[Assessment of a Tiapride solution for its administration through continuous intravenous perfusion]. / Estudio de estabilidad de tiaprida en disolución para administración en perfusión intravenosa continua.

OBJECTIVES: Tiapride is a substituted benzamide classified as an atypical neuroleptic. To our knowledge, there are no published data on its stability prepared as a continuous intravenous infusion. The current study analysed its stability in two different infusion solutions and concentrations over 48 hours. METHOD: Triplicate samples of tiapride were prepared in 0.9% sodium chloride and in 5% dextrose solutions at final concentrations of 1 and 2 mg/ml. Samples were collected in glass bottles without photoprotection and at room temperature (25 ± 2 °C). Sampling times at 0, 1, 3, 6, 12, 24 and 48 hours included a visual inspection for colour changes and appearance of precipitation as well as pH determination. Tiapride was quantified at selected times by mass spectrometry using high-performance liquid chromatography. Concentration values in the samples corresponding to 0 hours were given a reference value of 100%. Concentrations in subsequent samples greater than 90% were considered stable. RESULTS: No colour change or precipitation was observed during the study period. pH values ranged between 0.1 and 0.4 units. At 48 hours, the concentration of remaining tiapride in sodium chloride 1 mg/ml and 2 mg/ml was 93.8% and 91.6%, respectively. That in 5% dextrose 1 mg/ml and 2 mg/ml was 96.8% and 94.1%, respectively. CONCLUSION: Dilutions of tiapride in 0.9% sodium chloride and in 5% dextrose solution, at concentrations of 1 mg/ml and 2 mg/ml, in glass bottles and at room temperature were stable both physically and chemically during 48 hours.

Estudio de la estabilidad de tiaprida en disolución para administración en perfusión intravenosa continua / Assessment of a Tiapride solution for its administration through continuous intravenous perfusion

Objetivo: La tiaprida es una benzamida sustituida clasificada como neuroléptica atípica. Ante la ausencia de datos publicados sobre su estabilidad en disolución para administración en perfusión continua intravenosa, este estudio analiza la estabilidad de la tiaprida en diferentes soluciones para infusión intravenosa, a diferentes concentraciones y durante 48 horas. Método: Se prepararon muestras de tiaprida por triplicado en cloruro sódico al 0,9% y en glucosa al 5% a concentraciones de 1 y 2 mg/mL. Estas muestras se conservaron en recipientes de cristal sin fotoprotección, a temperatura ambiente (25 ± 2oC). Los tiempos de muestreo a las 0, 1, 3, 6, 12, 24 y 48 horas incluyeron inspección visual y determinación del pH. Se cuantificó la concentración de tiaprida en las muestras mediante cromatografía líquida de alta eficacia acoplada a espectrometría de masas. A los valores de concentración a tiempo 0 se les asignó el valor de referencia del 100%. Se consideraron estables aquellas muestras con concentración de tiaprida superior al 90% de la inicial. Resultados: No se observaron cambios visibles en las muestras analizadas. El valor del pH varió en un rango de entre 0,1 y 0,4 unidades. A las 48 horas, la concentración remanente en cloruro sódico a 1 y 2 mg/mL fue 93,8% y 91,6%, respectivamente. En glucosa al 5%, a 1 y 2 mg/mL fue 96,8% y 94,1%, respectivamente. Conclusión: Las disoluciones de tiaprida en cloruro sódico al 0,9% y en glucosa al 5%, a concentraciones de 1 y 2 mg/mL, en recipientes de cristal sin fotoprotección, a temperatura ambiente, son estables física y químicamente durante 48 horas (AU)

Objectives: Tiapride is a substituted benzamide classified as an atypical neuroleptic. To our knowledge, there are no published data on its stability prepared as a continuous intravenous infusion. The current study analysed its stability in two different infusion solutions and concentrations over 48 hours. Method: Triplicate samples of tiapride were prepared in 0.9% sodium chloride and in 5% dextrose solutions at final concentrations of 1 and 2 mg/ml. Samples were collected in glass bottles without photoprotection and at room temperature (25 ± 2oC). Sampling times at 0, 1, 3, 6, 12, 24 and 48 hours included a visual inspection for colour changes and appearance of precipitation as well as pH determination. Tiapride was quantified at selected times by mass spectrometry using high-performance liquid chro-matography. Concentration values in the samples corresponding to 0 hours were given a reference value of 100%. Concentrations in subsequent samples greater than 90% were considered stable. Results: No colour change or precipitation was observed during the study period. pH values ranged between 0.1 and 0.4 units. At 48 hours, the concentration of remaining tiapride in sodium chloride 1 mg/ml and 2 mg/ml was 93.8% and 91.6%, respectively. That in 5% dextrose 1 mg/ml and 2 mg/ml was 96.8% and 94.1%, respectively. Conclusion: Dilutions of tiapride in 0.9% sodium chloride and in 5% dextrose solution, at concentrations of 1 mg/ml and 2 mg/ml, in glass bottles and at room temperature were stable both physically and chemically during 48 hours (AU)

