Prediction of Sticking Potential for Continuous Direct Compression

连续直接压缩粘着潜力的预测

• 批准号: 2891745
• 金额: --
• 依托单位: University of Strathclyde
• 依托单位国家: 英国
• 项目类别: Studentship
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=studentship-2891745
• 关键词: Prediction; Sticking; Potential; Continuous; Direct

An increasing number of drugs in development are hydrophobic and considered as BCS class 2 compounds. In many cases these drugs require aggressive pre-processing to reduce particle size and accelerate the dissolution of these compounds. The reduction in particle size causes even more hydrophobic surfaces of the drug particles which magnifies sticking issues. Sticking occurs more frequently in direct compression as the drug is not embedded within a granulation matrix. Considering that the industry is growing the use of continuous direct compression (CDC), a fundamental understanding of the underlying mechanisms of sticking becomes even more important. Typically, sticking is not observed until later stages of development where any alterations in the formulation or manufacturing route causes a large penalty of change. This project aims to increase the understanding of the underlying sticking mechanisms enabling the early detection of sticking. This will be addressed by using complementary advanced characterisation techniques with a focus on understanding the impact of particle size (drug and diluent) [3] of various hydrophobic compounds and lubrication on sticking propensity. The project will deliver a workflow to identify sticking at an early stage in the development and reduce the risk of sticking in CDC.

越来越多的开发中的药物是疏水性的，被认为是BCS 2类化合物。在许多情况下，这些药物需要积极的预处理，以减少粒度和加速这些化合物的溶解。粒径的减小导致药物颗粒的疏水性更强，这放大了粘附问题。粘附在直接压片中更频繁地发生，因为药物未包埋在颗粒基质中。考虑到该行业越来越多地使用连续直接压缩（CDC），对粘附的潜在机制的基本理解变得更加重要。通常情况下，直到开发后期才观察到粘附，此时配方或生产路线的任何变更都会导致较大的变更损失。该项目旨在提高对潜在卡钻机制的理解，从而能够早期发现卡钻。这将通过使用补充的高级表征技术来解决，重点是了解各种疏水化合物的粒度（药物和稀释剂）[3]和润滑对粘附倾向的影响。该项目将提供一个工作流程，以在开发的早期阶段识别卡滞，并降低CDC卡滞的风险。