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Phenom use for pharmaceutical inspection
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(Nanowerk NanoBusiness Article) This application note illustrates how the Phenom can be used as a simple “point and shoot” instrument
for the rapid inspection and qualitative characterization of pharmaceutical particles.
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FEI’s Phenom is a revolutionary tabletop SEM with
magnifications up to 20,000x.
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The Phenom’s intuitive touch-screen controls and never-lost
sample navigation features remove the difficulties associated
with operating a traditional SEM. Pharmaceutical scientists
no longer have to outsource SEM work. High resolution
images of pharmaceutical particles can be obtained at the
lab bench within seconds. The Phenom can help shorten
drug development and validation cycles, enabling faster
time-to-market for new drug products.
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Particles
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Production of a solid drug dosage form typically begins with
the formation of an active pharmaceutical ingredient (API)
into particles, generally within the range of 0.1 to 10
micrometers. Once the API is in particulate form it is
blended with an excipient to form a larger particle called a
granule in order to improve the flow and physiochemical
properties with respect to the API.
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The size, shape, and morphology of API and granule particles
are important characteristics that can influence dissolution
behavior and drug bioavailability. Smaller particles with
minimal size and shape variance provide faster and more
predictable dissolution and absorption rates.
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Additionally, particle size and shape influence
pharmaceutical production properties such as flow,
compaction and dissolution.
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The Phenom can be used as an imaging tool at the
development, formulation, and manufacturing stages of
pharmaceutical product development.
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| Left: Figure 1. Kollidon 25; Right: Figure 2. Kollidon Cl.
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| Left: Figure 3. Powder sample; Right: Figure 4. Powder sample.
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The structure and surface morphology of two classes of
Kollidon provide their unique properties. For example,
Figure 1 illustrates the smooth surface and spherical shape
that provides Kollidon 25 with good film-forming and
dispersing action properties. Figure 2 provides excellent
views of the sponge-like structure of Kollidon Cl which allows
the particles to act as a disintegrant by absorbing water and
swelling.
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Phenom allows visualization of broken particles,
agglomerates, fines, and foreign particles. The powder
samples shown in Figures 3 and 4 were affixed to carbon
tape on a standard SEM stub before loading into the
Phenom.
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Source: FEI Company. Find your Phenom contact information on www.fei.com/phenon
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