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

I-Corps项目更广泛的影响/商业潜力是开发粉末压实模型，该模型可以用数学方法描述压缩过程中发生的复杂致密化过程。目前，在片剂配方的开发中，传统的策略可能是缓慢和昂贵的，并且在扩大规模后产品质量并不总是得到保证。提出的技术旨在通过提供粉末压缩性模型和表征粉末力学性能的方法来解决这些问题。这可以用于提取更多的信息，将表征时间从几小时缩短到几分钟，降低设备成本，并将表征所需的粉末量减少一个数量级。这些信息可以告知负责降低过程风险和确保商业产品成功的关键决策者。此外，该技术还可以应用于其他使用粉末压实的行业，包括金属零件和化妆品制造，洗涤剂片生产以及土壤科学和岩土工程中的建筑。这个I-Corps项目是基于添加剂粉末可压缩性模型的发展，该模型结合了几种现有的材料科学模型来表征粉末可压缩性。所提出的模型已经使用具有高度不同力学性能的材料进行了评估。采用模具内测量的综合表征消除了复杂的粉末压实过程，从而快速，准确和节省材料的重要材料特性表征，可以为配方决策提供信息。这些机械性能的反卷积，如可塑性和弹性，允许对材料更内在的理解，并加强对结构和性能之间关系的理解，这对于设计产品质量至关重要。所提出的粉末压缩表征方法和分析可用于捕获更准确和详细的信息，只需数十毫克的材料和几秒钟的收集时间。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.