# US 2025/0082579 A1 · Orally disintegrating nicotine tablet for use under lip > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0082579 A1 - Document ID: US20250082579A1 - Status: Published application - Kind: A1 - Application number: 18/608,586 - Filed: 2024-03-18 - Published: 2025-03-13 - Earliest claimed: 2023-09-12 - Assignees: Fertin Pharma A/S - Applicants: Fertin Pharma A/S - Inventors: Bruno Provstgaard Nielsen; Helle MARTINUSSEN; Kent Albin Nielsen - Web page: https://patentgrep.com/patent/US20250082579A1 ## CPC - A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals} - A61K 9/2009: {Inorganic compounds} - A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays} - A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates} - A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates} - A61K 9/205: {Polysaccharides, e.g. alginate, gums; Cyclodextrin} - A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose} - A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin} - A61K 31/465: Nicotine; Derivatives thereof - A61P 25/34: Tobacco-abuse - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract An orally disintegrating nicotine tablet for use in alleviation of nicotine craving is disclosed, the tablet comprising nicotine and a pH regulating agent, wherein the tablet is administered between the lip and gum. Also, a method for treatment of nicotine craving is disclosed. ## Claims ### Claim 1 An orally disintegrating nicotine tablet for use in alleviation of nicotine craving, the tablet comprising nicotine and a pH regulating agent, wherein the tablet is administered between the lip and gum. ### Claim 2 (depends on 1) The orally disintegrating nicotine tablet according to claim 1, wherein the tablet is administered between the upper lip and gum. ### Claim 3 (depends on 1, 2) The orally disintegrating nicotine tablet according to claim 1 or 2, wherein the tablet is designed to disintegrate within a period of 300 seconds upon oral administration between the lip and gum, such as within 270 seconds upon oral administration between the lip and gum, such as within 240 seconds upon oral administration, such as within a period of 210 seconds upon oral administration, such as within a period of 180 seconds upon oral administration, such as within a period of 150 seconds upon oral administration, such as within a period of 120 seconds upon oral administration, such as within a period of 90 seconds upon oral administration, such as within a period of 60 seconds upon oral administration. ### Claim 4 (depends on 1, 2, 3) The orally disintegrating nicotine tablet according to any of claims 1-3, wherein the tablet is designed to disintegrate within a period of 60 seconds in vitro, such as within 50 seconds in vitro, such as within 40 seconds in vitro. ### Claim 5 (depends on 1, 2, 3, 4) The orally disintegrating nicotine tablet according to any of claims 1-4, wherein the tablet is a compressed orally disintegrating nicotine tablet. ### Claim 6 (depends on 1, 2, 3, 4, 5) The orally disintegrating nicotine tablet according to any of claims 1-5, wherein the tablet is composed of a plurality of compressed particles. ### Claim 7 (depends on 1, 2, 3, 4, 5, 6) The orally disintegrating nicotine tablet according to any of claims 1-6, wherein the tablet comprises at least one sugar alcohol. ### Claim 8 (depends on 1, 2, 3, 4, 5, 6, 7) The orally disintegrating nicotine tablet according to any of claims 1-7, wherein the tablet comprises the at least one sugar alcohol sugar alcohol in an amount of at least 40% by weight of the tablet, such as at least 50% by weight of the tablet, such as at least 60% by weight of the tablet, such as at least 70% by weight of the tablet, such as at least 80% by weight of the tablet. ### Claim 9 (depends on 1, 2, 3, 4, 5, 6, 7, 8) The orally disintegrating nicotine tablet according to any of claims 1-8, wherein the at least one sugar alcohol comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and any combination thereof. ### Claim 10 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9) The orally disintegrating nicotine tablet according to any of claims 1-9, wherein the tablet further comprises a disintegrant. ### Claim 11 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10) The orally disintegrating nicotine tablet according to any of claims 1-10, wherein the tablet comprises disintegrant in an amount of at least 0.5% by weight of the tablet, such as at least 1% by weight of the tablet, such as at least 2% by weight of the tablet, such as at least 3% by weight of the tablet, such as at least 5% by weight of the tablet. ### Claim 12 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11) The orally disintegrating nicotine tablet according to any of claims 1-11, wherein the disintegrant is selected from the list consisting of starch, pregelatinated starch, modified cellulose, alginates, ion-exchange resin, calcium silicate, crosslinked cellulose, crosslinked polyvinyl pyrrolidone, crosslinked starch, crosslinked alginic acid, and combinations thereof. ### Claim 13 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) The orally disintegrating nicotine tablet according to any of claims 1-12, wherein the disintegrant comprises a superdisintegrant. ### Claim 14 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) The orally disintegrating nicotine tablet according to any of claims 1-12, wherein the tablet comprises superdisintegrant in an amount of at least 0.5% by weight of the tablet, such as at least 1% by weight of the tablet, such as at least 2% by weight of the tablet, such as at least 3% by weight of the tablet, such as at least 5% by weight of the tablet. ### Claim 15 (depends on 13, 14) The orally disintegrating nicotine tablet according to any of claims 13-14, wherein the superdisintegrant is selected from the group consisting of crosslinked cellulose, crosslinked polyvinyl pyrrolidone, crosslinked starch, crosslinked alginic acid, and any combinations thereof. ### Claim 16 (depends on 13, 14, 15) The orally disintegrating