Department of Pharmacy, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.
Reference Center for Inherited Metabolic Diseases, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.
Pharm Dev Technol. 2021 Mar;26(3):328-334. doi: 10.1080/10837450.2021.1871918. Epub 2021 Jan 17.
Hydroxychloroquine is an antimalarial drug indicated in the treatment of acute attacks of malaria due to , , , and susceptible strains of . It is also used for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and more recently proposed in COVID-19 therapy. Hydroxychloroquine is only available in tablets which are not easy to administer for pediatric and geriatric patients, and patients unable to swallow such as patients found in intensive care units. The aim of this work was to develop and optimize a ready to use liquid hydroxychloroquine formulation and to carry out the corresponding chemical and microbiological stability studies. The formulation was evaluated for ease of preparation, physical properties, and palatability. Its stability was performed at ambient temperature and under refrigeration. After 6 months of stability testing, the results showed no pH change, no drug loss, no microbial development, and no visual change. The formulation, employing excipients in a range that EMA has recommended, showed chemical and microbiological stability for at least 6 months even in the worst storage conditions.
羟氯喹是一种抗疟药物，适用于治疗由 、 、 和敏感株引起的疟疾急性发作。它也用于治疗类风湿关节炎、盘状和系统性红斑狼疮，最近还被提议用于 COVID-19 治疗。羟氯喹仅以片剂形式提供，对于儿科和老年患者以及无法吞咽的患者（如在重症监护病房中发现的患者）来说，片剂不太容易给药。本工作的目的是开发和优化即用型羟氯喹液体制剂，并进行相应的化学和微生物稳定性研究。该制剂的制备简便性、物理性质和可接受性进行了评估。其稳定性在环境温度和冷藏条件下进行。经过 6 个月的稳定性测试，结果表明 pH 值没有变化、药物没有损失、没有微生物生长，也没有外观变化。该制剂采用 EMA 推荐范围内的辅料，即使在最恶劣的储存条件下，至少在 6 个月内仍能保持化学和微生物稳定性。
