A Quantitative Approach to Understand Raw Material Variability

Abstract

The properties of raw materials can affect the properties and quality of intermediates and the final product. The flow behavior of powders, the form of the raw materials for solid oral drug product manufacturing processes, is poorly understood. Thus, the prediction of manufacturability and process performance is difficult. This is further complicated with variability in raw material flow properties. This chapter discusses seven properties typically characterized and the techniques used to measure them. The state of the art in applying this information to define a formulation of manufacturing process is also discussed.

Predicting pharmaceutical powder flow from microscopy images using deep learning

“…The flowability of a given pharmaceutical powder is a multivariate phenomenon. There are many methods that can be used to measure different powder properties that contribute to the overall flowability 10,11 . Factors which affect flowability include particle size, particle shape, density and surface area, as well as environmental factors such as moisture levels 12 .…”

“…There are many methods that can be used to measure different powder properties that contribute to the overall flowability. 10,11 Factors which affect flowability include particle size, particle shape, density and surface area, as well as environmental factors such as moisture levels. 12 As there are so many factors, it is challenging to use a single test which captures a complete profile of the flow behaviour.…”