Abstract
Background
Rocuronium bromide injection solutions are used as a muscle relaxant in emergency cases and intensive-care patients inter alia for the intubation. Ready-to-administer (RTA) rocuronium injection solutions prepared in the Pharmacy Department are beneficial for patient safety and efficiency of the utilisation process.
Purpose
The objective of this study was to evaluate the physicochemical stability of 10 mL RTA-syringes containing rocuronium bromide 10 mg/mL and prepared batch-wise in the pharmacy department.
Material and methods
Rocuronium bromide bulk solution 10 mg/mL in 500 ml glass bottles (type I) was manufactured in the sterile production unit of the Pharmacy Department, starting from the powder. Solutions were autoclaved (120°C, 15 min). Released bulk solution was used to prepare aseptically 10 mL BD plastipaK syringes by using the Plümatex pump (Plümat, Espelkamp, Germany) for semiautomatic filling and closure with combi stoppers. The products were stored refrigerated at 2°C–8°C. Rocuronium bromide concentration was determined by using a validated HPLC method with PDA detection at 220 nm for a planned period of 6 months (RTA-syringes) and 1 year (bulk solution).
Results
The concentration of the rocuronium bromide injection solution in 500 ml glass bottles and in 10 mL PP syringes remained unchanged over a period of 28 days. After 28 days of refrigerated storage, the rocuronium concentration amounted to 100% of the initial concentration in the RTA-syringes and 98% in the bottles, respectively. Degradation products were not detected during the study period. Regarding these results, batch production of the bulk solution and RTA syringes is feasible. Stability over 1 month is ensured.
Conclusion
Pharmacy-based aseptic preparation of 10 mL RTA-syringes containing rocuronium bromide injection solution 10 mg/mL is feasible in an effective manner, and advantageous for the users. Physicochemical stability is given over a period of at least 1 month.
References and/or Acknowledgements
We would like to thank Cigdem Cakmak and Julia Gehring for performing the analytical tests
No conflict of interest