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Framework for Rational Amorphous API Development

Rational 非晶 API 开发框架

基本信息

批准号：
2890494
负责人：
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-2890494
关键词：
Framework Rational Amorphous API Development

项目摘要

In this project the amorphous generation landscape will be explored by determining the impact of molecular structure, process history and impurities on the local structure, stability, and performance of relevant API compounds.To understand how different processing routes can favour desirable outcomes, the influence of processing and isolation routes on the ease of amorphous solid formation and stability will be investigated.The project will focus on key objectives including:1. Selection of initial API candidates to study.2. Take each API through a selected processing chain to include crystallisation, spray drying, melt quenching, ASD formulation.3. Explore the isolation and drying stages following amorphous solids generation to determine their impact on the final API stability and develop new strategies for optimising them (focus on understanding the impact of dynamic drying profiles with respect to Tg and on solvent plasticisation).4. Samples will be characterised using relevant techniques including optical, thermal, spectroscopic, diffraction/scattering and/or mechanical tests to identify consistency or variability in amorphous sample structure as a function of the processing route. Samples will also be subjected to stress//accelerated stability conditions to assess physical stability and changes/re-crystallisation as a function of key stress conditions (such as T, %RH, aqueous environments and mechanical).

在本项目中，将通过确定分子结构、工艺历史和杂质对相关API化合物的局部结构、稳定性和性能的影响来探索无定形生成景观。为了了解不同的工艺路线如何有利于获得理想的结果，将研究加工和分离路线对非晶固体形成的难易程度和稳定性的影响。该项目将集中于关键的目标包括：1.选择最初的API候选人进行研究。将每种API通过选定的加工链，包括结晶，喷雾干燥，熔融淬火，ASD配制。3.探索无定形固体生成后的分离和干燥阶段，以确定其对最终API稳定性的影响，并开发优化它们的新策略（重点了解动态干燥曲线对Tg和溶剂塑化的影响）。4.将使用相关技术（包括光学、热、光谱、衍射/散射和/或机械测试）对样品进行表征，以确定无定形样品结构的一致性或可变性（作为处理路线的函数）。还将对样品进行强制降解//加速稳定性条件处理，以评估物理稳定性和变化/重结晶（作为关键强制降解条件（如T、%RH、水性环境和机械）的函数）。