Development of in vitro - in vivo correlations for newly optimized Nimesulide formulations

PloS One
Muhammad HanifFarya Zafar

Abstract

Use of the human volunteers in bioequivalence studies is being discouraged by the Food and drug administration after the introduction of biowaiver approaches. In-vitro in-vivo correlation (IVIVC) with the level A is accepted for the registration of new molecules. In the present study deconvolution technique with numeric approaches was applied after compressing and in vitro validating the 100mg Nimesulide immediate, intermediate and slow release tablets. Single centered, crossover, randomized study was conducted in four phases with a two-week washout period to obtain the plasma drug concentration data after administrating test and reference products in male healthy volunteers. KineticaTM 4.4.1 (Thermoelectron corp, USA) was used for the calculation of two ways ANOVA with 90% CI from both log transformed and non- transformed data and Phoenix WinNonlin 7 and it's IVIVC toolkit version 7.0 was used for the application of numeric approaches of IVIVC. Results revealed that the individual internal percentage prediction error for AUCinf and Cmax were found to be < 15% while their average values were < 10% in all medium. Numeric values of % PE at pH 6.8 and pH 7.4 (50 rpm in USP II and 100 rpm in USP I and II apparatus) were found to be...Continue Reading

References

Dec 31, 1997·Journal of Pharmaceutical Sciences·K K MidhaJ W Hubbard
Jun 8, 2001·Journal of Controlled Release : Official Journal of the Controlled Release Society·V R Uppoor
Apr 6, 2006·Clinical Pharmacokinetics·Ekarat JantratidJennifer B Dressman
May 30, 2006·Journal of Pharmaceutical Sciences·H KortejärviP Pajunen
Aug 11, 2007·Journal of Pharmaceutical Sciences·Harikrishna DevalapallyMansoor M Amiji
Feb 19, 2008·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Bena-Marie LueAnette Müllertz
Oct 31, 2009·Biopharmaceutics & Drug Disposition·Sreeraj MachaSteven L Krill
Oct 1, 1997·Toxicology in Vitro : an International Journal Published in Association with BIBRA·E B Brittebo, I Brandt
Apr 20, 2013·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica·E ZhangFeng Yao
Mar 22, 2014·Journal of Pharmaceutical Sciences·Deliang ZhouCasey Chun Zhou

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Software Mentioned

Kinetica
Phoenix WinNonlin
WinNonlin IVIVC Toolkit
SPSS
IVIVC

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