Bend Research Inc., an independent drug-formulation development and manufacturing company, announced today that it is expanding its pharmaceutical manufacturing capabilities for hot-melt extrusion.
The company has purchased intermediate-scale equipment for hot-melt extrusion at its contract manufacturing facility to provide additional processing options for its clients.
The new equipment–an 18-mm extruder–provides capacity between existing 7.5-mm and 27-mm extruders. This enables manufacture at the appropriate scale for the development phase of the compound. The equipment reduces the amount of drug required for development work, resulting in savings to Bend Research clients and enables rapid, efficient advancement of compounds.
The three extruders enable seamless scale-up of a formulation from small-scale development work through large-scale manufacture of clinical supplies using cGMP regulations for human clinical trials.
“This added capability strengthens our established position as a leading drug-formulation outsource for pharmaceutical companies that need innovative delivery technologies,” said Bend Research President and CEO Rod Ray. “In addition, the new equipment broadens the company’s technology offerings for the delivery of low-solubility drugs.” Bend Research is a recognized international leader in the pharmaceutical industry for technologies that improve the solubility and bioavailability of hard-to-deliver pharmaceutical compounds. The company is well-known for its spray-dried dispersion (SDD) technologies, which have been used to advance hundreds of low-solubility compounds.
Based on pharmaceutical industry estimates, as many as 40% of pharmaceutical compounds in development require solubilization technologies to be orally absorbed into the body. The SDD and hot-melt extrusion technologies are well-known for their abilities to improve oral absorption.
Ray said Bend Research has had the capability to manufacture hot-melt extrusions since 2002 at its cGMP manufacturing facilities. Bend Research is adding specialized suites for high-potency pharmaceutical compounds and has a full range of equipment (e.g., mills, blenders, tableting equipment) to transform the hot-melt extrusion formulations into suitable dosage forms.
“Many people don’t realize that the first commercial pharmaceutical product we helped bring to market was based on hot-melt extrusion technology,” Ray noted. “We worked closely with a client to develop an innovative modified-release product based on hot-melt extrusion that made it possible for patients to take a single dose of an antibiotic rather than a multi-day regimen.” “As an established leader in hot-melt extrusion formulation and processing, we look forward to helping even more clients with this added capability.”