Developed and validated stability indicating HPLC method for the determination of epirubicin in bulk drug, marketed injection and polymeric nanoparticles

Present work is aimed to develop a simple, sensitive, robust and reliable HPLC method for routine quality control of epirubicin (EPI) in bulk drug, marketed injections and polymeric nanoparticles. Separation was carried out by C18 column. Isocratic elution was carried out using mobile phase A: 0.16% o-phosphoric acid solution, B: acetonitrile and methanol mixture (80:20, v/v) in the ratio of 60:40 (A: B) while the flow rate was maintained at 1mL/min. Analyses were performed at 233.5 nm using PDA detector. Excellent linear relationship was observed between peak-area versus drug concentration in the range of 1.0-100.0 µg/mL (r2, 0.999). Developed method was found to be sensitive (Limits of detection and quantification were found to be ~8 ng/mL and ~25 ng/mL, respectively), precise (RSD <1.0%, for repeatability and <2.0% for intermediate precision, within acceptable ranges of precision), accurate (recovery in different dosage form, 94.65 -100.26%, within acceptable range, 80-120%), specific and robust (% RSD <2, for system suitability parameters). Stress-induced degradation studies demonstrated that method can suitability be applied in the presence of degradants. Developed method has been successfully applied for the determination of entrapment efficiency, drug loading, in vitro release profile, in vitro permeation studies as well as stability assessment of polymeric nanoparticles

Hospitalización por episodios de cianosis en recién nacidos de edad gestacional igual o mayor a 34 semanas / Hospital Admissions due to cyanosis episodes in newborns with gestational age of 34 weeks or more

Objetivo: Caracterizar la hospitalización por episodios de cianosis en recién nacidos (RN) > 34 semanas. Pacientes y método: Estudio retrospectivo que incluyó la totalidad de los RN hospitalizados por episodios de cianosis entre enero de 2007 y diciembre de 2012. En ellos se aplicaron 2 protocolos de estudio que consideraban exámenes de primera y segunda línea; estos últimos ante la recurrencia de eventos. El protocolo de primera línea consideró exámenes bioquímicos generales, radiografía de tórax y ecocardiografía en casos seleccionados, en tanto que el protocolo de segunda línea incluyó electroencefalograma, electrocardiograma, resonancia magnética nuclear encefálica, screening metabólico ampliado, ácido pirúvico, ácido láctico y en caso de convulsiones, citoquímico y cultivo de líquido cefalorraquídeo y reacción en cadena de la polimerasa para herpes. Resultados: Noventa y ocho de un total de 3.454 (2,8%) RN hospitalizados ingresaron por episodio de cianosis. La edad gestacional (EG) fue 37,8 + 1,36 semanas; peso al nacimiento: 3145 + 477 g. Edad materna: 32 + 4,8 años. El 19,4% de las madres tenía antecedentes mórbidos: diabetes gestacional (8,1%), síndrome hipertensivo del embarazo (5,1%), colestasia intrahepática (3,1%) y retardo del crecimiento (3,1%). Género: 48,8% masculino, parto por cesárea: 68,4%. Edad al ingreso: 1,9 + 1,4 días; duración de la hospitalización: 4,2 + 4,2 días. En todos los pacientes se practicaron exámenes de primera línea y en el 39,8% exámenes de segunda línea. En el 21,4% de los RN se identificó una causa, siendo el síndrome convulsivo el más frecuente (33%). Los RN con diagnóstico asociado presentaron 3,8 + 2,7 episodios de cianosis versus 1,5 + 2,4 en el grupo sin diagnóstico (NS). El 15,4% se fueron de alta con monitor; no hubo reingresos. Conclusión: La incidencia de hospitalización neonatal por episodios de cianosis fue de 6 por 1.000 RN vivos. Solo en cerca de un 20% de ellos es posible identificar una causa, siendo la más frecuente el síndrome convulsivo.

