Bend Research, 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.
Bend Research president Jim Nightingale noted as leaders in bioavailability enhancement and modified release, the company is utilizing complementary technologies at Capsugel and Bend Research to improve our collective offerings and help our clients advance their best medicines.
"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," Nightingale added.
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 II 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.