PMID: 11923060Mar 30, 2002Paper

Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
B SchugH Blume

Abstract

The objective of this study was a comparative investigation of the influence of concomitant food intake on the bioavailability of two nifedipine-containing controlled-release formulations. Adalat OROS and CORAL were compared in a randomised, non-blind, four-way crossover design in 24 healthy, male subjects after single dose administration following a high fat American breakfast or an overnight fast of 12 h, respectively. Plasma samples were withdrawn until 48 h post-dose. In the fasted state, the bioavailability (AUC and C(max) values) was lower for CORAL than for Adalat OROS. Under fed conditions, differences in bioavailability between both products were markedly increased. With respect to the therapeutic use of both products, the most important finding was the significant dose-dumping effect observed after fed administration of CORAL, resulting in nifedipine plasma concentrations of nearly three- to four-fold in 11 of 24 volunteers. The mean ratio of C(max) was 235% comparing CORAL with Adalat OROS under these conditions. The formulation-dependent food interaction observed in this study may be therapeutically relevant, especially in the case of changing administration conditions or switching from one product to the other.

References

Feb 1, 1995·Journal of Clinical Pharmacology·S A Waldman, J Morganroth

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Citations

Apr 25, 2013·International Journal of Pharmaceutics·F J O VarumA W Basit
May 5, 2009·The AAPS Journal·Steven C Sutton
Apr 23, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Sandra CvijićPeter Langguth
Jun 10, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Marija IlićJelena Parojčić
Nov 8, 2008·Drug Development and Industrial Pharmacy·Vincent MalaterreRobert Gurny
Oct 28, 2010·Expert Opinion on Drug Delivery·Grzegorz GarbaczWerner Weitschies
Oct 7, 2005·Drug Development and Industrial Pharmacy·Ouyang DefangPan Weisan
May 19, 2004·Journal of Controlled Release : Official Journal of the Controlled Release Society·Alan RoyceUday Shah
Jul 14, 2009·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Grzegorz GarbaczWerner Weitschies
Jul 16, 2009·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Vincent MalaterreRobert Gurny
Dec 19, 2015·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Marija IlićJelena Parojčić
Jun 13, 2012·The Journal of Pharmacy and Pharmacology·Grzegorz Garbacz, Sandra Klein
Apr 3, 2016·Advanced Drug Delivery Reviews·Mirko KoziolekWerner Weitschies
Sep 26, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Nikunjkumar PatelDavid B Turner
Mar 27, 2016·Neurology·Emily L JohnsonGregory L Krauss
Jun 21, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Cord J AndreasJennifer B Dressman
Oct 28, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Jens Van Den AbeelePatrick Augustijns
Mar 21, 2012·Journal of Veterinary Pharmacology and Therapeutics·R P HunterP-L Toutain
Sep 27, 2005·Pharmazie in unserer Zeit·André Warnke, Henning Blume
Oct 11, 2005·Journal of Controlled Release : Official Journal of the Controlled Release Society·Werner WeitschiesHubert Mönnikes

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