# US 2023/0054414 A1 · DIETARY SUPPLEMENT COMPOSITION HAVING ENHANCED LSESr AND METHOD OF MAKING > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0054414 A1 - Document ID: US20230054414A1 - Status: Published application - Kind: A1 - Application number: 17/818,010 - Filed: 2022-08-08 - Published: 2023-02-23 - Earliest claimed: 2021-08-18 - Assignees: U.S. NUTRACEUTICALS, LLC d/b/a Valensa International - Applicants: U.S. Nutraceuticals, Inc., d/b/a Valensa International - Inventors: W. STEPHEN HILL; UMASUDHAN PALANISWAMY; MARGARET H. DOHNALEK; LAWRENCE T. McCARTY; ELIZABETH J. CARTWRIGHT - Web page: https://patentgrep.com/patent/US20230054414A1 ## CPC - A23L 33/105: Plant extracts, their artificial duplicates or their derivatives - A23L 5/23: {by extraction with solvents} - A23L 29/015: {Inorganic compounds} - A23L 29/04: {Fatty acids or derivatives} - A23L 29/294: Inorganic additives, e.g. silica - A23L 29/37: {Sugar alcohols} - A23L 33/12: Fatty acids or derivatives thereof - A61K 36/889: Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto - Y02P 20/54: using solvents, e.g. supercritical solvents or ionic liquids - A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B) - 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) - Y02P: CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS ## Abstract A dietary supplement composition includes a shelf stable, supercritical CO2 fluid extracted, enhanced lipidosterolic extract of Serenoa repens (LSESr) having about an enrichment of lauric, myristic, oleic and linoleic free fatty acids to total free fatty acids greater than about 82.0% and a ratio of free fatty acids to total fatty acids greater than about 80.0%. A method of making the enhanced LSESr includes subjecting aged saw palmetto powder to supercritical CO2 extraction followed by first and second separations. ## Claims ### Claim 1 A method of producing an enhanced lipidosterolic extract of Serenoa repens (LSESr), comprising: cryogenically milling at a temperature no greater than -20° C.entigrade dried, saw palmetto berries having greater than about 10% moisture into a saw palmetto powder; ageing the saw palmetto powder for at least 15 days; subjecting the aged saw palmetto powder to supercritical CO2 extraction at a first extraction pressure and first extraction temperature to produce a CO2 extract; fractionating the CO2 extract at a first separation pressure and first separation temperature to produce a first fraction, followed by fractionating at a second separation pressure and second separation temperature to produce a second fraction and an enhanced LSESr having a ratio of free fatty acids to total fatty acids that is greater than about 80.0% and an enrichment of lauric, myristic, oleic and linoleic acids as free fatty acids to total free fatty acids that is greater than about 82.0%. ### Claim 2 (depends on 1) The method of claim 1 wherein the enhanced LSESr has a balance of about 90.0% of total fatty acids to about 72.0% of free fatty acids. ### Claim 3 (depends on 1) The method of claim 1 wherein the enhanced LSESr has an enrichment of lauric, myristic, oleic and linoleic free fatty acids to total free fatty acids of about 82.0% to about 84.0%. ### Claim 4 (depends on 1) The method of claim 1 wherein the enhanced LSESr has a ratio of free fatty acids to total fatty acids of about 80.0% to about 82.0%. ### Claim 5 (depends on 1) The method of claim 1 wherein the supercritical CO2 extraction occurs at an extraction pressure of about 495 bar to about 695 bar at a temperature of about 77 to about 94° Cntigrade. ### Claim 6 (depends on 1) The method of claim 1 wherein the first fractionation occurs at about 126 bar to about 350 bar at a temperature of about 35 to about 85° Cntigrade. ### Claim 7 (depends on 1) The method of claim 1 wherein the second fractionation occurs at about 30 bar to about 80 bar at a temperature of about 12 to about 28° Cntigrade. ### Claim 8 (depends on 1) The method of claim 1 comprising cryogenically milling the saw palmetto berries into a ground saw palmetto powder having about 100% less than about 4 mesh and about 95% less than about 12 mesh. ### Claim 9 (depends on 1) The method of claim 1 comprising cryogenically milling at a temperature of about -50 to about -30° Cntigrade. ### Claim 10 (depends on 1) The method of claim 1 wherein the enhanced LSESr has a peroxide value that is less than about 3 meq/kg and shelf stability of at least about 4 years without added antioxidants and stabilizers. ### Claim 11 (depends on 1) The method of claim 1 comprising ageing the saw palmetto powder for about 15 to about 30 days. ### Claim 12 (depends on 1) The method of claim 1 comprising ageing the saw palmetto powder at a temperature from a mean of about 59 degrees to about 78° F. ### Claim 13 A method of producing an enhanced lipidosterolic extract of Serenoa repens (LSESr), comprising: cryogenically milling at a temperature from about -50 to about -30° C.entigrade dried, saw palmetto berries having about 10% to about 13% moisture into a saw palmetto powder having a fineness where about 100% is less than about 4 mesh and about 95% is less than about 12 mesh; ageing the saw palmetto powder for at least 15 days at a temperature from a mean of about 59 to about 78° F.; subjecting the aged saw palmetto powder to supercritical CO2 extraction at an extraction pressure of about 495 bar to about 695 bar at a temperature of about 77 to about 94° C.entigrade to produce a CO2 extract; fractionating the CO2 extract at a first separation pressure of about 126 bar to about 350 bar at a first separation temperature of about 35 to about 85 degrees Centigrade to produce a first fraction, followed by fractionating at about 30 bar to about 80 bar at a temperature of about 12 to about 28° C.entigrade to produce a second fraction, and blending first and second fractions to produce an enhanced LSESr having an enrichment of lauric, myristic, oleic and linoleic free fatty acids to total free fatty acids of about 82.0% to about 84.0%, and a ratio of free fatty acids to total fatty acids of about 80.0% to about 82.0%. ### Claim 14 (depends on 13) The method of claim 13 wherein the enhanced LSESr has a peroxide value that is less than about 3 meq/kg and shelf stability of at least about 4 years without added antioxidants and stabilizers. ### Claim 15 (depends on 13) The method of claim 13 comprising ageing the saw palmetto powder for about 15 to about 30 days. ### Claim 16 A dietary supplement composition, comprising a shelf stable, supercritical CO2 fluid extracted, enhanced lipidosterolic extract of Serenoa repens (LSESr), the LSESr comprising: an enrichment of lauric, myristic, oleic and linoleic free fatty acids to total free fatty acids greater than about 82.0%; and a ratio of free fatty acids to total fatty acids greater than about 80.0%. ### Claim 17 (depends on 16) The dietary supplement composition of claim 16 wherein the enhanced LSESr has a peroxide value that is less than about 3 meq/kg and shelf stability of at least about 4 years without added antioxidants and stabilizers. ### Claim 18 (depends on 16) The dietary supplement composition of claim 16 wherein the composition is formulated into an oral dosage form. ### Claim 19 (depends on 16) The dietary supplement composition of claim 16 wherein the composition is formulated into an oral dosage form and in a capsule of about 160 mg b.i.d. to about 320 mg, or about minimum 200 mg per dose of enhanced LSESr. ### Claim 20 (depends on 16) The dietary supplement composition of claim 16 wherein the composition includes less than about 0.2 percent w/w of saw palmetto sterols. ### Claim 21 (depends on 16) The dietary supplement composition of claim 16 wherein the composition includes a dry excipient comprising at least one of silicon dioxide, calcium silicate, calcium phosphate, magnesium oxide, magnesium carbonate, calcium carbonate, rice fiber and maltodextrin. ### Claim 22 (depends on 16) The dietary supplement composition of claim 16 wherein the enhanced LSESr has a balance of about 90.0% of total fatty acids to about 72.0% of free fatty acids. ### Claim 23 (depends on 16) The dietary supplement composition of claim 16 wherein the enhanced LSESr has an enrichment of lauric, myristic, oleic and linoleic free fatty acids to total free fatty acids of about 82.0% to about 84.0%. ### Claim 24 (depends on 16) The dietary supplement composition of claim 16 wherein the enhanced LSESr has a ratio of free fatty acids to total fatty acids of about 80.0% to about 82.0%.