EP4687914A1 — A room-temperature stable, unbuffered formulation of rocuronium bromide injection for intravenous administration and a method thereof

USPTO Abstract

According to an embodiment of the present disclosure, the room-temperature stable, unbuffered rocuronium injection formulation for intravenous administration comprises of 1% w/v of rocuronium bromide, a pH adjusting agent comprising hydrochloric acid at a concentration between 125 mMol and 20 mMol for the adjustment of pH between 3.5 to 4.5 and a quantity sufficient of water to make the formulation to 1 mL. The proposed formulation of the present disclosure is stabilized through optimization of pH of the formulation using only hydrochloric acid and/or sodium hydroxide as the pH adjusting agents without use of any buffering agents is suitable for moist heat sterilization. Further, the rocuronium injection formulation of the present disclosure contains lower than 3% of rocuronium related compound C, more preferably less than 2% over the stability period at room temperature conditions.