Discussion on the Pharmaceutical Development of Generic Betadex Sulfobutyl Ether Sodium Inclusion Complexes Injections

Betadex sulfobutyl ether sodium(SBECD) has been used in pharmaceutical preparations especially inclusion complexes injection for poorly soluble drugs. These injections have demonstrated definite good drug safety and therapeutic effectiveness, which can meet the patient’s demand to some extent. Based on literature investigation, this paper briefly analyzed the application cases and discussed the CMC requirements of generic SBECD inclusion complexes injection. The pharmaceutical considerations were put forward in terms of formulation, manufacturing process and quality control, especially the control of critical excipient, in order to provide references for the development of SBECD inclusion complexes injection.