I-Corps: Accelerated, materials sparing powder compaction characterization for improved pharmaceutical tablet formulation design

这个i-Corps项目的更广泛的影响/商业潜力是开发一种粉末压制模型，该模型在数学上描述了压缩过程中发生的复杂致密化过程。目前，在药物片剂配方开发中，传统策略可能会缓慢且昂贵，而且产品质量在扩大规模后并不总是得到保证。所提出的技术旨在通过提供表征粉末机械性能的粉末压缩模型和方法来解决这些问题。这可以用来提取更多的信息，将表征时间从几小时减少到几分钟，降低设备成本，并将表征所需的粉末数量减少一个数量级。这些信息可能会为负责降低流程风险和确保商业产品成功的关键决策者提供信息。此外，这项技术还可以应用于其他使用粉末压制的行业，包括金属零件和化妆品制造、洗涤剂片剂生产以及土壤科学和岩土工程中的建筑。这项i-Corps项目基于添加剂粉末压缩模型的开发，该模型统一了几个现有的材料科学模型来表征粉末压缩。所提出的模型已经使用具有高度不同机械性能的材料进行了评估。全面的表征使用模内测量来解开复杂的粉末压制过程，从而快速、准确且节省材料地表征重要的材料特性，从而为配方决策提供依据。这些机械性能的反卷积，如塑性和弹性，允许对材料的更内在的理解，并加强对结构和性能之间关系的理解，这对于将质量设计成产品是必不可少的。建议的粉末压缩表征方法和分析可以用来获取更准确和详细的信息，只需几十毫克的材料和几秒钟的收集时间。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of a powder compaction model that describes mathematically the complex densification process that occurs during compression. Currently, in pharmaceutical tablet formulation development, traditional strategies can be slow and expensive, and product quality is not always guaranteed upon scale-up. The proposed technology is designed to address these problems by providing a powder compressibility model and method for characterizing powder mechanical properties. This may be used to extract more information, lower characterization time from hours to minutes, reduce equipment costs, and reduce the amount of powder required for characterization by an order of magnitude. This information may inform key decision makers responsible for derisking the process and ensuring commercial product success. In addition, this technology may be applied to other industries that use powder compaction including metal part and cosmetic manufacturing, detergent tablet production, and construction in soil sciences and geotechnical engineering.This I-Corps project is based on the development of an additive powder compressibility model that unifies several existing materials science models to characterize powder compressibility. The proposed model has been evaluated using materials with highly diverse mechanical properties. The comprehensive characterization deconvolutes the complex powder compaction process using in-die measurements, resulting in a fast, accurate, and materials-sparing characterization of important material properties that may inform formulation decisions. Deconvolution of these mechanical properties, such as plasticity and elasticity, allows for a more intrinsic understanding of the material and strengthens the understanding of the relationship between structure and property, which is essential for designing quality into a product. The proposed powder compression characterization method and analysis may be used to capture more accurate and detailed information using only tens of milligrams of material and seconds to collect.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.