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US 10,478,413 B2Granted
Dermal therapeutic system with high adhesivity
AssigneeFidia Farmaceutici S.P.A.
InventorsGiovanni Gennari, Anna Maria Zanellato, Patrizia Santi, Cristina Padula
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Abstract
The present invention relates to a high adhesion dermal therapeutic system comprising an adhesive polymeric matrix with a salt of Diclofenac.
Claims19
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.
9 more elements
Dependencies are inferred from the claim text.