Ramosetron 3.0 μg/mL Combining with Dexamethasone (0.05, 0.1, 0.2 mg/mL) in Infusion Solutions: A Physicochemical...

Area of Science:

• Pharmacology
• Pharmaceutical Chemistry
• Clinical Pharmacy

Background:

• Dexamethasone and serotonin 3 receptor antagonists are used for nausea and vomiting.
• Chemotherapy-induced and postoperative nausea and vomiting (CINV/PONV) are common clinical challenges.
• Combined antiemetic therapy requires stability assessment for safe clinical application.

Purpose of the Study:

• To investigate the stability of ramosetron hydrochloride combined with dexamethasone in infusion solutions.
• To determine the optimal storage conditions for this antiemetic combination.
• To enhance the safety and clinical applicability of combined ramosetron and dexamethasone therapy.

Main Methods:

• Ramosetron hydrochloride (3.0 μg/mL) and dexamethasone (0.05–0.2 mg/mL) were prepared in 0.9% sodium chloride injection.
• Solutions were packaged in polyolefin bags or glass bottles.
• Stability was assessed under refrigeration (14 days, dark) and room temperature (48 h, dark).

Main Results:

• Drug concentrations remained above 97% in all solutions when protected from light.
• Light exposure led to a decline in drug concentrations over time.
• No changes in clarity, color, turbidity, or precipitation were observed; pH remained stable.
• Insoluble particles met Chinese Pharmacopoeia standards.

Conclusions:

• Ramosetron hydrochloride and dexamethasone sodium phosphate combinations in 0.9% sodium chloride injection are stable.
• Stable for 14 days at 4°C and 48 hours at 25°C when protected from light.
• Findings support the safe clinical use of this combined antiemetic therapy.