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用于肠内喂养管的复方阿哌沙班混悬液

Compounded Apixaban Suspensions for Enteral Feeding Tubes.

作者信息

Caraballo Maria L, Donmez Seda, Nathan Kobi, Zhao Fang

机构信息

St. John Fisher College, Rochester, NY, USA.

出版信息

Hosp Pharm. 2017 Jul;52(7):478-482. doi: 10.1177/0018578717720507. Epub 2017 Jul 25.

DOI:10.1177/0018578717720507
PMID:29326482
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5735708/
Abstract

There is limited information on compounded apixaban formulations for administration via enteral feeding tubes. This study was designed to identify a suitable apixaban suspension formulation that is easy to prepare in a pharmacy setting, is compatible with commonly used feeding tubes, and has a beyond-use date of 7 days. Apixaban suspensions were prepared from commercially available 5-mg Eliquis tablets. Several vehicles and compounding methods were screened for ease of preparation, dosage accuracy, and tube compatibility. Two tubing types, polyurethane and polyvinyl chloride, with varying lengths and diameters, were included in the study. They were mounted on a peg board during evaluation to mimic the patient body position. A 7-day stability study of the selected formulation was also conducted. Vehicles containing 40% to 60% Ora-Plus in water all exhibited satisfactory flowability through the tubes. The mortar/pestle compounding method was found to produce more accurate and consistent apixaban suspensions than the pill crusher or crushing syringe method. The selected formulation, 0.25 mg/mL apixaban in 50:50 Ora-Plus:water, was compatible with both tubing types, retaining >98% drug in posttube samples. The stability study also confirmed that this formulation was stable physically and chemically over 7 days of storage at room temperature. A suitable apixaban suspension formulation was identified for administration via enteral feeding tubes. The formulation consisted of 0.25 mg/mL apixaban in 50:50 Ora-Plus:water. The stability study results supported a beyond-use date of 7 days at room temperature.

摘要

关于通过肠内饲管给药的复方阿哌沙班制剂的信息有限。本研究旨在确定一种合适的阿哌沙班混悬液制剂,该制剂易于在药房配制,与常用的饲管兼容,且使用期限为7天。阿哌沙班混悬液由市售的5毫克艾乐妥片剂制备。筛选了几种赋形剂和配制方法,以评估其制备的难易程度、剂量准确性和与饲管的兼容性。研究中包括了两种不同长度和直径的管材,即聚氨酯管和聚氯乙烯管。在评估过程中,将它们安装在挂板上以模拟患者的身体姿势。还对所选制剂进行了为期7天的稳定性研究。含40%至60%水合Ora-Plus的赋形剂在通过饲管时均表现出令人满意的流动性。发现研钵/研杵配制方法比药丸破碎机或粉碎注射器方法能制备出更准确、更一致的阿哌沙班混悬液。所选制剂为50:50水合Ora-Plus:水配制的0.25毫克/毫升阿哌沙班,与两种管材均兼容,饲管后样品中药物保留率>98%。稳定性研究还证实,该制剂在室温下储存7天内在物理和化学性质上均稳定。确定了一种适合通过肠内饲管给药的阿哌沙班混悬液制剂。该制剂由50:50水合Ora-Plus:水配制的0.25毫克/毫升阿哌沙班组成。稳定性研究结果支持该制剂在室温下7天的使用期限。

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