	US 12,329,862 B2
	Transdermal therapeutic system containing asenapine
Patrick Mohr, Bad Breisig (DE); René Rietscher, Neuwied (DE); René Eifler, Koblenz (DE); and Olga Bourquain, Dürrholz (DE)
Assigned to LTS LOHMANN THERAPIE-SYSTEME AG, Andernach (DE)
Appl. No. 17/250,162
Filed by LTS LOHMANN THERAPIE-SYSTEME AG, Andernach (DE)
PCT Filed Jun. 19, 2019, PCT No. PCT/EP2019/066226 § 371(c)(1), (2) Date Dec. 7, 2020, PCT Pub. No. WO2019/243432, PCT Pub. Date Dec. 26, 2019.
Claims priority of application No. 18178877 (EP), filed on Jun. 20, 2018.
Prior Publication US 2021/0251914 A1, Aug. 19, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/70 (2006.01); A61K 31/407 (2006.01)

CPC A61K 9/7061 (2013.01) [A61K 31/407 (2013.01)]

17 Claims

1. A transdermal therapeutic system for the transdermal administration of asenapine comprising a self-adhesive layer structure containing a therapeutically effective amount of asenapine, said self-adhesive layer structure comprising:

A) a backing layer;

B) an asenapine-containing matrix layer comprising:

a) asenapine;

b) a polymer selected from acrylic polymers; and

c) medium chain triglycerides in an amount of from 5 to 12% of the matrix layer, wherein the fatty acid composition of the medium chain triglycerides

have a fatty acid composition according to one of:

(i) 0 to 5% hexanoic acid,

(ii) 40.0 to 90.0% octanoic acid,

(iii) 10.0 to 55.0% decanoic acid,

(iv) 0 to 5% dodecanoic acid, and

(v) 0 to 2% tetradecanoic acid;

(i) 0 to 2% hexanoic acid,

(ii) 50.0 to 80.0% octanoic acid,

(iii) 20.0 to 45.0% decanoic acid,

(iv) 0 to 2% dodecanoic acid, and

(v) 0 to 1% tetradecanoic acid;

(i) 0 to 2% hexanoic acid,

(ii) 50.0 to 65.0% octanoic acid,

(iii) 30.0 to 45.0% decanoic acid,

(iv) 0 to 2% dodecanoic acid, and

(v) 0 to 1% tetradecanoic acid;

(i) 0 to 2% hexanoic acid,

(ii) 65.0 to 80.0% octanoic acid,

(iii) 20.0 to 35.0% decanoic acid,

(iv) 0 to 2% dodecanoic acid, and

(v) 0 to 1% tetradecanoic acid

wherein the transdermal therapeutic system contains from 0.82 mg/cm²to 2.0 mg/cm²asenapine and wherein the transdermal therapeutic system comprises a synergistic amount of ascorbyl palmitate and α-tocopherol.