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Mechanistic determinants of biotherapeutics absorption following SC administration.

Richter, Wolfgang F and Bhansali, Suraj G and Morris, Marilyn E (2012) Mechanistic determinants of biotherapeutics absorption following SC administration. The AAPS journal, 14 (3). pp. 559-570. ISSN 1550-7416

Abstract

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.

Item Type: Article
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Additional Information: Can archive pre-print and post-print or publisher's version/PDF
Keywords: bioavailability; hypodermis; lymphatic uptake; subcutaneous; therapeutic proteins
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Date Deposited: 13 Oct 2015 13:14
Last Modified: 13 Oct 2015 13:14
URI: https://oak.novartis.com/id/eprint/8593

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