# US 10,478,413 B2 · Dermal therapeutic system with high adhesivity > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,413 B2 - Document ID: US10478413B2 - Status: Granted - Kind: B2 - Application number: 15/888,618 - Filed: 2018-02-05 - Published: 2018-06-07 - Granted: 2019-11-19 - Earliest claimed: 2014-10-17 - Assignees: Fidia Farmaceutici S.P.A. - Applicants: Fidia Farmaceutici S.P.A. - Inventors: Giovanni Gennari; Anna Maria Zanellato; Patrizia Santi; Cristina Padula - Web page: https://patentgrep.com/patent/US10478413B2 ## CPC - A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil - A61K 9/7061: {Polyacrylates} - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/12: Carboxylic acids; Salts or anhydrides thereof - A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones - 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 The present invention relates to a high adhesion dermal therapeutic system comprising an adhesive polymeric matrix with a salt of Diclofenac. ## Claims ### Claim 1 A dermal therapeutic system which comprises an adhesive polymeric matrix comprising an acrylate-vinyl acetate copolymer having a Tg below 0° C., which contains free hydroxyl groups, said acrylate-vinyl acetate copolymer being present in a percentage ranging from 45 to 65% by weight with respect to the total dry weight of the adhesive polymeric matrix and a basic butylated methacrylate copolymer, said basic butylated methacrylate copolymer being present in a percentage ranging from 5 to 20% by weight with respect to the total dry weight of the adhesive polymeric matrix, as adhesive components, an organic or inorganic acid in a percentage ranging from 0.5 to 3.5% by weight with respect to the total dry weight of the adhesive polymeric matrix, as stabilizer, a salt of Diclofenac in a percentage ranging from 8 to 20% by weight with respect to the total dry weight of the adhesive polymeric matrix, as active principle, an adhesion modulator in a percentage ranging from 10 to 30% by weight with respect to the total dry weight of the adhesive polymeric matrix, and the complement to 100 consisting of excipients and/or pharmaceutically acceptable additives, wherein said dermal therapeutic system does not allow said salt of Diclofenac to exert a systemic action, wherein the acrylate-vinyl acetate copolymer having a Tg below 0° C., containing free hydroxyl groups, is a self-curing acrylate-vinyl acetate copolymer having a Tg lower than 0° C., containing free hydroxyl groups and without free carboxyl groups or a non-curing acrylate-vinyl acetate copolymer having a Tg lower than 0° C., containing free hydroxyl groups and without free carboxyl groups; wherein the salt of Diclofenac is selected from the group consisting of alkaline metal salts of Diclofenac, hydroxyethylpyrrolidine salt of Diclofenac, and diethylammonium salt of Diclofenac; wherein the inorganic acid is hydrochloric acid; wherein the organic acid is selected from the group consisting of citric acid, succinic acid, lactic acid, maleic acid, fumaric acid, salicylic acid, acetic acid, and a mixture thereof; wherein the adhesive polymeric matrix has a thickness ranging from 50 to 500 microns and wherein the dermal therapeutic system has a surface ranging from 20 to 300 cm2. ### Claim 2 (depends on 1) The dermal therapeutic system according to claim 1, wherein the acrylate-vinyl acetate copolymer is present in a percentage ranging from 50 to 60% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 3 (depends on 1) The dermal therapeutic system according to claim 1, wherein the basic butylated methacrylate copolymer is a dimethylaminoethyl methacrylate copolymer having the following structure: ### Claim 4 (depends on 1) The dermal therapeutic system according to claim 1, wherein the basic butylated methacrylate copolymer is present in a percentage ranging from 6 to 16%, by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 5 (depends on 1) The dermal therapeutic system according to claim 1, wherein the salt of Diclofenac is selected from sodium salt or diethylammonium salt. ### Claim 6 (depends on 1) The dermal therapeutic system according to claim 1, wherein the organic acid is citric acid monohydrate. ### Claim 7 (depends on 1) The dermal therapeutic system according to claim 1, which also comprises a backing layer of the adhesive polymeric matrix and a protective layer. ### Claim 8 (depends on 2) The dermal therapeutic system according to claim 2, wherein the basic butylated methacrylate copolymer is a dimethylaminoethyl methacrylate copolymer having the following structure: ### Claim 9 (depends on 2) The dermal therapeutic system according to claim 2, wherein the basic butylated methacrylate copolymer is present in a percentage ranging from 6 to 16% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 10 (depends on 1) The dermal therapeutic system according to claim 1, wherein the acrylate-vinyl acetate copolymer is present in a percentage ranging from 53 to 58% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 11 (depends on 1) The dermal therapeutic system according to claim 1, wherein the basic butylated methacrylate copolymer is present in a percentage ranging 9 to 13% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 12 (depends on 1) The dermal therapeutic system according to claim 1, wherein the salt of Diclofenac is present in a percentage ranging from 10 to 20% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 13 (depends on 1) The dermal therapeutic system according to claim 1, wherein the adhesive polymeric matrix has a thickness ranging from 100 to 350 microns. ### Claim 14 (depends on 7) The dermal therapeutic system according to claim 7, wherein the backing layer of the adhesive polymeric matrix comprises a 100% polyester non-woven fabric, and the protective layer is selected from a siliconized polyester film, a non-woven polyester fabric, and a mono-siliconated glassine paper. ### Claim 15 (depends on 1) The dermal therapeutic system according to claim 1, having a surface ranging from 100 to about 150 cm2. ### Claim 16 (depends on 1) The dermal therapeutic system according to claim 1, wherein the salt of the Diclofenac is present in a percentage ranging from 12 to 16% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 17 (depends on 1) The dermal therapeutic system according to claim 1, wherein the adhesion modulator is selected from the group consisting of polyethylene glycol stearate, sorbitan oleate, and a mixture thereof, in a total percentage ranging from 12 to 25% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 18 (depends on 1) The dermal therapeutic system according to claim 1, wherein the organic acid is selected from the group consisting of citric acid, succinic acid, lactic acid, maleic acid, fumaric acid, salicylic acid, acetic acid, and a mixture thereof in a percentage ranging from 0.8 to 2.5% by weight with respect to the total dry weight of the adhesive polymeric matrix. ### Claim 19 (depends on 1) The dermal therapeutic system according to claim 1, wherein the adhesive polymeric matrix has a thickness equal to about 300 micron.