ANÁLISE DA PARTIÇÃO DE COMPRIMIDOS DE CARBAMAZEPINA
Resumo
ANALYSIS OF TABLET SPLITTING OF CARBAMAZEPINE
ABSTRACT
Splitting tablets often affects the dosage, especially when it refers to sustained-release tablets. The present study aims at analyzing and discussing the splitting of carbamazepine tablets with knifes or pill cutter. Carbamazepine (generic drug) and Tegretol® (reference medicine) tablets, classified respectively with Sample 1 (SPL1) and Sample 2 (SPL2), both at the concentration of 200 mg, were used for analysis. The tests of average weight, hardness, friability and disintegration were performed in both the intact tablets and in the split samples. The splitting was done with a pill cutter and with a kitchen knife and the results obtained were compared. In the test of average weight, the intact tablets of SPL1 and SPL2 presented satisfactory results; however, the split pills of both samples presented unsatisfactory results. For hardness, SPL1 was within the limits; on the other hand, some parts of SPL2 divided with knife and pill cutter were out of the limit. Satisfactory results were observed concerning the friability test in SPL1, but SPL2 with intact pills and some pieces were disapproved. The disintegration of the integral SPL1 was over the estimated time; the integral SPL2, however, disintegrated in a satisfactory time, and in both samples the split tablets disintegrated in approximately half the time of the intact tablets. Therefore, we observed that splitting pills is inadvisable, as the mass is altered, the resistance to adverse situations is compromised as well as the uniformity of the content is modified, placing the drug therapy in risk.
Palavras-chave
Texto completo:
PDFReferências
BRASIL. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Farmacopeia Brasileira. 5. ed. Brasília: Fiocruz, 2010. 545 p. Disponível em: http://www.anvisa.gov.br/hotsite/cd_farmacopeia/pdf/volume1%2020110216.pdf. Acesso em: 12 mar. 2017.
BRASIL. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Partição de Comprimido. Disponível em: http://tinyurl.com/y7cnq9tl. Acesso em: 03 mar. 2017.
CLARK, M. A. et al. Farmacologia Ilustrada. 5. ed. Porto Alegre: Artmed, 2013. 612 p.
COOK, T. J. et al. Variability in tablet fragment weights when splitting unscored cyclobenzaprine 10 mg tablets. Journal of the American Pharmacists Association, v. 44, n. 5, p. 583-6, 2004.
FERREIRA, A. A. A. et al. Avaliação do efeito da partição de comprimidos de furosemida sobre a uniformidade da dose. Revista de Ciências Farmacêuticas Básica e Aplicada, v. 32, n. 1, p. 47-53, 2011.
HILL, S. W. et al. Analysis of drug content and weight uniformity for half-tablets of 6 commonly split medications. Journal of Managed Care Pharmacy, v. 15, n. 3, p. 253-61, 2009.
MARRIOTT, J. L.; NATION, R. L. Splitting tablets: Australian Prescriber, 2002. Disponível em: https://www.nps.org.au/australian-prescriber/articles/splitting-tablets-6. Acesso em: 12 mar. 2017.
NAVARRO, R. P. Tablet splitting: much ado about nothing? Journal of Managed Care Pharmacy, v. 15, n. 3, p. 272-4, 2009.
NOTENBOOM, K. et al. Relationship between age and the Ability to Break Scored Tablets. Frontiers in Pharmacology, v. 7, n. 2, p. 22-31, 2016.
PINHEIRO, A. V. et al. 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 da Anfarmag, v. 65, n. 5, p. 3-5, 2006.
QUINZLER, R. et al. The frequency of inappropriate tablet splitting in primary care. European Journal of Clinical Pharmacology, v. 62, n. 12, p. 1065-1073, 2006.
RANG, H. P. et al. Farmacologia. 8. ed. Rio de Janeiro: Elsevier, 2016. 29.
RIET-NALES, D. A. V. et al. The accuracy, precision and sustainability of different techniques for tablet subdivision: Breaking by hand and the use of tablet splitters or a kitchen knife. International Journal of Pharmaceutics, v. 466, n. 1-2, p. 44-51, 2014.
ROWLEY, F. A. Minimize Bisect Risk: Fharmaceutical Manufacturing. 2016. Disponível em: http://www.pharmamanufacturing.com/articles/2006/188/. Acesso em: 10 mar. 2017.
SILVA, J. R. et al. Estudo Sobre Partição de Comprimidos de Besilato de Anlodipino. Ensaio e Ciência: Ciências Biológicas, Agrárias e da Saúde, v. 17, n. 5, p. 75-87, 2013.
TEIXEIRA, M.T. et al. Panorama dos aspectos regulatórios que norteiam a partição de comprimidos. Revista Panamericana Salud Publica, v. 39, n. 6, p. 372-377, 2016.
TEIXEIRA, M. T. Avaliação da influência de múltiplos fatores envolvidos na partição de comprimidos. 2015. 72 f. Tese (Mestrado em Ciências da Saúde) – Programa de Pós-Graduação em Ciências da Saúde, Universidade de Brasília. Brasília, 2015.
WINTER, M. E. Farmacocinética Clínica Básica. São Paulo: Pharmabooks, 2012. 522p.
DOI: http://dx.doi.org/10.25191/recs.v4i1.2371
Direitos autorais 2019 Revista Expressão Católica Saúde
ISSN: 2526-964X
Revista Associada |
---|
![]() |
![]() |
Indexadores | |||||||
---|---|---|---|---|---|---|---|
![]() |
![]() |
![]() |
![]() |
![]() |
![]() |
![]() |
![]() |
![]() |