| 摘要 |
PROBLEM TO BE SOLVED: To provide a modified release oral tranexamic acid (transformer-4-(aminomethyl) cyclohexane carboxylic acid) formulation which is an anti-fibrinolytic agent, and a therapeutic method using the same.SOLUTION: Provided is a modified release oral formulation comprising tranexamic acid or a pharmaceutically acceptable salt thereof and a modified release substance. The modified release substance, which is a modified release oral formulation with the in vitro elution rate of tranexamic acid or a pharmaceutically acceptable salt thereof, provides a modified release of tranexamic acid or a pharmaceutically acceptable salt thereof from the formulation to be suitable for two or three times a day administration. When the formulation is measured by a (USP 27) Apparatus Type II Paddle Method (50 RPM) in 900 ml water at 37±0.5°C, less than about 70% by weight of tranexamic acid or a pharmaceutically acceptable salt thereof is released in about 45 minutes, and about 100% by weight of tranexamic acid or a pharmaceutically acceptable salt thereof is released in about 120 minutes. |
