Zanon D, Musazzi U M, Manca A, De Nicolò A, D'Avolio A, Cilurzo F, Maximova N, Tomasello C, Clementi E, Minghetti P
Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy.
Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via Giuseppe Colombo, 71, 20133 Milan, Italy.
Data Brief. 2020 Dec;33:106445. doi: 10.1016/j.dib.2020.106445. Epub 2020 Oct 23.
The COVID-19 outbreak is now one of the most critical crises to manage for most of national healthcare systems in the world. The situation is complicated by the absence of vaccines and authorized pharmacological treatments, except for remdesivir. In this context, many medicaments, including different Ebola and HIV antivirals, are used off-label in the hospital wards as life-treating medicines for COVID-19 patients. Authorized medicaments manipulation is sometimes necessary because they are not always formulated to be administered to non-cooperative patients or they are in shortage. It is this the case of the fixed combination of lopinavir/ritonavir, which was extensively used in the first phase of the outbreak inducing a shortage of the oral solution available in the EU market. This work provides data on size distribution, osmolarity other than drug chemical stability of a lopinavir/ritonavir extemporaneous preparation made by using the solid dosage form (i.e., tablet) available on the market as drug source. The reported data indicate that such preparation is suitable to be delivered through a nasogastric tube, and enough stable for two weeks from the preparation at room temperature.
新型冠状病毒肺炎（COVID-19）疫情爆发，对于世界上大多数国家的医疗系统而言，这是目前最严峻的危机之一。由于缺乏疫苗以及除瑞德西韦之外的经批准的药物治疗方法，情况变得更加复杂。在此背景下，许多药物，包括不同的埃博拉病毒和艾滋病毒抗病毒药物，在医院病房中被作为治疗COVID-19患者的救命药物而超适应症使用。有时需要对经批准的药物进行调配，因为这些药物并非总是为不配合的患者设计的剂型，或者存在短缺情况。洛匹那韦/利托那韦的固定复方制剂就是这种情况，在疫情爆发的第一阶段被广泛使用，导致欧盟市场上的口服溶液短缺。这项工作提供了关于以市售固体剂型（即片剂）作为药物来源制备的洛匹那韦/利托那韦临时制剂的粒度分布、渗透压以及药物化学稳定性的数据。报告的数据表明，这种制剂适合通过鼻胃管给药，并且在室温下制备后两周内足够稳定。