nicotine tablet according to any of claims 13-15, wherein the disintegrant is a super disintegrant selected from the group consisting of crosslinked cellulose, crosslinked polyvinyl pyrrolidone (PVP), crosslinked starch, and any combinations thereof. ### Claim 17 (depends on 13, 14, 15, 16) The orally disintegrating nicotine tablet according to any of claims 13-16, wherein the disintegrant is a super disintegrant selected from the group consisting of crosslinked polyvinyl pyrrolidone, croscarmellose, sodium starch glycolate, and any combinations thereof. ### Claim 18 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17) The orally disintegrating nicotine tablet according to any of claims 1-17, wherein the tablet is compressed using a compression force of 1 to 35 kN, such as 2 to 30 kN, such as 2-20 kN. ### Claim 19 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18) The orally disintegrating nicotine tablet according to any of claims 1-18, wherein the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, a nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent binding, nicotine bound to zeolites, nicotine bound to cellulose, nicotine bound to starch microspheres, and any combination thereof. ### Claim 20 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19) The orally disintegrating nicotine tablet according to any of claims 1-19, wherein the nicotine comprises nicotine free base. ### Claim 21 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20) The orally disintegrating nicotine tablet according to any of claims 1-20, wherein the nicotine comprises nicotine salt. ### Claim 22 (depends on 21) The orally disintegrating nicotine tablet according to claim 21, wherein the nicotine salt is selected from the group consisting of nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, nicotine chloride, nicotine citrate, nicotine fumarate, nicotine lactate, nicotine mucate, nicotine laurate, nicotine levulinate, nicotine malate, nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine sulfate, and any combination thereof. ### Claim 23 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22) The orally disintegrating nicotine tablet according to any of claims 1-22, wherein the nicotine comprises nicotine bitartrate. ### Claim 24 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23) The orally disintegrating nicotine tablet according to any of claims 1-23, wherein the tablet comprises nicotine in an amount of at least 0.2 mg, such as at least 0.5 mg, such as at least 1.0 mg. ### Claim 25 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24) The orally disintegrating nicotine tablet according to any of claims 1-24, wherein the tablet comprises nicotine in an amount of at least 0.2% by weight of the tablet, such as at least 0.3% by weight of the tablet, such as at least 0.5% by weight of the tablet. ### Claim 26 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25) The orally disintegrating nicotine tablet according to any of claims 1-25, wherein the pH regulating agent is an alkaline pH regulating agent, such as an alkaline buffering agent. ### Claim 27 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26) The orally disintegrating nicotine tablet according to any of claims 1-26, wherein the pH regulating agent comprises pH regulating agent selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, trometamol, amino acids, di-alkali hydrogen phosphate, tri-alkali phosphate, or any combination thereof. ### Claim 28 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27) The orally disintegrating nicotine tablet according to any of claims 1-27, wherein the pH regulating agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, or any combination thereof. ### Claim 29 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28) The orally disintegrating nicotine tablet according to any of claims 1-28, wherein the pH regulating agent comprises or consists of sodium carbonate. ### Claim 30 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29) The orally disintegrating nicotine tablet according to any of claims 1-29, wherein the tablet comprises the pH regulating agent in an amount of at least 0.2% by weight of the tablet, such as at least 0.5% by weight of the tablet, such as at least 1% by weight of the tablet, such as at least 2% by weight of the tablet. ### Claim 31 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30) The orally disintegrating nicotine tablet according to any of claims 1-30, wherein the tablet has a weight of no more than 600 mg, such as no more than 500 mg, such as no more than 400 mg, such as no more than 300 mg, such as no more than 200 mg, such as no more than 150 mg, such as no more than 120 mg, such as no more than 100 mg. ### Claim 32 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31) The orally disintegrating nicotine tablet according to any of claims 1-31, wherein the tablet is a multilayer tablet comprising a first layer and a second layer. ### Claim 33 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32) The orally disintegrating nicotine tablet according to any of claims 1-32, wherein the tablet is a one-layer tablet. ### Claim 34 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33) The orally disintegrating nicotine tablet according to any of claims 1-33, wherein the tablet is free of effervescent agents. ### Claim 35 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34) The orally disintegrating nicotine tablet according to any of claims 1-34, wherein the tablet further comprises dissolution modifiers in an amount of at most 1% by weight of the tablet, such as at most 0.5% by weight of the tablet, such at most 0.25% by weight of the tablet, such at most 0.1% by weight of the tablet. ### Claim 36 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35) The orally disintegrating nicotine tablet according to any of claims 1-35, wherein the tablet is free of dissolution modifiers. ### Claim 37 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36) The orally disintegrating nicotine tablet according to