On the Use of a Twin Screw Extruder for Continuous Solid Feeding and Dissolution for Continuous Flow Processes,Organic Process Research & Development

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On the Use of a Twin Screw Extruder for Continuous Solid Feeding and Dissolution for Continuous Flow Processes
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2018-09-14 00:00:00 , DOI: 10.1021/acs.oprd.8b00187
Arabella M. McLaughlin ₁ , John Robertson ₂ , Xiong-Wei Ni ₁

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The progress from batch to continuous manufacture of pharmaceuticals has highlighted the challenging area of dosing solid material directly, efficiently, and accurately into continuous flow systems for workup in flow chemistry processes. Twin screw extruders (TSEs) have the advantage of decoupling the dry (loss in weight feeder end) from the wet (liquid input) to prevent solids from sticking around the feeder, thereby enabling continuous solid feeding into a flow process. In this study, the feasibility of a 16 mm TSE as a solid feeder is investigated, and efficient dissolution of an example active pharmaceutical ingredient (API) is demonstrated. Paracetamol and an 80:20 mixture of water and isopropyl alcohol are the solute and solvent, respectively. The concentrations of paracetamol during dissolution experiments are monitored using an in-line UV attenuated total reflectance probe connected to a spectrometer, and the dissolution kinetics is extracted. Full dissolution of powder particles is obtained within the residence time of the TSE. However, full dissolution of granular particles is achievable by lowering the feed rate or having a higher barrel temperature. We have, for the first time, proposed a methodology of estimating the power density of a TSE, enabling a fair comparison of the dissolution rates for this continuous system and a batch stirred tank.

中文翻译：

关于使用双螺杆挤出机进行连续固体进料和溶解的连续流程

从药品的批量生产到连续生产的过程突显了将固体材料直接，高效和准确地定量添加到连续流系统中以进行流化学过程后处理的挑战性领域。双螺杆挤出机（TSE）具有将干（进料口重量损失）与湿（进液口）分离的优点，以防止固体粘附在进料口周围，从而使固体连续进料到流动过程中。在这项研究中，研究了将16 mm TSE用作固体进料器的可行性，并证明了示例活性药物成分（API）的有效溶解。扑热息痛和水与异丙醇的80:20混合物分别是溶质和溶剂。使用连接到光谱仪的在线紫外线衰减全反射探头监测溶出度试验期间对乙酰氨基酚的浓度，并提取溶出动力学。在TSE的停留时间内可以完全溶解粉末颗粒。然而，通过降低进料速率或具有较高的料筒温度，可以实现粒状颗粒的完全溶解。我们首次提出了一种估算TSE功率密度的方法，从而可以对该连续系统和间歇式搅拌釜的溶出速率进行合理的比较。通过降低进料速率或具有较高的料筒温度，可以使颗粒完全溶解。我们首次提出了一种估算TSE功率密度的方法，从而可以对该连续系统和间歇式搅拌釜的溶出速率进行合理的比较。通过降低进料速率或具有较高的料筒温度，可以使颗粒完全溶解。我们首次提出了一种估算TSE功率密度的方法，从而可以对该连续系统和间歇式搅拌釜的溶出速率进行合理的比较。

更新日期：2018-09-14

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