High shear wet granulation is a common unit operation in solid dosage formulation, yet a mechanistic understanding is not well known. One goal of high shear granulation is to yield a repeatable granule size and granule shape distribution at the batch endpoint. This is necessary for consistent downstream drying, milling, flow properties, and content uniformity. However, inconsistencies often occur during granulation development and scale up due to changing API, raw materials, or changing process dynamics such as segregation, agglomeration, or breakage. The application of in situ particle characterization techniques are demonstrated to track a series of granulation batch process at pilot scale while varying the API, raw materials, shear, liquid addition, and wet massing time. It is now possible to directly link process control parameters to the particle distribution and the product quality. By designing a robust granulation process, you can ensure consistent downstream processing from granulation through tablet dissolution.
In this webinar, top driven 75 liter Collette high shear wet granulation experiments are compared with various formulation conditions, API, and excipients. The process repeatability is characterized.
High shear wet granulation is a complex process with competing mechanisms of breakage and agglomeration. Using in situ PAT for particle characterization it is possible to quantify the effect of critical process parameters during the high shear wet granulation process. FBRM® is ultimately used to target a specific growth profile, wet massing time, and endpoint particle size and shape distribution with various placebo and API formulations.