hydroxychloquine sulphate in oral liquid bases

Stability data of extemporaneous suspensions of hydroxychloquine sulphate in oral liquid bases after tablet manipulation.
Hydroxychloroquine is a well-known antimalarial and anti-rheumatic drug that has garnered unprecedented attention as potential therapeutic agent against COVID-19. Hydroxychloroquine sulphate is used off-label as lifetreating medicine for COVID-19 patients and is authorized in the EU as film-coated tablets (i.e. Plaquenil®), which cannot be administered to non-cooperative patients, such as those in intensive care units or, more in general, unable to swallow solid dosage forms. Therefore, the hospital pharmacist must manipulate the solid dosage form for the preparation of suspension, even if it can strongly affect the product quality. In this scenario, it is crucial to offer useful information and advice to assist hospital pharmacists in their activity. The data presented in this article suggest that extemporaneous suspensions of hydroxychloquine sulphate in oral liquid bases (fast oral solution, named Puccini and fast oral solution - sugar free, named Beethoven) after tablet manipulation are stable for at least 30 days.

本文展示了在片剂处理之后，羟氯喹硫酸盐在口服液体基质（速溶口服液，命名为普契尼；无糖速溶口服液，命名为贝多芬）中临时制备的悬浮液稳定性数据。羟氯喹作为一种广为人知的抗疟疾和抗风湿药物，因其作为COVID-19潜在治疗剂的潜力而受到前所未有的关注。羟氯喹硫酸盐作为非处方药物，被用作COVID-19患者的生命维持治疗药物，并在欧盟获得批准以薄膜包衣片剂形式（即Plaquenil®）上市，但无法用于无法合作的患者，例如重症监护室患者或更一般地，无法吞咽固体剂型的患者。因此，医院药剂师必须对固体剂型进行操作以制备悬浮液，即使这可能会严重影响产品质量。在此情况下，提供有用信息和建议以协助医院药剂师进行其活动显得尤为关键。本文所展示的数据表明，在片剂处理之后，羟氯喹硫酸盐在口服液体基质中临时制备的悬浮液至少稳定30天。