Archive June 2020

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.

#SaferMedicines #EnjoyReading #ExplainMyResearch

The PBNB model: Unlock your PK data

Today, our manuscript on the Physiologically-based Nanocarrier Biopharmaceutics (PBNB) Model was finally accepted for publication by the European Journal of Pharmaceutics and Biopharmaceutics. I explained the purpose of this model in my talk during the Explain-My-Research Virtual Conference in May 2020 and will go more into detail during a Live Webinar organized by Malvern Panalytical in July. Rather than providing a ‘convenient fit’ only, the model is designed to link the pharmacokinetics of nanocarriers to a physiologically-based distribution. Interesting parameters you may obtain with this model are, for example, the targeting capability and the mean residence time of the nanocarrier in the blood plasma. A lowered plasma concentration often indicates that more drug has been released from the carrier and is not available for targeting any more. The PBNB model recognizes such changes and calculates how much carrier-bounded drug is accumulated before this release happens. Expressed as a fraction of the total dose, this is the targeting capability (Ftarget) . The mean residence time of the carrier (MRTc) in the blood plasma indicates how much time the delivery system had for this accumulation process and is a marker for targeting accuracy.

Some of the simulations our PBNB model is capable of are provided on the servers of our collaborator isee systems.

Guest judge @ SPDS

I was very happy to act as a guest judge for the Society for Pharmaceutical Dissolution Science. For the last 10 years, my group has been passionate about developing novel release assays and it was good to have a conference putting this important part of drug product development in the spotlight. Students from all over India submitted their work on drug release testing. Congratulations to the finalists.