Lyophilized Injectable Drugs to 2024


There are currently more than four-hundred-seventy FDA-approved drugs supplied as powders requiring reconstitution prior to administration. Key factors in this trend are the expansion in the number of approved biologicals and the push toward self-administered injectables for chronic conditions. The therapeutic impact has been new and better treatments for numerous refractory diseases. The product impact has been an increasing effort to improve the safety and simplicity of the reconstitution process, leading to creative device designs that minimize patient errors.



Lyophilized injectable drugs are primarily therapeutic proteins, which  must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed – a requirement referred to as the ‘cold chain’. Alternatively, proteins can be formulated as powders (lyophilization). Lyophilized proteins must be reconstituted prior to injection. Lyophilized drugs are sold with reconstitution vial systems, or packaged in special injection devices (e.g., pens, needle-free injectors, two-part syringes) that allow reconstitution to take place in the device prior to injection.