Metrics Contract Services, the contract pharmaceutical development and manufacturing division of Mayne Pharma, has invested in additional equipment to enhance capacity in drug delivery. A Korsch XM-12 Bilayer Tablet Press and a Top Spray Fluidization system for the Glatt GPCG-120 PRO will further provide capacity and efficiency improvements in meeting increasing client demand for potent OSD product processing.
Metrics’ new Korsch XM-12 is a state-of-the-art small-scale press with hard-wall isolation/containment for potent product processing and is a strategic addition for Metrics’ formulation development team. The tablet press is designed for both single layer and bi-layer tablet production and has the added flexibility of both B and D quick changeout turrets for rapid changeover.
The Glatt 120 Top Spray Fluidization system enables top spray coating, the surface coating, which ensures improved product handling or storage stability to protect against moisture, oxygen or light. The spray liquid is sprayed from above onto the fluidized particles.
Along with the new top spray system, Metrics added a new vacuum transfer system that can transfer the API and excipient directly to the fluid bed dryer. Once the final product is ready, it can be transferred fully contained. The process also leaves “zero API in wastewater.”
Brad Gold, VP of Pharmaceutical Development noted that “both of these new technologies add capacity in our development/clinical and commercial sectors…allowing us to develop more complex dosage forms, explore enhanced drug delivery options, and meet demand for larger production orders. These additions are part of Metrics Contract Services’ commitment to continuous improvement on behalf of our customers.”
“In preparation for using the Korsch XM-12, Metrics’ scientists and manufacturing team underwent thorough training alongside Korsch factory technicians in parallel with qualification and validation that was performed by Metrics’ qualification/validation team experts,” Gold added.
“All were required to meet both industry standards and the standards set by Metrics validation and quality team leaders. The training targeted pharmaceutical development operators and scientists, technical transfer staff and maintenance staff. Both bilayer and single layer modules were challenged as well as instruction on changeovers, cleaning and containment testing.”
According to Gold, the XM-12 has the built-in technology to maintain consistent precision output with very little operator interaction after critical settings are put into place.
About Metrics Contract Services
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering proven scientific and operational excellence for novel oral dosage forms. Metrics’ areas of expertise include quality pharmaceutical formulation development; first-time-in-human formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing. Technical capabilities include highly potent and unstable compounds; Schedule II-V controlled substances; and products with poor bioavailability, for which we offer an impressive portfolio of advanced delivery methods. Metrics manufactured products are now approved by medicines regulators in more than 40 countries. Located in Greenville, N.C., Metrics is a proud member of Mayne Pharma.
About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on the application of drug delivery expertise to commercialize branded and generic pharmaceuticals. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide. Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that continue to be marketed around the world. Mayne Pharma has two drug development and manufacturing facilities based in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds.
