Formulation and Stability Study of Iodixanol Injectable Product

Abstract

Introduction: Stability is a crucial issue in pharmaceuticals, especially in the formulation of drug solutions. Utilizing methods and materials to enhance stability can extend the shelf life of a drug and simplify the storage of solution formulations.

Goals:The aim of this study is to prepare an injectable formulation of iodixanol and assess its stability.

Methods:To prepare the 320 mgI/ml iodixanol injectable solution, calcium disodium EDTA, sodium chloride, and necessary stabilizers were mixed together, and the required acidity was adjusted using a buffer to maintain a pH between 6.8 and 7.7 (with the solution pH adjusted to 7.4). The prepared solution was filtered through a 0.2-micron filter and then autoclaved at 121°C for 15 minutes. The formulated product was stored according to ICH guidelines for accelerated stability studies at 40°C and 75% humidity. Sampling was conducted at zero, one, two, four, and six months, and the remaining drug content was determined using HPLC.

Results:During the six-month study period, HPLC measurement results indicated that more than 95% of the iodixanol remained stable in the injectable formulation under the specified storage conditions. At each sampling stage, physical appearance examination of the solution showed no precipitation or color change, indicating that the iodixanol injectable formulation maintained suitable physical stability throughout the study period.

Conclusion:The results of this study indicate that the iodixanol injectable formulation at 320 mg/ml is chemically stable. Based on these results, a shelf life of two years can be considered for this formulation. This suggests that the developed formulation meets the necessary quality standards and can be effectively used in various diagnostic imaging procedures.