and mixed with a fermentative solution. The mixture is then fermented, typically for 5 days to 4 weeks at elevated temperature. After this the tobacco mass is mixed with a suitable buffer, such as e.g.
  • the water content in the final product may lie in the range from about 10 % to about 60 %.
  • additional compounds may be added, such as e.g. sweeteners, aroma substances and other taste additives, detergents and preservative, release modifying agents, and other liquids such as oil, organic solvents and herbal extracts.
  • the natural fermented tobacco may be partly or fully substituted with a tobacco substitute, such as, e.g., nicotine and/or a nicotine derivative, analog, salt, solvate or a mixture thereof selected from the group consisting of nor-nicotine, lobeline, methylanabasine, anabasine, nicotine hydrochloride, nicotine dihydrochloride, nicotine sulphate, nicotine monotartrate, nicotine bitartrate, nicotine salicylate or nicotine zinc chloride monohydrate.
  • a tobacco substitute such as, e.g., nicotine and/or a nicotine derivative, analog, salt, solvate or a mixture thereof selected from the group consisting of nor-nicotine, lobeline, methylanabasine, anabasine, nicotine hydrochloride, nicotine dihydrochloride, nicotine sulphate, nicotine monotartrate, nicotine bitartrate, nicotine salicylate or nicotine zinc chloride monohydrate.
  • some additional filler may be added, such as, e.g., non-digestible fiber
  • the tobacco and/or tobacco substitute may preferably have a content of nicotine and/or a nicotine derivative, analog, salt, solvate or a mixture thereof, from about 0% w/w to about 30% w/w such as, e.g., from about 0.5% w/w to about 25% w/w, from about 0.1% w/w to about 20% w/w, from about 0.1% w/w to about 15% w/w, from about 0.1% w/w to about 10% w/w, from about 0.1% w/w to about 9% w/w or from about 0.1% w/w to about 8% w/w.
  • a content of nicotine and/or a nicotine derivative, analog, salt, solvate or a mixture thereof from about 0% w/w to about 30% w/w such as, e.g., from about 0.5% w/w to about 25% w/w, from about 0.1% w/w to about 20% w/w, from about 0.1% w/w to about 15%
  • the tobacco and/or tobacco substitute is enclosed in a membrane material.
  • the membrane material may comprise one or more membranes.
  • membrane describes a thin polymeric film having natural pores and acting as a selective permeability barrier. The term does not include papermade material or polymeric materials in which not-naturally occurring openings have been made. At least one of the membranes may be water-insoluble to prevent spreading of the snuff in the oral cavity, and to maintain the beneficial properties of the selective membrane material during use, with respect to the withholding of unwanted substances.
  • At least one of the membranes may be water permeable in order to allow water to diffuse into the encapsulated tobacco and/or tobacco substitute and to allow e.g. nicotine to diffuse through the polymeric membrane material and thus becoming available for absorption.
  • the membranes may have a predominantly hydrophilic or hydrophobic nature.
  • the hydrophilic or hydrophobic nature of the membrane has an effect on the release of substances such as, e.g., nicotine through the membrane, since the flow of substances through the membrane is dependent on the ability of the membrane to hydrate, e.g. create hydro-channels through the membrane. These hydro-channels are a prerequisite for molecular transport when dry polymeric membranes are used.
  • the flow of hydrophilic substances through a hydrophobic membrane is slower compared to a hydrophilic membrane. This is probably due to less swelling of the hydrophobic membrane pores, i.e. in the hydrophobic membranes nicotine diffusion occurs through well-organized polymeric material and hydrophobic organized water.
  • One or more of the membranes used for making the composition may be a synthetic or semi-synthetic membrane.
  • a synthetic or semi-synthetic membrane As is given some examples of natural, synthetic and semi- synthetic hydrophilic and hydrophobic membranes, which may be used in a novel snuff composition according to the invention.
