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  • 1
    Electronic Resource
    Electronic Resource
    Evaluation of the Feasibility and Use of a Prototype Remote Drug Delivery Capsule (RDDC) for Non-Invasive Regional Drug Absorption Studies in the GI Tract of Man and Beagle Dog (1999)
    Springer
    Pharmaceutical research 16 (1999), S. 266-271 
    Details
    ISSN: 1573-904X
    Keywords: regional drug absorption ; gamma scintigraphy ; remote control capsule ; non-invasive
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. Evaluate a prototype Remote Drug Delivery Capsule (RDDC) for use in beagle dogs and human volunteers for non-invasive drug absorption studies in different regions of the gastrointestinal tract. Methods. The device was dual radiolabeled and GI transit of the RDDC was monitored by gamma scintigraphy. Beagles were used initially to demonstrate the functional utility of the device where a solution of ranitidine hydrochloride (150 mg) was non-invasively delivered to the stomach, proximal small intestine and distal small intestine. A subsequent first time in human study enrolled twelve healthy male volunteers where the intended site of release was the stomach, early small bowel, distal small bowel or colon. Results. Preliminary studies conducted in beagles indicated that the RDDC operated successfully and the onset of ranitidine serum levels were dependent on the time of capsule activation and site of drug release. Results from the human study showed that all twelve subjects swallowed the device with no discomfort. Mean gastric emptying of the RDDC was 1.50 ± 1.28 h (range = 0.25 to 4.25 h), and total small intestine transit was 4.79 ± 1.82 h (range = 2.00 to 8.25 h). The capsule was retrieved from the feces at 30.25 ± 15.21 h (range = 14.12 to 74.25 h) and there were no reported adverse events. The prototype RDDC operated successfully in nine of the twelve human volunteers and the cause for the three failures was attributed to mechanical failure while the electronics assembly performed favorably. Conclusions. This prototype remote control capsule was shown to be well tolerated and functional to use in human volunteers as well as beagles. The application of the device coupled with gamma scintigraphy has the potential to be a valuable and rapid method to non-invasively evaluate regional drug absorption in the gastrointestinal tract under conditions that are both pharmaceutically and physiologically meaningful.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018884510163
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  • 2
    Electronic Resource
    Electronic Resource
    Dual-Isotope Imaging of Neutron-Activated Erbium-171 and Samarium-153 and the in Vivo Evaluation of a Dual-Labeled Bilayer Tablet by Gamma Scintigraphy (1991)
    Springer
    Pharmaceutical research 8 (1991), S. 1335-1340 
    Details
    ISSN: 1573-904X
    Keywords: neutron activation ; erbium-171 ; samarium-153 ; gamma scintigraphy ; dual-isotope imaging ; dual-labeled dosage forms ; radiolabeled dosage forms ; bilayer tablet ; compton scatter
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1015876401639
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  • 3
    Electronic Resource
    Electronic Resource
    Manufacture and Properties of Erythromycin Beads Containing Neutron-Activated Erbium-171 (1990)
    Springer
    Pharmaceutical research 7 (1990), S. 264-269 
    Details
    ISSN: 1573-904X
    Keywords: neutron activation ; erbium-171 ; erythromycin ; drug delivery system ; gamma scintigraphy ; radiolabeled dosage forms ; scanning electron micrography ; erythromycin dissolution ; erythromycin antimicrobial activity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract To evaluate the effects of a neutron activation radiolabeling technique on an enteric-coated multiparticulate formulation of erythromycin, test quantities were produced under industrial pilot scale conditions. The pellets contained the stable isotope erbium oxide (Er-170), which was later converted by neutron activation into the short-lived gamma ray-emitting radionuclide, erbium-171. In vitro studies indicated that the dissolution profile, acid resistance, and enteric-coated surface of the pellets were minimally affected by the irradiation procedure. Antimicrobial potency was also unaffected, as determined by microbiological assay. Neutron activation thus appears to simplify the radiolabeling of complex pharmaceutical dosage forms for in vivo study by external gamma scintigraphy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1015826229323
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