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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Drug Formulations: Standards and Novel Strategies for Drug Administration in Pediatrics
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Drug Formulations: Standards and Novel Strategies for Drug Administration in Pediatrics

机译：药物制剂：儿科药物管理标准和新型策略

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摘要

Child-appropriate drug formulations are a prerequisite of successful drug therapy in children. Efficacy and safety must be given for the active pharmaceutical ingredient, but safety also for the used excipients, components of primary packaging materials, and devices. We are presently experiencing exciting times for pediatric drug development, stimulated by previous governmental incentives in both the European Union and the United States. The most important advances in pediatric drug formulation development are reviewed and evaluated in this article. Scientific publications and recent industry strategies indicate a clear shift from liquid dosage forms to novel solid dosage forms. Solid formulations are usually composed from excipients generally regarded as safe, whereas many liquid formulations contain excipients such as preservatives, antioxidants, or taste-masking agents that raise concerns. Further, some recent clinical studies on swallowability, acceptability, and preference indicate superiority for small-sized tablets, so-called mini-tablets, over conventional liquids. In general, multiparticulate solid dosage forms could partly replace the liquids and provide more stable and cheaper alternatives to existing drug products or new developments. Dispersible solid drug dosage forms like orodispersible tablets, mini-tablets and films are even better opportunities for efficient and safe use in pediatrics. Novel measuring and administration devices may facilitate the handling and drug administration of these modern drug dosage forms. Combination products (drug-device combinations) can easily be linked with new e-health technologies in near future to further improve pediatric drug therapy.
机译：儿童适当的药物制剂是儿童成功药物治疗的先决条件。必须给予活性药物成分的功效和安全性，但安全的赋形剂也适用于使用的赋形剂，初级包装材料的组分和装置。我们目前正在经历令人兴奋的儿科药物发展时期，由欧洲联盟和美国以前的政府激励刺激。在本文中审查和评估了儿科药物制剂的最重要进展。科学出版物和最近的行业策略表明从液体剂型与新型固体剂型的清晰转变。固体制剂通常由通常被认为是安全的赋形剂组成，而许多液体制剂含有赋形剂如防腐剂，抗氧化剂或味道掩蔽剂，其提高了担心。此外，最近关于吞咽性，可接受性和偏好的一些临床研究表明，小尺寸片剂，所谓的迷你片剂上的常规液体的优势。通常，多颗粒固体剂型可以部分取代液体，并为现有的药品或新的发育提供更稳定和更便宜的替代品。可分散的固体药物剂型如酸多解的片剂，迷你片剂和薄膜是更好的机会，用于儿童学科有效和安全。新型测量和给药装置可以促进这些现代药物剂型的处理和药物施用。组合产品（药物装置组合）在不久的将来可以轻松与新的电子健康技术联系，以进一步改善儿科药物治疗。

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