Evaluation of the nimesulide content in splitting tablets

Autores

  • Y. D. Silva Universidade Federal de Mato Grosso -UFMT
  • M. M. Valladão Universidade de Cuiabá - UNIC
  • M. P. R. Torres Universidade Federal de Mato Grosso -UFMT
  • A. L. Raiser Universidade Federal de Mato Grosso -UFMT
  • E. B. Ribeiro Universidade Federal de Mato Grosso -UFMT
  • C. R. Andrighetti Universidade Federal de Mato Grosso -UFMT
  • L. G. Vasconcelos Universidade Federal de Mato Grosso -UFMT
  • D. M. S. Valladão Universidade Federal de Mato Grosso -UFMT http://orcid.org/0000-0002-2643-1963

DOI:

https://doi.org/10.36560/1232019920

Palavras-chave:

Nimesulide, splitting tablets, quality control.

Resumo

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that inhibits the action of the enzyme cyclooxygenase-2 and is widely used in many countries for the treatment of pain and inflammation. It is often given on a dosage adjustment basis mainly in the elderly and children. In the present work the nimesulide tablet splitting process from three different suppliers was studied using a tablet cutter in order to verify the influence of the breakdown of the same on the content of each obtained fragment. The tests of average weight, hardness, friability, disintegration, dosage and uniformity of unit doses were performed following the official methodology established by the Brazilian Pharmacopoeia. The samples studied met the official specifications before being submitted to the partition procedure; however, after dividing the tablets, the drug content in the halves presented excessive variation, showing that this procedure should not be performed for the drug Nimesulide. In cases of need for varying administration doses of Nimesulide, it is recommended that the drug be manipulated or that another pharmaceutical form is used in order to ensure dosage in each unit of the dosage form.

Referências

BANKER, G. ANDERSON, N. The theory and practice of industrial phar¬macy. 3a ed. Filadélfia: Lea & Febiger. p. 856-883, 1986.

BERG, C., EKEDAHL, A. Dosages involving splitting tablets: common but unnecessary? Journal of Pharmaceutical Health Services Research 1:137-141, 2010.

BRASIL. Anvisa - Agência Nacional de Vigilância Sanitária. Farmacopeia Brasileira. 5. ed. Brasília: Anvisa, v.1-2, 2010.

BRUNTON, LL., CHABNER, BA., KNOLLMANN, BC. Goodman: as bases farmacológicas da terapêutica de Goodman & Gilman. 13. ed. Porto Alegre: Artmed. p. 847-875, 2012.

CONTI, MA., ALDELINO, CA., LEITE, LB., VASCONCELOS, SB. Partição de compri¬midos: considerações sobre o uso apropriado. Boletim Farmacoterapêutica XII(04–05):1–6, 2007.

FAHELELBOM, KMS., AL-TABAKHA, MMM., EISSA, NAM., JAVADI, J. Evaluation of certain pharmaceutical quality attributes of lisinopril split tablets. Scientia Pharmaceutica 84(4):646-653, 2016.

FERREIRA, AAA., PRANTES, EC., FERNADES, JPS., FERRARINI, M. Avaliação do efeito da partição de comprimidos de furosemida sobre a uniformidade da dose. Revista Ciências Farmacêuticas Básicas e Aplicadas 32(1):47-53, 2011.

HABIB, WA., ALANIZI, AS., ABDELHAMID, MM., ALANZINI, KF. Accuracy of tablet splitting: Comparison study between hand splitting and tablet cutter. Saudi Pharmaceutical Journal 22(5):454-459, 2014.

HILL, S., VARKER, AS., KARLAGE, K., MYRDAL, PB. Analysis of Drug Content and Weight Uniformity for Half-Tablets of 6 Commonly Split Medications. Journal Managed Care Pharmacy 15(3):253-61, 2009.

KATSUNG, BG., TREVOR, AJ. Farmacologia Básica e Clínica. 13. ed. Lange, Porto Alegre, 1216 p. 2017.

MORAIS, ALR., ARAÚJO, MB., PEREIRA, GR. Desenvolvimento e Validação de um Método Analítico Rápido por Cromatografia Líquida de Alta Eficiência para Determinação de Nimesulida em Estudos de Liberação In Vitro. Química Nova 32(1):165-168, 2009.

PINHEIRO, AV., SILVA COSTA, D., OLIVEIRA, GB., NOGUEIRA, RJL. Cápsulas magistrais: uma alternativa viável para a partição de comprimidos de liberação imediata de 40 mg de furosemida e de 25 mg de espironolactona comercialmente disponíveis no mercado nacional, Revista Associação nacional de farmacêuticos magistrais: encarte técnico p. 65, 2006.

QUINZLER, R., GASSE, C., SCHNEIDER, A., KAUFMANN-KOLLE, P., SZECSENYI, J., HAEFELI, E. The frequency of inappropriate tablet splitting in primary care. European Journal of Clinical Pharmacology 62: 1065-1073, 2006.

TEIXEIRA, MT., SÃ-BARRETO, LCL., SILVA, DLM., CUNHA-FILHO, MSS. Panorama dos aspectos regulatórios que norteiam a partição de comprimidos. Revista Panamericana de Salud Publica 39(6):372–77, 2016.

STAFFORD, RS., RADLEY, DC. The potential of pill splitting to achieve cost savings. American Journal Managed Care Pharmacy 8(8):706-12, 2002.

VAN SANTEN, E., BARENDS, DM., FRIJLINK, WK. Breaking of scored tables: a review. European Journal of Pharmaceutics and Biopharmaceutics 53:139-145, 2002.

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Publicado

2019-06-01

Como Citar

Silva, Y. D., Valladão, M. M., Torres, M. P. R., Raiser, A. L., Ribeiro, E. B., Andrighetti, C. R., Vasconcelos, L. G., & Valladão, D. M. S. (2019). Evaluation of the nimesulide content in splitting tablets. Scientific Electronic Archives, 12(3), 111–115. https://doi.org/10.36560/1232019920

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