Abstract
The morphology of free-flowed and gravity consolidated crystal powder beds of the alpha and beta polymorphic forms of l-glutamic acid, together with a detailed analysis of particle density and micr...
Highlights
The quality by design paradigm[1,2] for pharmaceutical product development and manufacture requires a number of robust computational models and workflows which can be used to determine the downstream processability of a chosen product formulation based on the material properties of its constituent ingredients
To obtain the beta form solids, the methodology used for the alpha form was repeated; the solution concentration was increased to 50 g/kg. and the cooling rate was decreased to 0.1 °C/min
This work demonstrates a novel application of modern X-ray computed tomography techniques to study the fundamental consolidation properties of the related alpha and beta polymorphic phases of L-glutamic acid
Summary
The quality by design paradigm[1,2] for pharmaceutical product development and manufacture requires a number of robust computational models and workflows which can be used to determine the downstream processability of a chosen product formulation based on the material properties of its constituent ingredients. Movement, breakage, and interactions can occur between individual particles and between particles and process equipment internals.[6] the density of the powder within the powder bed can change, leading in turn to variations in the local material properties within the tablet. All this can impact upon the content uniformity of the product and, in extreme cases, result in variable dissolution profiles with a concomitant impact on the safety and efficacy of the drug product leading to product failures and increased production costs
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