Capsugel said today that it expanded its late-stage inhalation formulation capabilities to move dry powder inhalation concepts through late-stage clinical trial and into commercial production. The company installed a new Harro Hofliger Modu-C MS encapsulation unit at its Oregon-based facility.
The machinery features specialized drum-dosing tech for use in dry powder inhalation development projects with spray-dry processing, Capsugel said.
“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,” Devon DuBose, head of inhalation product development at Capsugel’s Oregon facility, said in prepared remarks. “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.”
The Harro Hofliger Modu-C MS encapsulation unit has an operational capacity of more than 72,000 capsules per hour, Capsugel said, and boasts 100% monitoring of dosed powder mass, fill weight ranges between 5mg and 50mg, as well as proven dose accuracy.
The machine builds upon Capsugel’s Xcelodose 600S equipment that the company uses for capsule filling in Phase I and II trials.
“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,” head of biotherapeutics David Lyon added. “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.”