[Pharmacokinetics of aminophylline in rabbits after oral application of different tablet formulations with extended release of active substance. [Doctoral dissertation]] | Farmakokinetika aminofilina kod kunića posle oralne primene različitih formulacija tableta sa produženim oslobađanjem aktivne supstancije. Doktorska disertacija
2010
Petričević, S.M.
Conducted research aimed to examine three developmental tablet formulations with extended release of aminophylline, determine its pharmacokinetics in an vivo model, and their pharmacokinetic profiles compared with profiles of commercial tablets, to adapt and validity of analytical methods for qualitative and quantitative determination of theophylline in plasma and determine the suitability pharmacokinetic in vivo test on the model of rabbits as a selection model for bioequivalence studies. The study used Chinchillas rabbits breed, male, aged 8 months and the average body weight of 4 kg. In the experiment, were used the sustained-release type tablets of aminophylline (350 mg of aminophylline each), different technologically prepared, and from different manufacturers; three formulation were developed (formulated by the Institute Galenika) and two formulations present in the market (commercial products). Aminophylline tablets were applicated orally, once, in 1 tablet per rabbit. The proposed HPLC method for the determination of Theophylline in plasma of rabbits has been successfully validated, as has been proven its selectivity, suitability, linearity, accuracy and precision, and determined limit detection (similar or equal to 0.22 microg/mL) and limit of quantification (similar or equal to 0.68 microg/mL). Pharmacokinetics profiles of developmental and commercial tablet formulations with extended release of aminophyline were compared with each other, yielded statistically significant differences (p is less or equal to 0.05) between developmental and commercial formulations that initially showed the in vitro disolution profile similarity: Aminofilin I and Phyllocontin -350, respectively Aminofilin II Aminofilin retard. Conducted tests showed that developmental formulation Aminofilin III has a corresponding in vivo pharmacokinetic profile optimal for the final product, or bioequivalence study.
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