The aim of this study was to assess a residual gravimetric method based on weighing dry filters to measure the aerosol output of nebulizers. This residual gravimetric method was compared to assay methods based on spectrophotometric measurement of terbutaline (Bricanyl, Astra Zeneca, France), high-performance liquid chromatography (HPLC) measurement of tobramycin (Tobi, Chiron, U.S.A.), and electrochemical measurements of NaF (as defined by the European standard). Two breath-enhanced jet nebulizers, one standard jet nebulizer, and one ultrasonic nebulizer were tested. Output produced by the residual gravimetric method was calculated by weighing the filters both before and after aerosol collection and by filter drying corrected by the proportion of drug contained in total solute mass. Output produced by the electrochemical, spectrophotometric, and HPLC methods was determined after assaying the drug extraction filter. The results demonstrated a strong correlation between the residual gravimetric method (x axis) and assay methods (y axis) in terms of drug mass output (y = 1.00 x -0.02, r(2) = 0.99, n = 27). We conclude that a residual gravimetric method based on dry filters, when validated for a particular agent, is an accurate way of measuring aerosol output.
Abstract: Pediatric chemotherapy preparations are usually not analytically controlled, for several reasons. First, they are generally made in syringe, which does not allow to take a sample without changing the final volume. Secondly, the percentage of the dose consecrated to control is important and finally low concentrations can cause sensitivity problems. This lack of quality control, greatly reduces the security of the chemotherapy circuit.: The main objective is to develop an analytical control to low volume pediatric preparations, made in syringes or in infusion bags with a final volume from 20 to 50 mL.: The development of analytical control automatons, like QCPrep+: Our protocol implies the overfilling with one milliliter of solvent followed by a sampling of one milliliter. The analysis is performed with 900 µL. Ten cytotoxic drugs commonly used in pediatric oncology have been validated according to ICH recommendations. The development of analytical control for low volume preparations allows young patients to benefit the same level of safety and quality than adult patients.
Most studies assessing the macronutrient content of human milk are published retrospectively using analyzers that fail to determine sodium content and do not take into account the role of volume in milk composition. We aimed to describe macronutrient content and sodium content in human milk over time, observe any associations between them, and determine the factors associated with the evolution of milk composition. A prospective, longitudinal, monocentric study was undertaken. Contents of protein, fat, and lactose of 102 milk samples from 40 mothers were determined using a human milk analyzer and that of sodium with a flame spectrophotometer. Milk volumes along with clinical data were recorded. Protein content in the fourth quartile of volume was significantly lower than that in the first three, suggesting the existence of a volume threshold for protein content at approximately 445 mL. After multivariate analysis, it was found that maternal age, average volume, and lactation period remained significantly associated with protein content, maternal age remained significantly associated with fat content, and only average volume with sodium content. In consideration of previous findings along with our data, we suggest that extra care should be taken with fortification for feeding preterm infants when the mother’s milk volume is greater than 400–450 mL.
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