Consideration of Excipient Selection in Freeze-dried Injections / 中国药学杂志

ABSTRACT

OBJECTIVE: To provide reference and consideration for pharmaceutical development by expounding the basic considerations for the selection of freeze-dried injection excipients. METHODS: The excipients in freeze-dried injections approved by FDA in recent years have been listed, and the composition of excipients in the preparations and the maximum amount of excipients contained were summarized. The issues to be considered in the selection of freeze-dried injections were discussed. RESULTS: One quarter of the freeze-dried injections that have been marketed do not use excipients, while the most commonly used excipients are bulking agents, buffering agents and pH adjusters. Other excipients include solubilizing agent, antioxidants, etc.. CONCLUSION: The selection of freeze-dried injection excipients should focus on safety, formulation rationality, functionality-related characteristics and control of excipients.