Chemical Papers, Journal Year: 2024, Volume and Issue: unknown
Published: Dec. 21, 2024
Language: Английский
Chemical Papers, Journal Year: 2024, Volume and Issue: unknown
Published: Dec. 21, 2024
Language: Английский
Inorganic Chemistry Communications, Journal Year: 2024, Volume and Issue: unknown, P. 113747 - 113747
Published: Dec. 1, 2024
Language: Английский
Citations
4Drug Development and Industrial Pharmacy, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 34
Published: April 1, 2025
Cyclophosphamide, an active pharmaceutical ingredient (API), is accessible in monohydrate form and esteemed for its remarkable stability. Maintaining this post-lyophilization essential product This research aims to optimize lyophilization parameters effective robust cycle using a Quality by Design (QbD) methodology. Initially, thermal analysis performed evaluate the qualities of product. The defines critical process (CPPs) important quality attributes (CQAs), employing systematic methodology establish design space accordance with required Target Product Profile (QTPP). being examined are primary drying temperature, duration, vacuum. Meticulous results identifies optimum formulation. test successfully preserves water content between 6-7%, hence confirming existence form, as verified X-ray diffraction (XRD) examination. Furthermore, demonstrates minimal concentrations TBA ACN, maintains intact cake structure, achieves rapid reconstitution time less than 30 seconds. implementation concepts enhance offers significant insights developing generic formulations. Ultimately, reliable freeze-drying technique developed then requires validation on industrial-scale lyophilizers commercial applications.
Language: Английский
Citations
0International Journal of Biological Macromolecules, Journal Year: 2025, Volume and Issue: unknown, P. 144757 - 144757
Published: May 1, 2025
Language: Английский
Citations
0Chemical Papers, Journal Year: 2024, Volume and Issue: unknown
Published: Dec. 21, 2024
Language: Английский
Citations
0