# US 12,594,238 B2 · Low hygroscopicity active powder compositions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,238 B2 - Document ID: US12594238B2 - Status: Granted - Kind: B2 - Application number: 18/022,638 - Filed: 2021-08-31 - Published: 2023-10-05 - Granted: 2026-04-07 - Earliest claimed: 2020-09-03 - Assignees: Philip Morris Products S.A. - Applicants: Philip Morris Products S.A. - Inventors: Fabiana Spadaro; Gérard Zuber - Web page: https://patentgrep.com/patent/US12594238B2 ## CPC - A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles} - A24B 15/10: Chemical features of tobacco products or tobacco substitutes - A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules} - A61K 31/444: containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone - A61K 31/4545: containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine - A61K 31/465: Nicotine; Derivatives thereof - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - 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 - A61P 25/00: Drugs for disorders of the nervous system - 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) - A24B: MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract An inhalable powder includes crystalline dry powder particles. The crystalline dry powder particles include a solid salt of an alkaloid and a sugar alcohol. The salt is solid at 25° C. The sugar alcohol may include mannitol, erythritol, myo-inositol, adonitol, xylitol, or a combination thereof. The inhalable powder may be part of a powder system that further includes a second population of particles having a particle size greater than that of the crystalline dry powder particles. ## Claims ### Claim 1 An inhalable powder comprising: crystalline dry powder particles comprising: a solid salt of an alkaloid, wherein the salt of the alkaloid is solid at 25° C., wherein the solid salt of an alkaloid comprises nicotine bitartrate, nicotine aspartate, nicotine malate, or nicotine glutarate; and a sugar alcohol comprising erythritol, myo-inositol, adonitol, xylitol, or a combination thereof. ### Claim 2 (depends on 1) The inhalable powder claim 1, wherein the crystalline dry powder particles further comprise an amino acid. ### Claim 3 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise sugar alcohol, amino acid and solid salt of an alkaloid, and at least selected crystalline dry powder particles each comprise a sugar alcohol matrix and the solid salt of an alkaloid dispersed within the sugar alcohol matrix. ### Claim 4 (depends on 1) The inhalable powder of claim 1, wherein the sugar alcohol is erythritol or myo-inositol. ### Claim 5 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise about 60% wt. or greater sugar alcohol, and 10% wt. or greater amino acid and from about 1% to about 10% wt. solid salt of an alkaloid, and at least selected crystalline dry powder particles each comprise a sugar alcohol matrix and the solid salt of an alkaloid is dispersed within the sugar alcohol matrix. ### Claim 6 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise erythritol or myo-inositol, and leucine, and nicotine bitartrate, and at least selected crystalline dry powder particles each comprise an erythritol or myo-inositol matrix and the nicotine bitartrate is dispersed within the erythritol or myo-inositol matrix. ### Claim 7 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise erythritol or myo-inositol, and leucine, and nicotine aspartate, and at least selected crystalline dry powder particles each comprise an erythritol or myo-inositol matrix and the nicotine aspartate is dispersed within the erythritol or myo-inositol matrix. ### Claim 8 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise erythritol or myo-inositol, and leucine, and nicotine glutarate, and at least selected crystalline dry powder particles each comprise an erythritol or myo-inositol matrix and the nicotine glutarate is dispersed within the erythritol or myo-inositol matrix. ### Claim 9 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise erythritol or myo-inositol, and leucine, and nicotine malate, and at least selected crystalline dry powder particles each comprise an erythritol or myo-inositol matrix and the nicotine malate is dispersed within the erythritol or myo-inositol matrix. ### Claim 10 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise 70% to 80% erythritol, and 15% to 25% wt. leucine and from about 1% to about 10% wt. nicotine bitartrate, nicotine aspartate, nicotine malate, or nicotine glutarate. ### Claim 11 (depends on 1) An inhalable powder system comprising a first population of crystalline dry powder particles of the powder of claim 1 and a second population of particles having a particle size greater than that of the first population of particles. ### Claim 12 (depends on 11) The inhalable powder system of claim 11, wherein the first population of crystalline dry powder particles has an MMAD particle size of from about 1 micrometre to about 5 micrometres and the second population of particles has an MMAD particle size of from 20 micrometres to 200 micrometres. ### Claim 13 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise an amino acid coating the crystalline dry powder particles comprising the solid salt of an alkaloid dispersed within the crystalline sugar alcohol matrix. ### Claim 14 (depends on 6) The inhalable powder of claim 6, wherein the crystalline dry powder particles comprise 70% to 80% wt. erythritol or myo-inositol, and 15% to 25% wt. leucine and from about 1% to about 10% wt. nicotine bitartrate. ### Claim 15 (depends on 9) The inhalable powder of claim 9, wherein the crystalline dry powder particles comprise 70% to 80% wt. erythritol or myo-inositol, and 15% to 25% wt. leucine and from about 1% to about 10% wt. nicotine aspartate. ### Claim 16 (depends on 8) The inhalable powder of claim 8, wherein the crystalline dry powder particles comprise 70% to 80% wt. erythritol or myo-inositol, and 15% to 25% wt. leucine and from about 1% to about 10% wt. nicotine glutarate. ### Claim 17 (depends on 9) The inhalable powder of claim 9, wherein the crystalline dry powder particles comprise 70% to 80% wt. erythritol or myo-inositol, and 15% to 25% wt. leucine and from about 1% to about 10% wt. nicotine malate. ### Claim 18 (depends on 1) The inhalable powder of claim 1, wherein the crystalline dry powder particles comprise 70% to 80% myo-inositol, and 15% to 25% wt. leucine and from about 1% to about 10% wt. nicotine bitartrate, nicotine aspartate, nicotine malate, or nicotine glutarate.