Text book difficulty requires out of the book thinking

mixing dispersions

Our client, a pharmaceutical company, was planning for a clinical study and needed a formulation to be used. They turned to us because the demands on the formulation was such that no standard formulation could work.

The drug load needed to be extremely high, it was intended for intra-venous (IV) administration and the drug was a hydrophilic oil (if there is such a thing)! It was crucial for safety that the formulation did not include droplets too large for IV administration but of course, within minutes small droplets would coalesce to larger, too large drops.

This is a text book example of Ostwald ripening. Unfortunately, our client was not after a text book illustration of anything else but a successful study. Our solution was to combine hard work in the lab with thinking of the cause of Ostwald ripening and what one could do to slow down the kinetics, slow it down to be functional and safe for this first study. We made a new rational choice of excipient that slowed the process down. Not enough for a commercial product, but enough for this company to take this crucial step in their development plan. This is an example of science based pragmatism.

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