چکیده (انگلیسی):

There has been considerable interest in developing
biodegradable, injectable microspheres for the
controlled release of proteins and peptides [1-4].
Several transfer-required processes such as
filtration, centrifugation, and vacuum- or freezedrying
are necessary for preparation of
microspheres, and these processes might be
obstacles when scaling-up the manufacturing
process to produce sufficient quantities of sterile
material for clinical trials and, ultimately,
commercialization [5].
A vibro-filter dryer system using Sweco
PharmASep (Sweco Inc, Florence, KY) technology
[6-10] has been designed to facilitate aseptic
transfer of all of the solid-containing slurry from a
reactor vessel and/or a quench tank, to remove the
slurry liquid media, to dry the collected solid
product by purge-air/vacuum application, and to
efficiently recover the dried particles. The
PharmASep unit would also facilitate washing and
rinsing of the particles before drying.
In a previous study [10] the feasibility of using the
PharmASep unit to separate microspheres from an
aqueous slurry, rinse them on a screen, and vacuumdry
them before recovery was assessed. The
purpose of this study was to assess reproducibility
of results using the Sweco PharmASep unit and to
determine its utility for freeze-drying, often the final
step in the preparation of microspheres.