I am developing Pantoprazole powder for injection for that I am using reported lyophilization cycle method for vials. However when i keep solution in bulk i.e. in flasks lyophilization is not working out resulting in may be meltback or kind of phase separation.
What are the casues and what is the solution for this issue?
Prashant Mande Derive collapse temperature and set cycle accordingly. Also u can use smart lyophilization feature based on properties of ingredients in formulation.
Check the solid content in your formulation and Tc or Tg of solution.
If possible try with annealing process to avoid melt back or collapse.
What is the reported collapse temperature of product?
Actually my process is below collapse temperature it worked well for vails however for bulk in flask its failing
Prashant Mande - and you are freezing the whole flask on the shelf? What is the product depth in the flask? More or less than the vial?
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