Estudo de controle de qualidade físico-químico de suspensões orais manipuladas de naproxeno sódico

Abstract

Objective This study aimed to compare the quality control between the reference naproxen sodium oral suspension, Flanax®, named R, and oral suspensions acquired from six compounding pharmacies in the city of Natal, Rio Grande do Norte, Brazil, named A, B, C, D, E and F, at concentrations of 25mg/mL. Methods Tests were done to confirm the identity and concentration of the active ingredient and determine the pH, homogeneity, volume and organoleptic characteristics of the oral suspensions. Quantification of the active ingredient showed precision, accuracy, linearity and specificity. Results The active ingredient concentrations were below the pharmacopeial specifications in samples B, C and E, and above in sample F. Moreover, the pH of samples C, E and F were outside the specification limits. Samples C and E were not sufficiently homogeneous. The volumes of most samples were in agreement with the volumes reported on the labels, except for sample C. Conclusion The results show that better surveillance by the relevant agencies is needed to ensure patient safely and the quality of compounded drugs.