Transdermal therapeutic system containing asenapine and silicone acrylic hybrid polymer

1. A transdermal therapeutic system for the transdermal administration of asenapine comprising an asenapine-containing layer structure, said asenapine-containing layer structure comprising:

A) a backing layer; and

B) an asenapine-containing layer;

wherein the transdermal therapeutic system comprises a silicone acrylic hybrid polymer.

2. The transdermal therapeutic system according to claim 1 ,

wherein the asenapine-containing layer is a matrix layer.

3. The transdermal therapeutically system according to claim 1 ,

wherein the asenapine-containing layer structure is an asenapine-containing self-adhesive layer structure.

4. The transdermal therapeutic system according to claim 1 ,

wherein the asenapine-containing layer contains at least 0.10 mg/cm 2 asenapine.

5. The transdermal therapeutic system according to claim 1 ,

wherein the asenapine-containing layer has an area weight ranging from 50 to 230 g/m 2 .

6. The transdermal therapeutic system according to claim 1 ,

wherein the asenapine-containing layer contains from 2 to 25% asenapine.

7. The transdermal therapeutic system according to claim 1 ,

wherein the silicone acrylic hybrid polymer comprises from 55 to 98% by weight of the asenapine-containing layer.

8. The transdermal therapeutic system according to claim 1 ,

wherein the asenapine in the asenapine-containing layer comprises asenapine free base.

9. The transdermal therapeutic system according to claim 1 ,

wherein the silicone acrylic hybrid polymer is a silicone acrylic hybrid pressure-sensitive adhesive obtainable from

a silicon-containing pressure-sensitive adhesive composition comprising acrylate or methacrylate functionality.

10. The transdermal therapeutic system according to claim 9 ,

wherein the silicone acrylic hybrid polymer is a silicone acrylic hybrid pressure-sensitive adhesive comprising the reaction product of

(a) a silicon-containing pressure-sensitive adhesive composition comprising acrylate or methacrylate functionality;

(b) an ethylenically unsaturated monomer; and

(c) an initiator.

11. The transdermal therapeutic system according to claim 9 ,

wherein the silicon-containing pressure-sensitive adhesive composition comprising acrylate or methacrylate functionality comprises the condensation reaction product of

(a1) a silicone resin, and

(a2) a silicone polymer, and

(a3) a silicon-containing capping agent comprising acrylate or methacrylate functionality.

12. The transdermal therapeutic system according to claim 1 ,

wherein the silicone acrylic hybrid polymer comprises a reaction product of a silicone polymer, a silicone resin and an acrylic polymer, wherein the acrylic polymer is covalently self-crosslinked and covalently bound to at least one selected from the group consisting of the silicone polymer and the silicone resin.

13. The transdermal therapeutic system according to claim 1 ,

wherein the silicone acrylic hybrid polymer in the asenapine-containing layer is selected from the group consisting of a silicone acrylic hybrid polymer containing a continuous, silicone external phase and a discontinuous, acrylic internal phase, and a

silicone acrylic hybrid polymer containing a continuous, acrylic external phase and a discontinuous, silicone internal phase.

14. The transdermal therapeutic system according to claim 1 ,

wherein the asenapine-containing layer comprises a non-hybrid polymer selected from the group consisting of polysiloxanes, polyisobutylenes, styrene-isoprene-styrene block copolymers and acrylic polymers.

15. The transdermal therapeutic system according to claim 1 ,

wherein the total polymer content in the asenapine-containing layer ranges from 70 to 98%.

16. The transdermal therapeutic system according to claim 1 for use in a method of treating at least one selected from the group consisting of schizophrenia and bipolar disorder.

17. A method of treating at least one condition selected from the group consisting of schizophrenia and bipolar disorder, the method comprising applying the transdermal therapeutic system according to claim 1 to the skin of a patient.

18. The transdermal therapeutic system according to claim 1 ,

wherein the asenapine-containing layer comprises

asenapine and

the silicone acrylic hybrid polymer.

19. A process for manufacturing an asenapine-containing layer for use in the transdermal therapeutic system according to claim 18 , the process comprising:

1) combining at least the components asenapine and a silicone acrylic hybrid polymer in a solvent to obtain a coating composition;

2) coating the coating composition onto the backing layer or release liner; and

3) drying the coated coating composition to form the asenapine-containing layer.