New Glatt GPCG 10 Fluid Bed Granulator at Metrics
Enhancing 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.
The equipment has been commissioned and now is available to the 29 scientists working within Metrics’ formulation development group.
Wurster 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:
- 40-liter and 60-liter product bowls for fluid bed drying/granulating/coating.
- 7-inch and 12-inch Wurster HS processing units for high-speed spray and fine-particle coating.
- Solvent-capable, 12-bar pressure-shock-resistance construction.
- Human machine interface control panel with programmable recipe capability, and
- Low-humidity processing down to 0°C dew point.
Together, 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.
“Our scientists have worked on hundreds of compounds at every stage ranging from pre-formulation through to commercial process validation,” he said.
Michael 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.
“Our 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.”
As part of Metrics’ expanded multi-particulate capabilities, the organization will be adding a Zanasi Plus 16 encapsulator in July.
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.
“I 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.”
Moore’s analytical services group has significant experience developing methods for modified-release products and have worked on several products that have earned FDA approval.
The 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 development suites.
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.
At 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.
To 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.