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: Dissolution in buffer was > 85 %. In cola drink, it was < 80 %, while in grapefruit juice, it was in the range of 7 - 68 %. Using 2-way ANOVA, these media and the three naproxen brands showed significant differences (F = 68.90, p = 0.0000; F = 23.18, p = 0.0000). 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.
Highlights
Naproxen is one of the most frequently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in the world
The data obtained from the percentage dissolution of patent naproxen (Figure 1), generic naproxen (Figure 2) and similar naproxen (Figure 3) in the three media presented lower values than the pharmacopoeia limits acceptable to FEUM
The analyses with cola drink, grapefruit juice and milk were carried out with the purpose of investigating if the dissolution was modified by the natural properties of these media
Summary
Naproxen is one of the most frequently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in the world. It is slightly soluble in water (25 mg/L at 25 °C) [1,2].it has a low degree of dissolution which affects its bioavailability and bioequivalence. The degree of dissolution can predict the availability of a drug and its consistency from one lot to another [3]. It is important to determine the bioavailability of drugs administered orally, as well as their bioequivalence and interchangeability [4]. If the preferred route of administration is oral, it is important that oral dissolution and absorption of the drugs should be guaranteed. If the differences between generic and patent medicines are due to inactive ingredients, and if some generic formulations eliminate qualitatively and, sometimes quantitatively, the excipients of the patent formulation, this can affect their interchangeability [7]
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