Navegando por Palavras-chave "Drug stability"

Agora exibindo 1 - 4 de 4
  • Imagem de Miniatura
    Item
    Acesso aberto (Open Access)
    Estabilidade de soluções de cloridrato de dobutamina em diferentes tempos e a influência do aquecimento e da luminosidade decorrentes da infusão no interior de incubadora e sob fototerapia
    (Universidade Federal de São Paulo (UNIFESP), 2017-09-28) Domenicis, Tatiany Calegari de [UNIFESP]; Peterlini, Maria Angelica Sorgini [UNIFESP]; Pedreira, Mavilde da Luz Gonçalves; Rosa, Paulo César Pires; Mavilde da Luz Gonçalves Pedreira : http://lattes.cnpq.br/5901248667753975; Paulo César Pires Rosa : http://lattes.cnpq.br/4575080333650988; http://lattes.cnpq.br/1599622257763420; http://lattes.cnpq.br/8135197639370701; Universidade Federal de São Paulo (UNIFESP)
    Introduction: Critically ill children in intensive care unit often receive dobutamine hydrochloride in continuous infusion by central intravenous catheter. The environmental factors such as luminosity and temperature from this unit can compromise the drug stability. Objectives: Validating analytical methodology by High Performance Liquid Chromatography (HPLC) to determine the concentration and the dobutamine hydrochloride stability; analyzing the pH, the osmolality and the pure and diluted dobutamine hydrochloride in sodium chloride in 0,9% (NaCl 0,9%) concentration according to the exposure time under environment temperature/fluorescent lamps and high incubator temperature/phototherapy light influence. Methods: This is an experimental study developed at Universidade Federal de São Paulo. The developing analytical parameters were determined due to analytical methodology validation: selectivity, linearity, range, precision, accuracy, robustness and stability. The sample was composed by 60 pure dobutamine hydrochloride aliquots and 60 from the diluted drug (16 milliliters – mL of drug in 32 mL of NaCl 0,9%) with the syringe of 20,0 mL with disposable hypodermic needle 30,0 x 0,8 millimeters use, kept in graduated burettes, which was exposed to environmental conditions with fluorescent lamps/mean temperature of 23,1ºC±1,3 and phototherapy luminosity/high incubator temperature with the mean temperature of 39,8ºC±0,7. The pH analysis, osmolality and concentration were carried out immediately (T0), 2 (T2), 4 (T4), 24 (T24), 48 (T48) and 72 (T72) hours after preparing, by the digital benchtop pHmeter, osmometer and HPLC. The results were analyzed according to the mean (±standard deviation) and median (Interquartile range), tests were applied Student’s t-test, Mann-Whitney, ANOVA, Kruskal-Wallis and the significance level of p≤0,05 was established. Results: The developed method of dobutamine hydrochloride separation by HPLC has shown being selective, without interference of mobile phase, diluent and other compounds; linear in the range of 80% to 120% of the theorical concentration test; precise repeatability and intermediate precision; exact to the concentrations 0,40, 0,50 and 0,60 milligrams per milliliter (mg/mL); robust to the changes caused in the column temperature, composition and the flow rate of mobile phase; stable during 24 hours after the prepared sample. The pH has shown significant reduction as the pure as the diluted dobutamine hydrochloride and the osmolality variations weren’t significant in 72 hours exposure to environmental conditions and incubator/phototherapy. The concentration has kept stable to the pure and to the diluted drug from T0 until T72 (p=0,68 and p=0,25, respectively) in environmental condition. The pure drug concentration has shown slight increase (p=0,68) and the diluted drug has occurred statistically significant reduction during the exposure period (T0=96,90%±1,39 to T72=92,03%±1,47; p=0,0004) under high incubator temperature level and phototherapy, however, keeping the solution stability due to the changes has been lower to 10%. Conclusions: The chromatography method to analyze the dobutamine hydrochloride concentration was considered validated. The pure and diluted dobutamine hydrochloride has kept acid, hypotonic and chemical stable in 72 hours exposure to the environment and incubator/phototherapy.
