Amorphous drug transdermal systems, manufacturing methods,...

A - Human Necessities – 61 – K

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A61K 9/70 (2006.01)

Patent

CA 2679535

The present invention refers to a transdermal delivery device comprising a backing layer, an adhesive matrix layer comprising a supersaturated concentration of an active agent 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 at least one supersaturated active agent substantially in amorphous form. Further, the present invention refers to a method to stabilize and a method to reestablish the meta-stable amorphous-drug transdermal system during its manufacturing, storing, shipping and handling process.

L'invention concerne un système d'administration transdermique comprenant une couche de renfort ; une couche de matrice adhésive incluant une concentration sursaturée d'un agent actif sensiblement sous forme amorphe dans la matrice adhésive ; et un revêtement de libération. L'invention concerne également un procédé de préparation d'une matrice adhésive contenant au moins un agent actif sursaturé sensiblement sous une forme amorphe. De plus, l'invention concerne un procédé de stabilisation et un procédé de rétablissement du système transdermique pour médicament amorphe métastable pendant son processus de fabrication, de stockage, de transport et de manipulation.

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