Claims for Patent: 11,813,364

Summary for Patent: 11,813,364

Title:	Patch
Abstract:	In a patch comprising a support layer and an adhesive agent layer, the adhesive agent layer comprises free asenapine, a maleic acid alkali salt, and a rubber-based adhesive agent.
Inventor(s):	Atsushi Sonobe, Takashi Yasukochi, Yasunori Takada
Assignee:	Hisamitsu Pharmaceutical Co Inc
Application Number:	US17/404,571
Patent Claims:	1. A patch, comprising: a support layer; and an adhesive agent layer formed on the support layer and comprising asenapine and/or a pharmaceutically acceptable salt thereof, a maleic acid alkali salt, and a rubber-based adhesive agent such that a content of the maleic acid alkali salt in the adhesive agent layer is in a range of 1% by mass to 10% by mass, wherein the adhesive agent layer includes free asenapine derived from the asenapine and/or pharmaceutically acceptable salt thereof such that a content of the free asenapine in the adhesive agent layer is in a range of 2% by mass to 10% by mass and that a mass ratio of the free asenapine to the rubber-based adhesive agent is in a range of 1:17 to 1:1.2. 2. The patch according to claim 1, wherein a mass ratio of the free asenapine to the maleic acid alkali salt in the adhesive agent layer is in a range of 1:0.25 to 1:2. 3. The patch according to claim 1, wherein a content of the rubber-based adhesive agent in the adhesive agent layer is in a range of 10% by mass to 50% by mass. 4. The patch according to claim 1, wherein the rubber-based adhesive agent is at least one selected from the group consisting of styrene-isoprene-styrene block copolymer, polyisobutylene, and silicone rubber. 5. The patch according to claim 1, wherein the rubber-based adhesive agent is styrene-isoprene-styrene block copolymer and polyisobutylene such that a mass ratio of the styrene-isoprene-styrene block copolymer to the polyisobutylene is in a range of 15:2 to 2:15. 6. The patch according to claim 1, wherein the adhesive agent layer comprises tackifier such that a mass ratio of the rubber-based adhesive agent to the tackifier is in a range of 1:6 to 1.5:1. 7. The patch according to claim 1, wherein the maleic acid alkali salt is at least one of disodium maleate and monosodium maleate. 8. The patch according to claim 1, wherein the adhesive agent layer comprises at least one absorption enhancer selected from the group consisting of isostearyl alcohol, capric acid, propylene glycol monolaurate, isopropyl myristate, isopropyl palmitate, lauric acid diethanolamide, propylene glycol, and polyethylene glycol. 9. The patch according to claim 8, wherein a content of the absorption enhancer in the adhesive agent layer is in a range of 2% by mass to 40% by mass. 10. The patch according to claim 2, wherein a content of the rubber-based adhesive agent in the adhesive agent layer is in a range of 10% by mass to 50% by mass. 11. The patch according to claim 2, wherein the rubber-based adhesive agent is at least one selected from the group consisting of styrene-isoprene-styrene block copolymer, polyisobutylene, and silicone rubber. 12. The patch according to claim 2, wherein the rubber-based adhesive agent is styrene-isoprene-styrene block copolymer and polyisobutylene such that a mass ratio of the styrene-isoprene-styrene block copolymer to the polyisobutylene is in a range of 15:2 to 2:15. 13. The patch according to claim 2, wherein the adhesive agent layer comprises tackifier such that a mass ratio of the rubber-based adhesive agent to the tackifier is in a range of 1:6 to 1.5:1. 14. The patch according to claim 2, wherein the maleic acid alkali salt is at least one of disodium maleate and monosodium maleate. 15. The patch according to claim 2, wherein the adhesive agent layer comprises at least one absorption enhancer selected from the group consisting of isostearyl alcohol, capric acid, propylene glycol monolaurate, isopropyl myristate, isopropyl palmitate, lauric acid diethanolamide, propylene glycol, and polyethylene glycol. 16. The patch according to claim 1, wherein the mass ratio of the free asenapine to the rubber-based adhesive agent is in a range of 1:14 to 1:1.4. 17. The patch according to claim 1, wherein the rubber-based adhesive agent includes at least one selected from the group consisting of styrene-isoprene-styrene block copolymer, polyisobutylene, and silicone rubber. 18. The patch according to claim 1, wherein the rubber-based adhesive agent includes styrene-isoprene-styrene block copolymer and polyisobutylene. 19. The patch according to claim 1, wherein the rubber-based adhesive agent includes styrene-isoprene-styrene block copolymer and polyisobutylene such that a mass ratio of the styrene-isoprene-styrene block copolymer to the polyisobutylene is in a range of 15:2 to 2:15. 20. The patch according to claim 1, wherein the maleic acid alkali salt includes at least one of disodium maleate and monosodium maleate.