Formulation and stability assessment of injectable iopamidol product

Abstract

Introduction: Nowadays, most of the disease are diagnosed by medical imaging methods. Most imaging is done by using special drugs, we called radiopaque contrast agents.Contrast media are groups of chemical agents developed to aid in the characterization of pathology by improving the contrast resolution of an imaging modality. Specific contrast media has been developed for every structural imaging modality, and every conceivable route of administration. Iopamidol is an iodinated contrast media that is widely used in angiography, pediatric angiocardiography, myelography, cisternography CT, detecting some malignancies, and photography of non-neoplastic wounds. Although Iopamidol is widely employed in medicine in different fields, the domestic formulation of this drug is not existing.Aim: The aim of this study is formulation and evaluation the stability of iopamidol product, in order to localize this medicine, prevent foreign exchange so, it has economic importance to our country.Method: At first, iopamidol solution was produced by EDTA and tromethamine. Then the pH of the formulation was adjusted at 7.5 and the formulation was sterilized by autoclave. After autoclaving, the product was stored at 40°C and the relative humidity was 70%, and finally the stability of the formulation would be evaluated by HPLC under ICH instructions in 0, 1, 2, 4, 6 months and identification tests would be studied according to USP.Results: The produced formulation is stable in pH of 7.5 after evaluating for 6 months.Conclusion: According to our tests and investigations, by using EDTA and tromethamine, the stability of iopamidol product is improved and the product will be stable during its shelf-life.