Nahata Milap C, Allen Loyd V
College of Pharmacy, The Ohio State University, Columbus, Ohio 43210, USA.
Clin Ther. 2008 Nov;30(11):2112-9. doi: 10.1016/j.clinthera.2008.11.020.
Access to a special dosage form of a medication is essential when administration to infants and children and selected other populations is required. Some drugs necessary for pediatric patients are not commercially available in dosage forms appropriate for use in this population. These drugs may be prepared extemporaneously for use in individual patients. Physical and chemical properties of drugs and excipients should be considered when preparing extemporaneous formulations. These formulations, however, may lack studies to document stability, bioavailability, pharmacokinetics, pharmacodynamics, efficacy, and tolerability.
The goal of this article was to discuss factors involved in extemporaneous compounding of pediatric dosage forms.
The proceedings from a Pediatric Formulation Initiative workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, held December 6 and 7, 2005, in Bethesda, Maryland, were used as a source of information for this article. A literature search of PubMed/ MEDLINE (1966-October 2008) was also conducted, using the search terms extemporaneous, drug formulations, and pediatric.
Access to age-appropriate drug formulations is critical to provide effective and well-tolerated medications to patients. There continues to be a need for extemporaneous formulations of brand and generic drugs for neonates, infants, and children. Potential solutions to current limitations include the need to develop a prioritized list of essential formulations, increased funding of research, dissemination of data, and monitoring of clinical effectiveness and tolerability during use in various age groups of pediatric patients and the sharing of these clinical experiences.
To achieve desired therapeutic outcomes in pediatric patients, access to age-appropriate, stable, effective, and well-tolerated drug formulations is essential.
当需要给婴幼儿及其他特定人群用药时，获取药物的特殊剂型至关重要。一些儿科患者所需的药物没有适合该人群使用的市售剂型。这些药物可能需要临时配制以供个别患者使用。临时配制制剂时应考虑药物和辅料的物理及化学性质。然而，这些制剂可能缺乏关于稳定性、生物利用度、药代动力学、药效学、疗效和耐受性的研究。
本文的目的是讨论儿科剂型临时配制所涉及的因素。
2005年12月6日至7日在马里兰州贝塞斯达由尤尼斯·肯尼迪·施赖弗国家儿童健康与人类发展研究所主办的儿科制剂倡议研讨会的会议记录被用作本文的信息来源。还使用“临时”“药物制剂”和“儿科”等检索词在PubMed/MEDLINE（1966年 - 2008年10月）上进行了文献检索。
获得适合年龄的药物制剂对于为患者提供有效且耐受性良好的药物至关重要。仍然需要为新生儿、婴儿和儿童临时配制品牌药和仿制药。当前限制的潜在解决方案包括需要制定基本制剂的优先清单、增加研究资金、数据传播以及在儿科患者的各个年龄组使用期间监测临床有效性和耐受性，并分享这些临床经验。
为了在儿科患者中实现理想的治疗效果，获得适合年龄、稳定、有效且耐受性良好的药物制剂至关重要。
