Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, USA.
Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, USA.
Int J Pharm. 2023 Sep 25;644:123355. doi: 10.1016/j.ijpharm.2023.123355. Epub 2023 Aug 28.
The pharmaceutical industry has traditionally manufactured medicines in a limited range of dose strengths, with an emphasis on addressing the needs of the largest patient subgroups. This has disadvantaged smaller patient subsets, such as children, who often cannot find drug products in dosage levels suitable for their requirements. In recent years, development of pharmaceutical mini-tablets has emerged as an attractive solution to this problem. These are small-size dosages that offer attractive features such as flexible and personalized drug dosing, ease of swallowing, and tailored drug release, making them an excellent choice for administering medicines to children. This study presents a novel technique for manufacturing pharmaceutical mini-tablets, using a drop-on-demand (DoD) printing system. In this method, a DoD system is used to generate precise droplets of a melt-based formulation, which are then captured and solidified in an inert solvent bath to produce individual mini-tablets. The study also evaluates the performance of this technique for various formulations, and quantifies two critical quality attributes (CQAs) of the resulting mini-tablets: content uniformity and dissolution behavior. The findings demonstrate that the manufactured mini-tablets can meet regulatory specifications for both CQAs, and that their release profiles can be customized by modifying the excipients used. The study also discusses promising areas of application and limitations of this technique.
制药行业传统上生产的药物剂量强度有限，重点是满足最大的患者亚群的需求。这使得较小的患者亚群处于不利地位，例如儿童，他们往往找不到适合其需求的剂量水平的药物产品。近年来，药物微型片剂的开发已成为解决这一问题的一种有吸引力的方法。这些是小剂量的药物，具有灵活和个性化的药物剂量、易于吞咽以及定制的药物释放等吸引人的特点，是为儿童给药的绝佳选择。本研究提出了一种使用按需滴注（DoD）打印系统制造药物微型片剂的新技术。在该方法中，使用 DoD 系统生成基于熔融物的制剂的精确液滴，然后将其捕获并在惰性溶剂浴中固化，以生产单个微型片剂。该研究还评估了该技术对各种制剂的性能，并量化了所得到的微型片剂的两个关键质量属性（CQAs）：含量均匀度和溶解行为。研究结果表明，所制造的微型片剂可以满足两个 CQAs 的监管规范，并且可以通过修改所用的赋形剂来定制其释放曲线。该研究还讨论了该技术的有前途的应用领域和局限性。
