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

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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.