Issue: April 2017, Posted Date: 4/4/2017
Capsugel Expands Late-Stage Inhalation Product Development Capabilities
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.
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
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.
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.”
about how Capsugel is driving pulmonary delivery forward here.
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
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