a Lyndra Inc , Watertown , MA , USA.
b Department of Chemical Engineering and David H. Koch Institute for Integrative Cancer Research , Massachusetts Institute of Technology , Cambridge , MA , USA.
Expert Opin Drug Deliv. 2018 Dec;15(12):1189-1198. doi: 10.1080/17425247.2018.1544615. Epub 2018 Nov 13.
The development of oral sustained release dosage forms has been a longstanding goal due to the potential for ease of administration, improved pharmacokinetics, reduced dosing frequency, and improved adherence. The benefits of multiday single-dose drug delivery are evident in the success and patient adoption of injected and implanted dosage forms. However, in the space of oral medications, all current commercially available gastric resident dosage forms, and most in development, are limited to gastric residence of less than 1 day.
Reviews of systems to extend gastric residence reveal that 1 day or more residence has been an unmet challenge. New dosage forms are in development that seek to address many of the key physiological and design challenges of long-term gastric retention beyond 24 h and up to a week or longer. The present analysis highlights the design, material considerations and implications of unfolding dosage form systems with ultra-long-term gastric residence.
The development of oral dosage forms providing sustained release of high potency medications over days or weeks could transform care, significantly decrease patient burden in chronic disease management and improve outcomes.
由于具有给药方便、改善药代动力学、减少给药频率和提高顺应性等潜在优势,开发口服缓释剂型一直是人们长期追求的目标。多日单次给药的益处体现在注射和植入剂型的成功和患者接受度上。然而,在口服药物领域,所有当前市售的胃内滞留剂型,以及大多数正在开发的剂型,其胃内滞留时间都不到 1 天。
为延长胃内滞留时间而进行的系统评价表明,1 天或更长时间的胃内滞留时间是一个尚未得到满足的挑战。新剂型正在开发中,旨在解决超过 24 小时甚至一周或更长时间的长期胃滞留的许多关键生理和设计挑战。本分析重点介绍了具有超长期胃内滞留时间的展开剂型系统的设计、材料考虑因素和影响。
开发能够在数天或数周内持续释放高浓度药物的口服剂型,可能会改变治疗方式,显著减轻慢性病管理中的患者负担并改善治疗结果。