Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA,
AAPS J. 2013 Oct;15(4):1072-81. doi: 10.1208/s12248-013-9511-5. Epub 2013 Aug 2.
Despite the fact that a significant percentage of the population is unable to swallow tablets and capsules, these dosage forms continue to be the default standard. These oral formulations fail many patients, especially children, because of large tablet or capsule size, poor palatability, and lack of correct dosage strength. The clinical result is often lack of adherence and therapeutic failure. The American Association of Pharmaceutical Scientists formed a Pediatric Formulations Task Force, consisting of members with various areas of expertise including pediatrics, formulation development, clinical pharmacology, and regulatory science, in order to identify pediatric, manufacturing, and regulatory issues and areas of needed research and regulatory guidance. Dosage form and palatability standards for all pediatric ages, relative bioavailability requirements, and small batch manufacturing capabilities and creation of a viable economic model were identified as particular needs. This assessment is considered an important first step for a task force seeking creative approaches to providing more appropriate oral formulations for children.
尽管很大一部分人群无法吞咽片剂和胶囊，但这些剂型仍然是默认的标准。这些口服制剂使许多患者，尤其是儿童，无法使用，因为片剂或胶囊太大、味道不佳以及缺乏正确的剂量强度。其临床结果通常是缺乏依从性和治疗失败。为了确定儿科制剂的相关问题和需要研究及监管指导的领域，美国药物科学家协会成立了儿科制剂工作组，成员来自儿科、制剂开发、临床药理学和监管科学等各个领域。工作组确定了儿科各年龄段的剂型和口感标准、相对生物利用度要求、小批量生产能力以及可行的经济模式等特定需求。该评估被认为是工作组寻求创造性方法为儿童提供更合适的口服制剂的重要第一步。
