In silico design-space analysis of a novel tablet coating process using advanced modeling

IF 2.8 3区 工程技术 Q1 MATHEMATICS, INTERDISCIPLINARY APPLICATIONS
Peter Boehling, Dalibor Jajcevic, Frederik Detobel, James Holman, Laura Bower, Matthew Metzger, Johannes G. Khinast
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Abstract

Continuous manufacturing has been increasingly applied in the pharmaceutical industry. The advantages are a more flexible process, decreased costs, and opportunities for better quality control. However, performing experiments is still the way to go when developing a new process but most experiments offer only limited process insight. As part of its ConsiGma® continuous processing lines, GEA has developed a semi-continuous tablet coater with unique design and process mechanics. Simulations enable a deeper understanding of the process mechanics and allow the transition from an empirical process to a mechanistic understanding of the individual process units. We used simulations to improve the understanding of the ConsiGma® tablet coater through a digital multivariate design study. Our simulations demonstrate how the mechanical and material properties influence the tablet bed behavior. We tracked the effects of thermodynamic inputs on the coating quality via the tablet temperature and moisture. These results may be helpful in the future development of coating processes using limited experimental data.

Abstract Image

利用先进建模对新型片剂包衣工艺进行硅设计空间分析
连续生产已越来越多地应用于制药业。其优点是工艺更灵活、成本更低,并有机会进行更好的质量控制。然而,在开发新工艺时,进行实验仍然是一种方法,但大多数实验只能提供有限的工艺见解。作为其 ConsiGma® 连续加工生产线的一部分,GEA 开发了一种具有独特设计和工艺力学的半连续片剂包衣机。模拟可以加深对工艺机械的理解,并从经验工艺过渡到对单个工艺单元的机械理解。我们利用模拟,通过数字多元设计研究,加深了对 ConsiGma® 片剂包衣机的理解。我们的模拟演示了机械和材料特性如何影响片剂床的行为。我们通过片剂温度和水分跟踪了热力学输入对包衣质量的影响。这些结果可能有助于今后利用有限的实验数据开发包衣工艺。
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来源期刊
Computational Particle Mechanics
Computational Particle Mechanics Mathematics-Computational Mathematics
CiteScore
5.70
自引率
9.10%
发文量
75
期刊介绍: GENERAL OBJECTIVES: Computational Particle Mechanics (CPM) is a quarterly journal with the goal of publishing full-length original articles addressing the modeling and simulation of systems involving particles and particle methods. The goal is to enhance communication among researchers in the applied sciences who use "particles'''' in one form or another in their research. SPECIFIC OBJECTIVES: Particle-based materials and numerical methods have become wide-spread in the natural and applied sciences, engineering, biology. The term "particle methods/mechanics'''' has now come to imply several different things to researchers in the 21st century, including: (a) Particles as a physical unit in granular media, particulate flows, plasmas, swarms, etc., (b) Particles representing material phases in continua at the meso-, micro-and nano-scale and (c) Particles as a discretization unit in continua and discontinua in numerical methods such as Discrete Element Methods (DEM), Particle Finite Element Methods (PFEM), Molecular Dynamics (MD), and Smoothed Particle Hydrodynamics (SPH), to name a few.
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