Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms.
Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms.
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DOI：
10.1517/17425247.2015.1060218
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发表时间：
2015
影响因子：
6.6
通讯作者：
Gul MO
中科院分区：
文献类型：
--
作者：
Lopez FL;Ernest TB;Tuleu C;Gul MO
前言：大多数传统的给药系统对于儿科患者来说是不可接受的，因为他们的发育状况和剂量要求与其他人群不同。需要技术平台来帮助开发适合年龄的药物，以最大限度地提高患者的可接受性，同时保持安全性、有效性、可及性和可负担性。涵盖的领域：目前的方法和新的发展领域的适合年龄的药物输送的儿科患者进行了批判性的讨论，包括以患者为中心的配方，给药装置和包装系统。专家意见：尽管最近的法规修订和配方科学家的努力提供了激励措施，但仍然需要实施能够生产许可的适龄配方的制药技术。通过分享与儿科调查计划、产品开发路径和科学项目获得的数据相关的学习，协调监管机构、行业和学术界的努力，将是加快从板凳到市场年龄适当配方开发的前进方向。协作方法不仅将使儿科受益，而且其他患者群体，如老年病，也将受益于加速的以患者为中心的药物输送方法。
Introduction: Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability. Areas covered: The current approaches and novel developments in the field of age-appropriate drug delivery for pediatric patients are critically discussed including patient-centric formulations, administration devices and packaging systems. Expert opinion: Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. A collaborative approach will benefit not only pediatrics, but other patient populations such as geriatrics would also benefit from an accelerated patient-centric approach to drug delivery.