Capsugel expands late-stage inhalation product development capabilities

Installation of state-of-the-art Harro Hӧfliger encapsulation unit expands clinical- and commercial-scale capacity for dry powder inhalation applications.

Capsugel has expanded 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% monitoring of dosed powder mass, fill weight ranges between 5 mg and 50 mg, and dose accuracy of RSD<3%. The unit complements Capsugel’s Xcelodose 600S equipment that supports capsule filling for Phase I and Phase II 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."