Abstract

This study addresses suboptimal formulation practices observed in cyclodextrin (CD)- containing medicinal products within the post-Soviet region, particularly in Russia, where CDs are often used in amounts significantly lower than stoichiometric amounts. By analyzing ten products using transparent package inserts, this research underscores the unique transparency observed in the composition information of medicinal products within the post-Soviet region. This study highlights the importance of justifying cyclodextrin quantities in formulations and recommends thorough evaluation by the Ministry of Health for marketing authorization. The exceptional transparency observed in the post-Soviet region enables increased awareness among physicians, patients, and healthcare professionals regarding exposure to inactive ingredients and their functionality. This transparency provides valuable insights into optimizing the use of cyclodextrins in pharmaceutical formulations.

Keywords: Cyclodextrin formulations, medicinal product transparency, CD-to-API ratio, post-Soviet pharmaceutical market, marketing authorization process.