地塞米松在儿科的安全应用:一种新型稳定口服混悬液的设计和评价

Ana Santoveña-Estévez, Diego Dorta-Vera, I. González-García, Javier Suárez-González, Nuria Teigell-Pérez, J. Fariña
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引用次数: 2

摘要

背景地塞米松在儿科主要用于治疗组性和支气管肺发育不良。市面上可买到的儿科口服配方中含有不适合这一人群的辅料。当只有市售的成人口服剂型时,配制一种配方,通过操作经批准的片剂或注射剂型来减少剂量。大多数情况下,这种做法是在没有过程所需的质量和控制的情况下进行的。本研究的目的是提出一种配方安全,适合儿科使用的标准操作程序,确保其质量。方法采用适合儿科使用的最低数量和用量的辅料,避免使用地塞米松盐和防腐剂,设计两种剂型。提出了一种精确的分析方法和分析剂量均匀性的方法学。对其进行了物理、化学和微生物稳定性测试。结果柠檬酸/柠檬酸缓冲液酸化可提高地塞米松的稳定性。建议的混悬液符合使用地塞米松作为活性药物成分的口服非无菌制剂的质量标准,以及适用于儿科的辅料的最低数量和数量。结论该制剂在5、25℃条件下保存15 d,物理、化学和微生物性能稳定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safe use of Dexamethasone in pediatrics: design and evaluation of a novel stable oral suspension
Abstract Background Dexamethasone is used in pediatrics mainly for treatment of croup and bronchopulmonary dysplasia. Commercially available pediatric oral formulations include inadequate excipients for this population. When there are only commercially available oral dosage forms for adults, a formulation is prepared to reduce the dose by manipulation of authorized tablets or injectable dosage forms. This practice most of times is made without the quality and control that process requires. The aim of this study is to propose a formulation secure and suitable for pediatrics by the use of a Standard Operating Procedure that ensures its quality. Methods Design of two formulations was performed with lowest number and amount of excipients suitable for pediatrics, avoiding use of dexamethasone salts and preservatives. An accurate and precise analytical method and a methodology for analyzing uniformity of doses were developed. Physical, chemical and microbiological stability was tested. Results Stability of Dexamethasone was improved by acidification with citric/citrate buffer. Proposed suspension complies with quality criteria required for an oral non-sterile formulation using Dexamethasone as active pharmaceutical ingredient, and the minimum number and quantity of excipients suitable for pediatrics. Conclusions This formulation is physical, chemical and microbiologically stable during 15 days storage at 5 and 25 °C.
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