  • membranes are membranes made of cellulose acetate and derivates thereof, carboxymethyl cellulose membranes, polycellulose ester membranes, other cellulose derivatives such as, e.g., ethylcellulose, propylcellulose, polyethylene membranes, polypropylene membranes, polystyrene membranes, polyvinyl chloride membranes, polyvinyl acetate membranes, membranes made of polymers of methacrylates and acrylates, natural rubber membranes, polycarbonate membranes, polyethylene terephthalate membranes, polyester membranes, polyamide membranes and nylon membranes.
  • cellulose acetate and derivates thereof such as, e.g., ethylcellulose, propylcellulose, polyethylene membranes, polypropylene membranes, polystyrene membranes, polyvinyl chloride membranes, polyvinyl acetate membranes, membranes made of polymers of methacrylates and acrylates, natural rubber membranes, polycarbonate membranes, polyethylene tere
  • At least the outer membrane in the membrane material enclosing the tobacco and/or tobacco substitute may be made from a biocompatible and physiologically acceptable polymeric material, since the novel snuff composition has to be placed close to or in contact with the mucous membrane in the oral cavity during use.
  • At least one of the membranes in a membrane material may be surface treated with e.g. polycarbophils to obtain a bioadhesiveness of the novel snuff composition in the oral cavity.
  • the molecular weight cut off of the membrane material used in the novel snuff composition may be varied to obtain a desired release of nicotine and other substances through the membrane material.
  • the molecular weight cut-off of a membrane is defined as the molecular weight of the smallest molecule of which 90 % will be prevented from permeating the membrane.
  • the exact permeability of a molecule is dependent on the shape, the degree of hydration and the charge of the molecule.
  • At least one of the membranes comprising the membrane material may have a molecular weight cut-off from about 500 to about 40,000 such as, e.g., from about 500 to about 5,000, from about 800 to about 4,000, from about 1 ,000 to about 3,500; or from about 2,000 to about 40,000, from about 3,000 to about 30,000, from about 5,000 to about 25,000, from about 7,500 to about 20,000 or from about 10,000 to about 20,000.
  • the release of nicotine and/or other substances through the membrane material is also dependent on the thickness of the membrane materiel.
  • the diffusion process of molecules through the membrane is decreased when the membrane thickness is increased and vice versa.
  • the thickness of the membrane material may be varied in respect of obtaining a desired release of nicotine and other substances through the membrane material.
  • the lower limit for the membrane material thickness is determined by what is possible from a practical point of view, and the upper value is restricted by what will allow a comfortable fit of the novel snuff composition in the oral cavity of the user.
  • At least one of the membranes comprising the membrane material may have a thickness of from 2 to about 200 ⁇ m such as, e.g., from about 5 to about 100 ⁇ m, from about 7.5 to about 50 ⁇ m, from about 7.5 to about 40 ⁇ , from about 7.5 to about 35 ⁇ m, from about 7.5 to about 30 ⁇ m or from about 7.5 to about 25 ⁇ m.
  • the release profile may be designed with respect to the rate and amount of nicotine and unwanted substances released by the membrane.
  • the release of nicotine and/or a derivative, analog, salt, solvate or a mixture thereof from a novel snuff composition may be designed to be released in a sufficient amount and/or a sufficient rate to enable a desired effect and on the other hand be designed to retain substances, which normally give rise to side-effects, such as, e.g., nitrosamines, and/or to release such substances in a substantially low amount and/or at a substantially slow rate.
  • the Impurity Index - IPI - is introduced.
  • the IPI is calculated from the UV-spectra recorded from 200 nm to 900 nm as described in Example 2, and is defined as the ratio of the sum of peak heights other than that of nicotine (i.e. thus including unwanted and harmful substances) to the peak height of nicotine. In other words, a low IPI reflects that a large amount of nicotine is released through the membrane compared to the amount of unwanted substances.
  • the impurity index IPI is at the most 3.0 such as, e.g. at the most 2.75, at the most 2.5, at the most 2.0, at the most 1.75, at the most 1.5, at the most 1.5 or at the most 1.4 when measured after 90 min.
