Development of unit operation under continuous flow conditions for the production of a high potency progestógen

• Grant number: 23/09136-4
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: February 01, 2024
• End date: October 31, 2024
• Field of knowledge: Physical Sciences and Mathematics - Chemistry - Organic Chemistry
• Principal Investigator: Marcio Henrique Zaim
• Grantee: Marcio Henrique Zaim
• Company: Fluxofarma Pesquisa e Desenvolvimento Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: São Paulo
• Associated scholarship(s): 24/00780-0 - Development of unit operation under continuous flow conditions for the production of a high potency progestógen, BP.PIPE

Abstract

DSG/FLX is an orally administered bioactive synthetic progestogen, currently categorized as a high potency drug with high added value, being widely used in formulations of combined contraceptive drugs. It is known that, even with the constant updating of good manufacturing practices (GMP), the production of DSG is of high occupational risk and, until now, all of its production is carried out in batches. Therefore, the present project aims to develop a unitary operation under continuous flow conditions to obtain a DSG stereoselective precursor process using a specific lithium complex. It is intended to converge advantages inherent to flow organic synthesis, such as better heat and mass transfer rates, increased productivity due to reduced downtime and increased operational safety through minimization of handling operations of reagents and products. Characterizing the drug following the quality guidelines required by the United States Pharmacopeia (USP) and by RDC 166 (Anvisa) is also the objective of this proposal. (AU)