Stable, dilution formulation of carfilzomib
By preparing a room-temperature stable, dilution-compatible injectable formulation, the problems of complex reconstitution process and unstable storage of carfilzomib formulations have been solved. This achieves long-term stability at room temperature and simplifies the reconstitution process, making it suitable for the treatment of multiple myeloma.
Patent Information
- Application Number
- CN202180039555.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-11-12
- Filing Date
- 2021-04-15
- Publication Date
- 2025-10-28
- Estimated Expiration
- 2041-04-15
AI Technical Summary
Existing carfilzomib formulations are complex and unstable during the reconstitution process, and are prone to degradation, especially when stored at room temperature, leading to uncertain efficacy.
A room-temperature stable, dilution-injectable formulation is provided, comprising carfilzomib or a pharmaceutically acceptable derivative thereof, wherein a reconstituted dilution-injectable solution is formed by mixing component 1 and component 2, wherein component 1 is a room-temperature stable, dilution-injectable parenteral formulation of carfilzomib and component 2 is an acidifier, which can be directly combined with an infusion medium for the treatment of multiple myeloma.
It achieves the stability of carfilzomib formulation at room temperature for at least one month with impurity content not exceeding 6%, simplifies the reconstitution process, and improves the convenience of storage and use of the formulation.