How to prevent your cake from collapsing in Freeze Dried Products?

Many drugs are unstable in solution and degrade rapidly over time, therefore they must be freeze-dried to produce a suitable stable product which can be shipped and has an acceptable shelf-life for storage. The freeze-dried product can be reconstituted to produce a solution containing the drug ready for administration. Different drugs can be stabilised by freeze drying (lyophilisation), these include small molecules but also biological treatments such as vaccines, proteins, enzymes, and other larger molecules. Freeze drying API/ drug products comes with its own unique challenges and stability issues which need to be overcome. Many biological drug products require additional excipients to stabilise them during the freeze-drying process and during storage. These excipients typically stabilise the drug molecules by entrapping protein molecules in an amorphous matrix which reduces the mobility of the molecule slowing its degradation, and also by supporting the structure of the molecule when freeze-dried by replacing the hydrogen bonds interactions of water, which maintain the structure of the molecule in solution, allowing its structure to be maintained once the water has been removed. The resulting product is commonly a freeze-dried ‘cake’. To read the full article please follow the link

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