Chemical modification of Ciprofloxacin IV formulation to combat solubility and stability issues

摘要

Parenteral are sterile dosage form of therapeutic agent that are free of viable micro- organisms and they are injected through the skin or mucous membranes into the internal body compartments. Ciprofloxacin is a classic drug (Model drug) which is used in treating different kinds of severe bacterial infections. It is weakly basic and shows solubility only in acidic medium but it leads to irritation when injected. This problem can be solved by adding chemical modifiers like PEG-400 and PG at low concentration which would give 100% bioavailability with no toxicity and stable in pH 7.4. This study is performed to enhance solubility of Ciprofloxacin IV infusion by adding PEG-400 and PG have 75.33±0.57 and 98.66±0.52 mg/mL respectively. All formulations (F1-F9) were found to be sterile, clear, isotonic with blood plasma. Stability study showed that all formulations remains stable at temperature 40±2°C and 75±5% RH. Among all formulations F3 is best suited and passed all evaluation parameters.