Implementation study of patient-ready syringes containing 25 mg/mL methotrexate solution for use in treating ectopic...

Area of Science:

• Pharmacology
• Reproductive Medicine
• Pharmaceutical Science

Background:

• Ectopic pregnancy (EP) is a major cause of first-trimester morbidity and mortality.
• Medical management of small, unruptured tubal pregnancies often involves methotrexate (MTX).

Purpose of the Study:

• To assess the stability of a 25 mg/mL methotrexate solution.
• To develop a secure delivery system for MTX preparation and administration in EP management.

Main Methods:

• Methotrexate solutions (25 mg/mL) were stored in polypropylene syringes for 84 days.
• Storage conditions included protection from light at +2 to +8°C or 23°C.
• Physical and chemical stability were evaluated at intervals; a batch preparation circuit was implemented.

Main Results:

• Methotrexate solutions demonstrated stability over the 84-day storage period under tested conditions.
• Standard doses (50-100 mg) were successfully prepared.
• Pre-prepared MTX syringes can be made available by pharmacies for immediate dispensing upon EP diagnosis.

Conclusions:

• The 25 mg/mL MTX solution exhibits high stability in polypropylene syringes.
• A flexible, cost-effective delivery system for ready-to-use MTX can be established.
• This system facilitates 24-hour access to medication, preventing treatment delays for ectopic pregnancy.