Issue: April 2017, Posted Date: 4/12/2017
New Glatt GPCG 10 Fluid Bed Granulator at Metrics
its known expertise in developing multi-particulate and modified-release drug
products, Metrics Contract Services has acquired a new Glatt GPCG 10 fluid bed granulator
with Wurster inserts.
equipment has been commissioned and now is available to the 29 scientists working
within Metrics’ formulation development group.
processing is recognized within the pharmaceutical industry as being the
most precise coating process for reproducibility and film quality. The Glatt
GPCG 10 fluid bed granulator offers a number of important attributes to
Metrics’ formulation development scientists, said Joe Cobb, director of
pharmaceutical development. They include:
and 60-liter product bowls for fluid bed drying/granulating/coating.
and 12-inch Wurster HS processing units for high-speed spray and fine-particle
12-bar pressure-shock-resistance construction.
machine interface control panel with programmable recipe capability, and
processing down to 0°C dew point.
members of Metrics’ formulation development group have 60+ years worth of experience
processing modified-release products and taste masking using Wurster technology,
said Brad Gold, PhD, vice president of pharmaceutical development.
scientists have worked on hundreds of compounds at every stage ranging from
pre-formulation through to commercial process validation,” he said.
DeHart, PhD, senior scientist, agreed, adding that with their extensive understanding
of process controls and parameters, Metrics scientists can achieve a wide range
of dissolution profiles for clients’ projects.
collective experience is critical for developing a robust formulation and
process in the early stages,” he said. “We have the science and the equipment
to understand the front-end requirements, which influences the successful scale
up to commercial manufacturing.”
part of Metrics’ expanded multi-particulate capabilities, the organization will
be adding a Zanasi Plus 16 encapsulator in
The Glatt GPCG 10 fluid bed granulator and the Zanasi Plus 16
encapsulator will help Metrics scientists advance complex development projects
that ultimately will offer patients more choices for improved health and well
being, said Keith Moore, vice president of analytical services.
am excited about the opportunity to support multi-particulate formulations that
can achieve site-specific drug release, whether it is in support of continuous
colonic delivery, for example, or simply reducing the potential for dose
dumping in comparison to traditional, monolithic formulations,” Moore said. “In-vitro
dissolution testing will be key to ensure we support the manufacturing staff in
formulating the right delivery systems for our clients.”
analytical services group has significant experience developing methods for
modified-release products and have worked on several products that have earned FDA
new formulation development equipment is part of an $80-million capital investment that will
significantly expand facilities and equipment for Metrics Contract Services and
its parent company, Mayne Pharma. A highlight of that investment is construction
of an 126,000-square-foot, oral-dose commercial
manufacturing facility that will quadruple the company’s U.S. manufacturing
capacity, and create 10+ new analytical laboratories and formulation
Once the new facility opens,
Metrics Contract Services will offer a more comprehensive “concept to
commercialization” solution in one contiguous location for clients — providing larger scale and increased capabilities for seamless scale-up, and
eliminating the need for site transfers.
the conclusion of expansion, Metrics Contract Services will have four Glatt
fluid-bed systems — the GPCG 1, the GPCG 10, the GPCG 30 and the GPCG 120 — all
with Wurster inserts to support development through validation as well as commercial
manufacturing of modified-release compounds.
learn more about how Metrics’ formulation development and analytical services
can advance your drug development program, please contact Tom Salus at
973.557.1413 or Thomas.Salus@maynepharma.com.
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