Polymeric adhesive transdermal patch comprising rotigotine...

A - Human Necessities – 61 – K

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Details

A61K 31/381 (2006.01) A61K 9/70 (2006.01) A61K 31/045 (2006.01)

Patent

CA 2483120

The invention relates to a trans-epicutaneous pharmaceutical composition containing Rotigotin for effective treatment of Restless Leg Syndrome (RLS), especially in the form of a transdermal therapeutic system (TDS) based on acrylate or silicone having a surface of 2.5 - 20 cm2 and containing 1.125 9.0 mg/cm2 Rotigotin as an active component against Restless Leg Syndrome, which, according to the International Restless Leg Syndrome Study Group (IRLSSG) Rating Scale, results in an improvement in the conditions of human Restless Leg Syndrome patients in comparison with a placebo treatment of 2 units or more, after administration over a period of time of at least 8 days.

L'invention concerne une préparation pharmaceutique transcutanée contenant de la rotigotine, servant à traiter efficacement le syndrome des jambes sans repos, ladite préparation se présentant notamment sous la forme d'un système thérapeutique transdermique à base d'acrylate ou de silicone, comportant une surface d'une superficie de 2,5 à 20 cm?2¿ et renfermant 1,125 à 9,0 mg/cm?2¿ de rotigotine comme principe actif contre le syndrome des jambes sans repos. Selon l'échelle d'évaluation du Groupe d'étude international sur le syndrome des jambes sans repos (IRLSSG), ledit système entraîne une amélioration de l'état des patients, souffrant dudit syndrome, d'au moins 2 unités par rapport aux patients soumis à un traitement placebo, après administration sur une période d'au moins huit jours.

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