  • the release profile of nicotine and/or a derivative, analog, salt, solvate or a mixture thereof from the invention could e.g., be fast and equivalent to the release of nicotine from the commercially available moist snuff, while maintaining a low IPI value, i.e. limiting the release of unwanted substances.
  • a composition according to the invention can be designed to release nicotine and/or a derivative, analog, salt, solvate or mixture thereof in a controlled manner such as, e.g., fast (faster than from the reference product employed in the examples herein), relatively fast (i.e. similar or almost similar to the reference product employed in the examples herein), delayed (i.e. with a lag time in which period no nicotine is released followed by a release of nicotine), prolonged or sustained (i.e. a relatively slower release than the reference product to avoid any peak concentration and to obtain a relatively constant plasma concentration of nicotine after application).
  • fast fast
  • relatively fast i.e. similar or almost similar to the reference product employed in the examples herein
  • delayed i.e. with a lag time in which period no nicotine is released followed by a release of nicotine
  • prolonged or sustained i.e. a relatively slower release than the reference product to avoid any peak concentration and to obtain a relatively constant plasma concentration of nicotine after application.
  • the release of nicotine or a derivative, analog, salt, solvate or a mixture thereof may be delayed compared to the commercially available moist snuff, to mimic the effect of nicotine replacement products such as, e.g., patches.
  • the release of nicotine or a derivative, analog, salt, solvate or a mixture thereof may be determined by the release test described in Example 1 , but other suitable methods for determining the release of nicotine may also be used, i.e. the embodiments of the invention described below referrer to Example 1 without limiting the relevant release tests to the one described in Example 1.
  • the tobacco and/or tobacco substitute composition may be designed so that at least about 50% w/w of the total content of nicotine and/or a derivative, analog, salt, solvate or a mixture thereof is released within at the most 60 min when subject to the release test described in Example 1 below.
  • the tobacco and/or tobacco substitute composition may be designed so that at the most 25% w/w of the total content of nicotine and/or a derivative, analog, salt, solvate or a mixture thereof is released within at the most 60 min when subject to the release test described in Example 1 below.
  • the tobacco and/or tobacco substitute composition may be designed so that at least about 50% w/w of the total content of nicotine and/or a derivative, analog, salt, solvate or a mixture thereof is released within at the most 120 min when subject to the release test described in Example 1 below.
  • release profiles for compositions according to the invention are described as %w/w released of total nicotine content as a function of time, measured at 0, 3, 30, 90 and 180 minutes.
  • the release profiles according to the invention also includes profiles described by only one or any combination of the values below, i.e. a release profile according to the invention could be defined by e.g. the %w/w release of nicotine at 3 minutes and 90 min, or at 3 and 90 and 180 minutes, or at 90 and 180 minutes or any possible combination of the values shown below.
  • a composition according to the invention is suitable designed to release nicotine and/or a derivative, analog, salt, solvate or a mixture thereof from the tobacco or the tobacco substitute with the following characteristics:
  • op til 100 90 from about 10 to about 100 such as, e.g., from about 10 to about 95, from about 15 to about 90, from about 20 to about 90, from about 25 to about 85, from about 30 to about 80, from about 35 to about 80 or from about 40 to about 80, 180 from about 40 to about 100 such as, e.g. from about 45 to about 100, from about 50 to about 100, from about 55 to about
  • a composition according to the invention releases nicotine and/or a derivative, analog, salt, solvate or a mixture thereof from the tobacco or the tobacco substitute with the following release profile characteristics: time (min) % w/w released of total nicotine content
  • a composition according to the invention releases nicotine and/or derivative, analog, salt or solvate thereof from the tobacco or the tobacco substitute with the following release profile characteristics:
  • a composition according to the invention releases nicotine and/or a derivative, analog, salt, solvate or a mixture thereof from the tobacco or the tobacco substitute with the following release profile characteristics:
  • membrane material properties such as hydrophobicity, hydrophilicity, molecular weight cut-off and membrane thickness may be used in designing a desired release profile for nicotine or a derivative, analog, salt, solvate or mixture thereof.
