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
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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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