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Overview of authorized drug products for subcutaneous administration: Pharmaceutical, therapeutic, and physicochemical properties
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.ORCID iD: 0000-0002-7806-0447
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. Pharmetheus AB, S-75237 Uppsala, Sweden.ORCID iD: 0000-0003-4318-6039
2022 (English)In: European Journal of Pharmaceutical Sciences, ISSN 0928-0987, E-ISSN 1879-0720, Vol. 173, article id 106181Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Elsevier Elsevier, 2022. Vol. 173, article id 106181
Keywords [en]
Subcutaneous administration, Drug products, FDA, EMA, Health Canada, Market authorization
National Category
Pharmaceutical Sciences Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-478622DOI: 10.1016/j.ejps.2022.106181ISI: 000806400200004PubMedID: 35381330OAI: oai:DiVA.org:uu-478622DiVA, id: diva2:1678663
Funder
Vinnova, 2019-00048Available from: 2022-06-29 Created: 2022-06-29 Last updated: 2024-01-15Bibliographically approved

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Dubbelboer, Ilse R.Sjögren, Erik

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