50mg/mL 羟氯喹口服混悬液在 SyrSpend SF PH4（干）中的制备及理化稳定性。

Preparation and physicochemical stability of 50 mg/mL hydroxychloroquine oral suspension in SyrSpend SF PH4 (dry).

机构信息

University Hospital of Poitiers, Pharmacy Department, 2 rue de la milétrie, 86021 Poitiers, France; CIC Inserm 1402, HEDEX Group, 2 rue de la milétrie, 86021 Poitiers, France, and School of Medicine and Pharmacy, University of Poitiers, Poitiers, France.

CIC Inserm 1402, HEDEX Group, 2 rue de la milétrie, 86021 Poitiers, France, and School of Medicine and Pharmacy, University of Poitiers, Poitiers, France; University Hospital of Poitiers, Pharmacokinetics Department, 2 rue de la milétrie, 86021 Poitiers, France.

出版信息

Int J Antimicrob Agents. 2020 Dec;56(6):106201. doi: 10.1016/j.ijantimicag.2020.106201. Epub 2020 Oct 16.

DOI:10.1016/j.ijantimicag.2020.106201

PMID:33075513

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7566679/

Abstract

In the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, hydroxychloroquine has been proposed as a potential agent to treat patients with COVID-19 (coronavirus disease 2019) caused by SARS-CoV-2 infection. Older adults are more susceptible to COVID-19 and some patients may require admission to the intensive care unit, where oral drug administration of solid forms may be compromised in many COVID-19 patients. However, a liquid formulation of hydroxychloroquine is not commercially available. This study describes how to prepare a 50 mg/mL hydroxychloroquine oral suspension using hydroxychloroquine sulfate powder and SyrSpend SF PH4 (dry) suspending vehicle. Moreover, a fully validated stability-indicating method has been developed to demonstrate the physicochemical stability of the compounded hydroxychloroquine oral suspension over 60 days under refrigeration (5 ± 3 °C). Finally, use of the proposed oral suspension provides a reliable solution to perform safe and accurate administration of hydroxychloroquine to patients with SARS-CoV-2 infection.

摘要

在严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）大流行的背景下，羟氯喹被提议作为一种潜在的药物来治疗由 SARS-CoV-2 感染引起的 COVID-19（2019 年冠状病毒病）患者。老年人更容易感染 COVID-19，一些患者可能需要入住重症监护病房，而在许多 COVID-19 患者中，口服固体制剂的药物给药可能会受到影响。然而，羟氯喹的液体制剂尚未商业化。本研究描述了如何使用硫酸羟氯喹粉和 SyrSpend SF PH4（干）混悬剂载体制备 50mg/mL 的羟氯喹口服混悬剂。此外，还开发了一种完全验证的稳定性指示方法，以证明在冷藏（5±3°C）下配制的羟氯喹口服混悬剂在 60 天内的理化稳定性。最后，使用所提议的口服混悬剂为对 SARS-CoV-2 感染患者安全、准确地施用羟氯喹提供了可靠的解决方案。