Tranexamic acid formulations

摘要

Disclosed are modified release oral tranexamic acid formulations and methods of treatment therewith.

主权项

1. A tranexamic acid tablet formulation comprising:
tranexamic acid or a pharmaceutically acceptable salt thereof; and a modified release material; wherein the tranexamic acid or pharmaceutically acceptable salt thereof is present in an amount from about 50% to about 95% by weight of the formulation; wherein the modified release material is present in an amount from about 5% to about 50% by weight of the formulation; and wherein said tablet formulation provides an in-vitro dissolution release rate of the tranexamic acid or pharmaceutically acceptable salt thereof, when measured by a USP 27 Apparatus Type II Paddle Method @ 50 RPM in 900 ml water at 37±0.5° C., of less than about 70% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 45 minutes, and about 100% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof released at about 120 minutes.