Drumond Nélio, Stegemann Sven
Graz University of Technology, Inffeldgasse 13/III, 8010 Graz, Austria.
Pharmaceutics. 2020 Dec 28;13(1):32. doi: 10.3390/pharmaceutics13010032.
Oral drug administration provided as solid oral dosage forms (SODF) remains the major route of drug therapy in primary and secondary care. There is clear evidence for a growing number of clinically relevant swallowing issues (e.g., dysphagia) in the older patient population, especially when considering the multimorbid, frail, and polymedicated patients. Swallowing impairments have a negative impact on SODF administration, which leads to poor adherence and inappropriate alterations (e.g., crushing, splitting). Different strategies have been proposed over the years in order to enhance the swallowing experience with SODF, by using conventional administration techniques or applying swallowing aids and devices. Nevertheless, new formulation designs must be considered by implementing a patient centric approach in order to efficiently improve SODF administration by older patient populations. Together with appropriate SODF size reductions, innovative film coating materials that can be applied to SODF and provide swallowing safety and efficacy with little effort being required by the patients are still needed. With that in mind, a literature review was conducted in order to identify the availability of patient centric coating materials claiming to shorten esophageal transit times and improve the overall SODF swallowing experience for older patients. The majority of coating technologies were identified in patent applications, and they mainly included well-known water soluble polymers that are commonly applied into pharmaceutical coatings. Nevertheless, scientific evidence demonstrating the benefits of given SODF coating materials in the concerned patient populations are still very limited. Consequently, the availability for safe, effective, and clinically proven solutions to address the increasing prevalence of swallowing issues in the older patient population is still limited.
作为固体口服剂型(SODF)的口服给药仍然是初级和二级护理中药物治疗的主要途径。有明确证据表明,老年患者群体中临床上相关的吞咽问题(如吞咽困难)越来越多,尤其是考虑到患有多种疾病、身体虚弱且同时服用多种药物的患者。吞咽障碍会对固体口服剂型的给药产生负面影响,导致依从性差和不适当的改变(如碾碎、掰开)。多年来,人们提出了不同的策略,通过使用传统给药技术或应用吞咽辅助工具和装置来改善固体口服剂型的吞咽体验。然而,必须通过实施以患者为中心的方法来考虑新的制剂设计,以便有效地改善老年患者群体对固体口服剂型的给药。除了适当减小固体口服剂型的尺寸外,仍需要能够应用于固体口服剂型并在患者几乎无需费力的情况下提供吞咽安全性和有效性的创新薄膜包衣材料。考虑到这一点,我们进行了一项文献综述,以确定声称可缩短食管通过时间并改善老年患者整体固体口服剂型吞咽体验的以患者为中心的包衣材料的可用性。大多数包衣技术在专利申请中被发现,它们主要包括常用于药物包衣的知名水溶性聚合物。然而,证明特定固体口服剂型包衣材料对相关患者群体有益的科学证据仍然非常有限。因此,针对老年患者群体中日益普遍的吞咽问题,安全、有效且经过临床验证的解决方案仍然有限。