Effects of Heparin on Topical Use of Plasters Containing a Non-Steroidal Anti-Inflammatory Drug

A method of administering diclofenac from a transdermal patch containing diclofenac and heparin, the method comprising:

• topically applying a treatment transdermal patch containing diclofenac and heparin to the skin of a subject for no more than 24 hours,
• wherein prior to the topical application, a test transdermal patch containing diclofenac and heparin had been assessed by an in vivo method that quantifies the relative release of diclofenac and heparin from the test transdermal patch;
• wherein the treatment transdermal patch and the test transdermal patches each comprise:
• a substrate layer;
• an adhesive layer in the form of a polymeric hydrogel matrix, the adhesive layer comprising:
• an effective amount of diclofenac or a pharmaceutically acceptable salt thereof,
• sodium ethylenediamine tetraacetate,
• heparin,
• at least one thickening agent,
• at least one wetting agent, and
• at least one cross-linking agent;
• and
• a protective film which can be removed at the moment of use;
• wherein the in vivo method of quantifying the relative release of diclofenac and heparin from a transdermal patch comprises the steps:
• a) topically applying the test transdermal patch to the skin of a test subject for no more than 24 hours;
• b) measuring residual content of diclofenac in the test transdermal patch after topical application to determine the amount of diclofenac released from the test transdermal patch;
• c) measuring residual content of heparin in the test transdermal patch after topical application to determine the amount of heparin retained in the test transdermal patch;
• and
• d) comparing the amount of diclofenac released with the amount of heparin retained in said transdermal patch.