Simulate SubQ
Our latest research article on drug release testing of a long-acting depot formulation was just accepted by the International Journal of Pharmaceutics. This is great work by the young first author Ge Fiona Gao. One year ago she won a Best Abstract Award of the AAPS Annual Meeting, now she has done a tremendous job showing the influences of the physiological environment on formulations that remain at the injection site for several weeks.
The release assay elucidated the influence of proteins on microparticle release and how they affect discrimination between different batches of drug products. Even without affecting solubility, proteins stabilize particles and may affect the performance in the subcutaneous tissue. A mechanistic model helped us to understand the influences of such parameters and formulation characteristics on pharmacokinetics. Why does it matter? Without understanding what are the major drivers of drug release there will always be a high risk of failure when testing new long-acting therapeutics for chronic diseases.
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