The Physical Stability of Ciprofloxacin and Levofloxacin Parenteral Dosage Forms in the Polypropylene Plastic Container

Abstract

Polypropylene (PP) plastic container is often used as alternatives to glass containers in the primary packaging of parenteral dosage forms, but the usage poses a risk of interaction with the preparations during moist heat sterilization. Therefore, this study aimed to evaluate the physical stability of ciprofloxacin and levofloxacin parenteral dosage forms packaged in PP container after moist heat sterilization. Parenteral preparations were produced by dissolving the active ingredient ciprofloxacin lactate or levofloxacin hemihydrate in water for injection solvent. The solution obtained was then packaged in a 100 mL PP container and subjected to moist heat sterilization at 115°C for 30 minutes. The physical stability of the samples was then tested, including the weight, pH, clarity, number of particles, and sterility. The physical quality parameters before and after sterilization were compared. Data were analyzed using the paired t-test with significance at α 0.05. The results showed that parenteral preparations were sterile and maintained consistent physical stability after being sterilized, except for the number of particles. Furthermore, the number of particles in the sample met the standard requirements. Based on the results, ciprofloxacin or levofloxacin parenteral preparations in PP containers fulfilled the physical stability requirements after moist heat sterilization.