# US 9,517,179 B2 · Topical nitric oxide systems and methods of use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,517,179 B2 - Document ID: US9517179B2 - Status: Granted - Kind: B2 - Application number: 14/098,871 - Filed: 2013-12-06 - Published: 2014-04-17 - Granted: 2016-12-13 - Earliest claimed: 2011-03-17 - Assignees: Transdermal Biotechnology, Inc. - Applicants: Transdermal Biotechnology, Inc. - Inventors: Nicholas V. Perricone; Yousry Abdelrehim Sayed - Web page: https://patentgrep.com/patent/US9517179B2 ## CPC - A61K 33/00: Medicinal preparations containing inorganic active ingredients - A61J 1/14: Details; Accessories therefor (A61J7/00 takes precedence; openers B65D, B67B7/00) - 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 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants} - A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} - A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)} - A61K 9/1274: Non-vesicle bilayer structures, e.g. liquid crystals, tubules, cubic phases or cochleates; Sponge phases - 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 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids - A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis - A61P 15/10: for impotence - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - 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) - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention generally relates to compositions and methods for transdermal drug delivery. The compositions can be used in a variety of applications, including treating erectile dysfunction or sexual dysfunction, treating wounds, or causing or promoting hair growth. For example, in one aspect, the present invention is generally directed to compositions for delivery of nitric oxide, transdermally and/or to a mucosal surface. The composition may include nitric oxide. The nitric oxide may be present within a first phase comprising a lecithin, such as phosphatidylcholine. In certain embodiments, the lecithin is present in liposomes, micelles, or other vesicles containing nitric oxide. The composition can take the form of a gel, a cream, a lotion, an ointment, a solution, a solid “stick,” etc., that can be rubbed or sprayed onto the skin. In some embodiments, a composition comprising nitric oxide is unexpectedly stable and can be stored long-term. ## Claims ### Claim 1 A composition for transdermal delivery of nitric oxide, comprising: a non-liposomal liquid crystal emulsion comprising a first phase comprising molecular nitric oxide and lecithin, and a second phase comprising an emulsifier, wherein the lecithin is present at at least about 10% by weight of the composition, and wherein the first phase comprises no more than about 250 ppm of water by weight of the composition, and wherein the composition comprises no more than about 0.01% w/v oxygen gas. ### Claim 2 (depends on 1) The composition of claim 1, wherein the first phase forms discrete vesicles contained within the second phase. ### Claim 3 (depends on 1) The composition of claim 1, wherein the nitric oxide is present at at least about 0.5% by weight of the composition. ### Claim 4 (depends on 1) The composition of claim 1, wherein the lecithin comprises a phosphatidylcholine. ### Claim 5 (depends on 4) The composition of claim 4, wherein the phosphatidylcholine is present at between about 8% and about 65% by weight of the composition. ### Claim 6 (depends on 4) The composition of claim 4, wherein at least some of the phosphatidylcholine comprises a phosphatidylcholine comprising a stearic diglyceride linked to a choline ester of a phosphoric acid. ### Claim 7 (depends on 4) The composition of claim 4, wherein at least some of the phosphatidylcholine comprises a phosphatidylcholine comprising a palmitic diglyceride linked to a choline ester of a phosphoric acid. ### Claim 8 (depends on 4) The composition of claim 4, wherein at least some of the phosphatidylcholine comprises a phosphatidylcholine comprising an oleic diglyceride linked to a choline ester of a phosphoric acid. ### Claim 9 (depends on 4) The composition of claim 4, wherein at least some of the phosphatidylcholine comprises a polyenylphosphatidylcholine. ### Claim 10 (depends on 9) The composition of claim 9, wherein the polyenylphosphatidylcholine comprises linoleic acid. ### Claim 11 (depends on 9) The composition of claim 9, wherein the polyenylphosphatidylcholine comprises dilinoleoylphosphatidylcholine. ### Claim 12 (depends on 9) The composition of claim 9, wherein at least about 30 wt % of the phosphatidylcholine is a polyenylphosphatidylcholine. ### Claim 13 (depends on 1) The composition of claim 1, wherein the first phase comprises a fatty acid ester. ### Claim 14 (depends on 1) The composition of claim 1, wherein the composition is a gel. ### Claim 15 (depends on 1) The composition of claim 1, wherein the composition is a cream. ### Claim 16 (depends on 1) The composition of claim 1, wherein the composition is substantially transparent. ### Claim 17 (depends on 1) The composition of claim 1, wherein the composition has a viscosity of at least about 20,000 cP. ### Claim 18 (depends on 1) The composition of claim 1, wherein the nitric oxide is present within the emulsion as a gas or bound by hydrogen bonds or van der Waals forces to the lecithin. ### Claim 19 (depends on 1) A method, comprising contacting the skin of a subject with the composition of claim 1. ### Claim 20 (depends on 1) A method, comprising contacting a mucosal surface of a subject with the composition of claim 1. ### Claim 21 (depends on 1) A method, comprising contacting the penis of a male subject with the composition of claim 1. ### Claim 22 (depends on 1) A method, comprising contacting the vulva of a female subject with the composition of claim 1. ### Claim 23 (depends on 1) A method, comprising contacting a wound on the skin of a subject with the composition of claim 1. ### Claim 24 (depends on 1) An article comprising a container containing the composition of claim 1, wherein the container is sealed. ### Claim 25 (depends on 1) An article comprising a container containing the composition of claim 1, wherein the container is substantially watertight.