Enteric Coated Magnetic HPMC Capsules Evaluated in Human Gastrointestinal Tract by AC Biosusceptometry

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Abstract

Purpose

To employ the AC Biosusceptometry (ACB) technique to evaluate in vitro and in vivo characteristics of enteric coated magnetic hydroxypropyl methylcellulose (HPMC) capsules and to image the disintegration process.

Materials and Methods

HPMC capsules filled with ferrite (MnFe2O4) and coated with Eudragit® were evaluated using USP XXII method and administered to fasted volunteers. Single and multisensor ACB systems were used to characterize the gastrointestinal (GI) motility and to determine gastric residence time (GRT), small intestinal transit time (SITT) and orocaecal transit time (OCTT). Mean disintegration time (t50) was quantified from 50% increase of pixels in the imaging area.

Results

In vitro and in vivo performance of the magnetic HPMC capsules as well as the disintegration process were monitored using ACB systems. The mean disintegration time (t50) calculated for in vitro was 25±5 min and for in vivo was 13±5 min. In vivo also were determined mean values for GRT (55±19 min), SITT (185±82 min) and OCTT (240±88 min).

Conclusions

AC Biosusceptometry is a non-invasive technique originally proposed to monitoring pharmaceutical dosage forms orally administered and to image the disintegration process.

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