A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation

Dr Reddy's Laboratories Ltd. developed generic version of XYZ extended release tablets (ER) and achieved bioequivalence as per criteria mentioned by USFDA in both fasting and fed conditions for higher strength formulation (1200 mg). However, on comparison of multimedia dissolution profiles in p...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2022-06, Vol.111 (6), p.1820-1832
Hauptverfasser:	Aishwarya, R., Murthy, Aditya, Ahmed, Tausif, Chachad, Siddharth
Format:	Artikel
Sprache:	eng
Schlagworte:	Bioequivalence Dissolution Dissolution modelling GastroPlus modeling In silico modeling Mechanistic modeling Oral absorption Physiologically based pharmacokinetic (PBPK) Modeling
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Beschreibung
Zusammenfassung:	Dr Reddy's Laboratories Ltd. developed generic version of XYZ extended release tablets (ER) and achieved bioequivalence as per criteria mentioned by USFDA in both fasting and fed conditions for higher strength formulation (1200 mg). However, on comparison of multimedia dissolution profiles in pH 4.5 acetate media, the f2 similarity value was
ISSN:	0022-3549 1520-6017
DOI:	10.1016/j.xphs.2022.02.007