  • a multi-layer membrane is e.g. designed to contain one membrane material being hydrophilic and a second membrane material being lipophilic. Both membrane components are chosen in such a manner that the membrane material has a molecular cut off large enough for the relatively small nicotine molecule to pass through with ease.
  • amphiphilic nature of nicotine enables it to pass both hydrophilic and hydrophobic materials while a majority of both hydrophilic and lipophilic unwanted and harmful substances are excluded from permeation through the membrane material.
  • Many other combinations of different types of membranes are of course possible and based on the disclosure herein a skilled person will know how to chose different membranes in order to obtain a suitable release.
  • compositions according to the invention are a composition wherein the membrane material is a bi-layer membrane with one membrane being preferentially hydrophilic and one membrane being predominantly hydrophobic. Both membranes possess high permeability to nicotine while maintaining low aqueous pore diffusion.
  • the release profile of nicotine could either be identical to the release profile of original snuff or it could be designed to have a prolonged or sustained release. The unwanted and harmful substances from the tobacco should substantially be maintained inside the membrane.
  • a composition according to the invention may attain all possible sizes and shapes, such as, e.g. round, circular, oblong, elliptical, square, rectangular or trapezoidal.
  • the shape and/or size chosen may be such as to allow a comfortable fit in the oral cavity.
  • the location in the oral cavity of a composition according to the invention may be centered or to the sides under the upper front lip, centered or to the sides under the lower front lip, under the tongue or in the cheeks.
  • the invention also relates to use of a composition according to the invention as a smoke substitute and it can be used by persons who suffer from nicotine craving or who want to give up or reduce smoking.
  • the content of tobacco and/or a tobacco substitute is adjusted to the individual purposes and it is possible to design a kit comprising compositions according to the invention with different concentrations of tobacco and/or a tobacco substitute.
  • Such compositions in a kit could e.g. contain compositions with a decreasing content of tobacco or nicotine.
  • Figure 1 shows the release profile from moist tobacco using side-by-side diffusion cells equipped with specific membranes having different physical properties.
  • Figure 2 shows the impurity index (IPI) for various hydrophilic membranes with different thickness and molecular weight cut-offs.
  • the reference is filter paper.
  • Figure 3 shows the maximum flux of nicotine as a function of membranes thickness for a hydrophilic membrane with a molecular weight cut-off of 13,000.
  • the reference flux illustrates the flux through filter paper.
  • Membranes made of regenerated cellulose acetate dialysis tubing with varying MW cut-off together with vinyl and polyethylene membranes with various thicknesses were tested with respect to the diffusion profiles over the membranes of nicotine released from tobacco.
  • snuff tobacco SVENSKT SNUS, GOTHIATEK, General
  • PBS phosphate buffered saline according to Ph. Eur.
  • PBS with a pH of 6.6 was placed in the receiver chamber.
  • the cells of the diffusion chamber were kept at a temperature of 37°C ⁇ 0.5°C by attachment to a water bath. The temperature control was made in order to simulate the environment of the oral cavity.
  • Diffusion profiles were constructed by sampling from the receiver chamber at 0, 3, 30, 60, 90, 120, (110 min for the polyethylene membrane) and 180 min after the start of the diffusion experiment.
  • the concentration of nicotine in the receiver chamber was measured by HPLC, using a C-18, 5 ⁇ , 4.5 mm x 15 cm column, employing a mobile phase consisting of 70 % v/v 0.1 M phosphate buffer (pH 4.5), 30 % acetonitrile, and 2.3 g sodium dodecyl sulphate/liter at a flow rate of 1 ml /min and a temperature of 40°C.
  • the sample volume was 10 l and detection was carried out using a UV-detector running at 260 nm.
  • the membranes used were regenerated cellulose acetate dialysis tubing with varying MW cut-off and vinyl and polyethylene membranes with varying thickness.
