Pharma Mar has filed a patent for form B of lurbinectedin, detailing a process to create a lyophilized pharmaceutical composition. The process involves washing, basifying, solubilizing, and freeze-drying to convert the crystalline form of lurbinectedin to an amorphous form. GlobalData’s report on Pharma Mar gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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Lyophilized pharmaceutical composition of form b of lurbinectedin
The patent application (Publication Number: US20230416276A1) describes a lyophilized pharmaceutical composition containing lurbinectedin, prepared through a specific process. The process involves steps such as washing the solution with water-immiscible solvents, basifying the solution to precipitate a crystalline form of lurbinectedin, and freeze-drying to convert it into an amorphous form. Additional steps include dissolving the crystalline form in an organic acid solution, mixing with an organic acid buffer and a bulking agent, and freeze-drying to obtain the final composition.
Furthermore, the composition must meet specific criteria, such as having a residual solvent content of no more than 0.5% wt/wt, total impurities not exceeding 1.9% wt/wt, and no more than 0.3% wt/wt of any individual unspecified impurity. The process also involves sterilization filtration before filling the solution into vials and freeze-drying. The use of specific organic acids, bases, and bulking agents is outlined, along with the pH ranges required for different solutions. Overall, the patent application provides a detailed and specific method for preparing a lyophilized pharmaceutical composition containing lurbinectedin, ensuring high quality and purity standards are met throughout the process.
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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
