Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation

Abstract

Background and Aims: The aim of the research work was to compare excipient effects and develop a stable pharmaceuticalproduct in the form of lyophilized powder. Mannitol, lactose monohydrate, EDTA and glycine are widely used in pharmaceutical formulations and food products.Methods: The production method consists of mainly four parts: raw material weighing process, preparation of bulk solutions,lyophilization and analytical determination. A total of five formulations were prepared and lyophilized to the stability study.To improve the stability of hydroxocobalamin formulations (F1-F5), they were evaluated with different excipients (mannitol,lactose monohydrate, EDTA and glycine) during the stability period. Stability studies were performed to check impurity andassay of hydroxocobalamin.Results: The rate of impurity and assay results were compared to F1-F5 formulations. As a result of impurity and assay analysis for F3 and F4, the formulations were found to be within limit. Both of them were determined to the best formulations forimpurity of hydroxocobalamin.Conclusion: The research proposes a new stable formulation and proper storage conditions for lyophilized hydroxocobalamin parenteral solutions. The impurity problem of lyophilized hydroxocobalamin formulation was optimized with lactosemonohydrate and lactose monohydrate + EDTA combination.