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    Estudo da concentração e da estabilidade de comprimidos de captopril após o processo de partição, trituração e dissolução
    (Universidade Federal de São Paulo (UNIFESP), 2018-07-26) Kushiyama, Sandra Regina Pereira [UNIFESP]; Peterlini, Maria Angelica Sorgini [UNIFESP]; Kusahara, Denise Miyuki [UNIFESP]; http://lattes.cnpq.br/1599622257763420; http://lattes.cnpq.br/0730827143264007; Universidade Federal de São Paulo (UNIFESP)
    Introduction: The administration of Captopril tablets in pediatric clinical practice is a common process, mainly for the treatment of hypertension, heart failure and nephropathy. The unavailability of the necessary milligram dosage of Captopril tablets and the lack of pharmaceutical liquid formula in the national market don’t always meet the therapeutic needs, causing many professionals to partition, crush, dissolve and fractionate the drug. This practice may compromise the stability and concentration of the drug. Objective: To verify the concentration and stability of Captopril tablets after trituration and dissolution with three diluents, according to time of exposure to environmental conditions; and to verify the concentration of Captopril solutions after drug manipulation and dose fractionation by nurses, according to clinical practice; and to identify the presence and concentration of Captopril Disulfide from Captopril tablets after dissolution with three diluents, according to time. Materials and Methods: An experimental study in which the concentration and stability of 25mg Captopril tablets were analyzed by high performance liquid chromatography after trituration and dissolution with three different diluents, filtered water (FW), mineral water (MW) and deionized water (DW), having also the mobile phase (MP) for control. To verify time’s influence, analyses were performed immediately after preparation (T0), after 30 (T30) and again after 60 (T60) minutes, in triplicate, totaling 36 analyses. In order to study the concentration of triturated tablets, dissolved in FW and fractionated, three nurses performed this practice in an attempt to obtain 10mg of the drug. Analyses occurred at T0, T30 and T60. The sample for this stage of the study was 54 analyses. Data was analyzed using mean, standard deviation, median, KruskalWallis test and Dunn’s posttest (p≤0.05). Results: The median concentrations of the dissolved Captopril tablets were statistically different at T0 (p = 0.02), between FW (24.86mg), MW (25.74mg), DW (26.98mg) and MP (25.48mg). Between the initial and final times (T0 and T60), no significant differences were identified (FW p = 0.87, MW p = 0.99, DW p = 0.62, MP p = 0.83). The nurses, after turning the tablets into pharmaceutical liquid form, obtained, on average, higher concentrations than the one intended (Nurse A = 10.64mg, Nurse B = 10.55mg, Nurse C = 10.48mg), without any statistical difference between the professionals (p = 0.91). Conclusion: Captopril solutions remained stable after handling and within a period of 60 minutes, regardless of the diluent. There were variations in the concentration, according to the diluent used, FW being the lowest and DW the highest. There was a difference between the concentrations of the solutions prepared by the nurses, with averages above 10mg. The values of Captopril Dissulfer, degrading Captopril, did not present a statistically significant difference in the solutions studied, maintaining acceptable levels, both in the times and in the diluents tested. Descriptors: Pediatric Nursing; Nursing; Tablets; Dissolution; Dose fractionation; Drug Stability; High Performance Liquid Chromatography.