Production of an ophthalmic topic nanostructured solution (eye drop) batch to treat diabetic retinopathy: a new paradigm

• Grant number: 21/00979-3
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: June 01, 2022
• End date: April 30, 2023
• 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
• City: Campinas

Abstract

In this PIPE phase 1 proposal, the company VERLUX intends to acquire the inputs (high purity raw material) in sufficient quantities for the production of 750 ml of the ophthalmic solution (eye drops) with the participation of a technician from the field of nanopharmacology (TT3) in exclusive dedication, by consultant Dr. Claudia Regina and researcher Dr. Jacqueline M Lopes de Faria (responsible for the company and for the company's project). The use of the equipment will be subcontracted from the Chemical Engineering Institutes of Unicamp, USP-RP and USP-SP (Multiuser Equipment). The maturity of this technology is early, that is, it still requires essential complementary validations. But it is already prototyped and with pre-clinical tests already carried out (with promising results). This development is innovative for 3 reasons: identification of an active ingredient effective in protecting the retina from the toxic effects of diabetes, the route of "delivery" of this active ingredient to the target tissue, i.e., the retina, and finally the nano-technological basis of ophthalmic solution. This product does not have a direct competitor, since the therapeutic alternatives currently available for the treatment of diabetic retinopathy are surgical and, therefore, invasive, risky, costly and with unsatisfactory visual results. It has a patent filed with the INPI and with the granting of this proposal, it will reproduce the staggered production process of the eye drops and carry out characterization tests of the produced nanoparticles and also microbiological stability and shelf life. (AU)