Microbiological quality of pediatric oral liquid formulations / Calidad microbiológica de las formulaciones orales líquidas pediátricas

The oral administration of drugs to the pediatric population involves the extemporaneous preparation of liquid formulations. These formulations have studies on their physicochemical stability, but they often lack microbiological studies. The objective of this study is to check the microbiological quality of five oral liquid formulations prepared with different excipients, which represent five major combinations, in two conditions: kept unopened until the day of the test, and in a multi-dose vial opened daily. The formulations were prepared according to standard operating procedures. Half of each batch was packaged in vials that remained closed until the day of testing, and the other half in a single container which was opened daily. Both the vials and the containers had been previously sterilized. Microbiological tests were performed weekly during the first month of the study, and then every two weeks, until the expiration date. The microbiological quality of oral liquid formulations is determined by the Royal Spanish Pharmacopoeia. The conclusion was that none of the formulations prepared that were packaged in sterilized containers became contaminated, either in unopened vials or in multi-dose containers when they were opened daily (AU)

La administración oral de fármacos a la población pediátrica implica la preparación de fórmulas líquidas extemporáneas. Estas fórmulas tienen estudios de estabilidad fisicoquímica pero en muchas ocasiones carecen de estudios microbiológicos. El objetivo del estudio es comprobar la calidad microbiológica de cinco fórmulas orales líquidas, preparadas con diferentes excipientes, que representan mayoritariamente cinco combinaciones, en dos condiciones: conservadas sin abrir hasta el día del análisis y abriendo diariamente el envase multidosis. Se prepararon las fórmulas según los procedimientos normalizados de trabajo. La mitad del lote de cada fórmula se envasó en viales que estuvieron cerrados hasta el día del análisis y la otra mitad en un solo frasco que se abría diariamente. Tanto los viales como los frascos para el envasado estaban esterilizados previamente. El análisis microbiológico se realizó cada semana durante el primer mes de estudio y después cada dos semanas hasta llegar al periodo de caducidad. La calidad microbiológica de las fórmulas orales líquidas viene marcada por la Real Farmacopea Española. Se concluye que ninguna de las fórmulas elaboradas envasadas en contenedores esterilizados se contaminó ni en los viales cerrados ni en los frascos multidosis cuando se abrieron diariamente (AU)

Microbiological quality of pediatric oral liquid formulations.

The oral administration of drugs to the pediatric population involves the extemporaneous preparation of liquid formulations. These formulations have studies on their physicochemical stability, but they often lack microbiological studies. The objective of this study is to check the microbiological quality of five oral liquid formulations prepared with different excipients, which represent five major combinations, in two conditions: kept unopened until the day of the test, and in a multi-dose vial opened daily. The formulations were prepared according to standard operating procedures. Half of each batch was packaged in vials that remained closed until the day of testing, and the other half in a single container which was opened daily. Both the vials and the containers had been previously sterilized. Microbiological tests were performed weekly during the first month of the study, and then every two weeks, until the expiration date. The microbiological quality of oral liquid formulations is determined by the Royal Spanish Pharmacopoeia. The conclusion was that none of the formulations prepared that were packaged in sterilized containers became contaminated, either in unopened vials or in multi-dose containers when they were opened daily.

La administración oral de fármacos a la población pediátrica implica la preparación de fórmulas líquidas extemporáneas. Estas fórmulas tienen estudios de estabilidad fisicoquímica pero en muchas ocasiones carecen de estudios microbiológicos. El objetivo del estudio es comprobar la calidad microbiológica de cinco fórmulas orales líquidas, preparadas con diferentes excipientes, que representan mayoritariamente cinco combinaciones, en dos condiciones: conservadas sin abrir hasta el día del análisis y abriendo diariamente el envase multidosis. Se prepararon las fórmulas según los procedimientos normalizados de trabajo. La mitad del lote de cada fórmula se envasó en viales que estuvieron cerrados hasta el día del análisis y la otra mitad en un solo frasco que se abría diariamente. Tanto los viales como los frascos para el envasado estaban esterilizados previamente. El análisis microbiológico se realizó cada semana durante el primer mes de estudio y después cada dos semanas hasta llegar al periodo de caducidad. La calidad microbiológica de las fórmulas orales líquidas viene marcada por la Real Farmacopea Española. Se concluye que ninguna de las fórmulas elaboradas envasadas en contenedores esterilizados se contaminó ni en los viales cerrados ni en los frascos multidosis cuando se abrieron diariamente.

