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Development and Validation of a Discriminative Dissolution Test for Nimesulide Suspensions

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Abstract

The dissolution test for oral dosage forms has recently widened to a variety of special dosage forms such as suspensions. For class II drugs, such as nimesulide (NMS), this study is very important because formulation problems may compromise drug bioavailability. In the present work, tests with four brands of commercially available NMS (RA, TS, TB, and TC) have been performed in order to study their dissolution at different conditions. The suspensions have been characterized relatively to particle size, pH, and density besides NMS assay and the amount of drug in solution in the suspension vehicles. The dissolution study was conducted using the following media: simulated intestinal fluid, pH 6.8, containing polysorbate 80 (P80) or sodium lauryl sulfate (SLS); phosphate buffer, pH 7.4, with P80 and aqueous solution of SLS. Concerning the quantitative analysis, the UV–VIS spectrophotometry could have been used in substitution to high-performance liquid chromatography since the methodology had been adequately validated. The influence of the drug particle size distribution was significant on the dissolution profiles of NMS formulations, confirming to be a factor that should be strictly controlled in the development of oral suspensions.

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Acknowledgments

The authors would like to thank CAPES, Brazil for fellowship conferred to L.B. Fonseca, to LabCQ-UFRJ for financial support, and to Schering-Plough for supplying the reference substance.

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Authors and Affiliations

  1. Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Rio de Janeiro, Brazil

    Valéria Pereira de Sousa & Nadia Maria Volpato

  2. Departamento de Medicamentos, INCQS/FIOCRUZ, Rio de Janeiro, Brazil

    Márcio Labastie

  3. Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil

    Nadia Maria Volpato

  4. Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Av. Pau Brasil s/n, Edifício CCS, Bloco Bss sala 34–Ilha do Fundão, Rio de Janeiro, Rio de Janeiro, CEP: 21941-590, Brazil

    Laís Bastos da Fonseca

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  1. Laís Bastos da Fonseca
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  2. Márcio Labastie
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  3. Valéria Pereira de Sousa
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  4. Nadia Maria Volpato
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Correspondence to Laís Bastos da Fonseca.

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da Fonseca, L.B., Labastie, M., de Sousa, V.P. et al. Development and Validation of a Discriminative Dissolution Test for Nimesulide Suspensions. AAPS PharmSciTech 10, 1145–1152 (2009). https://doi.org/10.1208/s12249-009-9320-4

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  • DOI: https://doi.org/10.1208/s12249-009-9320-4

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