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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.

 

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