Methods to Assess Mixing of Pharmaceutical Powders.

Abstract

The pharmaceutical manufacturing process consists of several steps, each of which must be monitored and controlled to ensure quality standards are met. The level of blending has an impact on the final product quality; therefore, it is important to be able to monitor blending progress and identify an end-point. Currently, the pharmaceutical industry assesses blend content and uniformity through the extraction of samples using thief probes followed by analytical methods, such as spectroscopy, to determine the sample composition. The development of process analytical technologies (PAT) can improve product monitoring with the aim of increasing efficiency, product quality and consistency, and creating a better understanding of the manufacturing process. Ideally, these are inline methods to remove issues related to extractive sampling and allow direct monitoring of the system using various sensors. Many technologies have been investigated, including spectroscopic techniques such as near-infrared spectroscopy, velocimetric techniques that may use tracers, tomographic techniques, and acoustic emissions monitoring. While some techniques have demonstrated potential, many have significant disadvantages including the need for equipment modification, specific requirements of the material, expensive equipment, extensive analysis, the location of the probes may be critical and/or invasive, and lastly, the technique may only be applicable to the development phase. Both the advantages and disadvantages of the technologies should be considered in application to a specific system.