Optimization and stability evaluation of a pediatric spironolactone oral suspension: Formulation development and analytical validation

IF 4.3 2区医学 Q1 PHARMACOLOGY & PHARMACY

European Journal of Pharmaceutics and Biopharmaceutics Pub Date : 2025-06-26 DOI:10.1016/j.ejpb.2025.114801

Roxanne Desquines , Zoubeir Ramjaun , Acil Jaafar , Fabien Brouillet , Sandrine Cavalie , Thibaut Jamme , Céline Verdier , Laurent Cavalie , Camille Chagneau , Thomas Lanot , David Metsu , Camille Jurado

{"title":"Optimization and stability evaluation of a pediatric spironolactone oral suspension: Formulation development and analytical validation","authors":"Roxanne Desquines , Zoubeir Ramjaun , Acil Jaafar , Fabien Brouillet , Sandrine Cavalie , Thibaut Jamme , Céline Verdier , Laurent Cavalie , Camille Chagneau , Thomas Lanot , David Metsu , Camille Jurado","doi":"10.1016/j.ejpb.2025.114801","DOIUrl":null,"url":null,"abstract":"<div><div>The pediatric population often faces challenges in accessing appropriate medication formulations, particularly for circumstances like congenital heart disease requiring spironolactone therapy. This study aimed to optimize the pharmaceutical formulation of oral suspension spironolactone for pediatric use and assess its stability. A formulation with 0.2 % xanthan gum in InOrpha® was developed, showing improved stability and reduced sedimentation. Analytical method validation confirmed accuracy and precision for spironolactone quantification, while forced degradation studies ensured stability-indicating capability. Stability assessments demonstrated the oral suspension’s chemical, physical, and microbiological stability for up to 135 days pre-bottle opening and 37 days post-opening under varied storage conditions. This study provides crucial insights into enhancing spironolactone formulation for pediatric patients. Further research is needed to assess pharmacokinetic parameters such as bioavailability and pharmacodynamics to fully ascertain its efficacy in pediatric populations.</div></div>","PeriodicalId":12024,"journal":{"name":"European Journal of Pharmaceutics and Biopharmaceutics","volume":"214 ","pages":"Article 114801"},"PeriodicalIF":4.3000,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Pharmaceutics and Biopharmaceutics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S093964112500178X","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

The pediatric population often faces challenges in accessing appropriate medication formulations, particularly for circumstances like congenital heart disease requiring spironolactone therapy. This study aimed to optimize the pharmaceutical formulation of oral suspension spironolactone for pediatric use and assess its stability. A formulation with 0.2 % xanthan gum in InOrpha® was developed, showing improved stability and reduced sedimentation. Analytical method validation confirmed accuracy and precision for spironolactone quantification, while forced degradation studies ensured stability-indicating capability. Stability assessments demonstrated the oral suspension’s chemical, physical, and microbiological stability for up to 135 days pre-bottle opening and 37 days post-opening under varied storage conditions. This study provides crucial insights into enhancing spironolactone formulation for pediatric patients. Further research is needed to assess pharmacokinetic parameters such as bioavailability and pharmacodynamics to fully ascertain its efficacy in pediatric populations.

Abstract Image

查看原文本刊更多论文

小儿螺内酯口服混悬液的优化和稳定性评价：配方开发和分析验证。

儿科人群在获得适当的药物配方方面经常面临挑战，特别是对于需要螺内酯治疗的先天性心脏病等情况。本研究旨在优化小儿口服螺内酯悬浮液的处方并评价其稳定性。开发了一种含有0.2 % InOrpha®黄原胶的配方，显示出更好的稳定性和减少沉淀。分析方法验证证实了螺内酯定量的准确性和精密度，而强制降解研究确保了稳定性指示能力。稳定性评估表明，在不同的储存条件下，口服混悬液的化学、物理和微生物稳定性可达135 天开瓶前和37 天开瓶后。这项研究为加强小儿患者的螺内酯制剂提供了至关重要的见解。需要进一步的研究来评估药代动力学参数，如生物利用度和药效学，以充分确定其在儿科人群中的疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.