Understanding Interplay Between Dosage, Efficacy and Toxicity for Patent Protected Retinol Nano-micellar Formulations Inducing Enhanced Collagen Regeneration - VitAqua (TM)

该项目输出专家分析和测量数据，以优化下一代配方中的成分水平，用于局部递送皮肤恢复中的生物活性物质。需要NPL专家的专业知识、知识和能力来应对公司的挑战，并将显著提高公司的生产力和竞争力，将具有经过验证的功效的化妆品监管产品推向市场，并支持深入的再生数据（在这个市场上是新颖的）。为了改善化妆品（以及未来的再生医学应用）的声明支持，了解和量化作用部位（例如组织或细胞）的生物活性水平及其与配方活性剂量的关系至关重要。这对于理解具有不利影响的级别，支持法规文档和要求也很重要。我们的输送技术的所有组成部分的完整活性和安全性概况将建立知识，以优化健康皮肤和组织细胞更新的产品。此前，该公司已经证明了皮肤模型与UoS的配方渗透。这些研究表明，植物药胶束生物活性传递技术是一种成功、高效的渗透和传递生物活性的技术。然而，技术和设备的限制很快就达到了，即使有卓越的学术成就，所获得的结果也不足以证明配方剂量、构成和功效之间的可重复性和可利用的相关性。为了生成高精度和高含量的验证数据集，该公司应用了通过A4I提供的国家物理实验室计量专业知识。这项工作建立在NPL在M4R方案下进行的一项试点研究的基础上，该研究更准确地展示了配方的皮肤渗透，并提高了我们对皮肤中生物活性分布、配方稳定性以及配方过程和储存中产生的降解物的理解。这是对产品开发的重要贡献，促使需要更广泛的验证，证明配方性能，在化妆品法规文件可以准备之前。初步结果还表明，生物活性物质不会进入全身血液，而是留在有利于胶原蛋白健康更新的地方——皮肤中；知识在监管框架中很重要，在监管框架中，潜在的化妆品可以被定义为一种药物，并带来所有问题。通过第二个M4i项目ref10550，国家物理实验室已经制作了一份关于可用单元模型方法的审查文件，可以考虑解决该应用问题的各个方面。该项目告知但不包括下一阶段的实验工作。

The project outputs expert analytical and measurement data to optimise the levels of components in next-generation formulations for topical delivery of bio-actives in skin recovery. NPL specialist expertise, knowledge and capabilities are required to address the company challenge and will significantly boost the company's productivity and competitiveness for taking to market cosmetic regulated products with proven efficacy supported with in-depth regenerative data (novel in this market).To improve claims support for a cosmetic product (and future regenerative medicine applications), understanding and quantification of bio-active levels at the site of action, (e.g. tissues or cells), and their relationship to the dose of the formulated active is crucial. This is also important for understanding levels that have an adverse-affect, supporting regulatory documentation and requirements. A full activity and safety profile of all the components of our delivery technology will build the knowledge to optimise the product for healthy skin and tissue cell renewal.Previously, the company have demonstrated skin model penetration of the formulation with the UoS. These studies demonstrated that Phytoceutical micellar bioactive delivery technology is penetrating and delivering bio-actives successfully and efficiently. However, limits on techniques and equipment were quickly reached and, even with the academic excellence available, the obtained results were not conclusive enough to demonstrate reproducibility and exploitable correlations between formulation doses, constitution and efficacy.To generate high-accuracy and high-content validation datasets, the company applies to NPL metrology expertise made available via A4I. The work builds upon a pilot study performed by NPL under an M4R scheme, which demonstrated more accurately the skin penetration of formulations and advanced our understanding of both the bioactive distribution in the skin, the formulation stability and also degradants generated in the formulation process and under storage.This is an important contribution for product exploitation which prompted the need for more extensive validation, demonstrating formulation performance, before cosmetic regulatory documentation can be prepared. Preliminary results have also shown bio-actives do not pass systemically into the blood but remain where it can benefit collagen healthy renewal - in the skin; knowledge important in regulatory frameworks where a potential cosmetic product can be defined to be a medicine with all the issues that brings. Through a second M4i project, ref10550, NPL have produced a review document on the available cell model approaches that could be considered to solve aspects of this applications problem. This project informed but did not include the next stage experimental work.