Study on Formulation and Freeze-drying Process of Miriplatin for Injection

OBJECTIVE To study the formulation and manufacturing process of Miriplatin for Injection. METHODS The control range of manufacturing process and formulation were confirmed through choosing the kinds of freeze-drying solvent, solubility study of miriplatin, formulation selection and study on pre-freezing process. RESULTS The mixed solvents of tert-butyl alcohol and cyclohexane were selected to make freeze-drying formulation, the optimum ratio of cyclohexane was in the range of 10%-30%, the optimal drug concentration was in the range of 5-25 mg·mL^-1, stage pre-freezing method was used as final freeze-drying process. CONCLUSION The formulation and manufacturing process is feasible. The self-made drug product is shown the same with and reference listed drug in pharmaceutical aspects. The production cost can be greatly saved compared with the original grinding process.