  • Nenhuma Miniatura disponível
    Item
    Acesso aberto (Open Access)
    Estabilidade de soluções de cloridrato de vancomicina segundo concentração, tempo de infusão e temperatura
    (Universidade Federal de São Paulo (UNIFESP), 2014-12-17) Barbosa, Ana Paula Soares [UNIFESP]; Peterlini, Maria Angelica Sorgini Peterlini [UNIFESP]; http://lattes.cnpq.br/1599622257763420; Universidade Federal de São Paulo (UNIFESP)
    Estudo experimental que teve como objetivos validar metodologia analítica em cromatografia líquida de alta eficiência (HPLC) para determinar a concentração de cloridrato de vancomicina e analisar a estabilidade de soluções de cloridrato de vancomicina por meio de HPLC e pH, segundo concentração, tempo de exposição e temperatura. A separação cromatográfica foi realizada em colunas C-18 Phenosphere® (150 x 4,6mm, 5?m) e Kinetex® (100 x 4,6mm, 2,6?m), usando como fase móvel mistura de tampão fosfato monobásico de amônio 50mM e acetonitrila (92:8v/v), pH 4,0 (±1), em fluxo de 1 mL/min, com detecção no ultravioleta, ?=220nm em sistema isocrático de eluição. Os dados foram analisados segundo média e desvios padrão (m±dp). O método demonstrou linearidade para as faixas compreendidas entre 0,005 e 0,25mg/mL para a coluna Phenosphere® e 0,015625 - 0,25mg/mL para a coluna Kinetex®. O limite de quantificação para o método foi de 0,0005mg/mL e os coeficientes de variação no ensaio de repetitividade e precisão intermediária apresentaram valores entre 2,92% e 8,75%. Os tempos de retenção médios em coluna Phenosphere® foram de 7,446(±0,045), 7,524(±0,035) e 7,407(±0,159) minutos, com tempo de corrida cromatográfica de 10 minutos e na Kinetex® de 4,133(±0,127), 4,081(±0,106) e 3,978(±0,081) minutos, com tempo de corrida de cinco minutos. Boa exatidão (variações entre 86,2% e 111,9%) e alta seletividade foram verificadas. A análise da estabilidade foi realizada pela mensuração do pH e da concentração do fármaco após reconstituição com água para injetáveis e diluição com solução fisiológica (SF) em concentrações de 5 mg/mL e 10mg/mL, expostas às temperaturas de 22ºC(±1) e 37ºC(±1), administradas em bomba de infusão por período de 60 e 120 minutos. As amostras foram coletadas em triplicatas. Controlou-se o pH dos solventes, diluentes, soluções reconstituídas e soluções diluídas. A análise da concentração aconteceu no início e no final da infusão, cada triplicata foi analisada em quintuplicata. Os dados foram analisados segundo média e desvio padrão (m±dp). Foram verificados 120 valores de pH. Não foram observadas alterações importantes nos valores de pH das soluções em nenhuma das situações estudadas. Mensurou-se 240 valores de concentração. Na comparação das concentrações iniciais e finais das soluções a 5mg/mL, expostas à 22ºC(±1) em 60 e 120 minutos, houve aumento de 0,17% e 0,35%, respectivamente. As soluções na mesma concentração expostas à 37ºC(±1), nos mesmos intervalos de tempo, resultaram em redução da concentração de 1,20% em 60 minutos e de 16,3% em 120 minutos. Nas soluções a 10 mg/mL, expostas à 22ºC (±1) em 60 e 120 minutos, houve aumento de 4,03% e 21,11%, respectivamente. As soluções na mesma concentração expostas à 37ºC(±1), nos mesmos intervalos de tempo, resultaram em aumento da concentração de 4,59% em 60 minutos e diminuição de 10,28% em 120 minutos. Soluções de cloridrato de vancomicina diluídas a 5mg/mL e 10mg/mL quando expostas às temperaturas elevadas e infundidas em 120 minutos parece sofrer degradação.
  • Imagem de Miniatura
    Item
    Acesso aberto (Open Access)
    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.
  • Imagem de Miniatura
    Item
    Acesso aberto (Open Access)
    Potencial hidrogeniônico de soluções de antibióticos submetidas a condições ambientais: ensaio preliminar
    (Universidade de São Paulo, Escola de Enfermagem, 2012-04-01) Monteiro, Cíntia [UNIFESP]; Crepaldi, Renata Maria Coelho [UNIFESP]; Avelar, Ariane Ferreira Machado [UNIFESP]; Peterlini, Maria Angélica Sorgini [UNIFESP]; Pedreira, Mavilde da Luz Gonçalves [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    This experimental study was performed to assess the hydrogen potential (pH) of the antimicrobials ceftriaxone sodium, vancomycin hydrochloride, metronidazole, penicillin G potassium, and amikacin sulphate, following reconstitution, diluted with NaCl 0.9% (SF) and glucose solution 5% (GS), at eight different time intervals and under the normal daily conditions of lighting and temperature within the hospital unit (no air conditioning). The objective of this study was to verify the changes in the acid-base behavior of the solutions, which indicate chemical instability and can be associated with complications during intravenous therapy. Of the 186 analyzed pH values, there were no variations greater than 1.0 and no physical alterations visible to the naked eye. All solutions had a pH less than 7, and there were no significant differences for clinical practice regarding the diluent. The mean pH values after dilution with SF and GS for vancomycin hydrochloride, metronidazole, and amikacin sulphate are a risk factor for the development of intravenous complications due to their extreme acidity.