Nicotine pouches for smoking cessation
Provided herein, according to an embodiment, is a nicotine-containing moist granulate composition comprising: nicotine or a pharmaceutically acceptable salt thereof; mannitol, and cellulose; the composition having a total moisture content of between 35-45%. The granulate shows favorable organoleptic qualities such as taste and mouthfeel and is free flowing to enable packaging in pouches. Optionally, the composition further comprises an oral health enhancing agent.
1 . A nicotine-containing moist granulate composition comprising:
nicotine, or a pharmaceutically acceptable salt thereof, in an amount of nicotine free base equivalent between 0.1-4% by weight of the non-aqueous portion of the composition;
mannitol in an amount of between 38-45% by weight of the non-aqueous portion of the composition;
microcrystalline cellulose in an amount of between 28-38% by weight of the non-aqueous portion of the composition;
and total moisture of between 35-45%, wherein the composition has a mean particle diameter of between 50 and 250 micrometer.
2 . The composition according to claim 1 , wherein the nicotine is present in an amount of nicotine free base equivalent between 0.6-4% by weight of the non-aqueous portion of the composition.
3 . The composition according to claim 1 , further comprising at least one oral health enhancing agent.
4 . The composition according to claim 3 , wherein the oral health enhancing agent is present in an amount of between 5-10% by weight of the non-aqueous portion of the composition.
5 . The composition according to claim 3 , wherein the oral health enhancing agent is selected from the group consisting of: hydroxyapatite, tricalcium phosphite, dicalcium phosphate dihydrate, octacalcium phosphate, amorphous calcium phosphate, calcium carbonate, calcium sulfate dihydrate, fluorapatite, monocalcium phosphate, functionalized tricalcium phosphate, and casein phosphopeptide-amorphous calcium phosphate.
6 . The composition according to claim 1 , further comprising at least one buffer.
7 . The composition according to claim 6 , wherein the buffer is selected from the group consisting of NHCO 3 and Na 2 HCO 3 .
8 . The composition according to claim 1 , further comprising magnesium stearate.
9 . The composition according to claim 1 , further comprising xanthan gum, guar gum, alibizia gum, ficus vasta gum, sesbania gum, locust bean (carob) gum, or gum Arabic.
10 . The composition according to claim 1 , further comprising hydroxypropylmethyl cellulose.
11 . The composition according to claim 1 , further comprising at least one flavoring.
12 . The composition according to claim 1 , having a D90/D50 ratio of less than 2.0.
13 . The composition according to claim 12 , wherein the nicotine is in the form of nicotine monotartrate.
14 . The composition according to claim 1 , and having a pH of between 7.5-9.0.
15 . The composition according to claim 1 , wherein the nicotine is in the form of a pharmaceutical acceptable salt selected from the group consisting of: nicotine monotartrate and nicotine citrate.
16 . A method for manufacture of a nicotine-containing moist granulate composition according to claim 1 , the method comprising combining nicotine or a pharmaceutically acceptable salt thereof, mannitol, and microcrystalline cellulose in a mixer, and mixing while adding water.
17 . The method according to claim 16 wherein mixing comprising mixing at least 1000 revolutions in a mixer.
18 . A pouch comprising a granulate according to claim 1 .
19 . The pouch according to claim 18 , wherein the pouch is formed from a material selected from the group consisting of: cellulose, abaca, wood pulp, rayon/viscose, cellulose-synthetic composites, polypropylene (PP) spunbond nonwovens, polyethylene/polypropylene heat-seal layers, polyethylene terephthalate (PET) spunbond, PET-core/PP-sheath bicomponent fibers, polylactic acid (PLA) nonwovens, woven nylon meshes, and purpose-built snus/nicotine pouch papers in the range of 16-35 grams per square meter.