Nano particle for topical ophthalmic use (eye drops) in retinal diseases: novel biotechnological possibilities for therapeutic use

• Grant number: 24/07627-3
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: December 01, 2024
• End date: November 30, 2026
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Jacqueline Mendonça Lopes de Faria
• Grantee: Jacqueline Mendonça Lopes de Faria
• Company: J Lopes de Faria Sociedade Empresaria Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais ; Atividades de serviços de complementação diagnóstica e terapêutica
• Associated scholarship(s): 25/08708-0 - Nanoparticles for Topical Ophthalmic Use (Eye Drops) in Retinal Diseases: New Biotechnological Possibilities for Therapeutic Applications, BP.TT

Abstract

In the previous PIPE-1 project (2021/00979-3), we validated the scaled production process of a batch of nanotechnology-based eye drops for the topical pharmacological treatment (eye drops) of diabetic retinopathy. It is a formulation made up of liposomal nanometric particles incorporating the active ingredient (tempol nitroxide) (not included in the Brazilian or global pharmacopoeia) with very promising evidence in the pre-clinical studies carried out. This project was carried out at the R&D Laboratory in Pharmaceutical Processes - Faculty of Pharmaceutical Sciences of Ribeirão Preto (LAPROFAR, FCFRP/USP) coordinated by Prof. Dr. Wanderley P. Oliveira with the participation of Dr. Cláudia Regina Fernandes de Souza as technical consultant for the process through an Equipment Sharing contract with patent protection (DOC1).We obtained a batch of 1800 mL that were used for shelf stability and microbiological safety tests. This batch was tested by the ProLab® laboratory, which issued a report attesting to 100% microbiological safety (DOC2) and stability at room temperature (25° degrees C) for 18 months. These results were very important because we have an industrially scalable formulation that does not require refrigeration. Being a formulation that does not include preservatives, this information is very relevant and categorizes this nanoparticle as a potential drug delivery to the ocular interior. This project is continuing with pre-clinical testing at the Center for Pre-Clinical Studies (Pre-Clinical Nano) for new drugs at the Hospital Israelita Albert Einstein in São Paulo for studies of acute and chronic toxicity (of repeated doses) and biodistribution, with feature of FINEP's SibratecNano line.In this proposal, we intend to test the nanotechnological design of the particle developed for topical ocular application in non-invasive pharmacological treatment in the treatment of diabetic retinopathy with the following objectives:1. Does the nanoparticle (NP) that we developed and patented (DOC3) have the capacity to carry higher concentrations of the active ingredient and still cross the ocular barriers reaching the retina? If so, what is the maximum possible concentration while maintaining the physicochemical characteristics?2. Could NP carry the initial active ingredient combined with another drug into the intraocular environment?3. Verify the possible neuroprotector and antiinflamatory properties of the new designed nanoparticule through in vitro 3D assaysThese developments will improve the particle design and will be important in future clinical tests, where 2 doses are required in phase 1 and 2 clinical trails, in addition to classifying this NP as a drug delivery template for the intraocular environment in a non-invasive way. (AU)