Monolithic LC method applied to fesoterodine fumarate low dose extended-release tablets: Dissolution and release kinetics
Tài liệu tham khảo
Costa, 2001, Modeling and comparison of dissolution profiles, Eur. J. Pharm. Sci., 13, 123, 10.1016/S0928-0987(01)00095-1
Dash, 2010, Kinetic modeling on drug release from controlled drug delivery systems, Acta Pol. Pharm. Drug Res., 67, 217
Gao, 2011, Mathematical modeling of variables involved in dissolution testing, J. Pharm. Sci., 100, 4934, 10.1002/jps.22673
Malhotra, 2008, Pharmacokinetic profile of fesoterodine, Int. J. Clin. Pharmacol. Ther., 46, 556, 10.5414/CPP46556
Chapple, 2008, The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis, Eur. Urol., 54, 543, 10.1016/j.eururo.2008.06.047
Parekha, 2013, Investigation of ex vivo stability of fesoterodine in human plasma and its simultaneous determination together with its active metabolite 5-HMT by LC–ESI-MS/MS: application to a bioequivalence study, J. Chromatogr. B, 913–914, 1, 10.1016/j.jchromb.2012.11.010
Michel, 2008, Fesoterodine: a novel muscarinic receptor antagonist for the treatment of overactive bladder syndrome, Expert. Opin. Pharmacother., 9, 1787, 10.1517/14656566.9.10.1787
Food and Drug Administration, Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of in vitro/in vivo Correlations, Rockville, 1997, pp. 1–27.
Sakore, 2011, In vitro-in vivo correlation (IVIVC): a strategic tool in drug development, J. Bioequiv. Availab., S3, S1
Yáñez, 2011, Flip-flop pharmacokinetics --- delivering a reversal of disposition: challenges and opportunities during drug development, Ther. Deliv., 2, 643, 10.4155/tde.11.19
Sangoi, 2011, Fesoterodine stress degradation behavior by liquid chromatography coupled to ultraviolet detection and electrospray ionization mass spectrometry, Talanta, 84, 1068, 10.1016/j.talanta.2011.03.018
Sangoi, 2010, Determination of fesoterodine in pharmaceutical formulations by using liquid chromatography–tandem mass spectrometry, Eur. J. Mass Spectrom., 16, 653, 10.1255/ejms.1103
Sangoi, 2012, Second-order derivative UV spectrophotometric method for the determination of fesoterodine and comparison with LC, CE and LC-MS/MS in commercial extended-release tablets, Acta Chim. Slov., 59, 136
Sangoi, 2013, Determination of fesoterodine in pharmaceutical preparations by stability-indicating capillary zone electrophoresis method, J. AOAC Int., 96, 1308, 10.5740/jaoacint.11-082
United States Pharmacopoeia, 34th ed., 〈711〉 Dissolution, United States Pharmacopoeial Convention, Rockville, 2011, pp. 1–8.
ICH Guidelines, Q2 (R1): Validation of analytical procedures: text and methodology, in: International Conference on Harmonisation, Geneva, Switzerland, 2005, pp. 1–13.
United States Pharmacopoeia, Pharmacopeial Forum, 30, 2004, pp. 351–363.
Higuchi, 1963, Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices, J. Pharm. Sci., 52, 1145, 10.1002/jps.2600521210
Grassi, 2005, Mathematical modelling and controlled drug delivery: matrix systems, Curr. Drug Deliv., 2, 97, 10.2174/1567201052772906