New strategies to treat onychomycosis: development of curcumin photosensitizing formulations

• Grant number: 15/18615-7
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: July 01, 2016
• End date: March 31, 2017
• Field of knowledge: Biological Sciences - Microbiology
• Principal Investigator: Sergio Perussi Filho
• Grantee: Sergio Perussi Filho
• Company: PDT Pharma Indústria e Comércio de Produtos Farmacêuticos Ltda. - EPP
• Principal investigators: Ana Paula da Silva
• Associated researchers: Anderson Orzari Ribeiro ; Janice Rodrigues Perussi ; Kleber Thiago de Oliveira ; Vanderlei Salvador Bagnato
• Associated research grant(s): 17/09238-0 - New strategies for onychomycosis treatment: Development of a curcumin photosensitizer based formulation and an irradiation system for the treatment of onychomycosis, AP.PIPE

Abstract

A photosensitizer formulation with curcumin derivatives presented excellent result in the treatment of onychomycosis by Photodynamic Therapy, exceeding the results obtained with conventional treatments. Based on these results, the PDT Pharma recently requested to ANVISA a permission to produce and sale this new formulation.Based on our scientific and technical knowledgement to produce curcumin photosensitizing formulations, we propose for this PIPE project the studies to develop a new formulation to be used in the treatment of onychomycosis by the procedure known as "Daylight Photodynamic Therapy ", ie, photodynamic therapy that uses the sunlight as a source of irradiation.In this procedure, the photosensitizer is excited by sunlight, eliminating the use of an LED light equipment as the source of irradiation. The development of this new formulation will provide greater sales opportunities in the market, since waive the purchase of LED equipment together.Initial results obtained by PDT Pharma demonstrated that curcumin derivatives form reactive oxygen species under sunlight excitation, showing a potential to act against the micro-organisms responsible for onychomycosis when the treated infected region is exposed to sunlight.However, to develop this new photosensitizer formulation, Pharma PDT need to study in detail the best composition (percentage of active principle curcumin) and the best type of formulation for the treatment (cream, solution, gel, etc.). Thus, some scientific and technological challenges must be overcome:PIPE project Phase 1: PDT Pharma need to study and determine the best composition for the photosensitizer formulation. In this process will produce different types of formulation (liquid, gel, cream), with different percentages of photoactive curcumin. The photodynamic efficacy (in vitro) of each formulation will be evaluated against microorganisms of onychomycosis. In trials, parameters such as incubation time and solar energy dose will be checked. In the end of the work, the best formulation produced will be identified and study in complete details to be applyed in the onychomycosis treatment.PIPE Phase 2 Project (future project): Pharma PDT nwill perform advanced studies to demonstrate the efficacy of the formulation chosen in the end of Phase 1. In this case, the best protocol to treat patients will be studied, which involves the necessity to define aspects such as the amount of formulation to be used in the treatment, the time of exposure to sunlight, the frequency of treatment, the necessity of association with drugs traditionally employed, among others. These studies are needed to register a new product in ANVISA.This new formulation is designed for home use, expanding the sales possibilities to pharmacies and other similar stores, providing a significant economic and strategic developments for the company. Also, the new treatment may promote a social impact consistent with the values and the mission of the company, providing appropriate treatment for nails and skin infections that can prevent a big and expensive treatment. (AU)