Patch and method for producing the same

摘要

A method for producing a patch comprising a support layer and an adhesive agent layer comprises:
a mixture preparation step of mixing asenapine or a pharmaceutically acceptable salt thereof with sodium acetate whose particle diameter D50 at a cumulative volume of 50% in a particle diameter distribution is 40 to 1000 μm, in such a manner that the sodium acetate and sodium diacetate generated from the sodium acetate have a particle diameter D50 of 10 μm or smaller, thereby obtaining a mixture containing the sodium diacetate and the asenapine or pharmaceutically acceptable salt; andan adhesive-agent-layer formation step of forming the adhesive agent layer comprising the sodium diacetate, the asenapine or pharmaceutically acceptable salt, and a pressure-sensitive adhesive base agent, by using an adhesive agent layer composition obtained by mixing the mixture with the pressure-sensitive adhesive base agent.

主权项

1. A method for producing a patch, comprising:
mixing asenapine or a pharmaceutically acceptable salt thereof with sodium acetate whose particle diameter D50 at a cumulative volume of 50% in a particle diameter distribution is in a range of 40 μm to 1000 μm, such that sodium diacetate having a particle diameter D50 of 10 μm or smaller is generated from the sodium acetate, thereby obtaining a mixture comprising the sodium diacetate and the asenapine or pharmaceutically acceptable salt; obtaining an adhesive agent layer composition by mixing the mixture and a pressure-sensitive adhesive base agent, wherein acetic acid is not added; and forming an adhesive agent layer comprising the sodium diacetate, the asenapine or pharmaceutically acceptable salt thereof, and the pressure-sensitive adhesive base agent, by applying the adhesive agent layer composition to a support layer, wherein the adhesive agent layer measured by X-ray diffraction has a peak intensity from the sodium diacetate which is higher than a peak intensity from the sodium acetate.