| Peer-Reviewed

Conventional and Multivariate Statistical Methods for Evaluation of In vitro Dissolution Similarity of Bisoprolol Film-coated Tablets

Received: 9 June 2020     Accepted: 20 June 2020     Published: 4 July 2020
Views:       Downloads:
Abstract

In vitro dissolution testing is an important tool used for pharmaceutical development and approval of generic medicinal product, playing a pivotal role in regulatory decision-making. This study includes evaluation and comparative analysis of in vitro dissolution profiles of Bisoprolol film-coated tablets and in vitro dissolution profile of a reference medicinal product, using several model-independent and model-dependent statistical methods. The evaluated medicinal product belongs to BCS Class I (high solubility, high permeability). The similarity testing of dissolution profile is performed on the highest strength of the dosage form, in accordance with the regulatory requirements for bioequivalence study. Obtained results have shown that in vitro comparative dissolution analysis using pair-wise independent-model procedures, such as difference (f1) and similarity (f2) factors are not suitable, because one of the requirements (not more than one mean value dissolves more than 85%, for any of the formulations) was not fulfilled. Therefore, the comparison of the similarity of dissolution profiles was performed using Ratio test methodology and multivariate model-independent approach based on generalized statistical distance (Mahalanobis distance). Furthermore, other model-dependent approaches coupled to multivariate statistics (Weibull) were applied. The obtained results from the performed analysis indicated a significant similarity of the compared in vitro dissolution profiles between the tested batches from bisoprolol film-coated tablets and reference medicinal product). Implemented statistical methods can be considered as a regulatory accepted concept for evaluation of in vitro similarity of generic medicines.

Published in International Journal of Pharmacy and Chemistry (Volume 6, Issue 2)
DOI 10.11648/j.ijpc.20200602.12
Page(s) 16-25
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2020. Published by Science Publishing Group

Keywords

Generic Medicinal Product, In vitro Dissolution Similarity, Model-dependent Methods, Model-independent Methods, Bisoprolol Film-coated Tablets

References
[1] M. C. Gohel, M. K. Panchal, Comparison of in vitro dissolution profiles using a novel, model-independent approach, Pharm. Technol. 24 (2000) 92-102.
[2] J. W. Moore, H. H. Flanner, Mathematical comparison of dissolution profiles, Pharm. Technol. 20 (1996) 64-74.
[3] R. Cristofoletti, J. B. Dressman, Dissolution Methods to Increasing Discriminatory Power of In Vitro Dissolution Testing for Ibuprofen Free Acid and Its Salts, J. Pharm Sci. 106 (2017) 92-99.
[4] J. E. Polli, G. S. Rekhi, L. L. Augsburger, V. P. Shah, Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets, J. Pharm. Sci. 86 (1997) 690-700.
[5] FDA Guidance for industry: Dissolution testing of immediate release solid oral dosage forms, In. Rockville, MD (1997).
[6] FDA Guidance for industry: SUPAC-MR: Modified release solid oral dosage forms scale-up and post approval changes: chemistry, manufacturing and controls; in vitro dissolution testing and in vivo bioequivalence documentation, In. Rockville, MD (1997).
[7] European Medicines Agency, EMEA Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), London, (2010).
[8] M. E. Ruiz, M. G. Volonté, Biopharmaceutical Relevance of Dissolution Profile Comparison: Proposal of a Combined Approach, Dissolution Technologies, 21 (2014) 32-43.
[9] T. O’Hara, A. Dunne, J. Butler, J. Devane, A review of methods used to compare dissolution profile data, Pharm. Sci. Technol. To. 1 (1998) 214-223.
[10] V. Pillay, R. Fassihi, Evaluation and comparison of dissolution data derived from different modified release dosage forms: an alternative method, J. Control. Release 55 (1998) 45-55.
[11] US Pharmacopoeia 6th Edition, USP-31- NF 26, Vol 3: 3526, Monograph for Hydrochlorothiazide and Bisorprolol Tablets (2008).
[12] V. P. Shah, Y. Tsong, P. Sathe, J. P. Liu, In vitro dissolution profile comparison--statistics and analysis of the similarity factor, f2, Pharm Res. 15 (1998) 889-96.
[13] Y. Tsong, T. Hammerstrom, P. Sathe, V. P. Shah, Statistical assessment of mean differences between two dissolution data sets, Therapeutic Innovation and Regulatory Science 30 (1996) 1105-1112.
[14] N. Yuksel, A. E. Kanik, T. Baykara, Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and model-independent methods, Int. J. Pharm. 209 (2000) 57-67.
[15] H. Saranadasa, K. Krishnamoorthy, A multivariate test for similarity of two dissolution profiles, J. Biopharm. Stat. 15 (2005) 265.
[16] P. M. Sathe, Y. Tsong, V. P. Shah, In-vitro dissolution profile comparison: statistics and analysis, model dependent approach, Pharm. Res. 13 (1996) 1799-803.
[17] OriginPro 9.0.0, OriginLab Corporation (1991-2013).
[18] Mathematica 10.2.0.0, Wolfram Research, Inc. (1988-2015).
[19] Microsoft EXCEL 2007, Microsoft Corporation.
[20] V. Raju, K. V. R. Murthy, Development and Validation of New Discriminative Dissolution Method for Carvedilol Tablets, Indian J Pharm Sci. 73 (2011) 527–536.
Cite This Article
  • APA Style

