Patient-ready syringes containing 25 mg/mL methotrexate can be kept at temperature ranging from 4 °C to 37 °C for up to 12 weeks for use in psoriatic and rheumatologic conditions

Abstract

Background

Methotrexate (MTX) is a mainstay drug in the treatment of psoriatic and rheumatologic conditions. Subcutaneous MTX has become a feasible treatment alternative with the development of prefilled syringes or autoinjectors containing MTX solution that can be self-administered by the patient at home. However, MTX prefilled auto-injector pens are still not available in some countries.

Objective

This study aimed to investigate the stability and sterility of 25 mg/mL MTX solution in a disposable plastic syringe over a 12-week period under light protection at temperatures of 4 °C, 25 °C, and 37 °C.

Methods

This study was conducted during November 2019 to February 2020 at the Faculty of Medicine Siriraj Hospital, Mahidol University. Stability was evaluated using ultra-high-performance liquid chromatography technique, and sterility was assessed by cultures for bacterial and fungal contamination.

Results

Our results revealed that patient-ready syringes containing 25 mg/mL MTX solution can be prepared in advance and kept for up to 12 weeks under light protection, and they can be kept at temperatures ranging from 4 to 37 °C.

Conclusion

This system for delivering MTX to patients that are refractory to or intolerant of oral MTX via a self-administered pre-filled syringe is both efficient and easy to implement in care settings where commercially alternatives are not yet available.

Keywords:

• 4 °C to 37 °C
• 25 mg/mL methotrexate
• patient-ready syringes
• psoriatic and rheumatologic conditions
• temperature

Acknowledgments

The authors would like to thank Mr. Suthipol Udompunthurak for his assistance with statistical analysis.

Disclosure statement

All authors declare no personal or professional conflicts of interest, and no financial support from the companies that produce and/or distribute the drugs, devices, or materials described in this report.