Tobacco and/or tobacco substitute composition for use as a snuff in the oral cavity

Abstract

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. Methods for giving up smoking, reducing nicotine craving, reducing side effects normally related to smoking and snuffing of tobacco as welt a method for the preparation of a composition according to the invention.

1 . A composition for use in the oral cavity comprising a material selected from the group consisting of tobacco and tobacco in combination with a tobacco substitute, the material being encapsulated in a membrane material comprising one or more membranes at least one of which being water permeable and water-insoluble, and wherein the impurity index of the composition—when determined as described herein—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.  
     
     
         2 . A composition according to  claim 1  for use as snuff.  
     
     
         3 . A composition according to  claim 1 , wherein the composition is not in the form of a chewing gum.  
     
     
         4 . A composition according to  claim 1 , wherein at least one membrane is a synthetic or semi-synthetic membrane.  
     
     
         5 . A composition according to  claim 1 , wherein at least one membrane is made from natural rubber.  
     
     
         6 . A composition according to  claim 1 , wherein at least one membrane is a biocompatible membrane.  
     
     
         7 . A composition according to  claim 1 , wherein the membrane is of a polymeric material such as one selected from the group consisting of cellulose acetate and derivates thereof, carboxymethyl cellulose, polycellulose esters, other cellulose derivatives such as, e.g., ethylcellulose, propylcellulose, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinyl acetate, polymers of methacrylates and acrylates, natural rubber, polycarbonates, polyethylene terephthalate, polyesters, polyamides and nylon.  
     
     
         8 . A composition according to  claim 1 , wherein at least one of the membranes has predominantly hydrophilic character.  
     
     
         9 . A composition according to  claim 1 , wherein at least one of the membranes has predominantly hydrophobic character.  
     
     
         10 . A composition according to  claim 1 , wherein nicotine and/or a nicotine derivative, analog, salt, solvate or a mixture thereof is released from the tobacco or the tobacco substitute.  
     
     
         11 . A composition according to  claim 10 , wherein the release is a controlled release.  
     
     
         12 . A composition according to  claim 10 , wherein the nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof is 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.  
     
     
         13 . A composition according to  claim 1 , which i) is designed to release nicotine and/or a nicotine derivative, analog, salt, solvate or a mixture thereof in a sufficient amount and/or at a sufficient rate to enable a desired effect and ii) is designed to retain substances, which normally give rise to side-effects, and/or to release such substances in a substantially low amount and/or at a substantially slow rate.  
     
     
         14 . A composition according to  claim 1 , wherein at least one of the membranes comprising the membrane material has a molecular weight cut-off of 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.  
     
     
         15 . A composition according to  claim 1 , wherein at least one of the membranes comprising the membrane material has a thickness of from about 2 to about 200 μm such as, e.g., from about 5 to about 100 μm, from about 7.5 to about 50 μm, from about 7.5 to about 40 μm, from about 7.5 to about 35 μm, from about 7.5 to about 30 μm or from about 7.5 to about 25 μm.  
     
     
         16 . A composition according to  claim 1 , wherein at least about 50% w/w of the total content of nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof is released within at the most 60 min when subject to the release test described herein.  
     
     
         17 . A composition according to  claim 1 , wherein at the most 25% w/w of the total content of nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof is released within at the most 60 min when subject to the release test described herein.  
     
     
         18 . A composition according to  claim 1 , wherein at least about 50% w/w of the total content of nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof is released within at the most 120 min when subject to the release test described herein.  
     
     
         19 . A composition according to  claim 1 , wherein the release of nicotine and/or nicotine derivative, analog, salt, solvate mixture thereof from the tobacco or the tobacco substitute has the following characteristics:  
       
         
           
                 
                 
               
                     
                 
                     
                 
                   time (min) 
                   % w/w released of total nicotine content 
                 
                     
                 
                     
                 
                 
                 
               
                   0 
                   from about 0 to about 20 such as, e.g., from about 0 to 
                 
                     
                   about 15 or from about 0 to about10 
                 
                   3 
                   from about 0.5 to about 40 such as, e.g., from about 0.5 to 
                 
                     
                   about 35, from about 0.5 to about 30, from about 1 to  
                 
                     
                   about 25 or from about 1 to about 20 
                 
                   30 
                   from about 2 to about 65 such as, e.g., from about 2 
                 
                     
                   to about 60, from about 5 to about 60, from about 5 to 
                 
                     
                   about 55, from about 7.5 to about 55 or from about 10 
                 
                     
                   to about 50 
                 
                   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 100, from about 60 to about 100, 
                 
                     
                   from about 65 to about 100 or from about 
                 
                     
                   70 to about 100 
                 
                     
                 
                     
                 
             
                
                
                
                
               
               
                
               
            
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       and the release is determined as described herein.  
     
