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High-Tech - from IMPD to Visualisation
The labelling of an oral dosage form is achieved by adding a small quantity (0.5-5 mg) of black iron
oxide (during the manufacture or later via a hole bored into the tablet) followed by magnetisation.
The magnetic field of the magnetised dosage form is measured using special, highly sensitive multi-
channel SQUID (Super-conducting Quantum Interference Device) sensors (
Figure explains measurement device setup
). The magnetic flux density determined at different positions by the SQUID sensors enables the
investigator to localise a dosage form in the gastrointestinal tract and to measure the degree of
disintegration by the actual dipole moment (
see Figure
).
250 images are normally recorded each second with the result that even very rapid processes can be
followed with high precision. In this regard, the procedure is markedly superior to gamma-scintigraphy,
the standard procedure hitherto. A further relevant advantage of the method is that Magnetic Marker
Monitoring permits three-dimensional localization of the dosage form in the gastro-intestinal tract.
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The use of magnetite as a marker avoids toxicity problems since this black pigment (E172)
is a colouring material licensed for medicinal products and foodstuffs. Magnetite is
available in pharmaceutical quality and thus, questions on purity do not arise when
preparing the required IMPD (Investigational Medicinal Product Documentation).
These factors make it possible to use this investigational technique in pivotal studies
for drug registration purposes.
More detailed information may be taken from
our PDF-folder or
our review articles and scientific publications submitted on request:
"High-Resolution Monitoring of the Gastrointestinal Transit of a Magnetically Marked Capsule"
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