Pharmatek Laboratories, Inc., a contract
development and manufacturing organization supporting the pharmaceutical
industry, announced that it has added roller compaction to its solid oral dosage
form manufacturing capabilities. The company has purchased two roller
compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20
kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1
kg/hour. Both machines have been integrated into Pharmatek’s GMP facility and
are ready for GMP manufacturing.
“The
addition of roller compaction expands our granulation capability, especially in
the area of moisture sensitive and density-challenged API’s. When used in
conjunction with our microdose capsule filling technology (Xcelodose 600S and
Symyx Powdernium MTM2005), roller compaction also provides an option for larger
fill weights in powder-in-capsule dosage forms,” said Kevin Rosenthal, Director
of Manufacturing. “Additionally, with the purchase of two roller compactors we
now have dry granulation capability in our highly-potent and non-highly-potent
manufacturing facilities.”
Pharmatek
has also complemented existing manufacturing capacities by expanding
single-batch blending size capabilities three-fold (up to 36kg) with the
acquisition of a 3 cu. ft. V-blender, and increasing capsule and tablet
production by purchasing a Bosch GKF400 automated encapsulator with a rate of
23,000 capsules/hour and a Korsch PH-106 instrumented tablet press with rate of
32,400 tablets/hour.
“With the
roller compactors, Pharmatek can now support a broad range of solid oral
formulations that previously were not optimal or feasible using our existing wet
granulation equipment due to moisture sensitivity. The 3 cu. ft. V-blender and
Bosch encapsulator have positioned us well for large-scale Phase II clinical
trial manufacturing,” stated Jeff Bibbs, CEO and CSO of Pharmatek. “Also, by
expanding our existing encapsulation and tablet manufacturing capabilities, we
can better serve our clients‘ clinical
drug supply needs as they move beyond small-scale development and transition to
GMP manufacture of drug product for clinical trials.”
