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从商业可得产品临时制备的液体制剂-考虑到稳定性方面的新证据。

Liquid dosage forms extemporaneously prepared from commercially available products - considering new evidence on stability.

机构信息

School of Pharmacy, Griffith Health Institute, Griffith University, Gold Coast, QLD, Australia.

出版信息

J Pharm Pharm Sci. 2013;16(3):441-55. doi: 10.18433/j38887.

Abstract

Although the world's population is ageing and as a result of this an increasing number of patients are experiencing difficulty in swallowing, there remains a lack of commercially available oral liquids for both these older and paediatric patients. This presents a problem to health care professionals, especially the pharmacist in practice, who is often required to provide a solution for these patients by preparing oral liquids extemporaneously from commercially available products. Preparation of these oral liquids is challenging, both due to the lack of pharmacopoeial and stability-indicating formulae and the fact that their stability is not only determined by the active pharmaceutical ingredient, but also the ability of excipients from the commercial product to interact with each other and the active pharmaceutical ingredient. This increases the complexity of the stability considerations to be taken into account within these oral liquids, highlighting the number of parameters to be considered in the extemporaneous preparation of oral liquids. This paper presents new evidence on the stability of 42 oral liquids prepared from commercially available products, reported on in the literature since the previous review published in 2006. However, unlike the previous review where the stability concerns in 7.2% of the extemporaneously prepared oral liquids were mainly due to interaction between the active pharmaceutical ingredients and the excipients in the commercial product, most of these stability considerations have been recognised and this has resulted in the authors proposing solutions to these problems prior to the extemporaneous preparation of the oral liquid. As such this paper also focuses on the increased level of research that has been undertaken to solve previous issues related to stability, especially in terms of the use of commercial products, which is common practice in the extemporaneous preparation of oral liquids.

摘要

尽管世界人口正在老龄化,因此越来越多的患者吞咽困难,但仍然缺乏针对这些老年和儿科患者的商业可用口服液。这给医疗保健专业人员带来了问题,尤其是在实践中的药剂师,他们经常需要通过从市售产品中临时制备口服液来为这些患者提供解决方案。这些口服液的制备具有挑战性,这不仅是由于缺乏药典和稳定性指示配方,而且还因为它们的稳定性不仅取决于活性药物成分,还取决于商业产品中的赋形剂相互作用以及与活性药物成分的能力。这增加了在这些口服液中需要考虑的稳定性考虑因素的复杂性,突出了在临时制备口服液时需要考虑的参数数量。本文提供了自 2006 年上次综述以来文献中报道的 42 种从市售产品制备的口服液的稳定性新证据。然而,与上次综述中 7.2%的临时制备口服液的稳定性问题主要是由于活性药物成分与商业产品中的赋形剂相互作用不同,这些稳定性问题中的大多数已经得到认识,这导致作者在临时制备口服液之前提出了解决这些问题的方案。因此,本文还重点介绍了为解决与稳定性相关的先前问题而进行的更多研究,特别是在使用商业产品方面,这在临时制备口服液中是常见的做法。

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