An oral nicotine product comprising a ph adjusting agent

Abstract

The present disclosure relates to an oral pouched tobacco-free or low tobacco nicotine product, said product comprising a pH adjusting agent that includes:(i) Na2CO3, K2CO3, NaHCO3 and/or KHCO3, and(ii) a salt of Formula (I):M2+(An−)m   Formula Ior a hydrate of said salt,whereinM2+ is selected from Ca2+, Mg2+, Mn2+, Zn2+ and Fe2+,An− is an anion selected from chloride, lactate, malate, succinate, citrate, ascorbate, tartrate, acetate, phosphate, sulphate, nitrate, gluconate, alginate, ammonium, oxalate, aspartate, glycinate, picolinate, oxide, cysteinate, glutamate, hydroxide, laurate, stearate, palmitate, undecylenate, gluceptate, glucerophosphate, glubionate, glucoheptonate, guanylate, inosinate, propionate, sorbate, salicylate, benzoate, erythorbate, formate, iodide, pangamate and any combination thereof,n is 1 or 2,m is 1 or 2, and−(n×m)=−2said salt being present in an amount within the range of from 0.1 wt % to 5 wt %, based on the total weight of the filling material, andsaid salt having a water solubility equal to or above 0.04 M and/or equal to or above 1 g/L.

1 . An oral pouched nicotine product comprising a filling material and a saliva-permeable pouch of a packaging material enclosing the filling material, the filling material comprising:
 a particulate non-tobacco material,   a nicotine source,   water in an amount within the range of from 1 wt % to 50 wt % based on the total weight of the filling material, and   a pH adjusting agent comprising:   (i) Na 2 CO 3 , K 2 CO 3 , NaHCO 3  and/or KHCO 3 , and   (ii) a salt of Formula (I):
   M 2+ (A n− ) m    Formula I
 
   or a hydrate of said salt,   wherein   M 2+  is selected from the group consisting of Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+  and Fe 2+ ,   A n−  is an anion selected from the group consisting of chloride, lactate, malate, succinate, citrate, ascorbate, tartrate, acetate, phosphate, sulphate, nitrate, gluconate, alginate, ammonium, oxalate, aspartate, glycinate, picolinate, oxide, cysteinate, glutamate, hydroxide, laurate, stearate, palmitate, undecylenate, gluceptate, glucerophosphate, glubionate, glucoheptonate, guanylate, inosinate, propionate, sorbate, salicylate, benzoate, erythorbate, formate, iodide, pangamate and any combination thereof,   n is 1 or 2,   m is 1 or 2, and
   −( n×m )=−2,
 
   said salt being present in an amount within the range of from 0.05 wt % to 5 wt %, based on the total weight of the filling material,   said salt having a water solubility equal to or above 0.04 M and/or equal to or above 1 g/L, and   optionally a tobacco material in an amount within the range of from 0.05 wt % to 10 wt % based on the total weight of the filling material.   
     
     
         2 . An oral pouched nicotine product according to  claim 1  wherein said salt has a water solubility equal to or above 0.045 M, such as equal to or above 0.05 M, such as equal to or above 0.06 M, such as equal to or above 0.07 M, such as equal to or above 0.8 M, such as equal to or above 0.9 M, such as equal to or above 1.0 M. 
     
     
         3 . An oral pouched nicotine product according to  claim 1  or  2 , wherein said salt has a water solubility equal to or above 2 g/L, such as equal to or above 3 g/L, such as equal to or above 4 g/L, such as equal to or above 5 g/L, such as equal to or above 10 g/L, such as equal to or above 50 g/L, such as equal to or above 100 g/l, such as equal to or above 150 g/L, such as equal to or above 200 g/L, such as equal to or above 250 g/L, such as equal to or above 300 g/L, such as equal to or above 350 g/L such as equal to or above 400 g/L, such as equal to or above 450 g/L, such as equal to or above 500 g/L, such as equal to or above 600 g/L, such as equal to or above 700 g/L. 
     
     
         4 . An oral pouched nicotine product according to any one of  claims 1 - 3 , wherein said water solubility is measured at a temperature from 10° C. to 40° C., such as from 20° C. to 25° C. 
     
