David H. Koch Institute for Integrative Cancer Research and Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA, 02139, USA.
Division of Gastroenterology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.
Adv Healthc Mater. 2023 Oct;12(27):e2301101. doi: 10.1002/adhm.202301101. Epub 2023 Aug 13.
Simplification of complex medication regimens in polypharmacy positively contributes to treatment adherence and cost-effective improved health outcomes. Even though fixed dose combination (FDC) drug products are the only currently available single dose poly-pill regimens, the lack of flexibility in dose adjustment of a single drug in the combination limits their efficacy. To fill the existing gap in drug dose personalization and simplification of complex medication regimens commonly encountered in the treatment of cardiovascular disease, tuberculosis, and tapering of corticosteroid therapy, a modular titratable polypill approach that simultaneously addresses both aspects is proposed. The polypill consists of modular units that contain different drugs at incremental or decremental doses to be assembled in a single titratable polypill at the required dose for each drug through a stacking or interlocking process. The variable dose (VD) modular tablets are subjected to quality control tests and found to comply to pharmacopeia's acceptance criteria and requirements specified in the respective drug monographs. A cost-effectiveness analysis is conducted supporting the VD strategy as cost-effective compared to the FDC strategy and more effective and less expensive than standard of care. The VD approach stands to enable pill burden reduction, ease of administration, enhancement of treatment adherence, and potential cost-saving benefits.
简化复方药物治疗方案对提高治疗依从性和实现成本效益改善健康结果具有积极作用。虽然固定剂量复方（FDC）药物产品是目前唯一可用的单一剂量复方药丸治疗方案，但组合中单一药物剂量调整缺乏灵活性限制了其疗效。为了填补目前在药物剂量个体化和简化心血管疾病、结核病治疗中常见的复杂药物治疗方案方面的空白，并减少皮质类固醇治疗的剂量，提出了一种同时解决这两个方面的模块化可滴定复方药丸方法。该复方药丸由模块化单元组成，这些单元包含不同剂量的不同药物，通过堆叠或互锁过程，在单个可滴定复方药丸中组装成每个药物所需的递增或递减剂量。可变剂量（VD）模块化片剂经过质量控制测试，符合药典的验收标准和各自药物专论中规定的要求。进行成本效益分析支持 VD 策略具有成本效益，与 FDC 策略相比更有效且更经济，优于标准护理。VD 方法有望减轻药物负担，便于管理，提高治疗依从性，并具有潜在的节省成本的好处。
