Catalent Boston Adds to Oral Spray Drying Capacity & Capabilities to Support Late-Stage Clinical Trials & Commercialization

Catalent, the leading provider of oral drug development solutions, bioavailability enhancing technologies, and flexible manufacturing, has completed a series of upgrades to its large-scale spray drying unit (GEA PSD-4) at its Boston, MA, facility. The increased capacity, and addition of multi-solvent capabilities, cyclone collectors, and secondary dryers will enable Catalent to provide enhanced spray-drying services for amorphous solid dispersion (ASD) formulations across late-stage to commercialization projects, to meet the needs of global customers.

The use of ASDs has been widely adopted to successfully improve the solubility and bioavailability of oral dosage forms, particularly of compounds that fall within Biopharmaceutics Classification System (BCS) class II, characterized by low solubility and high permeability.

Catalent Boston’s enhanced ASD capabilities complement the company’s portfolio of bioavailability enhancing technologies, which include particle size engineering, lipid-based formulation, and hot melt extrusion (HME), and helps assure supply chain continuity through seamless integration with Catalent’s global network of downstream dosage form manufacturing facilities.

“Between 75%-80% of molecules in pre-clinical and clinical development are poorly soluble in water and require bioavailability enhancing technologies to enable their further development. Amorphous solid dispersions, produced by spray-drying, are a proven choice to overcome that poor bioavailability, and have been widely adopted. By adding these spray drying capabilities to our existing portfolio of solutions including lipid formulation and softgel manufacturing, micronization, and hot melt extrusion, Catalent becomes the CDMO with the widest commercial-scale bioavailability enhancing technologies,” said Lorenzo Carletti, President of Clinical Development and Supply, Catalent.

And, explaining the technical need for the upgrades to solvent handling, Lorenzo Carletti added: 

“Organic solvents, including for example acetone, methanol, ethanol, and dichloromethane, are commonly used in the manufacture of amorphous solid dispersions, or ASDs, to achieve kinetic stabilization of the drug within the polymer matrix prepared by spray drying, and to maximize drug loading. Catalent Boston’s capabilities already included ethanol handling, commonly used in the manufacture of spray dry powders for inhalation, and these have now been expanded to include other organic solvents for oral ASDs.”