Oxymorphone transdermal patch
The present invention relates to a transdermal patch comprising oxymorphone. The present invention also relates to processes for the preparation of the transdermal patches defined herein, as well as to the use of these patches for the treatment of pain.
1. A transdermal patch having a drug-containing layer comprising oxymorphone, or a pharmaceutically acceptable salt thereof, a penetration enhancer, and a pharmaceutically acceptable pressure sensitive adhesive,
wherein the oxymorphone is present at an amount of 1-10% w/w in the drug-containing layer;
wherein the penetration enhancer is present in an amount of 2-12% w/w of the drug-containing layer;
wherein the total amount of adhesive constitutes between 58 and 99% w/w of the drug-containing layer; and
wherein the drug containing layer has a first surface that contacts a backing membrane and a second opposing surface that contacts the skin during use.
2. A transdermal patch according to claim 1 , wherein the oxymorphone is present at an amount of 4-7% w/w in the drug-containing layer.
3. A transdermal patch according to claim 1 , wherein the oxymorphone is present in a non-salt form, e.g. as a free base.
4. A transdermal patch according to claim 1 , wherein the adhesive is selected from acrylate/polyacrylate materials, rubbers and silicones or mixtures thereof.
5. A transdermal patch according to claim 1 , wherein the adhesive is a mixture of an acrylate/polyacrylate adhesive and a silicone adhesive.
6. A transdermal patch according to claim 1 , wherein the penetration enhancer is oleic acid or ethyl oleate.
7. A transdermal patch according to claim 1 , wherein the drug-containing layer comprises a second penetration enhancer.
8. A transdermal patch according to claim 7 , wherein the second penetration enhancer is oleyl alcohol.