Amorphous rotigotine transdermal system

A - Human Necessities – 61 – K

Patent

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Details

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

Patent

CA 2739380

The present invention refers to a transdermal delivery device comprising a backing layer, an adhesive matrix layer comprising a supersaturated concentration of rotigotine substantially in amorphous form within the adhesive matrix, and a release liner. The present invention also refers to a method of preparing an adhesive matrix containing a supersaturated amount of rotigotine substantially in amorphous form. Further, the present invention refers to a method of stabilizing and a method of reestablishing the meta-stable amorphous-drug transdermal system during its manufacturing, storing, shipping and handling process.

La présente invention concerne un dispositif d'administration transdermique comprenant une couche de soutien, une couche de matrice adhésive contenant une concentration supersaturée de rotigotine sensiblement sous forme amorphe dans la matrice adhésive, et une doublure libérable. La présente invention porte également sur un procédé de préparation d'une matrice adhésive contenant une quantité supersaturée de rotigotine sensiblement sous forme amorphe. En outre, la présente invention concerne un procédé de stabilisation et un procédé de rétablissement du système transdermique de médicament amorphe métastable durant son processus de fabrication, de stockage, d'envoi et de manutention.

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