Transdermal therapeutic system

Patent metadata

Field	Value
Publication number	US-11752114-B2
Application number	US-201916386458-A
Country	US
Kind code	B2
Filing date	Apr 17, 2019
Priority date	Apr 17, 2019
Publication date	Sep 12, 2023
Grant date	Sep 12, 2023

Abstract

The present invention concerns a transdermal therapeutic system, comprising a backing layer, which is not permeable for the active ingredient, and a matrix layer on one side of the backing layer, wherein the matrix layer contains at least one pressure sensitive adhesive and ketamine or a pharmaceutically acceptable salt or solvate thereof, wherein the at least one pressure sensitive adhesive has free hydroxyl groups, as well as its use as medicament, in particular for the treatment of depression and pain.

First claim

The invention claimed is:

1. A transdermal therapeutic system comprising a backing layer which is not permeable for the active ingredient, and at least one matrix layer on one side of the backing layer, wherein the matrix layer includes at least one pressure sensitive adhesive comprising an acrylic copolymer including free hydroxyl groups and no free carboxyl groups, and (S)-ketamine or a pharmaceutically acceptable salt or solvate thereof, and a penetration enhancer comprising a mixture of levulinic acid and methyl laurate, wherein the matrix layer has an area weight of 100 to 275 g/m 2 , wherein the methyl laurate is present in an amount greater than the levulinic acid, and wherein the weight ratio of levulinic acid to methyl laurate is between about 1:1.66 and 1:1.68.

2. The transdermal therapeutic system of claim 1 , wherein the at least one pressure sensitive adhesive comprises an acrylic copolymer selected from 2-ethylhexyl acrylic acetate, vinyl acetate, and 2-hydroxyethyl acrylate.

3. The transdermal therapeutic system of claim 1 , wherein the matrix layer comprises the penetration enhancers in an amount of about 1 to 15 wt.-%, based on the weight of the matrix layer and wherein each penetration enhancer is present in an amount of between about 4 and 10 wt. %.

4. The transdermal therapeutic system of claim 1 , wherein the matrix layer comprises ketamine in an amount of about 1 to 25 wt.-%, based on the weight of the matrix layer.

5. The transdermal therapeutic system of claim 1 , wherein the matrix layer comprises at least one antioxidant.

6. The transdermal therapeutic system of claim 5 , wherein the at least one antioxidant is selected from the group consisting of alpha-tocopherol, ascorbyl, palmitate, dibutylhydroxy toluene, and mixtures thereof.

7. The transdermal therapeutic system of claim 1 , wherein the transdermal therapeutic system comprises a detachable protective layer on the side of the matrix layer on which the backing layer is not arranged.

8. The transdermal therapeutic system of claim 1 , wherein the pressure sensitive adhesive comprises between about 70 to 85 wt. % of an entirety of the matrix layer.

Assignees

• Lts Lohmann Therapie Systeme Ag

Inventors

• Hammes Florian
• Kleudgen Tobias
• Tomeleri Anja

Classifications

• A61K31/135 Primary

  having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)} · CPC title

• A61P25/24

  Antidepressants · CPC title

• A61K9/7061

  Polyacrylates · CPC title

• A61K47/14

  Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters · CPC title

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title