Bend Research Inc., part of Capsugel’s Dosage Form Solutions business unit, announced the addition of Capsugel’s Xcelodose precision powder-filling technology to its drug development process. This patented micro-dosing technology will further enhance Bend Research’s recently announced Rapid Advancement of Preclinical Compounds initiative. The technology will also facilitate fast and efficient scale up and transfer of powder-fill formulations within Capsugel’s global network of commercial production sites.
The Xcelodose 600S precision powder micro-dosing system enables the dispensing of dose weights as low as 100 micrograms, without excipients or bulking agents. This technology is widely established within the pharmaceutical industry for early stage clinical trials and small-scale production. In addition to streamlining and speeding the process of preparing product for clinical trials, the technology can lower costs by reducing the need for additional costly and time-consuming stability studies. It also gives the company the ability to fill capsules in a controlled environment.
The Xcelodose technology will have specific applications in Bend Research’s oral and inhalation product development. “As leaders in bioavailability enhancement and modified release, we are utilizing complementary technologies at Capsugel and Bend Research to improve our collective offerings and help our clients advance their best medicines,” explained Jim Nightingale, President of Bend Research.
“For example, integrating Bend Research’s expertise in particle engineering for inhalation, Capsugel’s Xcelodose® technology, and Capsugel’s expertise in development of customized dry powder inhalation (DPI) capsules will do just that in the area of inhalation drug development and delivery.” The rapid advancement of spray-dried dispersions (SDD) to the clinic will also benefit from the Xcelodose® technology and the overall formulation flexibility of capsule technology.
Precision capsule fill capability is imperative for dry powder inhalation drug products. The addition of the Xcelodose® technology to the Bend Research drug development technology portfolio further ensures that inhalation drug development can progress from proof of concept through Phase 2 in 20 weeks or less. The use of capsules for early feasibility and first-in-human clinical trials is a key component of the Rapid Advancement of Preclinical Compound initiative. Specifically, this initiative includes proof of concept (POC), feasibility, and scale-up for IND supporting toxicity and stability study analysis, as well as cGMP manufacturing capability. www.bendresearch.com/content/cgmp-manufacturing
ABOUT BEND RESEARCH INC. For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding. Bend Research is a leader in novel formulations, including spray-dried dispersions and hot-melt extrusions formulations, as well as controlled-release, inhalation, and biotherapeutics technologies. Bend Research is a part of Capsugel’s Dosage Form Solutions business unit. For more information, visit www.BendResearch.com
ABOUT CAPSUGEL Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care industry. The company’s Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other specialized capsule technologies, producing more than 200 billion capsules annually. Capsugel’s Dosage Form Solutions (DFS) business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. The company’s fast-to-clinic program streamlines product development from pre-formulation through clinical and commercial supply for finished dosage forms.
Headquartered in Morristown, N.J., Capsugel employs more than 3,100 people, has 13 manufacturing and R&D facilities across three continents, and serves more than 4,000 customers in over 100 countries.
For additional information, visit www.capsugel.com. (POC), feasibility, and scale-up for IND supporting toxicity and stability study analysis, as well as cGMP manufacturing capability. For a complete listing of Bend Research’s development and manufacturing equipment, please visit: www.bendresearch.com/content/cgmp-manufacturing
