Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, New Jersey, 08854, USA.
Synthetic Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, 46225, USA.
AAPS PharmSciTech. 2022 Apr 26;23(5):126. doi: 10.1208/s12249-022-02262-4.
Obtaining a homogeneous low-dose pharmaceutical powder blend without multi-step processing remains a challenge. One promising technology to address this risk is resonant acoustic mixing (RAM). In this study, the performance of a laboratory resonant acoustic mixer (LabRAM) was studied at low active pharmaceutical ingredient (API) concentrations (0.1-0.5% w/w), using three commercial grades of a model API (Acetaminophen) and diluents with varying physical properties. The performance was assessed by evaluating blend uniformity (BU) and capsule content uniformity (CU) as a function of mixing time. Overall, the LabRAM achieved acceptable BU in a single step even at 0.1% w/w drug loading. A reduction in API primary particle size led to improved mixing efficiency and uniformity. Moreover, the presence of surface cavities in the diluents used appeared to have led to improved uniformity. The results demonstrated that RAM could achieve uniform powder blends without multi-step processing, for low-dose formulations.
获得均质的低剂量药物粉末混合物而无需多步处理仍然是一个挑战。一种有前途的解决此风险的技术是共振声混合（RAM）。在这项研究中，研究了低活性药物成分（API）浓度（0.1-0.5％w / w）下实验室共振声混合器（LabRAM）的性能，使用了三种商业级别的模型 API（对乙酰氨基酚）和具有不同物理性质的稀释剂。通过评估混合时间的混合均匀度（BU）和胶囊内容物均匀度（CU）来评估性能。总体而言，LabRAM 甚至在 0.1％w / w 的药物载量下也能在单步实现可接受的 BU。API 初级粒径的减小导致混合效率和均匀度提高。此外，所用稀释剂中表面腔的存在似乎导致了均匀度的提高。结果表明，RAM 可以实现无需多步处理的低剂量配方的均匀粉末混合物。
