Title:	Avaliação da influência de múltiplos fatores envolvidos na partição de comprimidos
Authors:	Teixeira, Maíra Teles
Orientador(es)::	Cunha Filho, Marcílio Sérgio Soares da
Coorientador(es)::	Silva, Dayde Lane Mendonça da
Assunto::	Medicamentos - dosagem Preparações farmacêuticas Medicamentos fracionados
Issue Date:	15-May-2016
Data de defesa::	6-Aug-2015
Citation:	TEIXEIRA, Maíra Teles. Avaliação da influência de múltiplos fatores envolvidos na partição de comprimidos. 2015. 72 f., il. Dissertação (Mestrado em Ciências da Saúde)—Universidade de Brasília, Brasília, 2015.
Abstract:	Introduction and objective: Tablet splitting is a common practice, widely used in treatments of the elderly and children. Among the problems related to this activity are the possible dosage variation and the decrease of drug stability after split. Subdividing tablets acquires critical contours in the case of low therapeutic index drugs, since small changes in dosage can lead to serious repercussions on patient’s health. This study aimed to analyze the splitting problem in regulatory, technical and experimental aspects. Method: The first part of the study was dedicated to conduct an analysis of world’s health legislation concerned to regulation of tablets split. In second part, a study of the subject in scientific literature was conducted. In the third part, an experimental study to evaluate the impact of tablets subdivision on their physical and mechanical properties was done. Results: In most countries, including part of South America, drug subdivision is not regulated by health authorities. United States and Europe have rudimentary specifications and tests adapted to assess the performance of the tablets after split. Scientific studies on the subject are controversial and inconclusive about the safety of this practice and the best way to do it. In general, oblong, coated, flat surface and deep groove favor a more accurate subdivision. There is greater prevalence of advantageous results in manual breaking and tablet splitter device, compared to knife split. The experimental study conducted revealed results similar to the literature’s results, showing superiority in split with tablet splitter device compared with knife. Split tablets showed a decrease of approximately 50% in hardness, 0.65% increase in friability and disintegration around 20% faster compared to intact tablets. Weight loss related to fragmentation and crumbling of the tablets was up to 2% and weight variation varied between 0 and 50%, with an average of 10.0 ± 9.9%. The average of surface area variation of the tablets was 15.2%, showing a correlation with weight variation test (r = 0.169, p = 0.001). Round tablets exhibited weight loss (2.59% ± 0.23) and area change (17.57% ± 0.95) higher than those obtained by oblong ones (0.66 ± 0.78% and 5, 47% ± 0.52; p = 0.000 for both). Coated tablets had lower weight loss (p = 0.000), hardness (p = 0.022) and area (p = 0.009) variations, with values of 1.4% ± 0.2, and 51.5 ± 1.2% 13.0% ± 1.2 compared to uncoated tablets that had 2.8% ± 0.3% 54.4 ± 1.3, and 16.6 ± 1.1%. Finally, scored tablets had lower weight loss (p = 0.000) and area change (p = 0.000; 8.63% ± 0.7 and 13.44% ± 1.01) compared to nonscored tablets (12.63 % ± 0.72 and 18.57 ± 1.32%). Conclusion: There is a necessity of more researches and consistent health regulations to guide patients and healthcare professionals in tablets split.
metadata.dc.description.unidade:	Faculdade de Ciências da Saúde (FS)
Description:	Dissertação (mestrado)—Universidade de Brasilia, Faculdade de Ciências da Saúde, Programa de Pós-Graduação em Ciências da Saúde, 2015.
metadata.dc.description.ppg:	Programa de Pós-Graduação em Ciências da Saúde
Licença::	A concessão da licença deste item refere-se ao termo de autorização impresso assinado pelo autor com as seguintes condições: Na qualidade de titular dos direitos de autor da publicação, autorizo a Universidade de Brasília e o IBICT a disponibilizar por meio dos sites www.bce.unb.br, www.ibict.br, http://hercules.vtls.com/cgi-bin/ndltd/chameleon?lng=pt&skin=ndltd sem ressarcimento dos direitos autorais, de acordo com a Lei nº 9610/98, o texto integral da obra disponibilizada, conforme permissões assinaladas, para fins de leitura, impressão e/ou download, a título de divulgação da produção científica brasileira, a partir desta data.
DOI:	http://dx.doi.org/10.26512/2015.08.D.20234
Appears in Collections:	Teses, dissertações e produtos pós-doutorado

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