Journal
AAPS JOURNAL
Volume 14, Issue 3, Pages 559-570Publisher
SPRINGER
DOI: 10.1208/s12248-012-9367-0
Keywords
bioavailability; hypodermis; lymphatic uptake; subcutaneous; therapeutic proteins
Categories
Funding
- Center for Protein Therapeutics, University at Buffalo, State University of New York
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The subcutaneous (SC) route is of growing interest for the administration of biotherapeutics. Key products on the biotherapeutic market such as insulins, but also several immunoglobulins or Fc-fusion proteins, are administered SC. Despite the importance of the SC route, the available knowledge about the processes involved in the SC absorption of biotherapeutics is limited. This review summarizes available information on the physiology of the SC tissue and on the pharmacokinetic processes after SC administration including first pass catabolism at the administration site as well as transport in the extracellular matrix of the SC tissue, followed by absorption into the blood circulation or the lymphatic system. Both monoclonal antibodies and other biotherapeutics are discussed. Determinants of absorption after SC administration are summarized including compound properties such as charge or molecular weight. Scale-up of animal data to humans is discussed, including the current shortcomings of empirical scaling approaches and the lack of suitable mechanistic approaches.
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