a Unidad de Gestión Clínica de Farmacia, Hospital Universitario Virgen Macarena , Sevilla , Spain.
b Unidad de Gestión Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen Macarena , Sevilla , Spain.
Pharm Dev Technol. 2019 Apr;24(4):465-478. doi: 10.1080/10837450.2018.1514520. Epub 2018 Nov 19.
Pediatric patients present changing physiological features. Because of the lack of land suitable for commercial management, pediatric specialties very often need to prepare extemporaneous formulations to improve the dosage and administration of drugs for children. Oral liquid formulations are the most suitable for pediatric patients. Clonidine is widely used in the pediatric population for opioid withdrawal, hypertensive crisis, attention deficit disorders and hyperactivity syndrome, and as an analgesic in neuropathic cancer pain. The objective was to study the physicochemical and microbiological stability and determine the shelf life of an oral solution containing 20 µg/mL clonidine hydrochloride in different storage conditions (5 ± 3 °C, 25 ± 3 °C, and 40 ± 2 °C). Using raw material with excipients safe for all pediatric age groups, two oral liquid formulations of clonidine hydrochloride were designed (with and without preservatives). Solutions stored at 5 ± 3 °C (with and without preservatives) were physically and microbiologically stable for at least 90 days in closed containers and for 42 days after opening. Two oral solutions of clonidine hydrochloride 20 µg/mL were developed for pediatric use from raw materials that are readily available and easy to process, containing safe excipients that are stable over a long period of time.
儿科患者呈现出不断变化的生理特征。由于缺乏适合商业管理的土地，儿科专业通常需要准备临时制剂，以改善儿童用药的剂量和给药方式。口服液体制剂最适合儿科患者。可乐定在儿科人群中广泛用于阿片类药物戒断、高血压危象、注意缺陷多动障碍和多动综合征，以及作为神经源性癌痛的镇痛药。目的是研究含有 20μg/ml 盐酸可乐定的口服溶液在不同储存条件（5±3°C、25±3°C 和 40±2°C）下的物理化学和微生物稳定性，并确定其保质期。使用适用于所有儿科年龄组的原料和辅料，设计了两种盐酸可乐定的口服液体制剂（含防腐剂和不含防腐剂）。在 5±3°C（含和不含防腐剂）下储存的溶液在密闭容器中至少稳定 90 天，开封后至少稳定 42 天。从易于获得和易于处理的原料中开发了两种 20μg/ml 盐酸可乐定的口服溶液，适用于儿科使用，含有安全的辅料，在长时间内保持稳定。
