RESUMEN
The stability of intravenous famotidine in dextrose 5% injection (D5W), NaCl 0.9% injection (NS), and sterile water for injection stored in polyvinyl chloride (PVC) syringes at 4 degrees C for 14 days was studied. The concentration of famotidine samples was determined at time 0, 7 days, and 14 days by reverse-phase high-performance liquid chromatography. Samples were inspected for visual changes and tested for changes in pH. Results of the HPLC analysis indicated that the famotidine samples remained within 94-100 percent and 99-103 percent of the time 0 concentrations at 7 and 14 days, respectively. Repeated measures analysis of variance demonstrated a significant time effect on famotidine concentration as concentrations changed over time (p less than 0.01). This change was small in magnitude, however, and concentrations decreased at 7 days and increased at 14 days. Famotidine is stable at a concentration of 2 mg/mL in D5W, NS, and sterile water for injection stored in PVC syringes at 4 degrees C for 14 days.
Asunto(s)
Tiazoles/análisis , Cromatografía Líquida de Alta Presión , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Famotidina , Cloruro de Polivinilo , JeringasRESUMEN
Total nutrient solution (TNS) is a new method for delivering total parenteral nutrition (TPN) by admixing dextrose, amino acids, and lipids in a single container. Recommendations are to use nonpolyvinyl chloride (PVC) containers for admixture of these solutions. PVC is a hard, brittle, and inflexible substance, and plasticizers, predominantly diethylhexylphthalate (DEHP), are added to impart flexibility. DEHP is a lipid soluble suspected carcinogen, hepatotoxin, and teratogen which has been shown to leach from PVC products containing lipophilic admixtures. The purpose of this study was to quantitate the amount of DEHP which leaches from PVC bags containing TNS. Six study groups, which contained three formulas stored at 25 degrees C +/- 2 degrees C and 4 degrees C +/- 1 degree C, were assayed for DEHP at time 0, 12, 24, 48 and 72 hr, 1 wk, and 3 wk using high-performance liquid chromatography. The control group contained an amino acid source, a carbohydrate source, and standard electrolytes, and the other groups contained a 10% lipid source or a 20% lipid source in addition to the constituents of the control group. Lipid-containing groups demonstrated detectable levels of DEHP at 48 hr, and DEHP content increased in these groups throughout the 21-day study. DEHP concentrations were lower in lipid-containing groups stored at 4 degrees C than comparable groups stored at 25 degrees C.