Experiencia de uso de partículas DC Bead ® cargadas con doxorrubicina en quimioembolización hepática / Experience Using Doxorubicin-Loaded DC Beads ® During Hepatic Chemoembolisation

Introducción El carcinoma hepatocelular es el más común y agresivo del grupo de tumores hepatobiliares. La quimioembolización hepática con partículas DC Bead® cargadas de doxorrubicina es un tipo de terapia local para pacientes con nódulos localizados, no susceptibles de cirugía. El objetivo de este estudio es describir las situaciones clínicas en las que se ha utilizado este procedimiento y su toxicidad temprana. Métodos Estudio descriptivo retrospectivo de los pacientes tratados con partículas DC Bead® cargadas de doxorrubicina en quimioembolización hepática desde octubre de 2006 hasta julio de 2009. Los datos se obtuvieron del programa Farhos Oncología® y las historias clínicas. Resultados Durante el periodo de estudio fueron tratados 21 pacientes, 15 hombres y 6 mujeres con una mediana de edad de 66 años. El diagnóstico que motivó la utilización de la técnica fue hepatocarcinoma no resecable. Del total de pacientes, 6 se encontraban en lista de espera para trasplante hepático. Los pacientes fueron clasificados según el sistema Child-Pugh: 15 pacientes en el grupo A, 5 en el grupo B y uno en el C, y según el Sistema Okuda: 14 pertenecían al grupo I, 6 al grupo II y uno al grupo III. La toxicidad más frecuente fue la aparición de síndrome posquimioembolización en 16 pacientes, que se resolvió con medicación sintomática. Discusión La utilización de doxorrubicina cargada en microesferas DC Bead® en quimioembolización transarterial se ha ajustado a usos con evidencias científicas y ha sido bien tolerado en todos los pacientes. Las incidencias durante la administración fueron leves y se resolvieron con medicación sintomática (AU)

Introduction Hepatocellular carcinoma is the most common and aggressive liver and biliary tumour. Hepatic chemoembolisation with doxorubicin-loaded DC Beads® is a local therapy for patients with localised nodes, which are not suitable for surgery. The objective of this study is to describe the clinical situations in which this procedure has been used and its early toxicity. Methods Retrospective descriptive study of patients treated with doxorubicin-loaded DC Beads® undergoing hepatic chemoembolisation from October 2006 until July 2009. Data were taken from the Farhos Oncología® programme and clinical histories. Results Twenty-two patients were treated during the study period, 15 men and 6 women, with an average age of 66 years. This technique was used for patients diagnosed with unresectable liver cancer. Out of the patient total, 6 were on the liver transplant waiting list. Patients were assessed using the Child–Pugh score: 15 patients in group A, 5 in group B and 1 in group C; and according to Okuda staging system: 14 were in group I, 6 in group II and 1 in group III. The most common toxicity was post-chemoembolisation in 16 patients, who were treated with symptomatic medication. Discussion Using doxorubicin-loaded microspherical DC Beads® during transarterial chemoembolisation has been adapted to use with scientific evidence and tolerated by all patients. Incidences during administration were mild and were resolved with symptomatic medication (AU)

[Experience using doxorubicin-loaded DC Beads® during hepatic chemoembolisation]. / Experiencia de uso de partículas DC Bead® cargadas con doxorrubicina en quimioembolización hepática.

INTRODUCTION: Hepatocellular carcinoma is the most common and aggressive liver and biliary tumour. Hepatic chemoembolisation with doxorubicin-loaded DC Beads(®) is a local therapy for patients with localised nodes, which are not suitable for surgery. The objective of this study is to describe the clinical situations in which this procedure has been used and its early toxicity. METHODS: Retrospective descriptive study of patients treated with doxorubicin-loaded DC Beads(®) undergoing hepatic chemoembolisation from October 2006 until July 2009. Data were taken from the Farhos Oncología(®) programme and clinical histories. RESULTS: Twenty-two patients were treated during the study period, 15 men and 6 women, with an average age of 66 years. This technique was used for patients diagnosed with unresectable liver cancer. Out of the patient total, 6 were on the liver transplant waiting list. Patients were assessed using the Child-Pugh score: 15 patients in group A, 5 in group B and 1 in group C; and according to Okuda staging system: 14 were in group I, 6 in group II and 1 in group III. The most common toxicity was post-chemoembolisation in 16 patients, which were treated with symptomatic medication. DISCUSSION: Using doxorubicin-loaded microspherical DC Beads(®) during transarterial chemoembolisation has been adapted to uses with scientific evidence and tolerated by all patients. Incidences during administration were mild and were resolved with symptomatic medication.