Installation of state-of-the-art Harro Hӧfliger encapsulation unit expands clinical- and commercial-scale capacity for dry powder inhalation applications
Morristown, N.J., March 30, 2017 – Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions, today announced the expansion of its late-stage inhalation capabilities to advance dry powder inhalation (DPI) concepts through late-stage clinical trial and commercial production. The company has completed installation and validation of a new Harro Hӧfliger Modu-C MS encapsulation unit at its Bend, Ore. facility that includes specialized drum-dosing technology for use in DPI development projects utilizing spray-dry processing. The investment strengthens Capsugel’s full-service inhalation product-development capabilities, which include proprietary spray-dry processing, specialized CMC/analytical services, and encapsulation capacity to support development, clinical trial and commercial scale projects.
“Drug delivery via the lung is becoming an increasingly viable treatment option for a wide range of therapeutic areas, including infectious diseases, genetic disorders and acute systemic conditions that have traditionally been treated via other delivery routes,” said Devon DuBose, Head of Inhalation Product Development at Capsugel’s Bend, Ore. facility. “Spray-dry processing is finding greater utilization in DPI applications because of its superior particle size control, higher drug loading and fewer formulation dependencies compared to traditional lactose blend formulations. Our customers are seeking partners with not only advanced particle engineering technology and expertise, but also integrated inhalation product development solutions that minimize program risk and complexity.”
Capsugel’s new Harro Hӧfliger Modu-C MS encapsulation unit includes an operational capacity of more than 72,000 capsules per hour. The premier technology provides 100 percent monitoring of dosed powder mass, fill weight ranges between 5mg and 50mg, and dose accuracy of RSD<3%. The unit complements Capsugel’s Xcelodose® 600S equipment that supports capsule filling for Phase 1 and Phase 2 trials. Capsugel’s capabilities for DPI formulations include spray drying for all clinical phases and commercial manufacturing, formulation development and scale-up expertise, phase-appropriate encapsulation and full aerosol analytical capabilities in development and GMP.
“Building on 25 years of experience with spray-dry technology and with formulating more than 1,000 compounds for oral delivery, this expansion is part of our long-term effort to bring our particle engineering, spray-dry processing capabilities and encapsulation expertise to pulmonary drug delivery and growing DPI applications,” said David Lyon, Ph.D., Head of Biotherapeutics, Capsugel. “By broadening our inhalation product development capabilities, we are positioned as an industry leader in specialized oral delivery and in bringing innovative therapies to market.”
Learn more about how Capsugel is driving pulmonary delivery forward here.
Capsugel designs, develops, and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health and nutrition industries. Our unique combination of science, engineering, formulation and capsule expertise enables our customers to optimize the bioavailability, targeted delivery and overall performance of their products. We partner with more than 4,000 customers in over 100 countries to create novel, high-quality and customized solutions that align with our customers’ evolving needs and benefit patients and consumers. For more information, visit www.capsugel.com and follow us on Twitter, LinkedIn and YouTube.