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

Ivana Mitrevska; Ljupco Pejov; Marija Jovanovska; Suzan Memed-Sejfulah; Katerina Brezovska; Aneta Dimitrovska; Sonja Ugarkovic

doi:doi:10.11648/j.ijpc.20200602.12

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

Ivana Mitrevska, Ljupco Pejov, Marija Jovanovska, Suzan Memed-Sejfulah, Katerina Brezovska, Aneta Dimitrovska, Sonja Ugarkovic

Received: 9 June 2020 Accepted: 20 June 2020 Published: 4 July 2020

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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.

DOI	10.11648/j.ijpc.20200602.12
Published in	International Journal of Pharmacy and Chemistry (Volume 6, Issue 2, March 2020)
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), 2024. Published by Science Publishing Group

Keywords

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

References

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[5]	FDA Guidance for industry: Dissolution testing of immediate release solid oral dosage forms, In. Rockville, MD (1997).
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[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.
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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

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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

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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

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@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}
}

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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  -

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Author Information

Ivana Mitrevska

Research & Development, Alkaloid AD, Skopje, R. North Macedonia
Ljupco Pejov

Department of Chemistry, Bioscience and Environmental Engineering, Faculty of Science and Technology, University of Stavanger, Stavanger, Norway; Institute of Chemistry, ‘Ss. Cyril and Methodius” University, Faculty of Natural Sciences and Mathematics, Skopje, R. North Macedonia
Marija Jovanovska

Research & Development, Alkaloid AD, Skopje, R. North Macedonia
Suzan Memed-Sejfulah

Research & Development, Alkaloid AD, Skopje, R. North Macedonia
Katerina Brezovska

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

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

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

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Plain Text BibTeX RIS

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

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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

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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}
}

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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  -

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