Science Of Scale For Spray Dried Intermediates

By David K. Lyon, Ph.D., Senior Fellow, Research and John M. Baumann, Associate Director, R&D, Lonza

Speed to market is a critical aspect of developing new pharmaceutical products and scale-up—or scale-down—can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which can lead to poor bioavailability. Compounds with these challenging properties—estimated at 70% of the compounds in drug pipelines today—have a narrow window of absorption in the small intestine, reducing the amount of drug absorbed into the body and significantly decreasing efficacy.

Spray drying effectively addresses this challenge, improving the dissolution, solubility, and, hence, bioavailability of these compounds that might otherwise have to be abandoned, resulting in lost economic and therapeutic opportunities. Spray-dried dispersions (SDDs) have been produced as drug-product intermediates for a wide array of final dosage forms including tablets and capsules.

More than 20 products containing spray-dried intermediates have been brought to market, most within the last 10 years, and dozens more are currently advancing in pharmaceutical pipelines. As a result, substantial pressure has built to develop process understanding and science of scale tools so these promising compounds can rapidly and seamlessly progress from prototype preclinical and clinical formulations directly to commercial scale.