Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576104, Karnataka State, India.
STEERLife, Steer Engineering Pvt Ltd, No. 290, 4th Main Road, Ganapathy Nagar, Phase 3, Peenya Industrial Area, Peenya, Bangalore, 560058, Karnataka State, India.
AAPS PharmSciTech. 2021 Dec 14;23(1):24. doi: 10.1208/s12249-021-02173-w.
In order to be at pace with the market requirements of solid dosage forms and regulatory standards, a transformation towards systematic processing using continuous manufacturing (CM) and automated model-based control is being thought through for its fundamental advantages over conventional batch manufacturing. CM eliminates the key gaps through the integration of various processes while preserving quality attributes via the use of process analytical technology (PAT). The twin screw extruder (TSE) is one such equipment adopted by the pharmaceutical industry as a substitute for the traditional batch granulation process. Various types of granulation techniques using twin screw extrusion technology have been explored in the article. Furthermore, individual components of a TSE and their conjugation with PAT tools and the advancements and applications in the field of nutraceuticals and nanotechnology have also been discussed. Thus, the future of granulation lies on the shoulders of continuous TSE, where it can be coupled with computational mathematical studies to mitigate its complications.
为了与固体制剂的市场需求和监管标准保持同步，人们正在考虑通过系统的处理方法，使用连续制造（CM）和自动化基于模型的控制来进行转变，因为其具有优于传统批处理制造的基本优势。CM 通过集成各种工艺消除了关键差距，同时通过使用过程分析技术（PAT）保留了质量属性。双螺杆挤出机（TSE）就是制药行业采用的一种设备，可替代传统的批量制粒工艺。本文探讨了使用双螺杆挤出技术的各种制粒技术。此外，还讨论了 TSE 的各个组件及其与 PAT 工具的结合以及在营养保健品和纳米技术领域的进展和应用。因此，制粒的未来取决于连续 TSE，它可以与计算数学研究相结合，以减轻其复杂性。
