Comparative bioavailability of three ibuprofen formulations in healthy human volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 46, Issue 6, 2008, Pages 309-318

  Mendes, G D ^a,e   Mendes, F D ^a   Domingues, C C ^a   de Oliveira, R A ^c   da Silva, M A ^a   Chen, L S ^a   Ilha, J O ^a,b   Fernandes, C E ^d   De Nucci, G ^a,b  

^a UNIVERSITY OF CAMPINAS   (Brazil)

^b Cartesius Development of Clinical Research   (Brazil)

^c UNIVERSITY OF SÃO PAULO   (Brazil)

^d FACULDADE DE CIÊNCIAS MÉDICAS DA SANTA CASA DE SÃO PAULO   (Brazil)

^e NONE   (Brazil)

Author keywords

Bio availability; LC MS MS; Pharmaco kinetics; Tandem mass spectrometrj

Indexed keywords

ALIVIUM; IBUPROFEN; LIVER ENZYME; NAPROXEN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG HALF LIFE; DRUG TOLERABILITY; FEMALE; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NEGATIVE ION ELECTROSPRAY; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; STOMACH PAIN; TABLET; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT;

EID: 45949104593     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP46309     Document Type: Article

References (14)

1. Bienert A, Szkutnik-Fiedler D, Dyderski S, Grzeskowiak E, Drobnik L, Wolc A, Slawiniska U. Comparative bioavailability study of two ibuprofen preparations after oral administration in healthy volunteers. Arzneimittel forschung. 2006; 56: 647-651.
2. Bonato PS, Del Lama MP, de Carvalho R. Enantio-selective determination of ibuprofen in plasma by high-performance liquid chromatography-electro-spray mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2003; 796: 413-420.
3. Farrar H, Letzig L, Gill M. Validation of a liquid chromatographic method for the determination of ibuprofen in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2002; 780: 341-348.
4. Food and Drug Administration. In vivo bioequivalence guidances. Pharmacopeial 1993; 19: 6501-6508.
5. Food and Drug Administration. Bioavailability and bioequivalence requirements; abbreviated applications; proposed revisions-FDA. Proposed rule. Fed Regist. 1998; 63: 64222-64228.
6. Hernando MD, Heath E, Petrovic M, Barcelo D. Trace-level determination of pharmaceutical residues by LC-MS/MS in natural and treated waters. A pilot-survey study. Anal Bioanal Chem. 2006; 385: 985-991.
7. Kapil R, Nolting A, Roy P Fiske W, Benedek I, Abramowitz W. Pharmacokinetic properties of combination oxycodone plus racemic ibuprofen: two randomized, open-label, crossover studies in healthy adult volunteers. Clin Ther. 2004; 26: 2015-2025.
8. Klueglich M, Ring A, Scheuerer S, Trommeshauser D, Schuijt C, Liepold B, Berndl G. Ibuprofen extrudate, a novel, rapidly dissolving ibuprofen formulation: relative bioavailability compared to ibuprofen lysinate and regular ibuprofen, and food effect on all formulations. J Clin Pharmacol. 2005; 45: 1055-1061.
9. Panusa A, Multari G, Incarnato G, Gagliardi L. High-performance liquid chromatography analysis of anti-inflammatory pharmaceuticals with ultraviolet and electrospray-mass spectrometry detection in suspected counterfeit homeopathic medicinal products. J Pharm Biomed Anal. 2007; 43: 22-27.
10. Potthast H, Dressman JB, Junginger HE, Midha KK, Oeser H, Shah VP, Vogelpoel H, Barends DM. Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. J Pharm Sci. 2005; 94: 2121-2131.
11. Sadaba B, Campanero MA, Munoz-Juarez MJ, Gil Aldea I, Garcia-Quetglas E, Esteras A, Azanza JR. A comparative study of the pharmacokinetics of ibuprofen arginate versus dexibuprofen in healthy volunteers. Eur J Clin Pharmacol. 2006; 62: 849-854.
12. Vinci F, Fabbrocino S, Fiori M, Serpe L, Gallo P. Determination of fourteen non-steroidal anti-inflammatory drugs in animal serum and plasma by liquid chromatography/mass spectrometry. Rapid Commun Mass Spectrom. 2006; 20: 3412-3420.
13. Walter K, Weiss G, Laicher A, Stanislaus F. Pharmacokinetics of ibuprofen following a single administration of a suspension containing enteric-coated microcapsules. Arzneimittelforschung. 1995; 45: 886-890.
14. Wang P, Qi M, Liu L, Fang L. Determination of ibuprofen in dog plasma by liquid chromatography and application in pharmacokinetic studies of an ibuprofen prodrug in dogs. J Pharm Biomed Anal. 2005; 38: 714-719.