Soremekun Rebecca, Ogbuefi Irene, Aderemi-Williams Roseline
Department of Clinical Pharmacy, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria.
Faculty of Public Health, West African Postgraduate College of Pharmacists, Lagos, Nigeria.
BMC Res Notes. 2019 Jul 26;12(1):460. doi: 10.1186/s13104-019-4486-7.
Excipients are needed in the formulation of oral liquid medicines intended for children; they have however been reported to trigger safety issues. This study evaluated the concentrations and prevalence of ethanol and other potentially harmful excipients in pediatric formulations marketed in South Eastern Nigeria in line with international labeling guidelines and allowable daily limits (ADL). The study sampled oral pediatric formulations offered for sale in registered pharmacies. Those with accessible information leaflets were assessed for the presence and quantity of previously flagged excipients with potential to harm the pediatric population.
Of the 380 oral pediatric medicines, 140 provided access to list/quantity of ingredients. 47.9% (67) of the formulations contain at least one of the flagged excipients while the remaining only listed the active ingredients. Ethanol had the highest occurrence (62.7%) and was more in cough/cold medicines. A homeopathic cough and cold remedy had concentration of 90% v/v. Ethanol and sucrose in some formulations exhibited concentrations with a potential of crossing their approved daily intake (ADI) (1-90% v/v and 1.7 g-3.7 g/5 ml respectively). Ethanol use in studied pediatric formulations was quite high, with ethanol-containing formulations being prescribed for children 0-6 years and older. Only 26 (38.8%) completely satisfied the labelling requirements for ethanol containing formulations.
儿童口服液体药物制剂需要辅料；然而，据报道辅料会引发安全问题。本研究根据国际标签指南和每日允许限量（ADL），评估了尼日利亚东南部市场上儿科制剂中乙醇和其他潜在有害辅料的浓度及流行情况。该研究对注册药房中出售的儿科口服制剂进行了抽样。对那些附有可获取的信息单页的制剂，评估其中先前标记的可能对儿科人群有害的辅料的存在情况和含量。
在380种儿科口服药物中，140种提供了成分列表/含量信息。47.9%（67种）的制剂含有至少一种标记的辅料，其余制剂仅列出了活性成分。乙醇的出现率最高（62.7%），在止咳/感冒药中更为常见。一种顺势疗法止咳感冒药的乙醇浓度为90%（v/v）。某些制剂中的乙醇和蔗糖浓度有可能超过其批准的每日摄入量（ADI）（分别为1 - 90%（v/v）和1.7 g - 3.7 g/5 ml）。在研究的儿科制剂中乙醇的使用相当普遍，含乙醇的制剂被开给0至六岁及以上的儿童。只有26种（38.8%）制剂完全符合含乙醇制剂的标签要求。
