Overview of authorized drug products for subcutaneous administration: Pharmaceutical, therapeutic, and physicochemical properties

Abstract

There is a growing body of research about subcutaneously administered biologics, emphasizing the need for optimized bioavailability predictions. It is important to inform both translational and in silico models with properties of the drug products and compounds. However, the pharmaceutical, therapeutic and physicochemical properties of market authorized drug products for subcutaneous administration are currently not collated in the public domain. We provide an overview of subcutaneous administered drug products for humans and animals market authorized in EU, Canada, and the US. Data on the drug products were collected from the respective authorities, i.e. European Medicines Agency, Health Canada, and U.S. Food and Drug Administration. Physicochemical properties of active substances were gathered from DrugBank. Human drug products were often indicated for treatment of diabetes and anemia. EU veterinary drug products were often immunologicals. Canadian and US veterinary drug products often acted as antiinfectives for systemic use, on the genito-urinary system or as sex hormones. The final dataset with >1700 subcutaneous drug products is provided. In EU drug products, the majority of active substances were biologics. In the US, drug products most often contained small molecules. Solutions, emulsions and suspensions were the most common dosage forms. A minority of subcutaneous drug products were also registered for intramuscular or intravenous administration. The analysis presented here could aid further research, exploring formulation properties, prescription or sales of market authorized SC drug products and development of inclusive in silico models.

Keywords: Drug products; EMA; FDA; Health Canada; Market authorization; Subcutaneous administration.