Article
Process-Relevant Powder Characterization: A Powerful Tool For Development And Troubleshooting
March 23, 2009
•Featured Article: Process-Relevant Powder Characterization: A Powerful Tool For Development And Troubleshooting
By TIM FREEMAN
The pharmaceutical industry's current focus on Quality by Design (QbD) is intensifying requirements for process-relevant information early in a product's life. Closer integration of process and formulation development reduces the likelihood of problems with product quality or operability. This integration relies, however, on the ability to characterize materials, often using only small sample volumes, in ways that accurately predict processing performance.
Predicting the behavior of powders has always been a challenge. All too often, poor performance is detected only when a process fails, which wastes valuable resources. With reproducible, multifaceted powder characterization, this is no longer the case.
Measuring dynamic, bulk, and shear properties builds the most complete picture of powder behavior. In the processing environment, this information can be used to draw up specifications that define operability and reliably identify poorquality batches at the earliest opportunity. At the development stage, it helps tailor a formulation for optimal performance in a specified unit operation.
This article examines modern strategies for powder characterization in the pharmaceutical industry, with reference to commonly used technologies. It explores the value of systems that offer multiple methodologies and examines how they costeffectively and time-effectively generate data that support product development and process operation.
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•Featured Article: Process-Relevant Powder Characterization: A Powerful Tool For Development And Troubleshooting
