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

了解诱导增强胶原再生的专利保护视黄醇纳米胶束配方的剂量、功效和毒性之间的相互作用 - VitAqua (TM)

• 批准号: 10039828
• 金额: $ 1.83万
• 依托单位: PHYTOCEUTICAL LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10039828
• 关键词: Understanding; Interplay; Between; Dosage; Efficacy

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.

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，用于皮肤修复中局部递送生物活性物质。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，以便将具有经验证功效并得到深入再生数据支持的化妆品监管产品推向市场为了改善化妆品的声明支持，（以及未来的再生医学应用），了解和量化作用部位的生物活性水平，（例如，组织或细胞），并且它们与配制的活性物质的剂量的关系是至关重要的。这对于理解具有不良影响的水平、支持监管文件和要求也很重要。我们的输送技术的所有组件的完整活性和安全性概况将建立知识，以优化产品，促进健康皮肤和组织细胞更新。此前，该公司已经证明了UoS制剂的皮肤模型渗透。这些研究表明，Phytoceutical胶束生物活性传递技术是成功和有效地渗透和传递生物活性物质。然而，技术和设备的限制很快就达到了，即使拥有卓越的学术成就，所获得的结果也不足以证明配方剂量、组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内容的验证数据集，该公司应用了通过A4 I提供的NPL计量专业知识。这项工作建立在NPL根据M4 R方案进行的中试研究的基础上，该研究更准确地证明了制剂的皮肤渗透性，并加深了我们对皮肤中生物活性分布、制剂稳定性以及制剂过程和储存过程中产生的降解产物的理解。这对产品开发做出了重要贡献，促使需要进行更广泛的验证。证明配方性能，然后才能准备化妆品监管文件。初步结果还表明，生物活性物质不会全身进入血液，而是留在有利于胶原蛋白健康更新的地方-皮肤中;在监管框架中，潜在的化妆品产品可以被定义为具有所有问题的药物。通过第二个M4 i项目（参考10550），NPL已经制作了一份关于可用单元模型方法的审查文件，这些方法可以被考虑用于解决该应用问题的各个方面。该项目通知，但不包括下一阶段的实验工作。