    Ivana Mitrevska, Ljupco Pejov, Marija Jovanovska, Suzan Memed-Sejfulah, Katerina Brezovska, et al. (2020). Conventional and Multivariate Statistical Methods for Evaluation of In vitro Dissolution Similarity of Bisoprolol Film-coated Tablets. International Journal of Pharmacy and Chemistry, 6(2), 16-25. https://doi.org/10.11648/j.ijpc.20200602.12

    Copy | Download

    ACS Style

    Ivana Mitrevska; Ljupco Pejov; Marija Jovanovska; Suzan Memed-Sejfulah; Katerina Brezovska, et al. Conventional and Multivariate Statistical Methods for Evaluation of In vitro Dissolution Similarity of Bisoprolol Film-coated Tablets. Int. J. Pharm. Chem. 2020, 6(2), 16-25. doi: 10.11648/j.ijpc.20200602.12

    Copy | Download

    AMA Style

    Ivana Mitrevska, Ljupco Pejov, Marija Jovanovska, Suzan Memed-Sejfulah, Katerina Brezovska, et al. Conventional and Multivariate Statistical Methods for Evaluation of In vitro Dissolution Similarity of Bisoprolol Film-coated Tablets. Int J Pharm Chem. 2020;6(2):16-25. doi: 10.11648/j.ijpc.20200602.12

    Copy | Download

  • @article{10.11648/j.ijpc.20200602.12,
      author = {Ivana Mitrevska and Ljupco Pejov and Marija Jovanovska and Suzan Memed-Sejfulah and Katerina Brezovska and Aneta Dimitrovska and Sonja Ugarkovic},
      title = {Conventional and Multivariate Statistical Methods for Evaluation of In vitro Dissolution Similarity of Bisoprolol Film-coated Tablets},
      journal = {International Journal of Pharmacy and Chemistry},
      volume = {6},
      number = {2},
      pages = {16-25},
      doi = {10.11648/j.ijpc.20200602.12},
      url = {https://doi.org/10.11648/j.ijpc.20200602.12},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20200602.12},
      abstract = {In vitro dissolution testing is an important tool used for pharmaceutical development and approval of generic medicinal product, playing a pivotal role in regulatory decision-making. This study includes evaluation and comparative analysis of in vitro dissolution profiles of Bisoprolol film-coated tablets and in vitro dissolution profile of a reference medicinal product, using several model-independent and model-dependent statistical methods. The evaluated medicinal product belongs to BCS Class I (high solubility, high permeability). The similarity testing of dissolution profile is performed on the highest strength of the dosage form, in accordance with the regulatory requirements for bioequivalence study. Obtained results have shown that in vitro comparative dissolution analysis using pair-wise independent-model procedures, such as difference (f1) and similarity (f2) factors are not suitable, because one of the requirements (not more than one mean value dissolves more than 85%, for any of the formulations) was not fulfilled. Therefore, the comparison of the similarity of dissolution profiles was performed using Ratio test methodology and multivariate model-independent approach based on generalized statistical distance (Mahalanobis distance). Furthermore, other model-dependent approaches coupled to multivariate statistics (Weibull) were applied. The obtained results from the performed analysis indicated a significant similarity of the compared in vitro dissolution profiles between the tested batches from bisoprolol film-coated tablets and reference medicinal product). Implemented statistical methods can be considered as a regulatory accepted concept for evaluation of in vitro similarity of generic medicines.},
     year = {2020}
    }
    

