Development of organic, vegan and self-preserving dermocosmetic formulation for the treatment of skin dysfunctions such as acne and rosacea with minimization of side-effects

Abstract

The cosmetic market has rapidly evolved towards bringing more technologies and ingredients capable of delivering more results. In this evolution, came up the dermocosmetics, which are cosmetics containing active ingredients available in medications although in lower concentrations, being able to communicate aggressive claims about their efficacy, demanding clinical studies to prove this promised efficacy.Although there are cosmetics and dermocosmetics on the market that claim to improve and even treat acne and rosacea, these products have ingredients that have a high potential to cause side-effects. On the other hand, organic/natural cosmetics currently available on the market do not propose to improve these two skin problems concomitantly with great efficacy, as they do not use actives/ingredients that are compatible with skin that is susceptible to both conditions. Faced with this challenge, it was proposed to develop an organic, vegan and self-preserving dermocosmetic specially formulated for acne and sensitized/rosacea skin. After successfully work on the phase 1 of this project, the proof of concept of the dermocosmetic was developed and validated, and its excellent efficacy, safety and stability were proven.In order to transform the dermocosmetic formulation validated in phase 1 (prototype) into a final product that can reach the projected market by 2023, we will continue the development of the product, now working on the scale-up of the final formulation obtained during the PIPE phase 1 so that its process is validated on a large scale and in compliance with good manufacturing practices. In this context, we will optimize the formulation process by defining process parameters (critical and non-critical) and quality attributes, perform formulation scaling, monitor data through process performance indicators, and adjust processe's units of operations when necessary for suitability in industrial production. Additionally, it is necessary to validate that the efficacy, safety and stability after the scaling remain as the prototype obtained, so that the scaling can be considered successful. Finally, it is necessary to develop the appropriate packaging for the product, through packaging compatibility studies. These are, therefore, the goals of this project, and with the completion of all these steps we will be able to transfer the process to production by third parties and offer an effective, safe, stable, scalable final product.Keyword: Acne, Rosacea, Dermocosmetic, process escalation, efficacy and safety. (AU)