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Published on: March 29, 2019
Non-invasive MRI detection of individual pellets in the human stomach
Manfred Knörgen1, Rolf Peter Spielmann, Ahmed Abdalla
1Department of Diagnostic Radiology, Martin-Luther-University of Halle, Halle, Germany.
Abstract:
MRI is a powerful and non-invasive method to follow the fate of oral drug delivery systems in humans. Until now, most MRI studies focused on monolithic dosage forms (tablets and capsules). Small-sized multi-particulate drug delivery systems are very difficult to detect due to the poor differentiation between the delivery system and the food. A new approach was developed to overcome the described difficulties and permit the selective imaging of small multi-particulate dosage forms within the stomach. We took advantage of the different sensitivities to susceptibility artefacts of T(2)-weighted spin-echo sequences and T(2)-weighted gradient echo pulse sequences. Using a combination of both methods within a breath hold followed by a specific mathematical image analysis involving co-registration, motion correction, voxel-by-voxel comparison of the maps from different pulse sequences and graphic 2D-/3D-presentation, we were able to obtain pictures with a high sensitivity due to susceptibility effects caused by a 1% magnetite load. By means of the new imaging sequence, single pellets as small as 1mm can be detected with high selectivity within surrounding heterogeneous food in the human stomach. The developed method greatly expands the use of MRI to study the fate of oral multi-particulate drug delivery systems and their food dependency in men.
Insights
Magnetic Resonance Imaging (MRI) can now track tiny oral drug delivery systems in the stomach. A new MRI technique enhances visualization of small multi-particulate systems amidst food, improving drug delivery research.
Area of Science:
- Medical Imaging
- Pharmacology
- Biomedical Engineering
Background:
- Magnetic Resonance Imaging (MRI) is a valuable non-invasive tool for tracking oral drug delivery systems in humans.
- Detecting small, multi-particulate drug delivery systems within the stomach is challenging due to poor contrast with food.
- Previous MRI studies primarily focused on larger, monolithic dosage forms.
Purpose of the Study:
- To develop a novel MRI approach for selective imaging of small multi-particulate oral drug delivery systems in the human stomach.
- To overcome the limitations of differentiating small delivery systems from food contents.
- To enable detailed studies on the food dependency of oral multi-particulate drug delivery.
Main Methods:
- Utilized differential sensitivity to susceptibility artifacts between T(2)-weighted spin-echo and T(2)-weighted gradient echo pulse sequences.
- Implemented a combined imaging sequence within a single breath-hold.
- Employed advanced image analysis including co-registration, motion correction, and voxel-by-voxel comparison.
- Incorporated a 1% magnetite load in the drug delivery systems to enhance susceptibility effects.
- Developed 2D/3D graphical presentation of the imaging data.
Main Results:
- Achieved high sensitivity for detecting small multi-particulate drug delivery systems using the novel MRI technique.
- Successfully visualized single pellets as small as 1mm with high selectivity within heterogeneous food.
- Demonstrated the capability to differentiate the drug delivery systems from surrounding food material.
- Obtained clear images highlighting susceptibility effects caused by the magnetite load.
Conclusions:
- The developed MRI method significantly improves the detection and tracking of small multi-particulate oral drug delivery systems in the stomach.
- This technique overcomes previous limitations in visualizing small systems amidst food.
- Expands the application of MRI for studying oral drug delivery, including food effects, in human subjects.
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