RESUMO
Information on the physical compatibility of intravenous (IV) medications is vital for patient care and safety in acute care settings. Drug information resources list ondansetron and nafcillin as IV compatible, however, bolus concentrations of ondansetron are not reported. This study investigated the in vitro physical compatibility of bolus and infusion concentrations of ondansetron hydrochloride with nafcillin sodium. Two admixtures were prepared: 1) ondansetron hydrochloride 2 mg/mL and nafcillin sodium 20 mg/mL, and 2) ondansetron hydrochloride 0.16 mg/mL and nafcillin sodium 20 mg/mL. The admixtures were prepared in triplicate using aseptic technique according to manufacturer guidance and stored at room temperature (22-23 °C) for up to 24 hours. Admixtures were examined for visual precipitation, turbidity, and pH at baseline and at 1, 5, 8, and 24 hours. Admixture 1 developed a haze immediately after mixing, which was sustained over 24 hours. There was a demonstrative change in absorbance after 1 hour, but pH remained stable until hour 24. Admixture 2 developed a haze at 5 hours, but the absorbance and pH remained stable until hour 24; a decrease in the pH was observed in all samples at hour 24. This in vitro study revealed that ondansetron hydrochloride 2 mg/mL and nafcillin sodium 20 mg/mL are not physically compatible when administered through the same IV line. No demonstrative change was observed with ondansetron hydrochloride 0.16 mg/mL and nafcillin sodium 20 mg/mL; however, concurrent administration of these medications is questionable when delivered through an IV line for periods of five hours or longer.
Assuntos
Incompatibilidade de Medicamentos , Nafcilina , Ondansetron , Ondansetron/administração & dosagem , Ondansetron/química , Nafcilina/administração & dosagem , Nafcilina/química , Infusões Intravenosas , Administração Intravenosa , Estabilidade de Medicamentos , Concentração de Íons de Hidrogênio , Antieméticos/administração & dosagem , Antieméticos/química , Injeções IntravenosasRESUMO
Motion sickness also known as kinetosis is a condition in which there exists a disagreement between visually perceived movement and the vestibular system's sense of movement. Nausea, vomiting, dizziness, fatigue, and headache are the most common symptoms of motion sickness. This study mainly focuses on the taste masking of Promethazine Hydrochloride (PMZ) by inclusion complexation method, its formulation development in the chewing gum form by using directly compressible gum base HIG® and its quality and performance testing. Different molar ratios (1:1, 1:2, 1:3 and 1:4) of PMZ-cyclodextrin complexes were prepared by using ß-Cyclodextrin (ß-CD) as a taste masking agent. These complexes were evaluated for FTIR, DSC, % Entrapment Efficiency, % drug yield, and taste evaluation by E-Tongue. The optimized ratio was further evaluated by sophisticated analytical techniques such as Scanning Electron Microscopy (SEM) and X-Ray Diffraction (XRD). A central composite design (CCD) (3 ^2) was utilized to examine the effects of independent variables (amount of gum-X1 and amount of plasticizer-X2) on dependent variables (%CDRY1 and hardness Y2). The prepared gums were evaluated for drug content, organoleptic properties, in-vitro dissolution testing by fabricated disintegration apparatus, texture analysis, etc. The optimization statistics showed that on decreasing the amount of gum, in- vitro drug release increases and hardness decreases. The optimized batch MCG-2 of Promethazine MCG showed 92.34 ± 0.92% of drug release, whereas for marketed formulation (Phenergan®-25 mg) drug release value was 86.19 ± 1.88%. Results provided evidence that PMZ MCGs could be a better alternative to conventional tablet formulations with improved drug release, palatability and texture.
Assuntos
Antieméticos , Goma de Mascar , Prometazina , Paladar , beta-Ciclodextrinas , Prometazina/química , Prometazina/administração & dosagem , beta-Ciclodextrinas/química , Paladar/efeitos dos fármacos , Antieméticos/administração & dosagem , Antieméticos/química , Química Farmacêutica/métodos , Liberação Controlada de Fármacos , Difração de Raios X/métodos , Solubilidade , Composição de Medicamentos/métodos , Humanos , Enjoo devido ao Movimento/prevenção & controleRESUMO
Se realizó un ensayo Clínico en el Hospital Escuela "Dr. Roberto Calderón Gutiérrez" en el período de octubre a diciembre de 1999, comparando la profilaxis antiemética de tres fármacos (ondansetron, dehidrobenzoperidol y metaclopramida); en un total de 115 pacientes sometidos a anestecia general balanceada y cirugías electivas. Se seleccionarón tres grupos de estudio, homogéneos en cuanto a edad, sexo, peso y estado físico de la A.S.A. (I o II). Se encontraron diferencias significativas en la eficacia de los tres fármacos, siendo el grupo 1 el más eficaz como antiemético que los grupos 2 y 3 por otro lado no existió asociación entre la emesis postoperatoria y los antecedentes patológicos personales relacionados a.: naúseas y vómitos postoperatorios, migraña y/o cinetosis, (p>0.05). Se encontraron diferencias significativas en la profilaxis antiemética entre los tres grupos de estudio, siendo el grupo 1 (ondansetron) más eficaz para la profilasis antiemética que dehidrobezoperidol y que metoclopramida (p<0.05). La profilaxis antiemética con droperidol y metoclopramida seencontró asociada a sedación como principal reacciónadversa medicamentosa, 48.4 porciento (n=15) y 9.7porciento (n=3) respectivamente, siendo para el ondansetron el mareo la principal reacción adversa 16.1 porciento (n=5) los eventos antieméticos fueron más numerosos en las 4 primeras horas del postoperatorio para los tres grupos estudiados, sin embargo el grupo1 (ondansetron) presentó menos números de dichos eventos, siendo significativa la diferencia a los 90 minutos. Por otro lado se encontraron diferencias significativas en el efecto antiemético de los fármacosen cuanto a dósis total y por kilogramo de peso y así mismo en relación al tiempo anestésico, siendo máseficiente onsansetron que droperidol y que metaclopramida (p=0.006 y p=0.007 respectivamente). Al comparar el efecto antiemético de los tres fármacos se encontró que ondansetron presenta una tasa de éxito de94.6 porciento (n=35); dehidrobenzoperidol 90.4 porciento (n=38) y metaclopramida 52.7 porciento (n=19)