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盖伦制剂策略在开发儿科用耐胃酸奥美拉唑制剂中的应用。

Application of Galenic Strategies for Developing Gastro-Resistant Omeprazole Formulation for Pediatrics.

作者信息

Rouaz-El-Hajoui Khadija, García-Montoya Encarnación, Suñé-Pou Marc, Suñé-Negre Josep María, Pérez-Lozano Pilar

机构信息

Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, Spain.

Pharmacotherapy, Pharmacogenetics and Pharmaceutical Technology Research Group, Bellvitge Biomedical Research Institute [IDIBELL], Av. Gran via de l'Hospitalet, 199-203, 08090 Barcelona, Spain.

出版信息

Children (Basel). 2024 Aug 5;11(8):945. doi: 10.3390/children11080945.

DOI:10.3390/children11080945
PMID:39201880
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11352873/
Abstract

OBJECTIVES

This study addresses a critical need in pediatric pharmacotherapy by focusing on the development of an enteric formulation of omeprazole for pediatric use. Omeprazole, a widely used proton pump inhibitor, is essential for treating various gastrointestinal disorders in children. The main objective is to design a compounding formula that can be prepared in hospital pharmacy services without the need for industrial equipment, which is often unavailable in these settings.

METHODS

The research applied different galenic strategies to overcome the challenges of omeprazole's instability in acidic environments and its complex pharmacokinetic and physicochemical properties. The experiments were conducted sequentially, employing salting out, ionic gelation, and matrix granulation strategies. Based on the results obtained, the control conditions and parameters for the various trials were established.

RESULTS

Among the techniques used, wet granulation proved to be the most promising, achieving a gastro-resistance level of 44%. In contrast, the ionic gelation and salting-out techniques did not yield satisfactory results.

CONCLUSIONS

The findings of this study underscore the need to adopt alternative formulation strategies to ensure the stability of omeprazole. This goal requires a multidisciplinary approach and continuous effort to design omeprazole formulations that meet quality standards and appropriate gastro-resistance requirements.

摘要

目的

本研究聚焦于开发用于儿科的奥美拉唑肠溶制剂，以满足儿科药物治疗的一项关键需求。奥美拉唑是一种广泛使用的质子泵抑制剂，对于治疗儿童各种胃肠道疾病至关重要。主要目标是设计一种可在医院药房制备的配方，无需工业设备，而这些设备在医院环境中往往无法获得。

方法

该研究应用了不同的药剂学策略，以克服奥美拉唑在酸性环境中的不稳定性及其复杂的药代动力学和物理化学性质带来的挑战。实验依次采用盐析、离子凝胶化和基质造粒策略进行。根据所得结果，确定了各项试验的控制条件和参数。

结果

在所使用的技术中，湿法制粒被证明最具前景，实现了44%的抗胃酸水平。相比之下，离子凝胶化和盐析技术未取得满意结果。

结论

本研究结果强调需要采用替代制剂策略以确保奥美拉唑的稳定性。这一目标需要多学科方法和持续努力来设计符合质量标准和适当抗胃酸要求的奥美拉唑制剂。

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