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Pharmaceutical compliance

20 December 2010 No Comment

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Although I haven’t been at Malvern quite that long, Malvern Instruments has been delivering particle characterization solutions to the pharmaceutical industry over 30 years. Over those years laser diffraction has become one of the most widely used techniques for particle size analysis throughout the pharmaceutical industry, with applications from product development through to production and quality control.

As discussed in ICH Topic Q6A, particle size may have a significant influence on product solubility or bioavailability, processability, stability, dose-content uniformity, and appearance. Wherever particle size or particle size distribution is found to be critical to these performance attributes, the Food and Drug Administration (FDA) recommends that a particle size specification is provided.

Effective particle size analysis

Effective size analysis of pharmaceutical products and components is reliant upon:

  • Particle variables: the influence of manufacturing, processing, compatibility and storage
  • Sampling method: must account for bias caused by scale, context and protocol
  • Analytical technique: inherently dictates the robustness and reliability of final data
  • Data expression: statistical treatments and presentation effect results interpretation

One of the main strengths of laser diffraction is its simplicity. As a first-principles particle sizing technique it requires no external calibration. The measurement is non-destructive, non-intrusive, rapid and reliable, and can be used for either dry or wet samples across a broad range of sizes and formulation types. For these reasons, the decision to include a laser diffraction instrument within any pharmaceutical laboratory is, in my opinion, one of the easiest decisions to make!

Do you need to use laser diffraction?

Still unsure of the answer to this question? Several of my colleagues at Malvern Instruments have published multiple articles, application notes, webinars and podcasts on the specific advantages of pharmaceutical particle characterisation and laser diffraction technologies, all of which are available through Malvern’s extensive knowledge library. A good starting point in understanding whether you need to consider particle sizing is an article titled ‘Particle Size Analysis’, written by Dr Paul Kippax. Alternatively, you could check out the ‘Setting Realistic and Meaningful Size Specifications’ presentation, which formed part our our Laser Diffraction Masterclass series of webinars.