Diclofenac sodium patches for topical treatment of pain
View Patent ↗The invention provides an analgesic anti-inflammatory patch of a hydrophobic type for topical application containing, in a Pressure Sensitive Adhesive(PSA), diclofenac sodium, pyrrolidone or a derivative thereof, a polyhydric alcohol fatty acid ester, and an organic acid. The patch exerts the following effects: (1) diclofenac sodium is effectively and continuously released from a Pressure Sensitive Adhesive(PSA) and percutaneously absorbed, thereby attaining sustained, excellent pharmaceutical and pharmacological effects; (2) the patch per se has high tackiness and safety; and (3) diclofenac sodium remains stable in the Pressure Sensitive Adhesive(PSA).
1. A method of treating pain, comprising topically applying an analgesic anti-inflammatory Pressure Sensitive Adhesive (PSA) patch, comprising a soft support and a PSA layer on the soft support, to a subject in need thereof, wherein the PSA layer comprises
1 wt. % of diclofenac sodium,
2 to 4 wt. % of N-methyl-2-pyrrolidone,
2 wt. % of propylene glycol monocaprylate,
0.4 wt. % of citric acid,
28.5 to 38 wt % of a styrene-isoprene-styrene block copolymer,
2 to 4 wt % polyisobutylene,
12 to 25 wt % of an ester gum,
30 to 40 wt % of liquid paraffin, and
no added water.
2. The method of claim 1 , wherein the PSA layer further comprises 1-menthol.
3. The method of claim 2 , wherein the PSA layer contains 1 to 3 wt .% of the 1-menthol.
4. The method of claim 1 , wherein the PSA layer contains no 1-menthol.
5. The method of claim 1 , further comprising an anti-ageing agent.
6. The method of claim 1 , wherein the soft support does not permit permeation of the PSA layer through the back of the support.
7. The method of claim 1 , wherein the soft support is selected from the group consisting of woven fabrics, non-woven fabrics, plastic films, and films of a foamed blend of acrylic polymer or polystyrene-polybutadiene and polyisoprene.
8. The method of claim 1 , wherein the soft support is a plastic film selected from the group consisting of polyolefin film, polyvinyl alcohol film, vinyl chloride film, urethane alloy film, urethane-vinyl chloride copolymer film, and ethylene-vinyl acetate film.
9. The method of claim 8 , wherein the plastic film is a film of foamed blend of acrylic polymer or polystyrene-polybutadiene and polyisoprene.
10. The method of claim 1 , wherein the soft support has a thickness of about 1,000 μm or less.
11. The method of claim 1 , wherein the soft support has a thickness of 30-700 μm.
12. The method of claim 1 , wherein the patch is applied to the site of an inflamed joint.
13. The method of claim 1 , wherein the patch is applied to an inflamed site of the neck of the subject.
14. The method of claim 1 , wherein the patch is applied to an inflamed site of a muscle of the subject.