DEVELOPMENT OF A CONTINUOUS FLOW PROCESS FOR PRODUCING A HIGH POTENCY ESTROGEN.

• Grant number: 24/08766-7
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: December 01, 2024
• End date: August 31, 2025
• Field of knowledge: Physical Sciences and Mathematics - Chemistry - Organic Chemistry
• Principal Investigator: Carlos Eduardo da Costa Touzarim
• Grantee: Carlos Eduardo da Costa Touzarim
• Company: Fluxofarma Pesquisa e Desenvolvimento Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: São Paulo
• Associated scholarship(s): 24/23552-3 - Ketosteroids reduction to hydroxysteroids by continuous flow using NaBH4, BP.TT; 24/20012-8 - Development of a continuous flow process for producing a high potency estrogen, BP.PIPE

Abstract

Among the steroid hormones, estrone derivatives stand out. They are widely used in formulations of contraceptive drugs and hormone regulators, in addition to their use in livestock farming for stimulating heat and synchronizing the fertile period of animals. The most relevant bioactive estrogen derived from estrone is Estradiol. It is currently categorized as a high-potency, high-value-added drug, and its production is considered to be of high occupational risk. To date, all of its industrial production has been carried out in batches. In this context, the main objective of this project is to develop a continuous flow process for the production of Estradiol via a process based on reduction reactions. The aim is to combine the advantages inherent to organic synthesis in flow, such as better heat and mass transfer rates, increased productivity due to reduced downtime, and increased operational safety by minimizing reagent and product handling operations. The objective of this proposal is also to characterize the drug obtained following the quality guidelines required by the American Pharmacopoeia (USP) and RDC 166 (ANVISA) and to validate the production process following the standards/requirements of Good Manufacturing Practices (GMP) in pharmaceutical chemistry, in addition to the quality assurance requirements of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and RDC 166 (ANVISA). (AU)