Development of a formulation for dermatological application in tissue remodeling and healing

• Grant number: 22/10257-8
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: January 01, 2023
• End date: March 31, 2025
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Tainah Colombo Gomes
• Grantee: Tainah Colombo Gomes
• Company: Biotechno Science Farmacêutica
• CNAE: Comércio varejista de cosméticos, produtos de perfumaria e de higiene pessoal ; Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: São Paulo
• Associated researchers: Ana Olívia de Souza ; Durvanei Augusto Maria
• Associated research grant: 20/09777-1 - Development of formulation with wound healing property and tissue remodeling, AP.PIPE
• Associated scholarship(s): 23/04862-9 - Training in cell culture, preparation of dermatological formulations, extraction and purification of organic compounds., BP.TT; 23/01119-3 - Development of formulation for application dermatology in tissue remodeling and healing, BP.PIPE

Abstract

Microorganisms are important sources of molecules, many of which have already been described with application in the pharmaceutical field. The fungus Exserohilum rostratum isolated from an endemic plant of the Caatinga produces the secondary metabolite annularin I. This secondary metabolite in vitro studies promoted the proliferation of endothelial cells and human fibroblasts and showed a moderate antimicrobial action. An in vivo study showed that cream formulations carrying this compound were effective in wound healing in a murine model with excellent action in tissue remodeling and regeneration, with significant collagen production and absence of keloids. Pre-clinical trials carried out with the support of FAPESP for the PIPE phase 1 project showed that the formulation is safe and does not cause inflammatory or toxic changes, deposition in the dermis, hypersensitization and/or cellular degeneration, either at the site of application or systemic effect. As the objective of continuing the "Development of a formulation for dermatological application in tissue remodeling and healing" in this proposal, analyzes will be carried out to study the accelerated stability of the formulation and in vitro skin irritation test, and in vivo tests to evaluate oral toxicity, toxicokinetics and mutagenicity. Additionally, a study to optimize the process of obtaining the active ingredient will be conducted, in order to increase its production at least on a pilot scale. The tests will follow the Organization for Economic Cooperation and Development (OECD) protocols and the Agência Nacional de Vigilância Sanitária (ANVISA) standards for registration of a grade 2 dermatological product for topical use, for tissue repair and remodeling in wound healing. (AU)