The new, high-capacity pharmaceutical spray dryer (PSD) can be used for scale-up, quality-by-design studies (QbD), and the production of appropriate toxicology study supplies in a non-GMP environment, and comes as part of the first stage of a $20m (€15m) expansion at the site in Oregon, US operated by Bend Research which Capsugel acquired in September last year.
The firm is concurrently expanding its SDD capacity at its GMP commercial facility – set to be completed mid-2015 – but Dan Dobry, Vice President at Bend, spoke about the rise in demand from clients and partners for such bioavailability enhancement in pre-clinical and non-GMP activities, as well as clinical and commercial product advancement.
“We see a rise in demand for non-GMP services for two primary reasons,” he told in-Pharmatechnologist.com. “One, which is purely for manufacturing, is to produce quantities of high bioavailability material for stability or toxicology studies.
“The second is conducting process development and design space studies to build a knowledge base required to support the formulation and process filing as required by the current ICH guidances.”
Furthermore, in many cases clients are looking to use the same technology that will later be used to commercialise the drug in both development and toxicology studies, and even for non-GMP “SDD technology is very competitive in comparison with other bioavailability technologies,” Dobry said, adding “the cost of the technology often pays for itself in the reduction in dose needed to hit the target therapeutic effect.”
The installation is undergoing final qualification activities and Bend already has several customer projects lined up to use this new capability this summer, Dobry added.
SDD offers enhancement to the bioavailability of a product and in many cases “is truly enabling,” Dobry said, meaning there would be no product without it.
There are a number of alternative bioavailability enhancing technologies offered by Capsugel/Bend and its competitors, including hot melt extrudates (HME), nanocrystal approaches, and lipidic systems in liquid-filled hard capsules and soft gels.
However, “SDDs are often chosen due to broad applicability across a range of API physicochemical properties; a robust, scalable, and well-understood process; and in many cases, higher drug loading per unit dose than other approaches,” Dobry told us.
He added, however, factors varying from melting point and logP properties to the permeability and dose of a molecule are assessed before determining the best technology to enhance bioavailability.