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Particle Image Analysis In Pharmaceutical Ointment

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White Paper: Particle Image Analysis In Pharmaceutical Ointment

By Deborah Huck, Product Technical Specialist, Morphological Imaging, Malvern Instruments

The majority of pharmaceuticals are manufactured in multistage batch processes, using analysis after each step to confirm suitability for further processing. Final product quality is verified using a series of closely defined analyses, agreed with the competent authority in the country of marketing. For pharmaceuticals containing solids, particle size has a significant impact on processing and performance parameters such as blending efficiency, dissolution rate and bioavailability. Particle size is therefore a variable that is measured routinely during processing and for final quality control.

While many pharmaceutical companies rely on manual microscope-based measurements for specific analyses, these methods are time-consuming and can be influenced by both human subjectivity and analyst-to-analyst variability. An alternative approach is to use a high sensitivity automated image analyzer that can provide statistically relevant particle size and shape data in minutes. The benefits of this approach are illustrated here through a case study involving the detection of needle shaped crystals in an ointment using the Morphologi® particle image analyser from Malvern® Instruments.

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White Paper: Particle Image Analysis In Pharmaceutical Ointment

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