BACKGROUND/AIMS: Administration of tablets via feeding tube (FT) is often associated with significant drug losses, as was confirmed by weighing. The aim of this study was to measure the proportion of active substance losses (ASLs) in an in vitro model. METHODS: A film-coated tablet (FilmCT) containing clopidogrel (Trombex®) and a tablet with enteric coating (EntericCT) containing pantoprazole (Controloc®) were crushed in a mortar and transferred by method A (tablet powder was transferred into the beaker, poured into the syringe and water added) and method B (water was added into the mortar, suspension drawn into the syringe) and administered via FT in an in vitro model. Total losses were measured with analytical balance and, simultaneously, ASL were analyzed with high-performance liquid chromatography UV-detection (HPLC-UV). RESULTS: ASL was different to weighing only in the case of EntericCT prepared by method B (2.0 ± 4.2 and 10.7 ± 0.8% for HPLC-UV and weighing, respectively; p = 0.004). HPLC-UV confirmed significantly lower ASL when method B was used for either EntericCT (34.3 ± 7.2 vs. 2.0 ± 4.2%; p < 0.001) or FilmCT (14.1 ± 2.2 vs. 7.7 ± 4.1%; p < 0.01). CONCLUSION: Drug loss analysis with analytical balance may overestimate ASL, as was proved for EntericCT in this study. ASL were significantly lower when method B was used.

Clinical Pharmacology Unit Department of Anaesthesia and Intensive Care International Clinical Research Center St Anne's University Hospital Brno Brno Czech Republic Faculty of Medicine Masaryk University Brno Czech Republic

Department of Chemical Drugs Faculty of Pharmacy University of Veterinary and Pharmaceutical Sciences Brno Czech Republic

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