Effect of Precirol ATO5 concentration and twin-screw melt granulation temperature on the physical properties of ascorbic acid granules

Abstract

The pharmaceuticalindustry has a growing interest in continuous manufacturing, particularly forhigh-volume dosage forms such as solid oral tablets. This is driven by the obviousbenefits such as small footprint, batch size flexibility, the relative simplicityof scale-up and process control. Tablets are the most popular solid dosageform, while batch granulation is one of the most often used technologies intablet manufacturing. Using ascorbic acid as a model, we show the possibility ofproducing granules and tablets with a sustained-release profile using threetechnological operations: mixing, continuous melt-granulation, and tabletting.