In-vivo/in-vitro correlation of four extended release formulations of pseudoephedrine sulfate

Journal of Pharmaceutical and Biomedical Analysis
P MojaverianE Radwanski

Abstract

An in-vivo/in-vitro correlation was established for four formulations of pseudoephedrine sulfate modified release tablets exhibiting different in-vivo and in-vitro release rate and absorption characteristics. In-vitro release rate data were obtained for 12 individual tablets of each formulation using the USP Apparatus 2 paddle stirrer at 50 rev min-1 in 1000 ml 0.1 N hydrochloric acid for the first hour followed by 0.1 M phosphate buffer at pH 7.5 for hours 2-16. Inspection of the individual and mean release rate data indicated that the in-vitro release rate of pseudoephedrine sulfate was consistent with the intended design of the four extended release formulations. The in-vivo bioavailability and pharmacokinetics of these formulations were evaluated in 20 healthy volunteers under fasted conditions. Wagner-Nelson analyses of the in-vivo data revealed extended release absorption profiles for all four formulations. Linear regression analyses of the mean percentage of dose absorbed versus the mean in-vitro release resulted in statistically significant correlations (r2 > 0.99, p < 0.0001) for each formulation. Qualitative rank order correlations were observed among all combinations of in-vivo and in-vitro parameters. These data sup...Continue Reading

References

Dec 1, 1964·Journal of Pharmaceutical Sciences·G LEVY, L E HOLLISTER

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Citations

Dec 20, 2003·Journal of Controlled Release : Official Journal of the Controlled Release Society·Gesine SchlieckerThomas Kissel
Nov 14, 1997·Journal of Biopharmaceutical Statistics·D T Mauger, V M Chinchilli
May 1, 2008·AAPS PharmSciTech·Mahavir ChouguleAmbikanandan Misra
Mar 25, 2006·Drug Development and Industrial Pharmacy·Chen-Chao WangTimothy J Pryor
Sep 8, 2010·Journal of Pharmaceutical Sciences·Michalł OstrowskiTomasz Baczek
Oct 10, 2018·Journal of Liposome Research·Sandip HonmaneSachin Salunkhe
Aug 5, 2017·Neurology·Orrin DevinskyZian H Tseng
Nov 7, 2003·Pharmaceutical Development and Technology·Ying LiuEdwin T Sugita
Sep 29, 1998·The Journal of Pharmacy and Pharmacology·K YuD R Friend

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