Neisseria gonorrhoeae: resistencias antimicrobianas y estudio de la dinámica poblacional. Situación en 2011 en Barcelona / Neisseria gonorrhoeae: Antimicrobial resistance and study of population dynamics. Situation in Barcelona in 2011

INTRODUCCIÓN: Las altas tasas de resistencia de Neisseria gonorrhoeae (NG) a ciertos antibióticos, junto con la aparición de cepas con sensibilidad disminuida y resistencia a las cefalosporinas, hacen de la infección gonocócica un problema de salud pública. Los objetivos del estudio fueron: realizar el seguimiento de la sensibilidad antimicrobiana de NG obtenidas entre enero y agosto de 2011, y estudiar su dinámica poblacional. MÉTODOS: Se estudió la sensibilidad mediante el método disco-difusión y E-test. El genotipado se realizó mediante el NG-MAST. RESULTADOS: De un total de 100 cepas, el 59% presentaron sensibilidad intermedia a penicilina y el 9% resistencia. Según EUCAST, se detectaron 3 gonococos con sensibilidad disminuida a ceftriaxona, 10 a cefixima y uno con resistencia de alto nivel a ambos (CMI 1,5 μg/ml). La CMI50 y la CMI90 a cefixima fue de 0,016 y de 0,125 μg/ml, mientras que a ceftriaxona fue < 0,016 y 0,064 μg/ml. El 99% presentó resistencia a doxiciclina, el 53% a ciprofloxacino, el 3% a azitromicina y el 1% a espectinomicina. El ST más prevalente fue el ST1407, mayoritariamente asociado a resistencia o sensibilidad disminuida a cefalosporinas o macrólidos. CONCLUSIÓN: NG ha desarrollado tasas importantes de resistencia a distintos antibióticos. Se ha detectado una cepa con resistencia de alto nivel a las cefalosporinas de tercera generación y varias con sensibilidad disminuida, además de observarse un aumento de la CMI50 y de la CMI90 a estos antibióticos. La estructura poblacional de NG permanece estable y común al resto de Europa, aunque se han identificado 2 nuevos secuencio tipos (ST7226 y ST7227) con potencial para seleccionarse y adquirir altos niveles de resistencia a cefalosporinas

BACKGROUND: Due to the high rates of antimicrobial resistance to certain antibiotics, together with the emergence of Neisseria gonorrhoeae (NG) with reduced susceptibility and resistance to third-generation cephalosporins, gonococcal infection is becoming a public health problem. The objectives of the study were: To keep track of the antimicrobial susceptibility of NG strains obtained from January to August 2011. To study the population dynamics. METHODS: The antimicrobial susceptibility was studied by disk-diffusion and E-test. The genotyping was performed by NG-MAST method. RESULTS: Of a total of 100strains studied, 59% showed intermediate sensitivity to penicillin and 9% were resistant. According to EUCAST, we detected 3gonococci with reduced susceptibility to ceftriaxone, 10 to cefixime and one with high-level resistance to both antibiotics (MIC 1.5 μg/ml). MIC50 and MIC90 to cefixime were 0.016 and 0.125 μg/ml, respectively, whereas to ceftriaxone they were < 0.016 and 0.064 μg/ml, respectively. Almost all (99%) of the strains were resistant to doxycycline, 53% to ciprofloxacin, 3% to azithromycin, and 1% to spectinomycin. The most prevalent ST was ST1407, predominantly associated to resistance or reduced sensitivity to cephalosporins or macrolides. CONCLUSIONS: NG has developed significant rates of resistance to various antibiotics. One strain has been detected with high level resistance to third generation cephalosporins, and several strains with reduced susceptibility. An increase in MIC50 and MIC90 to these antibiotics has also been observed. NG population structure remains stable and common to the rest of Europe, although two new ST (ST7226 and ST7227) have been identified that could be selected and acquire high levels of resistance to cephalosporins

[Neisseria gonorrhoeae: antimicrobial resistance and study of population dynamics. Situation in Barcelona in 2011]. / Neisseria gonorrhoeae: resistencias antimicrobianas y estudio de la dinámica poblacional. Situación en 2011 en Barcelona.

BACKGROUND: Due to the high rates of antimicrobial resistance to certain antibiotics, together with the emergence of Neisseria gonorrhoeae (NG) with reduced susceptibility and resistance to third-generation cephalosporins, gonococcal infection is becoming a public health problem. The objectives of the study were: To keep track of the antimicrobial susceptibility of NG strains obtained from January to August 2011. To study the population dynamics. METHODS: The antimicrobial susceptibility was studied by disk-diffusion and E-test. The genotyping was performed by NG-MAST method. RESULTS: Of a total of 100strains studied, 59% showed intermediate sensitivity to penicillin and 9% were resistant. According to EUCAST, we detected 3gonococci with reduced susceptibility to ceftriaxone, 10 to cefixime and one with high-level resistance to both antibiotics (MIC 1.5µg/ml). MIC50 and MIC90 to cefixime were 0.016 and 0.125µg/ml, respectively, whereas to ceftriaxone they were <0.016 and 0.064µg/ml, respectively. Almost all (99%) of the strains were resistant to doxycycline, 53% to ciprofloxacin, 3% to azithromycin, and 1% to spectinomycin. The most prevalent ST was ST1407, predominantly associated to resistance or reduced sensitivity to cephalosporins or macrolides. CONCLUSIONS: NG has developed significant rates of resistance to various antibiotics. One strain has been detected with high level resistance to third generation cephalosporins, and several strains with reduced susceptibility. An increase in MIC50 and MIC90 to these antibiotics has also been observed. NG population structure remains stable and common to the rest of Europe, although two new ST (ST7226 and ST7227) have been identified that could be selected and acquire high levels of resistance to cephalosporins.