The stability of solid state bio-formulations

包括生物分子在内的固体颗粒制剂的稳定性在医疗保健、食品和消费品市场中至关重要。无论产品是含有酶的清洁配方还是基于蛋白质的疗法，产品的稳定性对于有效地提供相关的保健、营养或消费者利益都是重要的。对这类产品稳定性的更好了解将有助于改善医疗保健，以及从洗衣机粉末到食品等一系列消费产品的更有效和更环保的交付。这个项目将使用一系列先进的实验技术来检验模型和真实世界蛋白质和酶的稳定性。这项工作将包括重量分析和热分析方法。特别值得关注的是水分和温度对材料性能/行为的影响，包括扩散和渗透性、平衡水分含量以及对玻璃化温度的影响。决定所选蛋白质和酶的内在稳定性的因素将在进入包含这些特定生物物种的复杂粉末混合物之前确定。在这些生物配方中，我们将寻求在受控湿度条件下使用FTIR或NIR图像来绘制材料中水分分布的光谱图。然后，这种行为将与最终的粉末性能相关联。这里将建立水分稳定性与常见粉末问题(如结块和结块)之间的关系。这些信息将允许将合理的设计原则应用于生物制剂的制备。预计与宝洁和帝国理工学院的密切关系将促进最大限度的商业开发机会，如果这种机会出现在这个项目的范围内。这反过来又使英国在这项工作计划之后对LIKE质量的改善有了最好的变化。在适当的情况下，与商业相关的知识产权将受到专利申请的保护，这些专利申请可能通过帝国理工学院的商业开发部门IC Innovation Ltd.获得许可或剥离，以符合BBSRC学生资助的标准条款。在宝洁和帝国理工学院之间进行适当的内部讨论后，科学成果将通过一系列国内和国际相关会议，如英国粒子技术论坛进行交流。在帝国理工学院，博士生通常会在这样的会议上发布一些海报，并在博士后期口头介绍他们的研究成果。这项拟议的工作旨在了解固态生物制剂的配方、工艺条件和产品稳定性之间的关键关系。

The stability of solid state particulate formulations which include bio-molecules are critical in the healthcare, food and consumer product markets. Whether the product it is an enzyme containing cleaning formulation or a protein based therapeutics, the stability of the product is important for the effective delivery of the relevant healthcare, nutritional or consumer benefits. An improved understanding of the stability of such products will support improved healthcare and as well as the more efficient and environmentally sound delivery of a range of consumer products from washing machine powders through to food products. This project will examine the stability both model and real world proteins and enzymes using a range of advanced experimental techniques. This work will include gravimetric and thermal analysis approaches. Of specific interest will be the effects of moisture and temperature on material performance/behaviour including diffusion and permeability, equilibrium moisture content as well as the impact on Tg. The factors that determine the intrinsic stability of the selected proteins and enzymes will be determined prior to moving into complex powder mixtures which incorporate these specific biologic species. In these bio-formulations we will look to map spectroscopically the moisture distribution through the materials using FTIR or NIR image under controlled moisture conditions. This behaviour will then be correlated with the final powder performance. Here the relationship between moisture stability and common powder problems such as caking and agglomeration will be established. This information will allow rational design principles to be applied to the preparation of bio-formulations. It is anticipated that the close relationship with Procter and Gamble and Imperial College will facilitate the maximum opportunity for commercial exploitation should such opportunities arise within the scope of this project. This in return allows the best possible change of improvements to the quality of like in the UK following on from this work programme. Where appropriate, commercially relevant intellectual property will be protected by patent applications, which may be licensed or spun-out through IC Innovations Ltd., the commercial exploitation arm of Imperial College in line with the standard terms for BBSRC studentship grants. Scientific results will be communicated via range of national and international relevant conferences, such as the UK Particle Technology Forum, following appropriate internal discussions between Procter and Gamble and Imperial College. It would be normal practice at Imperial College for a PhD student to give a number of posters and, in the later stages of their PhD, oral presentations, of their research results at such meetings. The proposed work is targeted at understanding the key relationship between formulation, processing conditions and product stability for solid state bio-formulations.