A pharmaceutical composition containing ibrutinib and a preparation method thereof
By using colloidal silica to eliminate the insoluble complex salts of ibrutinib and sodium dodecyl sulfate, combined with the dry granulation process, the problem of low bioavailability of ibrutinib is solved and efficient industrial production is achieved.
CN119818691BActive Publication Date: 2025-08-05NINGBO MENOVO TIANKANG PHARMA CO LTD
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Patent Information
- Application Number
- CN202510317729.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-18
- Publication Date
- 2025-08-05
- Estimated Expiration
- 2045-03-18
AI Technical Summary
Technical Problem
The prior art is difficult to effectively solve the problem that idrutinib forms insoluble complex salts with sodium dodecyl sulfate under acidic conditions, resulting in low bioavailability and high complexity of existing processes, which is not suitable for large-scale industrial production.
Method used
Colloidal silica is used as a co-dispersant, and is preferentially mixed with idrutinib and sodium dodecyl sulfate. Combined with the dry granulation process, it eliminates insoluble complex salts, increases the dissolution rate and solubility, and prepares it into a capsule.
Benefits of technology
Significantly improve the bioavailability of ibrutinib, reduce production complexity, and make it suitable for large-scale industrial production.
✦ Generated by Eureka AI based on patent content.
Abstract
This application relates to the technical field of pharmaceutical preparations, and specifically discloses a pharmaceutical composition containing ibrutinib and its preparation method. The composition includes the active ingredient ibrutinib, colloidal silicon dioxide, solubilizers, and other excipients such as excipients; its preparation method is: the active ingredient ibrutinib is preferentially mixed with colloidal silicon dioxide and solubilizers, followed by dry granulation, mixing, and capsule filling. The composition of this application can be used for the treatment of diseases such as mantle cell lymphoma (MCL) / chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma, etc. It can effectively break the insoluble complex salt formed by ibrutinib and solubilizers, and has the advantages of fast dissolution rate and significantly improved bioavailability; in addition, the preparation method of this application has the advantages of good process reproducibility, simple process steps, low production cost, and being suitable for large-scale industrial production.
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