Hisamitsu Pharmaceutical Company, Inc.

Masayuki Suzuki

Yasunori Takada

Takashi Yasukochi

Hiroaki Okutsu

A method for producing a patch including a support layer, and an adhesive agent layer formed on the support layer and including sodium diacetate, a pressure-sensitive adhesive base agent, and asenapine and/or a pharmaceutically acceptable salt thereof. The sodium diacetate is generated from sodium acetate in the presence of the asenapine and/or salt thereof, a content of the asenapine and/or salt thereof in terms of free asenapine in the adhesive agent layer is in range of 3.0 to 20 mg, and when a content of the asenapine and/or salt thereof in terms of free asenapine in the adhesive agent layer is 6.4 mg and the patch is in contact with skin for 24 hours, Cof free asenapine is in range of 0.5 to 6.0 ng/mL and tof free asenapine is in range of 8 to 28 hr.

Patch and method for producing the same

A patch for administering asenapine includes a support layer, and an adhesive agent layer formed on the support layer and including an adhesive base agent and asenapine and/or a pharmaceutically acceptable salt thereof. The adhesive base agent has a content in a range of 10 to 90% by mass in the adhesive agent layer and includes a natural rubber, polyisobutylene, an alkyl vinyl ether(co)polymer, polyisoprene, polybutadiene, a styrene-butadiene copolymer, a styrene-isoprene copolymer, a styrene-isoprene-styrene block copolymer, or a combination thereof. When a content of the asenapine and/or pharmaceutically acceptable salt thereof in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUCfor a period starting from the time when the patch is brought into contact with a skin for 24 hours is 27,000 pg&#xb7;hr/mL or more, and an AUCof an asenapine metabolite is 20% or less of the AUCof the free asenapine.

Patch

A method for producing a patch comprising a support layer and an adhesive agent layer comprises:

In a patch comprising a support layer and an adhesive agent layer, the adhesive agent layer comprises asenapine and/or a pharmaceutically acceptable salt thereof, isopropyl palmitate, and an adhesive base agent.

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Tsukuba, Japan

Masayuki Suzuki