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Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect

Acta Pharmaceutica
Volume 65 (2015): Issue 4 (December 2015)
By:
Open Access
|Dec 2015

References

  1. 1. D. Fleisher, C. Li, Y. Zhou, L. H. Pao and A. Karim, Drug, meal and formulation interactions influencing drug absorption after oral administration clinical implications, Clin. Pharmacokinet. 36 (1999) 233-254; DOI: 10.2165/00003088-199936030-00004.10.2165/00003088-199936030-00004
    Search in Google Scholar
  2. 2. K. A. Lentz, Current methods for predicting human food effect, The AAPS Journal 10 (2008) 282-288; DOI: 10.1208/s12248-008-9025-8.10.1208/s12248-008-9025-8
    Search in Google Scholar
  3. 3. FDA/CDER (2002), Guidance for Industry: Food-effect Bioavailability and Fed Bioequivalence Studies.
    Search in Google Scholar
  4. 4. EMA/CPMP (2010), Guideline on the Investigation of Bioequivalence, CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **.
    Search in Google Scholar
  5. 5. EMA/CHMP (2014), Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms, EMA/CPMP/EWP/280/96 Corr1.
    Search in Google Scholar
  6. 6. W. Jiang, S. Kim, X. Zhang, R. A. Lionberger, B. M. Davit, D. P. Conner and L. X. Yu, The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation, Int. J. Pharm. 418 (2011) 151-160; DOI: 10.1016/j.ijpharm.2011.07.024.10.1016/j.ijpharm.2011.07.024
    Search in Google Scholar
  7. 7. E. S. Kostewicz, L. Aarons, M. Bergstrand, M. B. Bolger, A. Galetin, O. Hatley, M. Jamei, R. Lloyd, X. Pepin, A. Rostami-Hodjegan, E. Sjögren, C. Tannergren, D. B. Turner, C. Wagner, W. Weitschies and J. Dressman, PBPK models for the prediction of in vivo performance of oral dosage forms, Eur. J. Pharm. Sci. 57 (2014) 300-321; DOI: 10.1016/j.ejps.2013.09.008.10.1016/j.ejps.2013.09.008
    Search in Google Scholar
  8. 8. E. S. Kostewicz, B. Abrahamsson, M. Brewster, J. Brouwers, J. Butler, S. Carlert, P. A. Dickinson, J. Dressman, R. Holm, S. Klein, J. Mann, M. McAllister, M. Minekus, U. Muenster, A. Müllertz, M. Verwei, M. Vertzoni, W. Weitschies and P. Augustijns, In vitro models for the prediction of in vivo performance of oral dosage forms, Eur. J. Pharm. Sci. 57 (2014) 342-366; DOI: 10.1016/j. ejps.2013.08.024.
    Search in Google Scholar
  9. 9. EMA, QWP (2012), Guideline on Quality of Oral Modified Release Products, Draft, EMA/ 492713/2012.
