# US 8,541,470 B2 · Topical pharmaceutical formulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,541,470 B2 - Document ID: US8541470B2 - Status: Granted - Kind: B2 - Application number: 12/530,960 - Filed: 2008-02-15 - Published: 2010-04-22 - Granted: 2013-09-24 - Earliest claimed: 2007-03-13 - Assignees: Futura Medical Developments Limited - Applicants: Adrian Francis Davis - Inventors: Adrian Francis Davis - Web page: https://patentgrep.com/patent/US8541470B2 ## CPC - 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 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil - A61P 25/04: Centrally acting analgesics, e.g. opioids - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - 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: 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 for topical application of an NSAID comprises a solution or suspension of the NSAID in a carrier system comprising a polyhydric alcohol, a glycol ether and an ester of A higher fatty acid, the carrier system being present as a single phase at ambient temperatures. The NSAID may be diclofenac as diclofenac acid. The polyhydric alcohol may be a glycol such as isopropylene glycol and the glycol ether may be a diethylene glycol ether such as diethylene glycol monoethyl ether. ## Claims ### Claim 1 A composition for topical application of an NSAID, the composition comprising a solution or suspension of the NSAID as active ingredient in a carrier system comprising a polyhydric alcohol, a glycol ether and an ester of a higher fatty acid, wherein the composition is in a single phase at ambient temperatures, wherein water is essentially absent from the carrier system except in impurity amounts, and wherein the composition is not multiple phase. ### Claim 2 (depends on 1) The composition according to claim 1, wherein the NSAID as the active ingredient is diclofenac. ### Claim 3 (depends on 2) The composition according to claim 2, wherein diclofenac is present as diclofenac acid. ### Claim 4 (depends on 1) The composition according to claim 1, wherein the polyhydric alcohol comprises a glycol. ### Claim 5 (depends on 1) The composition according to claim 1, wherein the ester comprises a polar lipid. ### Claim 6 (depends on 5) The composition according to claim 5, wherein the polar lipid comprises a branched-chain alkyl ester of a C12 to C20 saturated carboxylic acid. ### Claim 7 (depends on 1) The composition according to claim 1, wherein the glycol ether comprises a diethylene glycol ether. ### Claim 8 (depends on 1) The composition according to claim 1 having the following amounts of the carrier system ingredients, percentages being given by weight: polyhydric alcohol 5-70% glycol ether 20-60% ester 2-70%. ### Claim 9 (depends on 1) The composition according to claim 1, wherein the amount of the NSAID is up to 10% by weight. ### Claim 10 (depends on 1) The composition according to claim 1, wherein the ratio of polyhydric alcohol to glycol ether is in the range 80:20 to 30:70 with the ester ranging from 2 to 20% by weight. ### Claim 11 (depends on 10) The composition according to claim 10, wherein the ratio of polyhydric alcohol to glycol ether is in the range 70:30 to 40:60 and the ester is in the range 3 to 10% by weight. ### Claim 12 (depends on 1) The composition according to claim 1, further comprising a volatile solvent. ### Claim 13 (depends on 12) The composition according to claim 12, wherein the volatile solvent comprises a lower alcohol containing up to 5 carbon atoms. ### Claim 14 (depends on 1) The composition according to claim 1, further comprising an antinucleating agent. ### Claim 15 (depends on 1) The composition according to claim 1, further comprising sensory signals. ### Claim 16 (depends on 4) The composition according to claim 4, wherein the glycol is isopropylene glycol. ### Claim 17 (depends on 7) The composition according to claim 7, wherein the diethylene glycol ether is diethylene glycol monoethyl ether. ### Claim 18 (depends on 9) The composition according to claim 9 wherein the amount of the NSAID is up to 5% by weight. ### Claim 19 (depends on 18) The composition according to claim 18 wherein the amount of the NSAID is up to 2.5% by weight. ### Claim 20 (depends on 13) The composition according to claim 13, wherein the volatile solvent is ethanol or a liquid-phase ketone. ### Claim 21 (depends on 15) The composition according to claim 15, wherein the sensory signals comprise menthol, eucalyptus oil or a mixture thereof.