Manufacture of tablets with structurally-controlled drug release using rapid tooling injection moulding.
Manufacture of tablets with structurally-controlled drug release using rapid tooling injection moulding.
复制标题
使用快速模具注射成型制造结构控制药物释放的片剂。
DOI：
10.1016/j.ijpharm.2022.121956
复制
发表时间：
2022
影响因子：
5.8
通讯作者：
Walsh E
中科院分区：
文献类型：
--
作者：
Walsh E
随着制药行业的进步推动更多的定制药物，片剂制造的新方法需求量很大。微规模批量生产的主要驱动力之一是微调药物释放的能力。本研究证明了使用快速模具注射成型（RTIM）的片剂生产。生产的片剂具有不同的结构特征，以改变表面积，同时保持相同的体积，从而产生不同的比表面积（SSA）。基于11种聚合物制剂评价该技术的精密度，其中片剂显示< 2%的质量变异性。在三种不同的基于聚合物的制剂中生产含有对乙酰氨基酚的其他片剂，以研究SSA对药物释放的影响。在基于聚合物聚乙烯醇（PVA）和Klucel ELF的制剂之间观察到显著差异。发现制剂的聚合物基质对药物释放曲线对SSA修饰的敏感性至关重要。通过添加结构特征以增加SSA来修改每种制剂内的药物释放曲线。
With advancements in the pharmaceutical industry pushing more towards tailored medicines, novel approaches to tablet manufacture are in high demand. One of the main drivers towards micro-scale batch production is the ability to fine-tune drug release. This study demonstrates the use of rapid tooling injection moulding (RTIM) for tablet manufacture. Tablets were manufactured with varying structural features to alter the surface area whilst maintaining the same volume, resulting in differing specific surface area (SSA). The precision of this technique is evaluated based on eleven polymer formulations, with the tablets displaying < 2% variability in mass. Further tablets were produced containing paracetamol in three different polymer-based formulations to investigate the impact of SSA on the drug release. Significant differences were observed between the formulations based on the polymers polyvinyl alcohol (PVA) and Klucel ELF. The polymer base of the formulation was found to be critical to the sensitivity of the drug release profile to SSA modification. The drug release profile within each formulation was modified by the addition of structural features to increase the SSA.