Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

In vitro dissolution characteristics of patent, generic and similar brands of naproxen in various dissolution media

Maria F Rocha-Alcaraz¹, Erandis D Torres-Sánchez¹, Juan H Torres-Jasso², Alán Y Yáñez-González¹, Mireya Z Reyna-Villela³, Daniel Rojas-Bravo³, Joel Salazar-Flores¹

¹Department of Medical Sciences and Life, Cu-Ciénega; ²Department of Biological Sciences, Division of Biological and Health Sciences, Cu-Coast; ³Department of Technological Cu-Ciénega, University of Guadalajara, Jalisco, México.

For correspondence:- Joel Salazar-Flores Email: joelos12@hotmail.com Tel:+523929257112

Accepted: 24 May 201 Published: 30 June 2019

Citation: Rocha-Alcaraz MF, Torres-Sánchez ED, Torres-Jasso JH, Yáñez-González AY, Reyna-Villela MZ, Rojas-Bravo D, et al. In vitro dissolution characteristics of patent, generic and similar brands of naproxen in various dissolution media. Trop J Pharm Res 2019; 18(6):1155-1160 doi: 10.4314/tjpr.v18i6.1

© 2019 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To investigate the dissolution properties of various brands of naproxen in four dissolution media in order to forecast their biological availability.

Methods: Dissolution tests were carried out in a dissolution tester with 48 tablets of different naproxen brands in 900 mL of 0.1 M phosphate buffer, pH 7.4. Subsequently, the medium was modified with 600 mL of buffer plus 300 mL of cola drink, grapefruit or milk. Each sample was taken and brought to a concentration approximating that of a reference solution. Absorbance at 332 nm was determined and the dissolution, Q, was calculated (Q values ≥ 80.0 ± 5 % were acceptable).

Results: The dissolution in buffer, cola drink and grapefruit juice was > 85 %, < 80 %, and 7 - 68 %, respectively. Using 2-way ANOVA, these media and the three naproxen brands showed significant differences (F = 68.90, p < 0.001; F = 23.18, p < 0.001). With Fisher's LSD test, two of these media contributed consistently to dissolution, and the three drug brands showed statistically different dissolution profiles (p ≤ 0.05).

Conclusion: Caution must be exercised cola drink, grapefruit juice and milk are used to administered naproxen as the biological availability of the drug may be altered.

Keywords: Naproxen brands, Dissolution, Phosphate buffer, Grapefruit, Cola drink, Milk