Method for producing patch, patch and package

摘要

A method for producing a patch comprising a support layer and an adhesive agent layer arranged on at least one surface of the support layer, the method comprising:
step A) obtaining an adhesive agent layer composition comprising free ropinirole in an amount which results in a content of 5 to 13.2% by mass in an obtained adhesive agent layer;step B) heating the adhesive agent layer composition at a temperature in a range from 50 to 76° C. for 5 minutes to 24 hours; andstep C) cooling the heated adhesive agent layer composition to normal temperature at an average rate of temperature drop of 1 to 20° C./hour, thereby obtaining the adhesive agent layer comprising the free ropinirole at a supersaturated concentration in a dissolved form.

主权项

1. A method for producing a patch comprising a support layer and an adhesive agent layer arranged on at least one surface of the support layer, the method comprising:
A) obtaining an adhesive agent layer composition comprising
free ropinirole in an amount which results in 5 to 13.2% by mass relative to a total mass of an obtained adhesive agent layer,at least one compound selected from the group consisting of benzyl alcohol, oleyl alcohol, octyldodecanol, and dimethyl isosorbide in an amount of 5 to 50 parts by mass relative to 100 parts by mass of the free ropinirole,at least one compound selected from the group consisting of isopropyl myristate, isopropyl palmitate, lauryl alcohol, glycerin monooleate, propylene glycol monolaurate, polyoxyethylene sorbitan monooleate, and lauric acid diethanolamide in an amount of 10 to 150 parts by mass relative to 100 parts by mass of the free ropinirole, anda rubber-based adhesive agent in an amount which results in 15 to 35% by mass relative to the total mass of the obtained adhesive agent layer; B) heating the adhesive agent layer composition at a temperature in a range from 50 to 70° C. for 5 minutes to 24 hours; and C) cooling the heated adhesive agent layer composition to a normal temperature ranging from 3 to 30° C. at an average rate of temperature drop of 1 to 20° C./hour, thereby obtaining the adhesive agent layer comprising the free ropinirole at a supersaturated concentration in a dissolved form, wherein no precipitation of free ropinirole crystals occur within 24 months in the obtained adhesive agent layer at a temperature of 25° C.