API Bulk and Vial Lyophilization

Some Active Pharmaceutical Ingredients [API’s] are freeze dried for preservation of activity, to enhance solubility and or to create a particular physical form.   Examples are amorphous or crystalline. The form enables long term stability with minimal degradation.

These products vary widely.  Any active ingredient that is produced that’s mixed with or blended with fillers, carriers, or in pure form may be 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.  The regulation may be harmonized globally. Typically 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.  Any of these products can also be filled into vials and dried, stoppered and crimp sealed.  The vials can be back filled with nitrogen or be stoppered under vacuum.

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 help you get started with practical suggestions and guidance.

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