NUS Graduate School for Integrative Sciences and Engineering, University Hall, Tan Chin Tuan Wing Level 04, #04-02, 21 Lower Kent Ridge Road, Singapore 119077, Singapore; Craft Health Pte Ltd., 21 Bukit Batok Crescent, #10-75, WCEGA Tower, Singapore 658065, Singapore; Department of Pharmacy, Faculty of Science, National University of Singapore, Block S4A, Level 3, 18 Science Drive 4, Singapore 117543, Singapore.
Craft Health Pte Ltd., 21 Bukit Batok Crescent, #10-75, WCEGA Tower, Singapore 658065, Singapore.
Int J Pharm. 2021 Apr 1;598:120360. doi: 10.1016/j.ijpharm.2021.120360. Epub 2021 Feb 4.
Personalized supplementation has found recent momentum with an estimated global market size of USD 1.6 billion in 2019 and an expected CAGR of 8.5% between 2020 and 2028. Alongside this rising trend, a simple, accurate, inexpensive and flexible method to produce personalized dosage forms of a wide variety of supplements would be beneficial to both the industry players and individual consumers. Here, we present a 3D printing method to fabricate a four-in-one oral polypill with multiple release profiles for personalized delivery of caffeine and vitamin B analogues. The 3D printable formulations were fabricated and optimized from existing FDA GRAS excipients based on their viscosity, shear thinning properties, recovery of paste and mechanical strength. In the polypill, vitamin B analogues and caffeine were used as the model dietary ingredients. We performed a standard 2 stage USP in vitro dissolution test of the polypill, and demonstrated that vitamin B1, B3 and B6 could be immediately released within 30 min, while caffeine could be slowly released over a period of 4 h. This demonstrated the ability dietary supplement containing different ingredients with varying release profiles, all within a single polypill. Throughout the formulation and 3D printing process, there were no detectable changes to the dietary ingredients nor any interactions with the excipients. This method serves as an intriguing complement to traditional manufacturing of oral tablets, especially when flexibility in design, dose, volume and release profiles of each dietary ingredient is required, as exemplified in personalized supplementation.
个性化补充剂最近受到关注，据估计，2019 年全球市场规模为 16 亿美元，预计 2020 年至 2028 年的复合年增长率为 8.5%。随着这一趋势的上升，一种简单、准确、廉价且灵活的方法来生产各种补充剂的个性化剂量形式，将有益于行业参与者和个人消费者。在这里，我们提出了一种 3D 打印方法，用于制造具有多种释放特性的四合一口服复方丸，以实现咖啡因和维生素 B 类似物的个性化传递。基于其粘度、剪切稀化特性、糊状物的恢复和机械强度，从现有的 FDA GRAS 赋形剂中制备和优化了可 3D 打印的配方。在复方丸中，维生素 B 类似物和咖啡因被用作模型膳食成分。我们对复方丸进行了标准的 2 阶段 USP 体外溶解试验，结果表明，维生素 B1、B3 和 B6 可以在 30 分钟内立即释放，而咖啡因可以在 4 小时内缓慢释放。这证明了含有不同成分且具有不同释放特性的膳食补充剂都可以在单个复方丸中实现。在整个配方和 3D 打印过程中，膳食成分没有发生任何可检测到的变化，也没有与赋形剂发生任何相互作用。这种方法为传统的口服片剂制造提供了一种有趣的补充，特别是在需要每个膳食成分的设计、剂量、体积和释放特性具有灵活性时，如个性化补充剂中所示。
