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Advances in the Pharmaceutical Industry Have Shaped Particle Sizing Technology
From QC to QbD and Beyond
Analytical technologies and bio/pharmaceutical process development have advanced in parallel through necessity and innovation.
The pharmaceutical industry is an exacting consumer of analytical technology, requiring techniques that deliver the data required to enable a knowledge-based approach to product development and to manage the risk of transfer of new products into manufacturing. The adoption of quality by design (QbD) and process analytical technology (PAT) has encouraged the pharmaceutical industry to embrace and exploit new analytical approaches.
The importance of particle size information throughout the pharmaceutical lifecycle means that the evolution of particle sizing techniques has closely tracked these advances. Today, a diverse range of particle sizing solutions is available, from techniques for the characterisation of complex formulations through to online PAT tools for real-time measurement.
The advancement of particle size analysis
Advances in software and hardware design have enabled the optimisation of laser diffraction instrumentation for the laboratory to the point where particle size measurements over a size range encompassing most pharmaceutical actives, excipients and intermediates can be achieved in under a minute. Smart software and analysis capabilities ease the burden of method development, validation and transfer.
While the past few decades have seen laser diffraction mature in its application, there has been a time of rapid innovation in the other areas of particle characterisation. The commercial availability of automated imaging systems has substantially reduced the time taken to obtain statistically relevant particle shape information. Automated imaging has been successfully combined with spectroscopy to deliver component-specific particulate data. Techniques such as morphologically directed Raman spectroscopy enable the measurement of the particle size and shape of discrete chemical entities within multicomponent formulations. These capabilities are now being applied to better understand blending processes, and also to support the demonstration of bioequivalence within generic-drug applications.
The future of pharmaceutical analysis
A progressive shift towards biopharmaceuticals, as opposed to small molecule drugs brings new, unique challenges in terms of developing the analytical technology needed to generate appropriate biophysical and biochemical data during pre-formulation, formulation and QC testing of these products.
Into the future, mutually beneficial collaboration between the pharmaceutical and analytical instrumentation industries looks certain to continue, to ensure new challenges are efficiently met. By sharing information with analytical technology providers, the pharmaceutical industry will prompt the agile development approaches required to commercialize new analytical techniques that fully meet its evolving needs.
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