# US 12,599,613 B2 · Composition comprising dutasteride > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,599,613 B2 - Document ID: US12599613B2 - Status: Granted - Kind: B2 - Application number: 17/413,450 - Filed: 2019-12-13 - Published: 2022-02-24 - Granted: 2026-04-14 - Earliest claimed: 2018-12-14 - Assignees: Chong Kun Dang Pharmaceutical Corp. - Applicants: Chong Kun Dang Pharmaceutical Corp. - Inventors: Tae Hyun Park; Ki Seong Ko; So Hyun Park; Sang Myoung Noh; Jong Lae Lim - Web page: https://patentgrep.com/patent/US12599613B2 ## CPC - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids - A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - A61P 5/24: of the sex hormones - A61P 13/08: of the prostate - A61P 17/14: for baldness or alopecia - 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 A composition of the present invention relates to a composition comprising dutasteride, wherein said composition may maintain a constant concentration of dutasteride in blood and continuously release a drug thereof for a long period of time while not precipitating dutasteride in a solid form when being administered into the human body, and also has an excellent safety without causing local irritations in an administration site. ## Claims ### Claim 1 A parenteral composition comprising dutasteride, optical isomers thereof or pharmaceutically acceptable salts thereof, lipid and an organic solvent, wherein: the lipid is selected from the group consisting of tocopherol, tocopherol acetate, pharmaceutically acceptable salts thereof and mixtures thereof and the lipid is present in an amount of 13 to 70 wt % with regard to the total weight of the composition. ### Claim 2 (depends on 1) The parenteral composition according to claim 1, wherein the parenteral composition does not comprise sorbitan unsaturated fatty acid ester. ### Claim 3 (depends on 1) The parenteral composition according to claim 1, wherein the organic solvent is selected from the group consisting of N-methyl-2-pyrrolidone, dimethyl sulfoxide, benzyl benzoate, benzyl alcohol, dimethylacetamide, ethanol and mixtures thereof. ### Claim 4 (depends on 1) The parenteral composition according to claim 1, wherein the organic solvent is selected from the group consisting of N-methyl-2-pyrrolidone, dimethyl sulfoxide, benzyl benzoate and mixtures thereof. ### Claim 5 A method for preventing or treating benign prostatic hyperplasia or androgenetic alopecia by administering a therapeutically effective dose of a composition comprising dutasteride, optical isomers thereof or pharmaceutically acceptable salts thereof, lipid and an organic solvent to a subject in need of treatment, wherein: the lipid is selected from the group consisting of tocopherol, tocopherol acetate, pharmaceutically acceptable salts thereof and mixtures thereof and the lipid is present in an amount of 13 to 70 wt % with regard to the total weight of the composition; and the composition is administered through an injection. ### Claim 6 (depends on 5) The method according to claim 5, wherein the composition does not comprise sorbitan unsaturated fatty acid ester. ### Claim 7 (depends on 5) The method according to claim 5, wherein a route of administration of the composition is a subcutaneous injection, an intradermal injection or an intramuscular injection. ### Claim 8 A parenteral composition comprising dutasteride, optical isomers thereof or pharmaceutically acceptable salts thereof; tocopherol; N-methyl-2-pyrrolidone and dimethyl sulfoxide, wherein tocopherol is present in an amount of 13 to 70 wt % with regard to the total weight of the composition. ### Claim 9 A method for preventing or treating benign prostatic hyperplasia or androgenetic alopecia by administering a therapeutically effective dose of a composition comprising dutasteride, optical isomers thereof or pharmaceutically acceptable salts thereof; tocopherol; N-methyl-2-pyrrolidone and dimethyl sulfoxide, wherein tocopherol is present in an amount of 13 to 70 wt % with regard to the total weight of the composition, and wherein the composition is administered through an injection. ### Claim 10 (depends on 9) The method according to claim 9, wherein a route of administration of the composition is a subcutaneous injection, an intradermal injection or an intramuscular injection. ### Claim 11 (depends on 8) The parenteral composition according to claim 8, wherein the parenteral composition does not comprise sorbitan unsaturated fatty acid ester. ### Claim 12 (depends on 9) The method according to claim 9, wherein the composition does not comprise sorbitan unsaturated fatty acid ester.