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 pharmaceutical product 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 and assay 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 for impurity 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 lactose monohydrate and lactose monohydrate + EDTA combination.

Keywords

• Drug formulation
• excipient
• lyophilization
• hydroxocobalamin
• stability

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