IVIVC in Oral Absorption for Fenofibrate Immediate Release Tablets Using a Dissolution/Permeation System

被引:67
|
作者
Buch, Philipp [1 ]
Languth, Peter [1 ]
Kataoka, Makoto [2 ]
Yamashita, Shinji [2 ]
机构
[1] Johannes Gutenberg Univ Mainz, Dept Pharmaceut Technol & Biopharmaceut, D-55099 Mainz, Germany
[2] Setsunan Univ, Fac Pharmaceut Sci, Osaka 5730101, Japan
关键词
biopharmaceutics classification system (BCS); Caco-2; cells; dissolution; permeation; in vitro/in vivo correlations (IVIVC); food-effect-studies; WATER-SOLUBLE DRUGS; FOOD; PERMEATION; PREDICTION; MICRONIZATION; FORMULATIONS; ENHANCEMENT; SOLUBILITY; DELIVERY; HUMANS;
D O I
10.1002/jps.21576
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly Soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in. vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and C-max of fenofibric acid. This study thus demonstrates the potential of the D/P system as valuable tool for absorption screening of dosage forms for poorly soluble drugs. (C) 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2001-2009, 2009
引用
收藏
页码:2001 / 2009
页数:9
相关论文
共 50 条
  • [41] Development of a dissolution method for lumefantrine and artemether in immediate release fixed dose artemether/lumefantrine tablets
    Belew, Sileshi
    Suleman, Sultan
    Duguma, Markos
    Teshome, Henok
    Wynendaele, Evelien
    Duchateau, Luc
    De Spiegeleer, Bart
    MALARIA JOURNAL, 2020, 19 (01)
  • [42] Assessment of absorption potential of poorly water-soluble drugs by using the dissolution/permeation system
    Kataoka, Makoto
    Yano, Koji
    Hamatsu, Yoriko
    Masaoka, Yoshie
    Sakuma, Shinji
    Yamashit, Shinji
    EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 2013, 85 (03) : 1317 - 1324
  • [43] CORRELATION OF ABSORPTION OF SULFAMETHAZINE BOLUSES WITH DISSOLUTION USING A NEW DISSOLUTION APPARATUS FOR VETERINARY TABLETS
    FRAZIER, WF
    NUESSLE, NO
    JOURNAL OF PHARMACEUTICAL SCIENCES, 1976, 65 (12) : 1823 - 1826
  • [44] Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets
    Pepin, Xavier J. H.
    Flanagan, Talia R.
    Holt, David J.
    Eidelman, Anna
    Treacy, Don
    Rowlings, Colin E.
    MOLECULAR PHARMACEUTICS, 2016, 13 (09) : 3256 - 3269
  • [45] A case study on the in silico absorption simulations of levothyroxine sodium immediate-release tablets
    Kocic, Ivana
    Homsek, Irena
    Dacevic, Mirjana
    Grbic, Sandra
    Parojcic, Jelena
    Vucicevic, Katarina
    Prostran, Milica
    Miljkovic, Branislava
    BIOPHARMACEUTICS & DRUG DISPOSITION, 2012, 33 (03) : 146 - 159
  • [46] Predicting in vivo performance of fenofibrate amorphous solid dispersions using in vitro non-sink dissolution and dissolution permeation setup
    Lentz, Karoline Aagaard
    Plum, Jakob
    Steffansen, Bente
    Arvidsson, Per-Ola
    Omkvist, Diana H. ojmark
    Pedersen, Anders Just
    Sennbro, Carl Johan
    Pedersen, Gitte Pommergaard
    Jacobsen, Jette
    INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2021, 610
  • [47] Automated measurement of permeation and dissolution of propranolol HCl tablets using sequential injection analysis
    Motz, Stephan A.
    Klimundova, Jana
    Schaefer, Ulrich F.
    Balbach, Stefan
    Eichinger, Thomas
    Solich, Petr
    Lehr, Claus-Michael
    ANALYTICA CHIMICA ACTA, 2007, 581 (01) : 174 - 180
  • [48] Characterization of the absorption of theophylline from immediate- and controlled-release dosage forms with a numerical approach using the in vitro dissolution-permeation process using Caco-2 cells
    Noureddine, N
    Zerrouk, N
    Nicolis, I
    Allain, P
    Sfar, S
    Chaumeil, JC
    DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2005, 31 (4-5) : 397 - 404
  • [49] In vitro system to evaluate oral absorption of poorly water-soluble drugs:: Simultaneous analysis on dissolution and permeation of drugs
    Kataoka, M
    Masaoka, Y
    Yamazaki, Y
    Sakane, T
    Sezaki, H
    Yamashita, S
    PHARMACEUTICAL RESEARCH, 2003, 20 (10) : 1674 - 1680
  • [50] In Vitro System to Evaluate Oral Absorption of Poorly Water-Soluble Drugs: Simultaneous Analysis on Dissolution and Permeation of Drugs
    Makoto Kataoka
    Yoshie Masaoka
    Yukako Yamazaki
    Toshiyasu Sakane
    Hitoshi Sezaki
    Shinji Yamashita
    Pharmaceutical Research, 2003, 20 : 1674 - 1680