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

该I-Corps项目更广泛的影响/商业潜力是开发粉末压实模型，该模型从数学上描述了压缩过程中发生的复杂致密化过程。 目前，在药物片剂制剂开发中，传统策略可能缓慢且昂贵，并且产品质量在扩大规模时并不总是得到保证。 所提出的技术旨在通过提供粉末可压缩性模型和表征粉末机械性能的方法来解决这些问题。 这可用于提取更多信息，将表征时间从数小时缩短到数分钟，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工艺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、清洁剂片剂生产以及土壤科学和岩土工程中的建筑。I-Corps项目是基于开发一种添加剂粉末压缩性模型，该模型将现有的几种材料科学模型统一起来，以表征粉末压缩性。 所提出的模型进行了评估，使用具有高度不同的机械性能的材料。全面的表征使用模内测量对复杂的粉末压制过程进行解卷积，从而对重要的材料特性进行快速、准确和节省材料的表征，从而为配方决策提供信息。这些机械性能（如塑性和弹性）的解卷积允许对材料进行更内在的理解，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。 建议的粉末压缩表征方法和分析可用于捕获更准确和更详细的信息，只需几十毫克的材料和几秒钟的收集。该奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.