# US 2023/0053622 A1 · Lozenge > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0053622 A1 - Document ID: US20230053622A1 - Status: Published application - Kind: A1 - Application number: 17/758,724 - Filed: 2021-01-14 - Published: 2023-02-23 - Earliest claimed: 2020-01-15 - Assignees: McNeil Corporation - Applicants: McNeil AB - Inventors: Kristina Thyresson; Katarina Lindell - Web page: https://patentgrep.com/patent/US20230053622A1 ## CPC - A61K 31/465: Nicotine; Derivatives thereof - 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 9/209: {containing drug in at least two layers or in the core and in at least one outer layer} - A61K 47/02: Inorganic compounds - A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - A61K 47/38: Cellulose; 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 This invention relates to a nicotine lozenge giving an immediate release and uptake of nicotine and an extended release and uptake of nicotine as well as describing suitable manufacturing processes for such lozenge formulations and the use of the lozenge for the treatment of a human being suffering from cravings from tobacco and/or e-cigarette dependency. ## Claims ### Claim 1 A lozenge comprising nicotine within a core, and i) a first portion/layer comprising at least one buffer and at least one sugar alcohol fused onto an outside of the core, and ii) a second portion/layer comprising a nicotine salt and at least one sugar alcohol fused onto the core, wherein a nicotine release from the second portion/layer is immediate and a nicotine release from the core is extended, and wherein the at least one buffer promotes a rapid uptake of nicotine through an oral mucosa. ### Claim 2 (depends on 1) The lozenge according to claim 1, wherein the at least one buffer is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, Trometamol-base (Tris-base) Trometamol-hydrochloride (Tris-HCl), Tris (hydroxymethyl) amino methane, trisodium phosphate, disodium hydrogenphosphate, sodium dihydrogen phosphate, tripotassium phosphate, dipotassium hydrogenphosphate, potassium dihydrogen phosphate, sodium citrate, potassium citrate and mixtures thereof. ### Claim 3 (depends on 2) The lozenge according to claim 2, wherein the at least one buffer is selected from the group consisting of sodium carbonate, sodium bicarbonate, trometamol base (Tris base) Trometamol-hydrochloride (Tris-conjugated acid) or mixtures thereof. ### Claim 4 (depends on 1) The lozenge according to claim 1, wherein the at least one buffer is present in an amount from about 1.0 to about 7.5 mg/lozenge (calculated as the free base). ### Claim 5 (depends on 1) The lozenge according to claim 1, wherein the nicotine in the core is nicotine polacrilex and the nicotine salt in the second portion/layer is nicotine bitartrate or nicotine ditartrate dihydrate. ### Claim 6 (depends on 1) The lozenge according to claim 1, wherein the core comprises nicotine in an amount of from about 1.0 mg to about 7.5 mg and the second portion/layer comprises nicotine salt present in an amount of from about 0.25 mg to about 2.5 mg (calculated as the free base). ### Claim 7 (depends on 10) The lozenge according to claim 10, wherein the at least one polymer-based film is selected from the group consisting of hydroxy propyl methyl cellulose (HPMC), methyl hydroxy ethyl cellulose (MHEC), hydroxy propyl cellulose (HPC), hydroxyethyl cellulose (HEC), ethyl hydroxyl ethyl cellulose (EHEC) and polyvinyl alcohol (PVOH or PVA). ### Claim 8 (depends on 1) The lozenge according to claim 1, wherein the lozenge is direct compressed or granulated and compressed. ### Claim 9 (depends on 1) Use of the lozenge according to claim 1 for the treatment of a human bcing suffering from cravings from tobacco and/or e-cigarette dependency. ### Claim 10 A lozenge comprising nicotine within a core, and i) at least one polymer-based film coating covering the core comprising at least one buffer, at least one flavor and at least one sweetener, and ii) at least one portion/layer comprising a nicotine salt and at least one sugar alcohol fused onto the at least one polymer-based film coating, wherein a nicotine release from the at least one portion/layer is immediate and a nicotine release from the core is extended, and wherein the at least one buffer promotes a rapid uptake of nicotine through an oral mucosa. ### Claim 11 A lozenge comprising nicotine within a core, and i) at least one polymer-based film coating covering the core comprising at least one flavor and at least one sweetener, and ii) a first portion/layer comprising at least one buffer and at least one sugar alcohol fused onto an outside of the at least one polymer-based film coating, and iii) a second portion/layer comprising a nicotine salt and at least one sugar alcohol fused onto an outside of the at least one polymer-based film coating, wherein a nicotine release from the second portion/layer is immediate and a nicotine release from the core is extended, and wherein the at least one buffer promotes a rapid uptake of nicotine through an oral mucosa.