Mannitol is a popular excipient in lyophilized injectable small and large molecule formulations. Mannitol crystallizes readily in aqueous solutions enabling primary drying at elevated temperature, thus substantially reducing cycle time and cost. The existence of crystalline mannitol in the final lyophile yields an elegant cake. Three anhydrous polymorphs of mannitol and mannitol hemihydrate have been observed in freeze-dried formulations. The understanding of the phase behavior of mannitol in aqueous systems, during the various stages of freeze-drying, can be critical for the optimization of freeze-drying cycle parameters in multi-component formulations. Importantly, the existence of metastable crystalline mannitol hemihydrate in the final lyophile may pose certain challenges, necessitating appropriate mitigation strategies. This webinar summarizes the current knowledge and the use of orthogonal techniques for attaining a stable and cost-effective lyophilized drug product containing mannitol. Dr. Seema Thakral is a pharmaceutical scientist with broad research experience in the formulation development of small and large molecules. Research areas of interest include pre-formulation, solid-state characterization and lyophilization (process and formulation). Dr. Thakral has been in academic, research and leadership roles for ~17 years and am author of ~49 research publications. She is currently working as Head, Preclinical Formulation lab, BIPI, US division. It is indeed a privilege to be able to contribute to development of safe and effective medicines for unmet medical needs.
-
Products
Pharmaceutical Processing Equipment Fill-Finish / Aseptic Processing Equipment Development, Pilot & Production Freeze Dryers Lyophilization Techology & PAT Tools
-
Segments
Find Products by Applications & Industries
- Brands
-
Learning Lab
Explore the Learning Lab
- Service & Support
-
About Us
Learn more about SP