  • Table I shows a comparison of the release profile of nicotine for a commercial non-woven snuff-bag, and a piece of filter paper used as reference in the experiments. The measurements were performed as described above, and the results are the mean of 2 single runs. Table I. Comparison of the nicotine release profile for a commercial non-woven filter and a reference paper filter
  • Hydrophobic membranes e.g. vinyl and polyethylene membranes
  • the slower profile is probably due to less swelling of the hydrophobic membrane pores, i.e. in the hydrophobic membranes nicotine diffusion occurs through well-organized polymeric material and hydrophobic organized water rather than through aqueous pores.
  • Figure 1 shows that the release of nicotine over a hydrophilic membrane made of regenerated cellulose acetate dialysis tubing is high and close to the nicotine release over the reference filter paper.
  • Figure 1 also shows that the physical properties, i.e. the molecular weight cut-off and thickness of the hydrophilic membrane, affect the permeability of nicotine as stated below.
  • a membrane with a relatively small molecular weight cut-off tends to have a sigmoid release profile for nicotine.
  • a considerable lag time is expected before the nicotine starts to permeate the membrane, even though the size of a nicotine molecule is significantly smaller than the molecular weight cut-off of 3,500.
  • a membrane with a higher molecular weight cut-off e.g. a molecular weight cutoff of 13,000, seems to have a release profile for nicotine that is very close to the release profile for nicotine of the reference filter paper.
  • This difference may be due to a much lower aqueous mobility of nicotine in the membrane with a molecular weight cut-off of 3,500, compared to the membrane with a molecular weight cut-off of 13,000.
  • Figure 1 also shows that when the thickness of a membrane increases, then the flux of nicotine through the membrane decreases.
  • Example 1 shows that it is possible to design a polymeric membrane which gives rise to a release profile of nicotine from moist tobacco through the membrane very similar to the release profile through a commercial non-woven snuff-bag, i.e. with respect to the shape of the profile and the individual release data (time, percentage released). Especially, it seems that a hydrophilic membrane material is suitable. Furthermore, the release profile is dependent of the molecular weight cut-off of the membrane, the thickness of the membrane and of the membrane material itself.
  • Example 1 also shows that some hydrophobic membranes, e.g. vinyl and polyethylene membranes, have a slower nicotine release profile compared to the hydrophilic membranes.
  • hydrophobic membranes e.g. vinyl and polyethylene membranes
  • Membranes made from regenerated cellulose acetate dialysis tubing with varying thickness and molecular weight cut-off were tested for their selectivity in transporting nicotine across the membrane, while unwanted and potentially harmful substances are retained in the tobacco.
  • the Impurity Index - IPI - was introduced as a measure for the selective release of nicotine.
  • the IPI is calculated from the UV-spectra recorded from 200 nm to 900 nm, and is defined as the ratio of the sum of peak heights other than that of nicotine (i.e. thus including unwanted and harmful substances) to the peak height of nicotine. All measurements are performed in the receiver chamber, i.e. after permeation through the membrane in question. The IPI is measured 3, 30 and 90 min after start of the experiment, cf. above. In those cases where any additionally substances are added to the tobacco composition such as, e.g., sweeteners, flavors, detergents, buffers, etc. the peak heights of these are normally not included when calculating the sum of peak height as described above.
  • IPI Impurity index
  • the decrease in IPI is not merely a result of a decrease in the overall release rate. Accordingly, the release profiles relating to nicotine and employing cellulose membranes with a molecular weight cut-off of 13,000 are only a few percent lower than the release profile for the reference filter paper. Thus, employment of such membranes enables a release, which permits release of wanted substances (i.e. nicotine) while retaining unwanted substances.
  • Example 2 shows that no significant loss in membrane selectivity is observed as the membrane thickness is being decreased. Therefore, further studies to investigate the relationship between membrane thickness, molecular weight cut-off of the membrane and amount of nicotine transferred over the membrane were performed by analyzing selected data from Example 1.
  • the maximum slope for each release profile has been deduced.
  • the maximum slope i.e. percentage nicotine release per time unit, dR/dt represents the maximum flux of nicotine through the membranes (see Table 4).