any of claims 1-36, wherein the tablet is free of mucoadhesives. ### Claim 38 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37) The orally disintegrating nicotine tablet according to any of claims 1-37, wherein the tablet comprises flavor. ### Claim 39 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38) The orally disintegrating nicotine tablet according to any of claims 1-38, wherein the tablet is free of flavor. ### Claim 40 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39) The orally disintegrating nicotine tablet according to any of claims 1-39, wherein the maximum plasma concentration (Cmax) of nicotine is increased by administration between the lip and gum compared to administration on the tongue. ### Claim 41 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40) The orally disintegrating nicotine tablet according to any of claims 1-40, wherein the maximum plasma concentration (Cmax) of nicotine is increased by at least 10% by administration between the lip and gum compared to administration on the tongue, such as by at least 20% by administration between the lip and gum compared to administration on the tongue, such as by at least 30% by administration between the lip and gum compared to administration on the tongue. ### Claim 42 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41) The orally disintegrating nicotine tablet according to any of claims 1-41, wherein the maximum plasma concentration (Cmax) of nicotine is increased by administration between the lip and gum compared to sublingual administration. ### Claim 43 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42) The orally disintegrating nicotine tablet according to any of claims 1-42, wherein the maximum plasma concentration (Cmax) of nicotine is increased by at least 10% by administration between the lip and gum compared to sublingual administration, such as by at least 20% by administration between the lip and gum compared to sublingual administration, such as by at least 30% by administration between the lip and gum compared to sublingual administration. ### Claim 44 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43) The orally disintegrating nicotine tablet according to any of claims 1-43, wherein the area under the curve (AUC) for nicotine is increased by administration between the lip and gum compared to administration on the tongue. ### Claim 45 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44) The orally disintegrating nicotine tablet according to any of claims 1-44, wherein the area under the curve (AUC) for nicotine is increased by at least 10% by administration between the lip and gum compared to administration on the tongue, such as by at least 15% by administration between the lip and gum compared to administration on the tongue, such as by at least 20% by administration between the lip and gum compared to administration on the tongue. ### Claim 46 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45) The orally disintegrating nicotine tablet according to any of claims 1-45, wherein the area under the curve (AUC) for nicotine is increased by administration between the lip and gum compared to sublingual administration. ### Claim 47 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46) The orally disintegrating nicotine tablet according to any of claims 1-46, wherein the area under the curve (AUC) for nicotine is increased by at least 10% by administration between the lip and gum compared to sublingual administration, such as by at least 15% by administration between the lip and gum compared to sublingual administration, such as by at least 20% by administration between the lip and gum compared to sublingual administration. ### Claim 48 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47) The orally disintegrating nicotine tablet according to any of claims 1-47, wherein the time (Tmax) until maximum plasma concentration (Cmax) of nicotine occurs is decreased by administration between the lip and gum compared to administration on the tongue. ### Claim 49 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48) The orally disintegrating nicotine tablet according to any of claims 1-48, wherein the time (Tmax) until maximum plasma concentration (Cmax) of nicotine occurs is decreased by at least 10% by administration between the lip and gum compared to administration on the tongue, such as by at least 20% by administration between the lip and gum compared to administration on the tongue, such as by at least 30% by administration between the lip and gum compared to administration on the tongue. ### Claim 50 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49) The orally disintegrating nicotine tablet according to any of claims 1-49, wherein the tablet is free of nicotine bound to a ceramic material. ### Claim 51 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50) The orally disintegrating nicotine tablet according to any of claims 1-50, wherein the tablet is free of ceramic material. ### Claim 52 An orally disintegrating nicotine composition for use in alleviation of nicotine craving, the composition comprising nicotine and a pH regulating agent, wherein the composition is administered between the lip and gum. ### Claim 53 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52) The orally disintegrating nicotine composition according to claim 52 and any of claims 1-51. ### Claim 54 A method for treatment of nicotine craving, the method comprising the steps of administering a therapeutically effective amount of nicotine, wherein the nicotine is provided in an orally disintegrating nicotine tablet comprising the nicotine and a pH regulating agent, and wherein the tablet is positioned between the lip and gum. ### Claim 55 (depends on 54) The method according to claim 54, wherein the tablet is positioned between the upper lip and gum. ### Claim 56 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 54, 55) The method according to claim 54 or 55, wherein the orally disintegrating nicotine tablet is in accordance with any of claims 1-51.