Co-Processing of Amorphous Solid Dispersions via Co-precipitation

通过共沉淀共处理非晶固体分散体

• 批准号: 2890503
• 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-2890503
• 关键词: Co; Processing; Amorphous; Solid; Dispersions

Overarching scopeTo prepare drug forms in the amorphous state to increase bioavailability, improve dissolution, flowability and stability for continuous manufacturing via anti-solvent co-precipitation. Why? Amorphous pharmaceuticals are more soluble in the body than crystalline forms. Industry interest in amorphous drug forms allows for the co-precipitation method to be utilised. Co-precipitation reduces the chances of API destruction which is more common in HME and spray drying where high temperatures are used. How?Initially, scoping out the instrumentation by benchmarking against a model crystalline system will allow for an understanding of the behavior of the system. Mixing speeds, sheer rates, temperatures, flow rates, different solvents will be used to test the reproducibility, accuracy, and precision of the equipment. This data will be used to expand to a well-studied polymer. After initial testing a well understood polymer-API system will be realised. This will allow the ability to move on to other polymer-API systems that are not yet realised. At all stages, processed materials will be characterised via XRPD, DSC, particle sizers, electron microscopy (solid state, physical properties). FinallyCo-amorphous system prediction, using data from DDMAP work packages 1-3 we can predict optimal process/composition selection for manufacture of stable ASDs.

总体上的Scopeto在非晶态状态下准备药物形式，以增加生物利用度，改善溶解度，流动性和稳定性，以通过抗溶剂共同进行连续制造。为什么？与晶体形式相比，无定形药物在体内更可溶。行业对无定形药物形式的兴趣允许使用共同沉积方法。共沉淀减少了API破坏的机会，而API破坏的机会在使用高温的HME和喷雾干燥中更为常见。最初，如何通过对模型晶体系统进行基准测试来范围范围，将允许了解系统的行为。混合速度，透明速率，温度，流速，不同的溶剂将用于测试设备的可重复性，准确性和精度。这些数据将用于扩展到研究良好的聚合物。初始测试后，将实现知识良好的聚合物API系统。这将使能够继续进入尚未实现的其他聚合物API系统。在各个阶段，将通过XRPD，DSC，粒子片，电子显微镜（固态，物理特性）来表征加工的材料。最后，使用DDMAP工作包中的数据1-3，我们可以预测稳定ASD的制造的最佳过程/组成选择。