Lyophilization is frequently used for exactly that purpose . There are several aspects of the “increased” stability. Removal of water often shut down many pathways for chemical degradation. If you have a suspension product, properties such as Ostwald ripening are greatly reduced. There are also fewer concerns with biological growth in a dry system. This is also why one uses solid dosage forms (tablets, capsules) for oral administration. One usually talks about parenteral products when using Lyo (due to cost).
Dear Mr.Ryde,
What sort of precautionary measures has to be taken during lyophilized omeparazole filling in to vials?
Dear Amir Haider, The lyophilization is espacially done for those products which can not be kept in liquid state espacially injectables. As your question is concern, the main precuationary measure should be the sterility and a pyrogenicity which should be taken care of. Regards
Just to add to Syed’s comment, typically you need to have a sterile product which therefore needs to be filled in a sterile environment. Vials and stoppers should be sterile and pyrogen free. The level of controls depends on what you intend to do with your product. Is it a R&D animal study, GLP tox, Clinical trials or finished product? I strongly suggest that you consult with a regulatory person than knows the regulation for the country you intend to evaluate/distribute your product.
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