Introduction: Continuous renal replacement therapy (CRRT) efficiently eliminates fluconazole. However, the routes of elimination were not clarified. Adsorption of fluconazole by filters is a pending question. We studied the elimination of fluconazole in a model mimicking a session of CRRT in humans using the NeckEpur® model. Two filters were studied. Methods: The AV1000®-polysulfone filter with the Multifiltrate Pro. Fresenius and the ST150®-polyacrylonitrile filter with the Prismaflex. Baxter-Gambro were studied. Continuous filtration used a flowrate of 2.5 L/h in post-dilution only. Session were made in duplicate. Routes of elimination were assessed using the NeckEpur® model. Results: The mean measured initial fluconazole concentration (mean ± SD) for the four sessions in the central compartment (CC) was 14.9 ± 0.2 mg/L. The amount eliminated from the CC at the end of 6 h-session at a 2.5 L/h filtration flowrate for the AV1000®-polysulfone and the ST150®-polyacrylonitrile filters were 90%–93% and 96%–94%, respectively; the clearances from the central compartment (CC) were 2.5–2.6 and 2.4–2.3 L/h, respectively. The means of the instantaneous sieving coefficient were 0.94%–0.91% and 0.99%–0.91%, respectively. The percentages of the amount eliminated from the CC by filtration/adsorption were 100/0%–95/5% and 100/0%–100/0%, respectively. Conclusion: Neither the ST150®-polyacrylonitrile nor the AV1000®-polysulfone filters result in any significant adsorption of fluconazole.
Background The active form of vitamin B6, called pyridoxal-5-phosphate (P5P), is an essential cofactor for several enzymes involved in various pathways of intermediary metabolism. PNPO is the rate-limiting enzyme in the synthesis of pyridoxal from vitamin B6 and a lack of activity causes dependency on an external source of pyridoxal. Epileptic seizure is the clinical outcome of P5P deficiency. Purpose To provide a dosage form suitable for newborns and children. Capsules containing standardised P5P were compounded. Moreover, a fully soluble powder blend was formulated to fill the capsules and a method to determine the stability of the P5P content was developed. Materials and Methods Dissolution assays were performed using oral syringes as nurses do. Time to complete dissolution and concentration were determined at each test. P5P content was determined by HPLC-UV (205 nm). The mobile phase consisted of phosphate buffer (0.05 M; pH 2.6) at a flow rate of 1 ml/min. The right active ingredient was tested by adding vitamin B6 to samples. Degradation by-products in stress conditions were also determined. The method was validated according to ICH recommendations. Results Strengths were standardised at 10, 25, 50, 100 or 250 mg/capsule. The adopted blend is quickly solubilised in water and has a sweet taste. The HPLC readings were linear (r² = 0.9994) at the wavelength used, indicating good reproducibility and repeatability (SD = 0.46%). No matrix effect due to the diluent was observed. Conclusions As P5P is a low toxicity compound, a test treatment with P5P is given to every newborn with idiopathic seizure before any treatment with standard antiepileptics. This method allows rapid routine assay of P5P. Stability testing of 3 compounded batches is ongoing. No conflict of interest.
ObjectivesDrugs are developed for adults, making it difficult to find suitable treatments for children. Hospital pharmacy has developed alternatives to respond to this medical need. The objective of this study is to present a new liquid formulation of ursodeoxycholic acid (UDCA) at a concentration suitable for treatment of neonatal jaundice, and to introduce a novel high pressure liquid chromatography (HPLC) assay method.MethodsFour formulations have been developed using suspension vehicles due to the low solubility of the active ingredient, and different concentrations of excipient, xanthan gum, needed to facilitate resuspension. An HPLC method coupled to a diode array detector (DAD) has been developed. This method was used to analyze chemical and microbiologic stabilities, as well as physicochemical properties and palatability.ResultsAfter formulation was chosen, our new HPLC method assay was developed and validated for the quantification of chemical and microbiological stabilities of our product. Both parameters were stable over three months. Palatability has been improved thanks to the addition of universal suspension adjuvants. Odor, appearance and taste were judged pleasant despite a bitter aftertaste, with a persistence of the UDCA resuspension after one month.ConclusionsThree months after informing neonatal department about the availability of the drug, patients and caregivers are satisfied, and production campaigns are routinely planned.
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