:: AZoNanotechnology Article
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Topics Covered
Introduction
Particles
Performing Pharmaceutical Inspection with the Phenom
Introduction
FEI's
Phenom is a revolutionary tabletop SEM with magnifications up to
20,000x.
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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Figure 1. Phenom Desktop SEM
Particles
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.
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. Additionally,
particle size and shape influence pharmaceutical production properties such as
flow, compaction and dissolution.
The Phenom can be used as an imaging tool at the development,
formulation, and manufacturing stages of pharmaceutical product development.
Performing Pharmaceutical Inspection with the Phenom
The structure and surface morphology of two classes of Kollidon provide their
unique properties. For example, Figure 2 illustrates the smooth surface and
spherical shape that provides Kollidon 25 with good film-forming and dispersing
action properties. Figure 3 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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Figure 2. Kollidon 25
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Figure 3. Kollidon Cl
Phenom allows visualization of broken particles, agglomerates,
fines, and foreign particles. The powder samples shown in Figures 4 and 5 were
affixed to carbon tape on a standard SEM stub before loading into the Phenom.
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Figure 4. Powder sample
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Figure 5. Powder sample
Source: "Phenom use for Pharmaceutical Inspection" Application
Note by Phenom-World
For more information on this source please visit Phenom-World