Department of Chemical & Biotechnological Engineering, Pfizer Industrial Research Chair, Université de Sherbrooke, 2500 boulevard de l'Université, Sherbrooke, Québec, Canada J1K 2R1.
Manufacturing Process Analytics and Control, Pfizer Global Supply, 1025 boulevard Marcel-Laurin, Saint-Laurent, Québec, Canada H4R 1J6.
Talanta. 2019 Apr 1;195:87-96. doi: 10.1016/j.talanta.2018.11.034. Epub 2018 Nov 13.
Near infrared spectroscopy (NIRS) used as process analytical technology tool to monitor Active Pharmaceutical Ingredient concentrations during tablet manufacturing has been reported to enhance overall product quality assurance. NIRS applications in different manufacturing stages are facilitated by their ability to handle different sample presentations - be it solids, liquids, gels or powders. The present study evaluates NIRS suitability for monitoring Ibuprofen concentrations (coated pellets form) inside the feed frame of a tableting press as well as in output tablets. Process monitoring was undertaken with quantitative chemometric analysis. NIRS-based predictions of concentrations both inside the feed frame and in tablets were compared to ultraviolet (UV) spectroscopy assays of temporally stratified tablet samples. Process dynamics were also compared in terms of concurrent concentrations change kinetics in the feed frame and in output tablets. NIRS showed good sensitivity to Ibuprofen concentrations despite the use of coated pellets. Ibuprofen contents as low as 1.7% w/w were detected effectively. NIRS-based quantitative predictions in the feed frame and in tablets closely matched the UV assay values of sampled tablets. As anticipated from the 2-wheel feed frame geometry, upon the addition of each consecutive blend, results show that the predicted concentration inside the feed frame were delayed compared with that of the tablets exiting the tablet press. For these tests, the delay was estimated to be 1.25 min. This finding highlights the importance of NIRS probe position inside the feed frame as a function of its geometry. Successive feed frame and tablet monitoring by NIRS could prove beneficial for real time release testing of tablet formulations.
近红外光谱（NIRS）被用作过程分析技术工具，用于监测片剂制造过程中的活性药物成分浓度，以提高整体产品质量保证。NIRS 在不同制造阶段的应用得益于其处理不同样品呈现方式的能力——无论是固体、液体、凝胶还是粉末。本研究评估了 NIRS 用于监测压片机进料框架内布洛芬浓度（包衣丸形式）以及片剂中布洛芬浓度的适用性。过程监测采用定量化学计量分析进行。将进料框架内和片剂中的 NIRS 基于浓度的预测与紫外线（UV）光谱法对分层片剂样品的时间分析进行了比较。还比较了进料框架和片剂中同时发生的浓度变化动力学的过程动力学。尽管使用了包衣丸，NIRS 对布洛芬浓度仍具有良好的灵敏度。有效检测到低至 1.7%w/w 的布洛芬含量。进料框架和片剂中的 NIRS 基于定量的预测与采样片剂的 UV 测定值非常匹配。从 2 轮进料框架的几何形状可以预期，每次添加连续的混合物时，结果表明，进料框架内预测的浓度与片剂压出机的浓度相比存在延迟。对于这些测试，延迟估计为 1.25 分钟。这一发现突出了 NIRS 探头在进料框架内位置的重要性，这取决于其几何形状。通过 NIRS 对进料框架和片剂进行连续监测，可能有助于实时释放测试片剂配方。
