Patch
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.
1. A patch, comprising:
a support layer; and
an adhesive agent layer formed on the support layer and comprising isopropyl palmitate, an adhesive base agent, sodium diacetate, and at least one of asenapine and a pharmaceutically acceptable salt thereof,
wherein a mass ratio of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine to the isopropyl palmitate in the adhesive agent layer is in a range of 1:0.1 to 1:5.
2. The patch according to claim 1 , wherein a mass ratio of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine to the isopropyl palmitate in the adhesive agent layer is in a range of 1:0.41 to 1:5.
3. The patch according to claim 1 , wherein a mole ratio of the asenapine and/or pharmaceutically acceptable salt to the sodium diacetate in the adhesive agent layer is in a range of 1:0.5 to 1:4.
4. The patch according to claim 1 , wherein the adhesive base agent is at least one selected from the group consisting of a (meth)acrylic ester (co)polymer, a rubber-based adhesive agent, a silicone polymer, and a polyurethane-based adhesive agent.
5. The patch according to claim 1 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
6. The patch according to claim 2 , wherein a mole ratio of the asenapine and/or pharmaceutically acceptable salt to the sodium diacetate in the adhesive agent layer is in a range of 1:0.5 to 1:4.
7. The patch according to claim 2 , wherein the adhesive base agent is at least one selected from the group consisting of a (meth)acrylic ester (co)polymer, a rubber-based adhesive agent, a silicone polymer, and a polyurethane-based adhesive agent.
8. The patch according to claim 2 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 of the free asenapine for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
9. The patch according to claim 3 , wherein the adhesive base agent is at least one selected from the group consisting of a (meth)acrylic ester (co)polymer, a rubber-based adhesive agent, a silicone polymer, and a polyurethane-based adhesive agent.
10. The patch according to claim 3 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 of the free asenapine for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
11. The patch according to claim 4 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 of the free asenapine for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
12. The patch according to claim 7 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 of the free asenapine for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
13. The patch according to claim 6 , wherein the adhesive base agent is at least one selected from the group consisting of a (meth)acrylic ester (co)polymer, a rubber-based adhesive agent, a silicone polymer, and a polyurethane-based adhesive agent.
14. The patch according to claim 6 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 of the free asenapine for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
15. The patch according to claim 13 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 of the free asenapine for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
16. The patch according to claim 9 , wherein when a content of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC 2-120 of the free asenapine for a period starting from the time when the patch is brought into contact with skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC 2-120 of an asenapine metabolite is 20% or less of the AUC 2-120 of the free asenapine.
17. The patch according to claim 3 , wherein a mass ratio of the asenapine and/or pharmaceutically acceptable salt in terms of free asenapine to the isopropyl palmitate in the adhesive agent layer is in a range of 1:0.5 to 1:5.