    Search in Google Scholar
  10. 10. B. Abrahamsson, K. Roos and J. Sjogren, Investigation of prandial effects on hydrophilic matrix tablets, Drug Dev. Ind. Pharm. 25 (1999) 765-771; DOI: 10.1081/DDC-100102236.10.1081/DDC-100102236
    Search in Google Scholar
  11. 11. J. Parojčić, D. Vasiljević, S. Ibrić and Z. Đurić, Tablet disintegration and drug dissolution in viscous media: Paracetamol IR tablets, Int. J. Pharm. 355 (2008) 93-99; DOI: 10.1016/j.ijpharm.2007.11.058.10.1016/j.ijpharm.2007.11.058
    Search in Google Scholar
  12. 12. B. Abrahamsson, M. Alpsten, B. Bake, U. E. Jonsson, M. Eriksson-Lepkowska and A. Larsson, Drug absorption from nifedipine hydrophilic matrix extended-release (ER) tablet - comparison with an osmotic pump tablet and effect of food, J. Control. Rel. 52 (1998) 301-310; DOI: 10.1016/ S0168-3659(97)00267-8.10.1016/S0168-3659(97)00267-8
    Search in Google Scholar
  13. 13. C. Wagner, K. Thelen, S. Willmann, A. Selen and J. B. Dressman, Utilizing in vitro and PBPK tools to link ADME characteristics to plasma profiles: Case example nifedipine immediate release formulation, J. Pharm. Sci. 102 (2013) 3205-3219; DOI: 10.1002/jps.23611.10.1002/jps.23611
    Search in Google Scholar
  14. 14. B. S. Schug, E. Brendel, D. Wolf, M. Wonnemann, M. Wargenau and H. H. Blume, Formulationdependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union, Eur. J. Pharm. Sci. 15 (2002) 279-285; DOI: 10.1016/S0928-0987(02)00008-8.10.1016/S0928-0987(02)00008-8
    Search in Google Scholar
  15. 15. M. Wonnemann, B. Schug, K. Schmücker, E. Brendel, P. A. van Zwieten and H. Blume, Significant food interactions observed with a nifedipine modified-release formulation marketed in the European Union, Int. J. Clin. Pharmacol. Ther. 44 (2006) 38-48; DOI: 10.5414/CPP44038.10.5414/CPP44038
    Search in Google Scholar
  16. 16. M. Wonnemann, B. S. Schug, M. Anschutz, E. Brendel, G. De Nucci and H. H. Blume, Comparison of two marketed nifedipine modified-release formulations: An exploratory clinical food interaction study, Clin. Ther. 30 (2008) 48-58; DOI: 10.1016/j.clinthera.2008.01.001.10.1016/j.clinthera.2008.01.001
    Search in Google Scholar
  17. 17. N. Patel, S. Polak, M. Jamei, A. Rostami Hodjegan and D. B. Turner, Quantitative prediction of formulation-specific food effects and their population variability from in vitro data with the phys iologically-based ADAM model: A case study using the BCS/BDDCS Class II drug nifedipine, Eur. J. Pharm. Sci. 57 (2014) 240-249; DOI: 10.1016/j.ejps.2013.09.006.10.1016/j.ejps.2013.09.006
    Search in Google Scholar
  18. 18. T. J. Rashid, U. Martin, H. Clarke, D. G. Waller, A. G. Renwick and C. F. George, Factors affecting the absolute bioavailability of nifedipine, Br. J. Clin. Pharmacol. 40 (1995) 51-58; DOI: 10.1111/ j.1365-2125.1995.tb04534.x.10.1111/j.1365-2125.1995.tb04534.x
    Search in Google Scholar
  19. 19. J. C. Loo and S. Riegelman, New method for calculating the intrinsic absorption rate of drugs, J. Pharm. Sci. 57 (1968) 918-928; DOI: 10.1002/jps.2600570602.10.1002/jps.2600570602
    Search in Google Scholar
  20. 20. B. Agoram, W. S. Woltosz and M. B. Bolger, Predicting the impact of physiological and biochemical processes on oral drug bioavailability, Adv. Drug Deliv. Rev. 50 (2001) S41-S67; DOI: 10.1016/ S0169-409X(01)00179-X.10.1016/S0169-409X(01)00179-X
    Search in Google Scholar
  21. 21. M. Ilić, J. Đuriš, I. Kovačević, S. Ibrić and J. Parojčić, In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study, Eur. J. Pharm. Sci. 62 (2014) 212-218; DOI: 10.1016/j.ejps.2014.05.030.10.1016/j.ejps.2014.05.03024911992
    Search in Google Scholar
  22. 22. E. Jantratid, N. Janssen, C. Reppas and J. B. Dressman, Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update, Pharm. Res. 25 (2008) 1663-1676; DOI: 10.1007/s11095-008-9569-4.10.1007/s11095-008-9569-418404251
    Search in Google Scholar
  23. 23. Summary of Product Characteristics: Adalat modified release tablets, Bayer plc, revision date April 12, 2012 (www.medicines.org.uk).
