A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium

Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to beta-lactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 µg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine.A ceftriaxona sódica é uma cefalosporina de terceira geração de uso parenteral, com amplo espectro de atividade e resistente a b-lactamases. Este estudo apresenta o desenvolvimento e validação de um bioensaio por difusão em ágar usando o método de cilindros em placas para determinação da potência deste antibiótico. A validação desenvolvida apresentou bons resultados em termos de linearidade, precisão, exatidão, especificidade e robustez. Empregou-se o Staphylococcus aureus ATCC 6538P como micro-organismo teste. Os resultados dos ensaios foram tratados estatisticamente utilizando-se análise de variância (ANOVA). O método apresentou linearidade (r=0,99999) na faixa de doses selecionada (16-64 µg/mL), precisão (repetibilidade: DPR=1,4%; precisão intermediária: inter-dias DPR=2,1% e inter-analistas: DPR=2,5%) e exatidão de 100,5%. A especificidade do bioensaio foi avaliada através da análise comparativa, por cromatografia líquida de alta eficiência, de amostras degradadas a 50 ºC nos tempos zero, 24 e 48 h. Os resultados encontrados demonstraram a validade do bioensaio proposto, o qual permite a quantificação confiável de ceftriaxona sódica em produtos farmacêuticos comerciais. Por ser metodologia simples e de baixo custo constitui-se em alternativa para a análise de rotina do controle de qualidade de medicamentos

PROSPECÇÃO TECNOLÓGICA DA PRODUÇÃO DE GOMA XANTANA AO LONGO DOS ANOS

A goma xantana é um polímero natural de ampla aplicação, produzido por bactérias fitopatogênicas do gênero Xanthomonas. Devido às suas características de resistência à degradação pelo calor, estabilidade em ampla faixa de concentração de sais e de temperaturas altas, vem sendo utilizada em uma gama de indústrias (alimentícia, farmacêutica, cosmética e petrolífera) de muitos países, principalmente nos Estados Unidos, os quais dominam a tecnologia de produção de goma xantana, obtendo destaque como principais inventores e titulares, de acordo com esta prospecção realizada. Foi constatado que a maioria das patentes depositadas são de empresas norte-americanas, revelando o grande interesse do país pela tecnologia. Além disso, foram verificados os códigos de classificação normalmente utilizados nas patentes requeridas, podendo ser úteis como informação básica para buscas de anterioridade relacionadas ao polímero

Brazilian Journal of Pharmaceutical Sciences

p. 753-762Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to beta-lactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 µg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine

A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium

Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to beta-lactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 µg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine

Brazilian Archives of Biology and Technology

p. 942-947This study aimed to evaluate and select different dermatological bases incorporated with propolis for veterinary use as well as to analyze the chemical compounds of the propolis hydroalcoholic extract by LC-MS/MS. Thus, formulations were submitted to accelerated stability tests under different temperatures and to mechanical stress, and evaluated for the appearance, color, odor, pH, viscosity, spreadability, and the mean size of the dispersed globules from the internal phase during a period of three months. The creamy gel formulation showed satisfactory results for all the evaluated items with an excellent capability to incorporate the hydroalcoholic extract of propolis associated to the maintenance of its physicochemical properties. The propolis used in this study had been shown to possess antibacterial and antifungal in vitro activity against the main microorganisms responsible for such diseases. Therefore, the propolis creamy gel described here could be a promising formulation for use in the veterinary medicine

Stability evaluation of propolis topical bases for veterinary use

This study aimed to evaluate and select different dermatological bases incorporated with propolis for veterinary use as well as to analyze the chemical compounds of the propolis hydroalcoholic extract by LC-MS/MS. Thus, formulations were submitted to accelerated stability tests under different temperatures and to mechanical stress, and evaluated for the appearance, color, odor, pH, viscosity, spreadability, and the mean size of the dispersed globules from the internal phase during a period of three months. The creamy gel formulation showed satisfactory results for all the evaluated items with an excellent capability to incorporate the hydroalcoholic extract of propolis associated to the maintenance of its physicochemical properties. The propolis used in this study had been shown to possess antibacterial and antifungal in vitro activity against the main microorganisms responsible for such diseases. Therefore, the propolis creamy gel described here could be a promising formulation for use in the veterinary medicine

A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium

Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to beta-lactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 µg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine

Professores e Alunos: o engendramento da violência da escola

The school violence engendering is partially analyzed, considering the violence production in the school environment. This is a bibliographic research with quantitative and qualitative approach. Sources: 77 theses and 15 dissertations carried out in Brazil (2007 to 2012). Data collection and organization: Content Analysis. Main reference: Bernard Charlot and Pierre Bourdieu. Results: the sources showed that Brazilian teachers participate effectively in the school violence engendering, contributing to violence production in the school environment. The students are the main victims. The teacher is less affected by physical and verbal violence. The symbolic power is the most perpetrated by the teacher against the student. The school also plays a major role in it.Analisa-se o engendramento de uma face da violência da escola, tendo em vista a produção da violência em espaço escolar. Pesquisa bibliográfica quanti-qualitativa. Fontes: 77 dissertações e 15 teses produzidas no Brasil (2007 a 2012). Coleta e organização dos dados: Análise de Conteúdo. Fundamentação base: Bernard Charlot e Pierre Bourdieu. Resultados: as fontes apontaram que professores brasileiros são protagonistas na constituição da violência da escola, contribuindo para a produção da violência em espaço escolar. Os alunos são as principais vítimas dessa violência. O professor sofre menos violência física e verbal do que o aluno. A violência simbólica é a mais usada pelo professor contra o aluno. A escola também usa desse expediente