Evaluating dosing accuracy and galenic dispersion quality in Hospital-Based pediatric spironolactone oral suspension.

IF 4.4 2区医学 Q1 PHARMACOLOGY & PHARMACY

European Journal of Pharmaceutics and Biopharmaceutics Pub Date : 2025-05-08 DOI:10.1016/j.ejpb.2025.114741

Desquines Roxanne, Gallissot Romain, Viard Caroline, Metsu David, Ramjaun Zoubeir, Jurado Camille

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引用次数: 0

Abstract

Compounded oral suspensions of spironolactone are commonly used in pediatric patients with heart conditions. However, due to its poor solubility in water, spironolactone suspensions may lead to sedimentation, compromising homogeneity and dose accuracy. This study aimed to assess dose accuracy of spironolactone suspension in critical care settings. Over one month in 2020 and 2022, samples prepared by nurses in Pediatric (PICU) and Neonatal Intensive Care Units (NICU) were collected and analysed using an HPLC/UV validated method to evaluate dose deviations from target. Educational interventions on suspension preparation were conducted between the two periods. In 2020, only 28% (NICU) and 0% (PICU) of samples met target dose with greater variability in PICU. After educational intervention from the pharmacy teams, in 2022 improvements were observed, but underdosing and variability remained significant, reflecting ongoing challenges in suspension homogeneity. These findings highlight the need for a more stable pediatric formulation to enhance patient safety and treatment effectiveness.

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评价以医院为基础的儿童螺内酯口服混悬液的给药准确性和galenic分散质量。

复合口服螺内酯混悬液常用于患有心脏病的儿科患者。然而，由于其在水中的溶解度差，螺内酯悬浮液可能导致沉淀，影响均匀性和剂量准确性。本研究旨在评估螺内酯悬浮液在重症监护环境中的剂量准确性。在2020年和2022年的一个多月时间里，收集儿科（PICU）和新生儿重症监护病房（NICU）护士准备的样本，并使用HPLC/UV验证方法进行分析，以评估剂量偏离目标。在两个时期之间进行休学准备的教育干预。2020年，只有28% （NICU）和0% （PICU）的样本达到了目标剂量，PICU的差异更大。经过药房团队的教育干预，在2022年观察到改善，但剂量不足和变异性仍然显著，反映了悬液均匀性的持续挑战。这些发现强调需要一个更稳定的儿科配方，以提高患者的安全性和治疗效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Pharmaceutics and Biopharmaceutics 医学-药学

CiteScore

8.80

自引率

4.10%

发文量

211

审稿时长

36 days

期刊介绍： The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics. Topics covered include for example: Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids) Aspects of manufacturing process design Biomedical aspects of drug product design Strategies and formulations for controlled drug transport across biological barriers Physicochemical aspects of drug product development Novel excipients for drug product design Drug delivery and controlled release systems for systemic and local applications Nanomaterials for therapeutic and diagnostic purposes Advanced therapy medicinal products Medical devices supporting a distinct pharmacological effect.