Feasibility Study on the Infusion Packaged with Domestic Non-PVC 5-layers Co-extruded Film

OBJECTIVE To prepare the infusion packaged with domestic non-PVC 5-layers co-extruded film and perform feasibility study. METHODS The levofloxacin lactate and sodium chloride infusion packaged with domestic 5-layers co-extruded film was prepared, the compatibility between the drug products and packaging materials was performed by extraction test, migration test and adsorption test etc. RESULTS The content of antioxidant, metal ions and styrene in domestic 5-layers co-extruded film conformed to the requirements. The content of antioxidant, metal ions and styrene in levofloxacin lactate and sodium chloride infusion met the requirements under the accelerated testing condition. The results of adsorption test, stability test and water loss on permeation met the requirements. CONCLUSION It is feasible that the infusion packaged with domestic non-PVC 5-layers co-extruded film can be produced and meet the requirements.