Tablet and Particle Attrition in Pharmaceutical Processes

制药过程中的片剂和颗粒磨损

• 批准号: 0625792
• 负责人: Carl Wassgren
• 金额: --
• 依托单位: Purdue University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-10-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0625792&HistoricalAwards=false
• 关键词: Tablet; Particle; Attrition; Pharmaceutical; Processes

National Science Foundation - Division of Chemical &Transport Systems - Particulate & Multiphase Processes Program (1415)ABSTRACTProposal Number: 0625792Principal Investigator: Wassgren, Carl R.Affiliation: Purdue UniversityProposal Title: Tablet and Particle Attrition in Pharmaceutical ProcessesIntellectual MeritThe proposed work will study the attrition of tablets in pharmaceutical processes, specifically the accuracy of attrition sub-models embedded within discrete element model (DEM) computer simulations for predicting pharmaceutical tablet and particle damage during blending and coating operations will be evaluated by experimental testing to better estimate the degree of attrition of pharmaceutical tablets and particles in common pharmaceutical processing operations. Additionally, recommendations will be made for how to modify material properties, such as shape and surface hardness, and operating conditions, such as blender speed and mixing element design, so that tablet and particle attrition may be minimized. These objectives will be achieved by conducting experiments and corresponding 3D soft-particle DEM simulations in which the mass loss and surface damage are recorded for tablets in a standard friability tester, tablets and particles in a rotating cylindrical drum, and tablets and particles in a pan coater and V-blender, respectively. The degree and method of attrition will be compared between the experiments and computer models to determine which attrition sub-models are most accurate at describing tablet and particle damage during common pharmaceutical processing operations.Broader ImpactsThe work outlined in this proposal will result in an improved understanding of the significant attrition mechanisms acting on particles during common unit operations found in the pharmaceutical, food, and agro-chemical industries, computational tools for designing and controlling unit operations so that attrition may be minimized, testing procedures and equipment that will accurately assess the degree of attrition for materials in common unit operations, and design modifications to equipment, operational procedures, and materials to reduce attrition damage. More broadly, this work will significantly reduce the material losses incurred due to material damage in a wide range of industries as well as reduce the health and environmental risks resulting from the formation of the dust caused by attrition. The results are also expected to benefit the mining and milling community where particle attrition is desired to reduce particle size.

国家科学基金会-化学运输系统分部-颗粒多相过程计划（1415）摘要提案编号：0625792主要研究员：Wassgren，Carl R. 普渡大学提案标题：制药过程中的片剂和颗粒磨损智力价值拟议的工作将研究制药过程中片剂的磨损，特别是嵌入离散元模型（DEM）中的磨损子模型的准确性将通过实验测试来评估用于预测混合和包衣操作期间药物片剂和颗粒损伤的计算机模拟，常见的药物加工操作中的颗粒。此外，还将对如何修改材料特性（如形状和表面硬度）和操作条件（如搅拌器速度和混合元件设计）提出建议，以便最大限度地减少片剂和颗粒磨损。这些目标将通过进行实验和相应的3D软颗粒DEM模拟来实现，其中分别记录标准脆碎度测试仪中片剂、旋转圆柱形鼓中片剂和颗粒以及锅包衣机和V型混合机中片剂和颗粒的质量损失和表面损伤。磨损的程度和方法将在实验和计算机模型之间进行比较，以确定哪些磨损子模型在描述普通制药加工操作过程中片剂和颗粒损伤时最准确。和农业化学工业，用于设计和控制单元操作以使磨损最小化的计算工具，将准确评估普通单元操作中材料磨损程度的测试程序和设备，以及对设备、操作程序和材料的设计修改以减少磨损损坏。更广泛地说，这项工作将大大减少由于各种行业的材料损坏而造成的材料损失，并减少由于磨损造成的粉尘形成而造成的健康和环境风险。这些结果也有望使采矿和研磨行业受益，因为这些行业需要颗粒磨损来降低粒度。