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

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

Published in International Journal of Pharmacy and Chemistry (Volume 6, Issue 2)

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

Views: Downloads:

Download PDF

Share This Article

Twitter
Linked In
Facebook

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

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

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

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
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

Download PDF

Sections

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

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