The Design of Novel 3D-Printed, Moulded, and Oral Viscous Budesonide Formulations for Paediatrics: A Comparative Evaluation of Their Mucoadhesive Properties.

IF 4.9 3区医学 Q1 PHARMACOLOGY & PHARMACY Pharmaceutics Pub Date : 2024-10-18 DOI:10.3390/pharmaceutics16101338

María Magariños-Triviño, Eduardo Díaz-Torres, Javier Suárez-González, Ana Santoveña-Estévez, José B Fariña

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Abstract

Background/objectives: Paediatric eosinophilic oesophagitis (EoE) treatment is challenging due to the limited number of age-appropriate formulations. This study aims to develop and evaluate oral viscous suspensions and solid formulations of budesonide (BUD), focusing on their in vitro mucoadhesive properties, to enhance drug delivery and therapeutic outcomes in paediatric EoE.

Methods: This study encompasses the development of oral viscous suspensions and orodispersible solid formulations (moulded tablets and 3D-printed dosage forms) containing BUD. The formulations underwent quality control tests as per the European Pharmacopoeia, chemical stability assessments, and an in vitro evaluation of their mucoadhesiveness properties.

Results: A validated analytical method enabled accurate BUD quantification and efficient extraction, and all developed formulations demonstrated chemical stability for 30 days, meeting Ph. Eur. quality standards. Three-dimensional printing using SSE successfully produced 1 mg and 0.5 mg BUD printlets, complying with quality tests for conventional tablets. Formulations containing xanthan gum (L2-XG and P1-0.5-XG) exhibited superior mucoadhesive properties. L2-XG showed significantly higher mucoadhesion than L1-MC. Among the solid formulations, P1-0.5-XG demonstrated the highest mucoadhesive properties.

Conclusions: This is the first study to develop solid oral dosage forms of BUD at a very low dose, specifically for paediatric use. The results highlight the potential of 3D printing for developing individualised orodispersible BUD formulations with improved bioadhesion for paediatric EoE treatment. The L2-XG formulation and the XG-containing printlets are the most promising formulations in terms of increasing contact time with the oesophageal mucosa, which could translate into improved therapeutic efficacy in this patient population.

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设计用于儿科的新型三维打印、模制和口服粘稠布地奈德制剂：对其黏附性能的比较评估

背景/目的：由于适龄制剂数量有限，儿童嗜酸性食管炎（EoE）治疗面临挑战。本研究旨在开发和评估布地奈德（BUD）的口服粘稠混悬液和固体制剂，重点关注其体外粘附特性，以提高药物输送和儿科食管炎的治疗效果：本研究包括开发含BUD的口服粘稠混悬液和口服可分散固体制剂（模制片剂和3D打印剂型）。根据《欧洲药典》对制剂进行了质量控制测试、化学稳定性评估，并对其粘附性进行了体外评估：结果：经过验证的分析方法能够准确定量并高效提取 BUD，所有开发的制剂均具有 30 天的化学稳定性，符合欧洲药典的质量标准。使用 SSE 进行的三维印刷成功生产出了 1 毫克和 0.5 毫克的 BUD 印刷片，符合传统片剂的质量检测标准。含有黄原胶的配方（L2-XG 和 P1-0.5-XG）表现出优异的粘附性。L2-XG 的粘附性明显高于 L1-MC。在固体制剂中，P1-0.5-XG 的粘附性最高：这是第一项专门针对儿科使用的极低剂量 BUD 口服固体制剂的研究。研究结果凸显了三维打印技术在开发用于儿科咽喉炎治疗的具有更好生物粘附性的个体化口服 BUD 制剂方面的潜力。L2-XG制剂和含XG的打印颗粒是最有前景的制剂，它们能增加与食道粘膜的接触时间，从而提高对这一患者群体的疗效。

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来源期刊

Pharmaceutics Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

7.90

自引率

11.10%

发文量

2379

审稿时长

16.41 days

期刊介绍： Pharmaceutics (ISSN 1999-4923) is an open access journal which provides an advanced forum for the science and technology of pharmaceutics and biopharmaceutics. It publishes reviews, regular research papers, communications, and short notes. Covered topics include pharmacokinetics, toxicokinetics, pharmacodynamics, pharmacogenetics and pharmacogenomics, and pharmaceutical formulation. Our aim is to encourage scientists to publish their experimental and theoretical details in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.