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Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses.
Eur J Pharm Sci. 2009 Sep 10; 38(2):147-55.EJ

Abstract

In order to improve the predictability of dissolution testing new apparatuses have been proposed that mimic hydrodynamic and mechanical conditions in the gastrointestinal tract. In this study tested were four different nifedipine extended release (ER) formulations using the paddle apparatus and the reciprocating cylinder as pharmacopoeial test devices as well as two newly developed test apparatuses: the rotating beaker apparatus and the dissolution stress test apparatus. Investigated were Adalat OROS in strengths of 30 and 60 mg, and two hydrophilic matrix formulations: 60 mg nifedipine Coral and Nifedipin Sandoz 40 mg retard. The results demonstrate that the dissolution characteristic of the ER tablets is strongly dependent on the applied test conditions. The dosage form related food effects for Coral 60 mg tablets that were previously observed in human bioequivalence studies could be predicted with the two non-compendial dissolution test devices. The dissolution of Sandoz 40 mg tablets was very sensitive to all applied test conditions. The stable drug delivery characteristics of Adalat OROS observed in numerous in vivo studies was also observed in all of the dissolution tests. In conclusion, the present study shows that besides pH dependency the aspect of the mechanical robustness may be an essential factor affecting the dissolution characteristic of hydrogel matrix formulations.

Authors+Show Affiliations

Department of Biopharmaceutics and Pharmaceutical Technology, Institute of Pharmacy, University of Greifswald, Friedrich-Ludwig-Jahn-Strasse 17, 17487 Greifswald, Germany. grzegorz.garbacz@uni-greifswald.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19591927

Citation

Garbacz, Grzegorz, et al. "Comparison of Dissolution Profiles Obtained From Nifedipine Extended Release once a Day Products Using Different Dissolution Test Apparatuses." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 38, no. 2, 2009, pp. 147-55.
Garbacz G, Golke B, Wedemeyer RS, et al. Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses. Eur J Pharm Sci. 2009;38(2):147-55.
Garbacz, G., Golke, B., Wedemeyer, R. S., Axell, M., Söderlind, E., Abrahamsson, B., & Weitschies, W. (2009). Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 38(2), 147-55. https://doi.org/10.1016/j.ejps.2009.06.010
Garbacz G, et al. Comparison of Dissolution Profiles Obtained From Nifedipine Extended Release once a Day Products Using Different Dissolution Test Apparatuses. Eur J Pharm Sci. 2009 Sep 10;38(2):147-55. PubMed PMID: 19591927.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses. AU - Garbacz,Grzegorz, AU - Golke,Berit, AU - Wedemeyer,Ralph-Steven, AU - Axell,Marie, AU - Söderlind,Erik, AU - Abrahamsson,Bertil, AU - Weitschies,Werner, Y1 - 2009/07/08/ PY - 2009/02/19/received PY - 2009/04/27/revised PY - 2009/06/26/accepted PY - 2009/7/14/entrez PY - 2009/7/14/pubmed PY - 2009/11/10/medline SP - 147 EP - 55 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 38 IS - 2 N2 - In order to improve the predictability of dissolution testing new apparatuses have been proposed that mimic hydrodynamic and mechanical conditions in the gastrointestinal tract. In this study tested were four different nifedipine extended release (ER) formulations using the paddle apparatus and the reciprocating cylinder as pharmacopoeial test devices as well as two newly developed test apparatuses: the rotating beaker apparatus and the dissolution stress test apparatus. Investigated were Adalat OROS in strengths of 30 and 60 mg, and two hydrophilic matrix formulations: 60 mg nifedipine Coral and Nifedipin Sandoz 40 mg retard. The results demonstrate that the dissolution characteristic of the ER tablets is strongly dependent on the applied test conditions. The dosage form related food effects for Coral 60 mg tablets that were previously observed in human bioequivalence studies could be predicted with the two non-compendial dissolution test devices. The dissolution of Sandoz 40 mg tablets was very sensitive to all applied test conditions. The stable drug delivery characteristics of Adalat OROS observed in numerous in vivo studies was also observed in all of the dissolution tests. In conclusion, the present study shows that besides pH dependency the aspect of the mechanical robustness may be an essential factor affecting the dissolution characteristic of hydrogel matrix formulations. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/19591927/Comparison_of_dissolution_profiles_obtained_from_nifedipine_extended_release_once_a_day_products_using_different_dissolution_test_apparatuses_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(09)00182-1 DB - PRIME DP - Unbound Medicine ER -