     
         5 . An oral pouched nicotine product according to any one of the preceding claims, wherein A n−  is an anion selected from one or more of the following: chloride, lactate, malate, citrate, ascorbate, acetate, sulphate, nitrate, gluconate, glutamate, guanylate, inosinate, propionate, sorbate, benzoate, formate, pangamate. 
     
     
         6 . An oral pouched nicotine product according to any one of the preceding claims, wherein A n−  is an anion selected from one or more of the following: chloride, lactate, citrate, ascorbate, acetate, sulphate, nitrate, propionate, benzoate, formate, pangamate. 
     
     
         7 . An oral pouched nicotine product according to any one  claims 1 - 5 , wherein A n−  is an anion selected from one or more of the following: chloride, lactate, citrate, acetate, sulphate, nitrate, gluconate, benzoate, formate. 
     
     
         8 . An oral pouched nicotine product according to any one of  claims 1 - 7 , wherein A n−  is an anion selected from one or more of the following: chloride, acetate, sulphate, nitrate, formate. 
     
     
         9 . An oral pouched nicotine product according to any one of  claims 1 - 5 , wherein A n−  is an anion selected from one or more of the following: chloride, acetate, sulphate, nitrate, gluconate, propionate, formate. 
     
     
         10 . An oral pouched nicotine product according to any one of  claims 1 - 7 , wherein A n−  is an anion selected from one or more of the following: chloride, lactate, sulphate, nitrate. 
     
     
         11 . An oral pouched nicotine product according to any one of  claims 1 - 4 , wherein A n−  is an anion selected from one or more of the following: chloride, lactate, malate, citrate, ascorbate, tartrate, acetate, gluconate, aspartate, glycinate. 
     
     
         12 . An oral pouched nicotine product according to any one of the preceding claims, wherein the filling material does not comprise a tobacco material. 
     
     
         13 . An oral pouched nicotine product according to any one of  claims 1 - 11 , wherein the tobacco material is present in an amount within the range of from 0.1 wt % to 10 wt %, such as from 0.1 wt % to 5 wt %, such as from 0.1 wt % to 1 wt %, based on the total weight of the filling material. 
     
     
         14 . An oral pouched nicotine product according to any one of the preceding claims, wherein the amount of water is within the range of from 0.5 wt % to 12 wt %, such as from 0.5 wt % to 5 wt %, such as 3 wt %, based on the total weight of the filling material. 
     
     
         15 . An oral pouched nicotine product according to any one of  claims 1 - 13 , wherein the amount of water is within the range of from 20 wt % to 50 wt %, such as from 20 wt % to 45 wt %, based on the total weight of the filling material. 
     
     
         16 . An oral pouched nicotine product according to any one of the preceding claims, wherein the salt of Formula (I), or hydrate of said salt, is present in an amount within the range of from 0.05 wt % to 5 wt %, such as from 0.1 wt % to 5 wt %, such as from 0.1 wt % to 3 wt %, such as from 0.1 wt % to 2 wt %, such as from 0.1 wt % to 1 wt %, based on the total weight of the filling material. 
     
     
         17 . An oral pouched nicotine product according to any one of the preceding claims, wherein the salt of Formula (I), or a hydrate of said salt, is present in an amount within the range of from 0.05 wt % to 0.3 wt %, based on the total weight of the filling material. 
     
     
         18 . An oral pouched nicotine product according to any one of the preceding claims, wherein the Na 2 CO 3 , K 2 CO 3 , NaHCO 3  and/or KHCO 3  of the pH adjusting agent is/are present in an amount within the range of from 1 wt % to 10 wt %, such as from 1.5 wt % to 4 wt % or from 4 wt % to 9 wt %, based on the total weight of the filling material. 
     
     
         19 . An oral pouched nicotine product according to any one of the preceding claims, wherein M 2+  is Ca 2+ . 
     
     
         20 . An oral pouched nicotine product according to any one of the preceding claims, wherein M 2+  is Mg 2+ . 
     
     
         21 . An oral pouched nicotine product according to any one of  claims 1 - 8 , wherein M 2+  is Mn 2+ . 
     
     
         22 . An oral pouched nicotine product according to any one of the preceding claims, wherein M 2+  is Zn 2+ . 
     
