O'Mahoney Niamh, Chmielak Ewelina, Fitzpatrick Dara
School of Chemistry, Analytical and Biological Chemistry Research Facility (ABCRF), University College Cork, Ireland.
Eli Lilly, Dunderrow, Cork, Ireland.
Int J Pharm. 2025 Apr 15;674:125433. doi: 10.1016/j.ijpharm.2025.125433. Epub 2025 Mar 4.
Oral suspension formulations are advantageous over other drug dosage methods due to ease of administration, swallowability and taste masking. A large market exists for this particular form of drug introduction, particularly among paediatric and geriatric patients. This paper highlights a proof of concept approach to an alternative quality control test for oral suspension formulations using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS). BARDS measurements are based on reproducible changes in the compressibility of a solvent during the dispersion of a formulation, which is monitored acoustically via associated changes in the frequency of induced acoustic resonances. This study offers a new approach to tracking the loading of oral suspension formulations. Suspension formulations containing various Active Pharmaceutical Ingredients (APIs) and excipients were investigated to examine the effect of API dosage and formulation on their overall dissolution. The data shows oral suspension formulations have an intrinsic acoustic signature specific to their manufacturing and formulation composition. It was also found that the level of API present determines the acoustic response. BARDS represents a possible future surrogate for In-Process Control (IPC) testing as a Process Analytical Technology (PAT) method. It also offers an alternative approach to assessing patient compliance and for determining drug precipitation. This study represents a greener, cost-effective, and time-efficient product testing method with no requirement for organic solvents or high-end instrumentation.
口服混悬液制剂因易于给药、可吞咽性和掩味性而优于其他药物剂型。这种特殊的药物引入形式存在着巨大的市场，尤其是在儿科和老年患者中。本文重点介绍了一种使用宽带声学共振溶解光谱法（BARDS）对口服混悬液制剂进行替代质量控制测试的概念验证方法。BARDS测量基于制剂分散过程中溶剂可压缩性的可重现变化，通过诱导声共振频率的相关变化进行声学监测。本研究提供了一种跟踪口服混悬液制剂负载量的新方法。研究了含有各种活性药物成分（API）和辅料的混悬液制剂，以考察API用量和制剂对其整体溶解的影响。数据表明，口服混悬液制剂具有特定于其生产和制剂组成的固有声学特征。还发现API的含量决定了声学响应。作为一种过程分析技术（PAT）方法，BARDS代表了一种未来可能替代过程控制（IPC）测试的方法。它还提供了一种评估患者依从性和确定药物沉淀的替代方法。本研究代表了一种更环保、经济高效且省时的产品测试方法，无需有机溶剂或高端仪器。
