Regenerative dermal filler with tunable properties for cosmetic applications

• Grant number: 20/01428-8
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Duration: October 01, 2020 - February 28, 2023
• Field of knowledge: Interdisciplinary Subjects
• Convênio/Acordo: National Research Council of Canada
• Principal Investigator: Hélida Gomes de Oliveira Barud
• Grantee: Hélida Gomes de Oliveira Barud
• Host Company: Biosmart Nanotechnology Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: Araraquara
• Associated researchers: Clovis Augusto Ribeiro ; Marisa Masumi Beppu
• Associated scholarship(s): 20/13356-1 - Regenerative dermal filler with tunable properties for cosmetic applications, BP.TT

Abstract

Dermal fillers for cosmetic and reconstructive applications are estimated to have a global market value of over 22.5 billion US dollars by 2024 and are currently increasing at Compound Annual Growth Rate (CAGR) of 26.5%. Although both the market and number of procedures these materials are used in is incredibly broad, the number of types of dermal fillers on the market is currently limited to only a few technologies, each possessing significant limitations. Current dermal fillers are primarily based on collagen and/or hyaluronic acid gels cross-linked using various agents to slow diffusion and create bulk as well as diluents (surfactants/solvents) to aid in flow for application. Both the crosslinking agents and diluents have varying degrees of toxicity and can induce localized inflammation. Furthermore, improper crosslinking can result in a filler that is either too rigid or diffuses away too rapidly, reducing the outcome of the procedure. The aim of this project is to design the next generation of innovative dermal fillers with tunable behavior and degradation properties to be used in cosmetic applications and tissue augmentation. To accomplish this, a novel high-adherent, localized hydrogel will be formulated by the addition of Cohesys bioadhesive polymer as the localizing compound and novel crosslinking agent and BioSmart Nanotechnology bacterial cellulose, which will act regenerative scaffold and bulk, to hyaluronic acid (HA, one commercial and one produced by BioSmart Nano). Both Cohesys bioadhesive polymer and BioSmart Nano bacterial cellulose will be incorporated into HA in low and high rates. Sixteen dermal fillers with low, high and very high crosslinking rates, from different current and well consolidated brands presenting great market acceptance will be used as controls because of their approving for use in humans in terms of properties and also regulations laws. Resultant products will be characterized by a series of in vitro and in vivo studies. Structural morphology, elemental chemical composition, molecular structure characteristic, thermodynamic and viscoelastic behaviors, tissue support, swelling, injectability, enzymatic degeneration rates, cyto, genus and mutagenicity will be tested in vitro. In vivo study includes validation of tissue response, degradation rate and biological safety of novel hydrogels. At the end of this 24-months project, it is expected to obtain a patent versatile hydrogel with properties comparable to commercial products in the market, which will then be prototyped for submission to regulatory agencies in USA, Canada and Brazil. We expect the product to start commercialization in the cited markets approximately three years following formulation design lock. (AU)