  • Table 4 Values for the maximum flux (% nicotine released per time unit, dR dt) and lag time for different thicknesses of membranes with cut off 3500 Mw, 13000 Mw and reference filter
  • Figure 3 shows a plot of the maximum flux as a function of membrane thickness for the cellulose membrane with a molecular weight cut-off of 13,000.
  • the Figure shows that the flux of nicotine through a membrane is approaching the flux through a reference filter paper, which practically has no barrier to the nicotine diffusion, at a membrane thickness of about 10 ⁇ m.
  • a hydrophilic membrane with a molecular cut off about 13,000 does not seem to give rise to any boundary layer/membrane effects or any major diffusion limitations for nicotine.
  • a thickness of approx.10 ⁇ m will give a release profile equal to the original commercially available non-woven moist snuff pouches.
  • the sensation of taking up nicotine into the blood stream from the oral cavity was scored using a scale rating from zero to five, with zero indicating no feeling and 5 indicating a very strong feeling of uptake, leading to dizziness and nausea.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Manufacture Of Tobacco Products (AREA)
  • Cosmetics (AREA)

Abstract

L'invention concerne une nouvelle composition s'utilisant comme tabac à priser dans la cavité buccale. Cette composition comprend du tabac et/ou un substitut de tabac encapsulé dans une matière membrane comportant une ou plusieurs membranes, au moins une d'entre elles étant perméable à l'eau et insoluble dans l'eau. Cette composition permet de libérer de manière sélective de la nicotine, par exemple, et de réduire en même temps la libération de matières comportant en temps normal des effets secondaires indésirables. Les compositions de l'invention peuvent constituer une alternative plus saine au tabac à priser et à d'autres produits à base de tabac tels que cigarettes, cigares et pipe par exemple. L'invention concerne aussi des méthodes pour arrêter de fumer, qui réduisent l'état de manque provoqué par la nicotine ainsi que les effets secondaires normalement associés à l'habitude de fumer et à la consommation de tabac à priser ; et un procédé de préparation d'une composition.
PCT/EP2002/014853 2001-12-21 2002-12-17 Composition de substitut de tabac et/ou de tabac ameliore s'utilisant comme tabac a priser dans la cavite buccale Ceased WO2003053175A2 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
DK02795287T DK1458252T3 (da) 2001-12-21 2002-12-17 Tobak og/eller tobak i kombination med tobakssubstitutkomposition til anvendelse som snus i den orale kavitet
US10/499,552 US20050061339A1 (en) 2001-12-21 2002-12-17 Tobacco and/or tobacco substitute composition for use as a snuff in the oral cavity
EP02795287A EP1458252B1 (fr) 2001-12-21 2002-12-17 Tabac et/ou substitut de tabac en combinaison avec du tabac s'utilisant comme tabac a priser dans la cavite buccale
AU2002360097A AU2002360097A1 (en) 2001-12-21 2002-12-17 Tobacco and/or tobacco substitute composition for use as a snuff in the oral cavity
DE60224832T DE60224832T2 (de) 2001-12-21 2002-12-17 Tabak und/oder tabak in kombination mit tabakersatz zusammensetzung zur verwendung als schnupf in der mundhöhle

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200101945 2001-12-21
DKPA200101945 2001-12-21

Publications (2)

Publication Number Publication Date
WO2003053175A2 true WO2003053175A2 (fr) 2003-07-03
WO2003053175A3 WO2003053175A3 (fr) 2003-10-09

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DE60224832T2 (de) 2009-01-22
DE60224832D1 (de) 2008-03-13
AU2002360097A8 (en) 2003-07-09
DK1458252T3 (da) 2008-05-13
EP1458252A2 (fr) 2004-09-22
WO2003053175A3 (fr) 2003-10-09
AU2002360097A1 (en) 2003-07-09
US20050061339A1 (en) 2005-03-24
ATE384450T1 (de) 2008-02-15
EP1458252B1 (fr) 2008-01-23

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