Why Lyophilize?
Why Lyophilize?
August/September 2003
By Walt Pebley
PharmaQuality
Lyophilization is traditionally used for preserving heat-sensitive parenterals. The elegance of lyophilization or
?low-temperature, low-pressure preservation? is in its ability to retain form and functionality.
This preserved form and functionality is capable of delivering actives in numerous forms: Shape, dimension
and rehydrate rate. Each format depends on several factors. Thermal analysis establishes the optimal freezing protocol before drying into the finished format and defines the temperature and pressure parameters required to preserve functionality during sublimation or vacuum dehydration.
There are several potential applications for lyo. Imagine freeze-dried platelets delivering stabilized growth factors embedded in an advanced wound care platform. Or an oncologist placing a freeze-dried tablet that expands within the space of a removed tumor slowly delivering a significantly smaller dose of chemotherapy than traditional follow-up mechanisms. Or stabilized dermal grafts reconstituted before application on a diabetes-related foot ulcer.
These are just a few R&D examples that may become reality. The product development team at Oregon Freeze Dry Inc., Albany, OR, for example, already has prepared numerous proof-of-concept samples in delivery platforms for comparison to traditional delivery methods, including quick-dissolving tablets, slow-dissolving patches, stabilized therapeutic agents contained within advanced wound care dressing, expanding lyophilized sponges, bulk active ingredients and complexes preserved as a nanoparticle or pastilles of 1mm to 4mm in diameter, and liposomes. Walt Pebley is Vice President, Business & Technical Development at OFD.
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