Compatibility and stability of methylprednisolone sodium succinate and granisetron hydrochloride in 0.9% sodium chloride solution

Abstract

A combination of methylprednisolone sodium succinate (MSS) and granisetron hydrochloride (GH) is generally devoted to treating the chemotherapy-induced nausea and vomiting. To date, none of these novel mixtures have been commercially available. The present study was aimed at investigating physical and chemical compatibility and stability of a combination of MSS with GH in 0.9% sodium chloride injection for 72 hours at 4°C and 25°C. A mixture of MSS (0.4–0.8 mg/mL) with GH (0.03 mg/mL) was prepared and stored in both polyvinyl chloride bags and glass bottles using 0.9% sodium chloride injection as a diluent. The study was performed using a validated and stability-indicating high-performance liquid chromatography method. The physical compatibility was assessed by a spectrometer. Furthermore, the pH measurement of each sample was measured electronically. All test solutions stored at 4°C or 25°C had a no >2% loss of the initial concentration throughout the 72-hour study period. All solutions remained clear and colorless throughout the study and were without precipitation or turbidity in any of the batches. The drug mixtures of MSS (0.4–0.8 mg/mL) and GH (0.03 mg/mL) in 0.9% sodium chloride injections were physically and chemically stable for at least 72 hours when stored at 4°C or 25°C in polyvinyl chloride bags or glass bottles.

Quality by Design Approach for Development and Characterization of Granisetron Hydrochloride-Loaded Orodispersible Films

“…Its affinity for the 5-HT 3 receptor is 4,000 to 40,000 times greater than other receptors, making it a viable antiemetic drug option. [1][2][3] Compared with ondansetron, another frequently used 5-HT 3 receptor antagonist, granisetron offers benefits such as a prolonged onset time and a decreased drug dosage due to its longer half-life. Additionally, granisetron has a strong performance in terms of drug safety, allowing the application on children over 2 years old and patients aged 65 years or older.…”