# US 12,214,042 B2 · Method for stabilization and delivery of therapeutic molecules > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,214,042 B2 - Document ID: US12214042B2 - Status: Granted - Kind: B2 - Application number: 18/166,412 - Filed: 2023-02-08 - Published: 2023-09-21 - Granted: 2025-02-04 - Earliest claimed: 2011-06-16 - Assignees: Nayan Patel - Applicants: Nayan Patel; Chinh Tran - Inventors: Nayan Patel; Chinh Tran - Web page: https://patentgrep.com/patent/US12214042B2 ## CPC - A61K 47/40: Cyclodextrins; Derivatives thereof - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/1617: {Organic compounds, e.g. phospholipids, fats} - A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) - A61K 31/34: having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide - A61K 31/355: Tocopherols, e.g. vitamin E - A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof - A61K 31/385: having two or more sulfur atoms in the same ring - A61K 31/724: Cyclodextrins - A61K 38/063: {Glutathione} - A61K 38/16: Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof {(enzyme inhibitors A61K38/005)} - A61K 47/186: {Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide} - A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones - A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34) - 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) ## Abstract A method of treatment is disclosed, comprising administering a composition of Cyclodextrin and reduced, nanonized L-Glutathione to a patient in need of treatment, wherein the L-Glutathione molecule is non-acetylated, non-Esterified, and non-fatty acid attached. ## Claims ### Claim 1 A composition comprising: an inclusion complex comprising reduced glutathione and gamma cyclodextrin; wherein the reduced glutathione is non-esterified, non-acetylated, and non-fatty acid attached; wherein the molar ratio of the reduced glutathione to the gamma cyclodextrin is between about 4:1 and 13:1; wherein ultrasonic waves nanonize the pH stabilized inclusion complex into nanoparticles; wherein the nanoparticles have a particle size range between 2 to 160 nanometers; and wherein the composition is configured for topical administration. ### Claim 2 (depends on 1) The composition of claim 1, further comprising ascorbic acid. ### Claim 3 (depends on 2) The composition of claim 2, wherein the complex is pH stabilized to a pH of between about 4.0 and about 7.8. ### Claim 4 (depends on 1) The composition of claim 1, wherein the molar ratio of reduced glutathione to gamma cyclodextrin is between about 5:1 and 12:1. ### Claim 5 (depends on 1) The composition of claim 1, wherein the molar ratio of reduced glutathione to gamma cyclodextrin is between about 6:1 and 10:1. ### Claim 6 (depends on 1) The composition of claim 1, wherein the molar ratio of reduced glutathione to gamma cyclodextrin is about 5:1. ### Claim 7 (depends on 1) The composition of claim 1, wherein the topical administration facilitates rapid absorption into the bloodstream. ### Claim 8 (depends on 1) The composition of claim 1, wherein the composition is formulated as a liquid, cream, lotion, oil, emulsion, spray, aerosol, dissolving strip, bolus, or suppository. ### Claim 9 (depends on 8) The composition of claim 8, wherein the composition is formulated as a liquid. ### Claim 10 (depends on 1) The composition of claim 1, wherein the topical administration comprises sublingual, transdermal, cutaneous, subcutaneous, mucosal, transmucosal, inhalation, intralesional, or buccal routes. ### Claim 11 (depends on 10) The composition of claim 10, wherein the topical administration comprises a transdermal route. ### Claim 12 (depends on 2) The composition of claim 2, wherein the reduced glutathione is stabilized in a reaction mixture by bringing the reduced glutathione and the ascorbic acid in contact with the gamma cyclodextrin solubilized in a polar solution. ### Claim 13 (depends on 12) The composition of claim 12, wherein the reaction mixture is capped under vacuum after mixing at a pH range of 3.0 to 7.0. ### Claim 14 (depends on 12) The composition of claim 12, wherein the polar solution further comprises benzalkonium chloride. ### Claim 15 (depends on 1) The composition of claim 1, wherein nanoparticles have a particle size range between 140 to 160 nanometers. ### Claim 16 (depends on 1) The composition of claim 1, wherein the nanoparticles have a particle size range between 120 to 140 nanometers. ### Claim 17 (depends on 1) The composition of claim 1, wherein the nanoparticles have a particle size range between 100 to 120 nanometers. ### Claim 18 (depends on 1) The composition of claim 1, wherein the nanoparticles have a particle size range between 80 to 100 nanometers. ### Claim 19 (depends on 1) The composition of claim 1, wherein the nanoparticles have a particle size range between 60 to 80 nanometers.