AAPS PharmSciTech

, 10:1145 | Cite as

Development and Validation of a Discriminative Dissolution Test for Nimesulide Suspensions

  • Laís Bastos da Fonseca
  • Márcio Labastie
  • Valéria Pereira de Sousa
  • Nadia Maria Volpato
Research Article

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.

Key words

dissolution nimesulide particle size suspension validation 

References

  1. 1.
    Siewert M, Dressman J, Brown CK, Shah VP. FIP/AAPS guidelines to dissolution in vitro release testing of novel special dosage forms. AAPS PharmSciTech. 2003;7:1–10.Google Scholar
  2. 2.
    Jamzad S, Fassihi R. Role of surfactant and pH on dissolution properties of fenofibrate and glipizide—a technical note. AAPS PharmSciTech. 2006;33:E1–6.Google Scholar
  3. 3.
    Fallavena PRB, Schapoval EES. pK a determination of nimesulide in methanol–water mixtures by potentiometric titrations. Int J Pharm. 1997;158:109–12.CrossRefGoogle Scholar
  4. 4.
    Singh S, Sharda N, Mahajan L. Spectrophotometric determination of pK a of nimesulide. Int J Pharm. 1999;176:261–4.CrossRefGoogle Scholar
  5. 5.
    Amidon GL, Lennernas H, Shah VP, Crison JR. A theorical basic for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution in vivo bioavailability. Pharm Res. 1995;12:413–20.CrossRefPubMedGoogle Scholar
  6. 6.
    Brown CK, Chokshi HP, Nickerson B, Reed RA, Rohrs BR, Shah PA. Acceptable analytical practices for dissolution testing of poorly soluble compounds. Pharm Technol. 2004;12:56–65.Google Scholar
  7. 7.
    He Z, Zhong D, Chen X, Liu X, Tang X, Zhao L. Development of a dissolution medium for nimodipine tablets based on bioavailability evaluation. Eur J Pharm Sci. 2004;21:487–91.CrossRefPubMedGoogle Scholar
  8. 8.
    International Conference on Harmonisation (ICH). Validation of analytical procedures: text and methodology Q2(R1). Geneva: ICH Secretariat; 2005.Google Scholar
  9. 9.
    The United States Pharmacopeia, Reagents, USP Convention, Rockville, USA; 2006. p. 3167–8.Google Scholar
  10. 10.
    Jenke DR. Chromatographic method validation: a review of current practices and procedures. II. Guidelines for primary parameters. J Liq Chromatogr Relat Technol. 1996;19:737–57.CrossRefGoogle Scholar
  11. 11.
    Fortunato D. Dissolution method development for immediate release solid oral dosage forms. Dissolution Technologies; 2005. p. 12–4.Google Scholar
  12. 12.
    Lindenberg M, Wiegand C, Dressman JB. Comparison of the adsorption of several drugs to typical filter materials. Dissolution Technologies; 2005. p. 22–5.Google Scholar
  13. 13.
    Oliveira MRS. MSc thesis in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio de Janeiro, Brazil; 2003. p. 101.Google Scholar
  14. 14.
    Silva RL, Volpato NM. Meios para dissolução de comprimidos de nimesulida: ação dos tensoativos. Braz J Pharm Sci. 2002;38:163–72.Google Scholar
  15. 15.
    CDER/FDA. Guidance for industry. Dissolution testing of immediate release solid oral dosage forms; 1997.Google Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2009

Authors and Affiliations

  • Laís Bastos da Fonseca
    • 4
  • Márcio Labastie
    • 2
  • Valéria Pereira de Sousa
    • 1
  • Nadia Maria Volpato
    • 1
    • 3
  1. 1.Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de FarmáciaUniversidade Federal do Rio de JaneiroRio de JaneiroBrazil
  2. 2.Departamento de MedicamentosINCQS/FIOCRUZRio de JaneiroBrazil
  3. 3.Faculdade de FarmáciaUniversidade Federal do Rio Grande do SulPorto AlegreBrazil
  4. 4.Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de FarmáciaUniversidade Federal do Rio de JaneiroRio de JaneiroBrazil

Personalised recommendations