Hi,
I have a product being lyophilized, and would like to know what aspects of formulation (Not the cycle parameters) decide how much water content will be left out post freeze drying. Any leads would help me a lot.
Thanks,
Bharadwaj.
Dear Vemparala,
The drying cycle is part of that equation ... it cannot be avoided.
Crystal size, set at freezing will determine surface area ... that will affect residual moisture.
Generally in formulation, the quantity and nature of sugars in the formulation will affect residual water levels. Other excipients may have an effect ... each has it's own particular influence.
Kind regards
Rob
Validation of working of the lyophilizer is an important criterion to determine the good working condition of lyophilizer and an efficient moisture removal from the nanoformulation. Thus the residual moisture content can be determined by Karl fisher titration.
The cycle parameters are crucial to a correct lyophilization, so they cannot be avoided. Residual water can be determined via Karl Fisher titration. The excipient has little influence on the residual water (it should be more able to bound water than the lyophilized API), since in most of the cases acts only as a support to grant adequate flowability of the powder and the faster dissolution once water is added.
- Badges
- Science topic
- Similar topics
- Biological Science
- Microbiology
- Microorganisms
- Bacteria