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A multivariate investigation into the relationship between pharmaceutical characteristics and patient preferences of bioequivalent ibuprofen tablets

Authors Alonso TR, Gagol A, Scherer M, Matji A, Torrado-Santiago S, Serrano DR, Garcia-Arieta A, Torrado JJ

Received 29 May 2018

Accepted for publication 26 July 2018

Published 26 September 2018 Volume 2018:12 Pages 1927—1935

DOI https://doi.org/10.2147/PPA.S174479

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 2

Editor who approved publication: Dr Johnny Chen


Tatiana R Alonso,1 Adrianna Gagol,1 Maximilian Scherer,1 Antonio Matji,1 Santiago Torrado-Santiago,2 Dolores R Serrano,1 Alfredo Garcia-Arieta,3 Juan J Torrado1

1Pharmaceutics and Food Technology, School of Pharmacy, Complutense University, Madrid, Spain; 2Industrial Pharmacy Institute, Complutense University, Madrid, Spain; 3Service on Pharmacokinetics and Generics, Department of Human Use Medicines, Division of Pharmacology and Clinical Evaluation, Spanish Agency for Medicines and Health Care Products, Madrid, Spain

Background: In Spain the price of all ibuprofen 600 mg tablet generic products is the same due to reimbursement existing rules so for the patient there is not any economic incentive to choose a particular one. Bearing in mind that the quality of generic products should be similar, it could be questioned if differences in patient preferences evaluated as sales could be related to differences on their pharmaceutical properties. The aims of this work were to study the variability on the pharmaceutical characteristics of marketed bioequivalent tablet formulations and its impact on patient preferences.
Methods: Thirty-six batches corresponding to fourteen different generic products were chosen among the best-selling products of the Spanish market in the years 2011 and 2015 and were compared to the reference product. The effect on patient preferences of six variables was studied through a multivariate analysis. The first two variables were marketing characteristics: 1) years in the market and 2) the number of other generic products marketed by the same manufacturer, which could be related to the size and service provided by the manufacturer. The other four variables studied were pharmaceutical tablet properties: 3) mean weight, 4) hardness, 5) disintegration, and 6) dissolution. A multiple linear regression analysis was performed to identify the effect on sales of the six variables studied.
Results: The disintegration time was the most significant (P=0.018) factor affecting the sales of Ibuprofen tablets which may be related to the onset of action.
Conclusion: The faster the tablet disintegration, the higher its sales. Two possible explanations are suggested: 1) the most specialized ibuprofen tablet manufacturer considers fast disintegration as a key parameter and/or 2) habitual consumers of ibuprofen can detect small differences on the onset of action among different marketed formulations. In this work, all marketed ibuprofen tablets comply with the pharmacopoeia specifications.

Keywords: ibuprofen, sales, disintegration, generic, multiple linear regression analysis, multivariate analysis

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