     
         23 . An oral pouched nicotine product according to any one of the preceding claims, wherein M 2+  is Fe 2+ . 
     
     
         24 . An oral pouched nicotine product according to any one of  claims 1 - 9 , wherein the salt of Formula (I) comprises or consists of CaCl 2  or a hydrate thereof. 
     
     
         25 . An oral pouched nicotine product according to any one of the preceding claims, wherein the filling material further comprises NaCl, such as NaCl in an amount within the range of from 0.1 wt % to 5 wt % such as from 0.1 wt % to 3 wt %, based on the total weight of the filling material. 
     
     
         26 . An oral pouched nicotine product according to any one of the preceding claims, wherein the filling material further comprises MgCO 3 . 
     
     
         27 . An oral pouched nicotine product according to any one of the preceding claims, wherein said product comprises no further salt and/or no further pH adjuster. 
     
     
         28 . An oral pouched nicotine product according to any one of the preceding claims, wherein said filling material of said oral pouched nicotine product has a pH from 7 to 10, such as from 8 to 9, such as 8, 8.3, 8.5 or 8.8, when it is dispersed in purified water. 
     
     
         29 . An oral pouched nicotine product according to any one of the preceding claims, wherein at least part of the filling material is water-insoluble. 
     
     
         30 . An oral pouched nicotine product according to any one of the preceding claims, wherein the particulate non-tobacco material comprises microcrystalline cellulose and optionally maltitol. 
     
     
         31 . An oral pouched nicotine product according to any one of the preceding claims, wherein the filling material comprises one or more water-insoluble fibers selected from the group consisting of maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buck wheat fibers, wheat fibers, pea fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, citrus fibers, and any combination thereof. 
     
     
         32 . An oral pouched nicotine product according to any one of the preceding claims, wherein the nicotine source is one or more of the following: nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine polacrilex. 
     
     
         33 . An oral pouched nicotine product according to any one of the preceding claims, wherein the nicotine source is nicotine bitartrate and/or nicotine bitartrate dihydrate. 
     
     
         34 . An oral pouched nicotine product according to any one of the preceding claims, wherein the pH of said filling material of said oral pouched nicotine product does not exceed 9.5 upon storage and/or changes by no more than ±0.5 pH units upon storage,
 such as storage taking place 
 at a relative humidity from 60% to 75%, 
 at a temperature from 22° C. to 30° C., and/or 
 for a time of 15 weeks. 
 
     
     
         35 . Use of a salt of Formula (I), or a hydrate of said salt, as defined in any one of the preceding claims for controlling pH in an oral pouched nicotine product comprising a filling material, said filling material comprising said salt of Formula (I), or a hydrate thereof, and:
 a particulate non-tobacco material,   a nicotine source,   water in an amount within the range of from 1 wt % to 50 wt % such as from 1 wt % to 45 wt % based on the total weight of the filling material, and   a pH adjusting agent comprising or consisting of Na 2 CO 3 , K 2 CO 3 , NaHCO 3  and/or KHCO 3 , and   optionally a tobacco material within the range of from 0.05 wt % to 10 wt % based on the total weight of the filling material,   when said product is stored, such as stored   at a relative humidity from 60% to 75%,   at a temperature from 22° C. to 30° C., and/or   for a time of 15 weeks.   
     
     
         36 . Use according to  claim 35 , wherein said controlling comprises or consists of mitigating an increase in pH in said product, preventing pH in said product from exceeding a value of 9.5, and/or preventing pH in said product from changing by more than ±0.5 pH units. 
     
     
         37 . Use according to  claim 35  or  36 , wherein the salt of Formula (I), is as defined in any one of  claims 1 - 11 . 
     
     
         38 . Use according to any one of  claims 35 - 37 , wherein the salt of Formula (I), Na 2 CO 3 , NaHCO 3 , K 2 CO 3  and/or KHCO 3  is/are present in a total amount from 1 wt % to 15 wt %, such as from 1 wt % to 10 wt %, such as from 1 wt % to 9 wt %, such as from 1 to 7 wt % or such as from 1 wt % to 5 wt %, based on the total weight of the filling material.