Three is a Good Number

What is lyophilization?

Also known as freeze drying, it is process of removing water from a product.

What is lyophilized?

Typically, a frozen aqueous solution of the drug, together with non-active components (called excipients).

What is the product of lyophilization?:

The lyophilization process yields a vial containing a low density, typically white, solid, called a “cake”.

How do you administer a lyophilized product?:

A sterile, aqueous diluent—typically saline or water for injection—is added to the vial to dissolve the material (process called reconstitution).

What are the advantages of a lyophilized pharmaceutical?

By removing water from a pharmaceutical, can:

• Prolong the shelf-life
• Protect the drug from water-initiated degradation
• Increase storage temperature flexibility

What are the disadvantages of a lyophilized pharmaceutical?

The disadvantages are the added complexity in preparation of the pharmaceutical and administration to a patient, specifically:

• Manufacturing a lyophilized pharmaceutical product takes several days to produce and requires specialized equipment (a freeze dryer). However, this is a common
• Reconstitution – the lyophilized pharmaceutical must be dissolved (reconstituted) in a sterile liquid (diluent) prior to administration which adds a source of error to dosing.