Patch
US-2015202183-A1 · Jul 23, 2015 · US
US2015164862A1 · US · A1
| Field | Value |
|---|---|
| Publication number | US-2015164862-A1 |
| Application number | US-201314417205-A |
| Country | US |
| Kind code | A1 |
| Filing date | Jul 25, 2013 |
| Priority date | Jul 26, 2012 |
| Publication date | Jun 18, 2015 |
| Grant date | — |
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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 D 50 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 D 50 of 10 μm or smaller, thereby obtaining a mixture containing the sodium diacetate and the asenapine or pharmaceutically acceptable salt; and an 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.
Opening claim text (preview).
1 . A method for producing a patch comprising a support layer and an adhesive agent layer, the method comprising: 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; and an 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. 2 . The method for producing a patch according to claim 1 , wherein, in measuring the adhesive agent layer by an X-ray diffraction method, a peak intensity derived from the sodium diacetate is higher than a peak intensity derived from the sodium acetate. 3 . The method for producing a patch according to claim 1 , wherein the pharmaceutically acceptable salt of asenapine is asenapine maleate. 4 . The method for producing a patch according to claim 1 , wherein no acetic acid is added to the adhesive agent layer composition. 5 . The method for producing a patch according to claim 1 , wherein the adhesive agent layer composition further comprises isopropyl palmitate. 6 . The method for producing a patch according to claim 5 , wherein a mass ratio of the asenapine and/or pharmaceutically acceptable salt to the isopropyl palmitate (a mass of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine:a mass of the isopropyl palmitate) is 1:0.1 to 1:10. 7 . A patch comprising a support layer and an adhesive agent layer, the patch obtained by the method for producing a patch according to claim 1 .
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