C&EN, February 12, 2018
To address a significant market interest in Advanced APIs (aAPI®), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying, an advanced particle design technology. Building on its accumulated expertise in all major areas of API development and cGMP manufacture, a full range of cGMP Spray Drying facilities operating at lab, pilot and industrial scale have now been installed at Hovione's API manufacturing plant in Europe and are currently being installed at Hovione’s Technology Transfer Centre in New Jersey, USA.
Building on the state-of-the-art spray drying industrial facility installed in 2004, Hovione now operates three additional units at lab scale and two others at pilot scale. All units comply to the most stringent cGMP requirements, allowing production from just a few grams for feasibility studies to full scale commercial production. Offering process scale-up throughout all phases of product development, Hovione's multi-scale spray drying facilities further widen our ability to provide customized solutions. Designed to support both Custom Synthesis and Generic Product customers, Hovione’s spray drying technology is complemented by complete R&D and analytical studies on particle properties as per specific product requirements, thus offering all expertise and capabilities for successful product development.
All Hovione spray dryers operate with nitrogen as the drying gas and are designed to support both aqueous and organic feeds. The manipulation of the operational parameters during spray drying offers the possibility to control the design of the particle and it’s attributes to meet the requirements of final product. Optimal sizing and shaping of particles, together with a variety of encapsulation options, can improve product stability and bioavailability. Spray drying also overcomes micronization issues associated with conventional grinding and jet milling processes.
The industrial unit has the versatility of operating as a conventional spray dryer or as a fluidized spray dryer. In conventional spray drying operation the process involves continuous atomization of solutions, suspensions and emulsions to generate from ultra-fine particles (below 5-10 micron) up to large particles (100 micron) either in amorphous or crystalline form. In fluidized spray drying, the unit produces dustless free flowing agglomerated powders (up to 400 microns) that can be directly compressible, have increased bulk/tap density, and demonstrate improved wettability/dissolution behavior. Operation in either mode can have applications for processing thermally labile APIs, co-processing APIs with inactive ingredients, as-well-as aid in the reduction of residual solvents and OVIs.
Moreover, complementing Hovione’s growing suite of cutting-edge capabilities, the Company is investing in other state-of-the-art technologies, which will further enhance our particle engineering capabilities.
Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and aAPIs® for the Pharmaceutical Industry. With a 45-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization.