Method for producing active agent administering systems by means of pad printing processes

Patent metadata

Field	Value
Publication number	US-12508257-B2
Application number	US-202017622531-A
Country	US
Kind code	B2
Filing date	Jun 26, 2020
Priority date	Jun 27, 2019
Publication date	Dec 30, 2025
Grant date	Dec 30, 2025

Abstract

The present invention relates to a pad printing method for producing an administration form for a pharmaceutical active agent, wherein the method comprises providing a substrate of the administration form and transferring the active agent by means of a pad from a cliché onto the substrate, wherein the area of the cliché is larger than the active-agent-containing area printed onto the substrate. This method is especially suitable for producing transdermal therapeutic systems with volatile active agents. The present invention also relates to arrangements by means of which a method of this kind can be implemented.

First claim

The invention claimed is:

1 . A pad printing method for producing an administration form for a pharmaceutical active agent, comprising providing a non-absorbent substrate of the administration form and transferring the active agent by means of a pad from a cliché onto the non-absorbent substrate, wherein the area of the indentation of the cliché is larger than the area of the active-agent-containing imprint printed onto the non-absorbent substrate.

2 . The pad printing method according to claim 1 , characterised in that the cliché is circular and has a diameter which is at least 5 mm larger than the diameter of the active-agent-containing imprint printed onto the non-absorbent substrate.

3 . The pad printing method according to claim 1 , characterised in that the administration form is a transdermal therapeutic system (TTS).

4 . The pad printing method according to claim 1 , characterised in that the non-absorbent substrate to which the pharmaceutical active agent is applied by means of a pad has an upper layer formed from adhesive to which the active agent is applied.

5 . The pad printing method according to claim 4 , characterised in that the pharmaceutical active agent is formulated for the transfer onto the non-absorbent substrate comprising an adhesive in the form of a polyacrylate adhesive.

6 . The pad printing method according to claim 5 , characterised in that the adhesive is a pressure sensitive adhesive.

7 . The pad printing method according to claim 1 , characterised in that the pharmaceutical active agent has a boiling point of at most 250° C. at a pressure of 101.3 kPa.

8 . The pad printing method according to claim 7 , characterised in that the pharmaceutical active agent is present in the form of nicotine.

9 . The pad printing method according to claim 7 , characterised in that the pharmaceutical active agent is present in the form of a mixture of essential oils or contains an essential oil or an ester thereof.

10 . The pad printing method according to claim 7 , characterised in that the printed active agent is then covered by an active-agent-impermeable backing layer.

11 . The pad printing method according to claim 1 , characterised in that the cliche is circular and has a diameter which is at least 10 mm larger than the diameter of the active-agent-containing imprint printed onto the non-absorbent substrate.

12 . The pad printing method according to claim 1 , characterised in that the cliche is circular and has a diameter which is at least 25 mm larger than the diameter of the active-agent-containing imprint printed onto the non-absorbent substrate.

13 . An arrangement for applying an active agent to a non-absorbent substrate with the aid of a pad printing system, comprising a device with a pad and a cliché, wherein the cliché is filled at least in part with an active-agent-containing formulation, and a non-absorbent substrate for receiving the active-agent-containing formulation from the pad from the device, wherein the device is adapted such that the contact area of the pad is smaller than the area of an indentation of the cliché.

14 . The arrangement according to claim 13 , comprising a storage container for storing the active-agent-containing formulation and means for introducing the formulation into the cliché.

15 . The arrangement according to claim 13 , wherein the active-agent-containing formulation contains an active agent with a boiling point of at most 250° C. at a pressure of 101.3 kPa.

16 . The arrangement according to claim 13 , wherein the active agent is in the form of nicotine.

Assignees

• Lts Lohmann Therapie Systeme Ag

Inventors

• Hille Thomas
• Botzem Petra
• Wionzek Albert

Classifications

• A61K9/7084 Primary

  Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches · CPC title

• A61K31/465 Primary

  Nicotine; Derivatives thereof · CPC title