    Search in Google Scholar
  24. 24. K. Hirasawa, W. F. Shen, D. T. Kelly, G. Roubin, K. Tateda and J. Shibata, Effect of food ingestion on nifedipine absorption and haemodynamic response, Eur. J. Clin. Pharmacol. 28 (1985) 105-107; DOI: 10.1007/BF00635716.10.1007/BF006357163987781
    Search in Google Scholar
  25. 25. V. Challenor, D. G. Waller, B. S. Gruchy, A. G. Renwick, C. F. George, E. T. McMurdo and J. McEwen, The effect of food and posture on the pharmacokinetics of a biphasic release preparation of nifedipine, Br. J. Clin. Pharmacol. 22 (1986) 565-570; DOI: 10.1111/j.1365-2125.1986.tb02936.x.10.1111/j.1365-2125.1986.tb02936.x14011743790403
    Search in Google Scholar
  26. 26. J. Armstrong, V. F. Challenor, B. S. Macklin, A. G. Renwick and D. G. Waller, The influence of two types of meal on the pharmacokinetics of a modified-release formulation of nifedipine (Adalat Retard), Eur. J. Clin. Pharmacol. 53 (1997) 141-143; DOI: 10.1007/s002280050352.10.1007/s0022800503529403286
    Search in Google Scholar
  27. 27. FDA/CDER (1998), Bioequivalence Review: Application Number 75-108.
    Search in Google Scholar
  28. 28. K. B. Nemes, V. Horvath, G. Grezal, G. Horvai, A. Hrabeczy-Pall, E. Kocsi, S. Drabant, M. Csorgo, G. Rencez and I. Klebovich, Food interaction pharmacokinetic study of Cordaflex 20 mg retard film tablet in healthy volunteers, Int. J. Clin. Pharmacol. Ther. 36 (1998) 263-269.
    Search in Google Scholar
  29. 29. B. S. Schug, E. Brendel, M. Wonnemann, D. Wolf, M. Wargenau, A. Dingler and H. H. Blume, Dosage form-related food interaction observed in a marketed once-daily nifedipine formulation after a high-fat American breakfast, Eur. J. Clin. Pharmacol. 58 (2002) 119-125; DOI: 10.1007/s00228-002-0444-7.10.1007/s00228-002-0444-712012144
    Search in Google Scholar
  30. 30. B. S. Schug, E. Brendel, E. Chantraine, D. Wolf, W. Martin, R. Schall and H. H. Blume, The effect of food on the pharmacokinetics of nifedipine in two slow release formulations: pronounced lagtime after a high fat breakfast, Br. J. Clin. Pharmacol. 53 (2002) 582-588; DOI: 10.1046/j.1365-2125. 2002.01599.x.
    Search in Google Scholar
  31. 31. J. M. Custodio, C. Y. Wu and L. Z. Benet, Predicting drug disposition, absorption/elimination/ transporter interplay and the role of food on drug absorption, Adv. Drug Deliv. Rev. 60 (2008) 717-733; DOI: 10.1016/j.addr.2007.08.043.10.1016/j.addr.2007.08.043229281618199522
    Search in Google Scholar
  32. 32. S. Klein, The use of biorelevant dissolution media to forecast the in vivo performance of a drug, The AAPS Journal 12 (2010) 397-406; DOI: 10.1208/s12248-010-9203-3.10.1208/s12248-010-9203-3289543820458565
    Search in Google Scholar
  33. 33. C. Piovella, Clinical efficacy and bioavailability of a sustained release nifedipine formulation, Arzneimittelforschung 37 (1987) 832-835.
    Search in Google Scholar
DOI: https://doi.org/10.1515/acph-2015-0039 | Journal eISSN: 1846-9558 | Journal ISSN: 1330-0075
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Language: English
Page range: 427 - 441
Accepted on: Sep 2, 2015
Published on: Dec 17, 2015
Published by: Croatian Pharmaceutical Society
In partnership with: Paradigm Publishing Services
Publication frequency: 4 times per year
Keywords:
absorption,
dissolution,
food effect,
in silico modeling,
deconvolution,
GastroPlusTM
Related subjects:
Pharmacy,
Pharmacy, other

© 2015 Marija Ilić, Ivan Kovačević, Jelena Parojčić, published by Croatian Pharmaceutical Society
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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