    Copy | Download

  • TY  - JOUR
    T1  - Conventional and Multivariate Statistical Methods for Evaluation of In vitro Dissolution Similarity of Bisoprolol Film-coated Tablets
    AU  - Ivana Mitrevska
    AU  - Ljupco Pejov
    AU  - Marija Jovanovska
    AU  - Suzan Memed-Sejfulah
    AU  - Katerina Brezovska
    AU  - Aneta Dimitrovska
    AU  - Sonja Ugarkovic
    Y1  - 2020/07/04
    PY  - 2020
    N1  - https://doi.org/10.11648/j.ijpc.20200602.12
    DO  - 10.11648/j.ijpc.20200602.12
    T2  - International Journal of Pharmacy and Chemistry
    JF  - International Journal of Pharmacy and Chemistry
    JO  - International Journal of Pharmacy and Chemistry
    SP  - 16
    EP  - 25
    PB  - Science Publishing Group
    SN  - 2575-5749
    UR  - https://doi.org/10.11648/j.ijpc.20200602.12
    AB  - In vitro dissolution testing is an important tool used for pharmaceutical development and approval of generic medicinal product, playing a pivotal role in regulatory decision-making. This study includes evaluation and comparative analysis of in vitro dissolution profiles of Bisoprolol film-coated tablets and in vitro dissolution profile of a reference medicinal product, using several model-independent and model-dependent statistical methods. The evaluated medicinal product belongs to BCS Class I (high solubility, high permeability). The similarity testing of dissolution profile is performed on the highest strength of the dosage form, in accordance with the regulatory requirements for bioequivalence study. Obtained results have shown that in vitro comparative dissolution analysis using pair-wise independent-model procedures, such as difference (f1) and similarity (f2) factors are not suitable, because one of the requirements (not more than one mean value dissolves more than 85%, for any of the formulations) was not fulfilled. Therefore, the comparison of the similarity of dissolution profiles was performed using Ratio test methodology and multivariate model-independent approach based on generalized statistical distance (Mahalanobis distance). Furthermore, other model-dependent approaches coupled to multivariate statistics (Weibull) were applied. The obtained results from the performed analysis indicated a significant similarity of the compared in vitro dissolution profiles between the tested batches from bisoprolol film-coated tablets and reference medicinal product). Implemented statistical methods can be considered as a regulatory accepted concept for evaluation of in vitro similarity of generic medicines.
    VL  - 6
    IS  - 2
    ER  - 

    Copy | Download

Author Information
  • Research & Development, Alkaloid AD, Skopje, R. North Macedonia

  • Department of Chemistry, Bioscience and Environmental Engineering, Faculty of Science and Technology, University of Stavanger, Stavanger, Norway

  • Research & Development, Alkaloid AD, Skopje, R. North Macedonia

  • Research & Development, Alkaloid AD, Skopje, R. North Macedonia

  • Institute of Applied Chemistry and Pharmaceutical Analysis, ‘Ss. Cyril and Methodius” University, Faculty of Pharmacy, Skopje, R. North Macedonia

  • Institute of Applied Chemistry and Pharmaceutical Analysis, ‘Ss. Cyril and Methodius” University, Faculty of Pharmacy, Skopje, R. North Macedonia

  • Research & Development, Alkaloid AD, Skopje, R. North Macedonia

  • Sections