Objectives: A retrospective study was performed between January 2007 and December 2012 to assess the admission rates of newborns due to episodes of cyanosis Patients and method: Retrospective study that included all the newborns hospitalized with episodes of cyanosis between January 2007 and December 2012. In them were employed two study protocols that considered first and second line tests, the latter in view of recurrence of events. The first line protocol considered general biochemical tests, chest x-ray and echocardiography in selected cases, while the second line protocol included electroencephalogram, electrocardiogram, nuclear magnetic resonance of the brain, expanded metabolic screening, pyruvic acid, lactic acid, and in case of seizures, cytochemical, and culture of cerebrospinal fluid (CSF) and PCR (polymerase chain reaction) for herpes. Results: A total of 98 (2.8%) out of 3,454 newborns were admitted due to episodes of cyanosis. Gestational age: 37.8 + 1.4 weeks, birth weight: 3,145 + 477 g. Maternal age: 32 + 4.8 years. Disease was present in 19.4% of mothers; gestational diabetes (8.1%), pregnancy induced hypertension (5.1%), intrahepatic cholestasis (3.1%), and intrauterine growth retardation (3.1%). Gender: 48.8% male, 51.2% female (NS). Birth: caesarean section, 68.4%, and vaginal delivery, 31.6%. Age on admission 1.9 + 1.4 days. Hospital stay: 4.2 + 4.2 days. First line tests were performed in 100% of patients with 39.8% fulfilling the criteria for second line study. A condition was detected in 21.4%, with convulsive syndrome was the most frequent (33%). Newborns with an identified condition had 3.8 + 2.7episodes versus 1.5 + 2,4 in those without diagnosis (NS). A home oxygen monitor was given to 15.4%. There were no re-admissions. Conclusions: Most newborns admitted due to cyanosis are discharged with a condition of unknown origin. In this study, convulsive syndrome was the most frequent cause.

High dose epirubicin versus mitoxantrone in a seven-drug combination regimen for intermediate and high grade NHL: results of a randomized pilot study

The aim of the present pilot study was an attempt to improve the therapeutic outcome of this group of patients by increasing the dose of the most active drug i.e. anthracycline, through the use of high dose Epirubicin and compare it with the standard regimen in common use in the institution. Also, this work aimed at studying the safety of increasing the Epirubicin dose especially in terms of hematological [BM] and cardiotoxicity

Consequências da quimioterapia antitumoral sobre a composiçäo corpórea e o balanço nitrogenado: estudo experimental / Influence of antitumoral chemotherapy on body composition and nitrogen balance: experimental study

O tumor maligno e a quimioterapia constituem condiçöes potencialmente geradoras de desnutriçäo. Com o intuito de estudar a inter-relaçäo dessas duas situaçöes, foram utilizados ratos Wistar divididos em 5 grupos: Grupo C (12), ratos controle: grupo T (6), ratos partadores de carcinossarcoma 256 Walker; grupo TE (11), ratos em que se fez a administraçäo de 4-epidoxorrubicina (4-EPI) EV simultaneamente ao implante tumoral; grupo E (11), em que se fez apenas administraçäo de 4-EPI. Praticaram-se diariamente medidas do balanço nitrogenado por mensuraçäo do nitrogênio total ingerido e excretado; por ocasiäo do sacrifício dos animais (20§ dia do experimento) foi colhido material para determinaçäo de parâmetros de composiçäo corpórea. Realizou-se análise estatística adequada, assumindo como significativas as diferenças quando p < 0,05. Observou-se prejuizo da ingestäo alimentar no período próximo à injeçäo de 4-EPI, o qual se traduziu para perda de peso da carcaça nos grupos E e T6E, até 14 dias após a aplicaçäo do quimioterápico. A incorporaçäo nitrogenada acumulada foi menor nos grupos TE e T6E, nos períodos de 0 a 5 dias, o a 14 e 0 a 20 dias. Quanto à composiçäo corpórea verificou-se que o peso seco sem gordura e a gordura corpórea total encontram-se reduzidos nos grupos T e T6E em comparaçäo com o grupo C. No entanto, 20 dias após a aplicaçäo da 4-EPI näo se encontraram alteraçöes significativas na composiçäo corpórea, em comparaçäo com o grupo controle. Destarte, a quimioterapia aplicada em raos portadores de tumor maligno prejudica a incorporaçäo nitrogenada; outossim, apresenta repercussäo na composiçäo corpórea em termos de perda de gordura e massa sólida desengordurada pelo menos até 14 dias após a administraçäo da droga