Some Active Pharmaceutical Ingredients [API’s] are freeze dried for preservation of activity, to enhance solubility, to create a particular physical form such as amorphous or crystalline, to enable concentration with minimal degradation and other proprietary reasons.
These products vary widely and can take the form of any active ingredient that is produced to be mixed with or blended with fillers, carriers, or in pure form and constituted as the final product. The API may be a chemical entity [small molecule] or any compound that has a positive or deleterious effect upon organisms. These products are regulated by many different authorities, both harmonized globally and produced under the auspices of any state or governmental body.
Freeze dried API’s such as anti cancer drugs [Methotrexate], perhaps contained in liposomes, are freeze dried in bulk, in trays inside a freeze-dryer.
Call upon Applewood Scientific to assist you in determining process parameters, freeze drying cycle troubleshooting, or if you are contemplating use of freeze-drying as a unit operation. We are able to help you get started with practical suggestions and guidance.