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Developing and optimizing an in vitro gel-based diffusion assay for subcutaneously administered insulins with the USP apparatus IV

Over the years, there has been a notable rise in interest in the subcutaneous (SC) administration of drugs, enabling the non-oral delivery of biologics. Challenges in drug absorption and knowledge gaps related to the mechanics inside the SC tissue necessitate a nuanced approach to drug development. Biopredictive performance testing, combining in vitro and in silico methods, offers insights into these release mechanisms post-injection.

This research addresses the lack of standardized in vitro assays for SC drug performance and introduces an innovative in vitro methodology using tissue-like gel matrices inside USP apparatus IV flow-through cells. Using several insulin formulations as model drugs, this setup is used to accurately predict their performance in vivo.


Power in Numbers

David Li

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8 February 2024

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