     
         20 . A composition according to  claim 1 , wherein the release of nicotine and/or nicotine derivative, analog, salt, solvate mixture thereof from the tobacco or the tobacco substitute has the following characteristics:  
       
         
           
                 
                 
               
                     
                 
                     
                 
                   time (min) 
                   % w/w released of total nicotine content 
                 
                     
                 
                     
                 
                 
                 
               
                   0 
                   from about 0 to about 15 
                 
                   3 
                   from about 1 to about 25 
                 
                   30 
                   from about 7.5 to about 55 
                 
                   90 
                   from about 36 to about 80 
                 
                   180 
                   from about 65 to about 100 
                 
                     
                 
                     
                 
             
                
                
                
                
               
               
                
               
            
             
                
                
                
                
                
                
                
               
            
           
         
       
       and the release is determined as described herein.  
     
     
         21 . A composition according to  claim 1 , wherein the release of nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof from the tobacco or the tobacco substitute has the following characteristics:  
       
         
           
                 
                 
               
                     
                 
                     
                 
                   time (min) 
                   % w/w released of total nicotine content 
                 
                     
                 
                     
                 
                 
                 
               
                   0 
                   from about 0 to about 10 
                 
                   3 
                   from about 1 to about 20 
                 
                   30 
                   from about 10 to about 50 
                 
                   90 
                   from about 40 to about 90 
                 
                   180 
                   from about 70 to about 100 
                 
                     
                 
                     
                 
             
                
                
                
                
               
               
                
               
            
             
                
                
                
                
                
                
                
               
            
           
         
       
       and the release is determined as described herein.  
     
     
         22 . A composition according to  claim 1 , wherein the release of nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof from the tobacco or the tobacco substitute has the following characteristics:  
       
         
           
                 
                 
               
                     
                 
                     
                 
                   time 
                   % w/w released of 
                 
                   (min) 
                   total nicotine content 
                 
                     
                 
                     
                 
                 
                 
               
                   0 
                   from about 0 to about 10 
                 
                   3 
                   from about 1 to about 20 
                 
                   30 
                   from about 30 to about 50 
                 
                   90 
                   from about 65 to about 90 
                 
                     
                 
                     
                 
             
                
                
                
                
                
               
               
                
               
            
             
                
                
                
                
                
                
               
            
           
         
       
       and the release is determined as described herein in.  
     
     
         23 . A composition according to  claim 1 , wherein the tobacco is processed from the leafs of the plant family Solanaceae and the genus  Nicotiana , such as, e.g.,  Nicotiana tabacum  and  Nicotiana rustica.    
     
     
         24 . A composition according to  claim 1 , comprising nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof as claimed in  claim 12  together with tobacco in the form of snuff tobacco and/or a suitable filler substance.  
     
     
         25 . A composition according to  claim 1 , wherein the composition further comprises sweeteners, aromas, taste additives, detergents, pH adjusting substances, preservatives, buffers, release modifying agents and/or fillers.  
     
     
         26 . A composition according to  claim 1 , wherein the composition further comprises chemical compounds that enables enhances the release of nicotine from tobacco such as, e.g., pH regulating buffers, e.g. carbonates buffers oil, organic solvents and herbal extracts.  
     
     
         27 . A composition according to  claim 1 , wherein the tobacco or tobacco substitute contains nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof in an concentration of about from 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.  
     
     
         28 . A composition according to  claim 1 , wherein the membrane material is composed of at least two different kinds of membranes with respect to e.g. thickness, molecular weight cut-off, hydrophilic/hydrophobic nature and water permeability.  
     
     
         29 . A composition according to  claim 1 , wherein the composition has a size and/or shape, which is suitable for application under the upper lip of a human.  
     
     
         30 . A composition according to  claim 1 , containing a mixture of tobacco and a tobacco substitute.  
     
     
         31 . A composition according to  claim 1  for use as a smoke substitute.  
     
     
         32 . A composition according to  claim 30  for use in reducing nicotine craving and/or nicotine abstinence.  
     
     
         33 . A method for controlling the release of nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof from tobacco and/or tobacco substitute in the oral cavity, the method comprising encapsulating a material selected from the group consisting of tobacco and tobacco in combination with a tobacco substitute in a membrane material comprising one or more membranes at least one of which being water permeable and water-insoluble so that nicotine and/or nicotine derivative, analog, salt, solvate or a mixture thereof is released in a sufficient amount and/or at a sufficient rate to i) enable a desired effect and ii) retain substances, which normally give rise to side-effects, and/or release such substances in a substantially low amount and/or at a substantially slow rate.  
     
     
         34 . A method for delivering nicotine and/or derivative, analog, salt or solvate thereof to a person in need thereof, the method comprising applying a composition according to  claim 1  to the oral cavity.  
     
     
         35 . A method for giving up smoking, the method comprising applying a composition according to  claim 1  to the oral cavity.  
     
     
         36 . A method for reducing nicotine craving, the method comprising applying a composition according to  claim 1  to the oral cavity.  
     
     
         37 . A method for reducing side effects related to smoking and/or snuffing tobacco, the method comprising applying a composition according to  claim 1  to the oral cavity.  
     
     
         38 . Use of a composition according to  claim 1  as an alternative to and/or substitute for smoking tobacco.  
     
     
         39 . A method for the preparation of a composition according to  claim 1 , the method comprising encapsulating tobacco and/or a tobacco substitute in a membrane material comprising one or more membranes at least one of which being a water permeable and a water-insoluble membrane.