In-vivo gamma scintigraphic evaluation and determination of a gastro-resistant etodolac tablet in humans.
A gastro-resistant (enteric coated) etodolac tablet dosage form, was evaluated by using in vitro and in vivo methods. In vitro drug release studies have shown that enteric coated tablet dosage form protects the drug from being released under conditions mimicking stomach to small intestine transit. The gastro-intestinal transit of radiolabeled 300 mg enteric coated etodolac tablets in six healthy, fed and fasted state volunteers was monitored using external gamma camera. Dosage form position was reported at several time intervals. Etodolac serum concentrations were determined from serum samples drawn over 420 min following dosing. Differences in gastro-intestinal transit between fed and fasted volunteers had little effect on etodolac bioavailability. AUC, Tmax and C max values were calculated for both types of studies.
Ozkan
Yalçin
Y
Gülhane Military Medical Academy, Department of Pharmaceutical Technology, Etlik, Ankara, Turkey. yozkangata@gmail.com
Ceyhan
Timurhan
T
Arslan
Nuri
N
Narin
Yavuz
Y
Işimer
Aşkin
A
D000328:Adult; D001682:Biological Availability; D016503:Drug Delivery Systems; D005215:Fasting; D005772:Gastrointestinal Transit; D057166:High-Throughput Screening Assays; D006801:Humans; D008297:Male; D011877:Radionuclide Imaging; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000032:analysis* / Q000493:pharmacokinetics*
D013608:Tablets, Enteric-Coated