Center for Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou, China.
Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou, China.
Drug Dev Ind Pharm. 2020 Apr;46(4):531-538. doi: 10.1080/03639045.2020.1734018. Epub 2020 Mar 12.
Orodispersible films (ODFs) are promising drug delivery systems for customized medicines as it provide an alternative approach to increase consumer acceptance by advantages of rapid dissolution and administration without water. The aim of this study was to develop a platform to support the realization of tailored treatments suitable for the extemporaneous production of ODFs by semi-solid extrusion (SSE) 3D printing (3DP). Hydroxypropyl methyl cellulose (HPMC) was used as the polymer of ODFs, and levocetirizine hydrochloride was used as the model drug. The optimal formulation was HPMC:API:PS:maltitol:sucralose at a ratio of 64:10:10:15:1. Seventeen percent HPMC solution and optimal formulation were used to prepare film precursors. The impact of dynamic viscosities and fluid mechanics difference on printing applicability was discussed. The ODFs of cube designs with aimed dose of 1.25 mg, 2.5 mg, and 5 mg were printed by SSE 3DP. Good linear relationship between theoretical model volume and drug content ( = 0.999) and good dose accuracy indicate that 3DP is a suitable method for preparing individualized ODFs.
口溶膜（ODFs）是一种有前途的药物传递系统，适用于定制药物，因为它通过快速溶解和无需用水的给药方式提供了一种增加消费者接受度的替代方法。本研究的目的是开发一个平台，通过半固态挤出（SSE）3D 打印（3DP）来支持适合临时生产 ODFs 的定制治疗的实现。羟丙甲纤维素（HPMC）被用作 ODFs 的聚合物，左西替利嗪盐酸盐被用作模型药物。最佳配方为 HPMC:API:PS:麦芽糖醇:蔗糖，比例为 64:10:10:15:1。将 17%的 HPMC 溶液和最佳配方用于制备膜前体。讨论了动态粘度和流体力学差异对打印适用性的影响。通过 SSE 3DP 打印了设计剂量为 1.25mg、2.5mg 和 5mg 的立方体形 ODFs。理论模型体积与药物含量之间存在良好的线性关系（r=0.999）和良好的剂量准确性表明，3DP 是制备个体化 ODFs 的合适方法。
