To address the challenges associated with poor bioavailability, we have developed a program of technologies aimed at improving drug solubility and permeability.
Our Highway to clinic platform streamlines development by assessing a range of advanced formulation technologies to overcome bioavailability and stability challenges.
Administering an API in a dissolved form allows the dissolution step to be bypassed, thus accelerating the absorption phase.
Our formulation experts have proven track experience in selecting the best approaches to overcome the low aqueous solubility of new chemical entities, such as modifying the API via salt formation and incorporating solubilizing excipients such as complexing agents, surfactants or co-solvents.
Reducing drug particle size to micro- or even nanometer scale drastically increases the surface area available for solvation and thus improves dissolution kinetics.
At Eurofins CDMO, we have extensive experience in top-down particle size reduction processes via wet milling followed by stabilization of these nanosuspensions.
These formulations typically consist of lipids, surfactants, and co-solvents, which solubilize the drug and facilitate its absorption in the gastrointestinal tract.
Self-emulsifying drug delivery systems (SEDDS) are a prime example of lipid formulations designed to enhance drug solubility and bioavailability. Upon administration, SEDDS spontaneously form oil-in-water emulsions, increasing drug solubilization and promoting absorption through lymphatic transport.
ASDs represent an innovative approach for bioavailability enhancement by dispersing poorly water-soluble drugs in a polymer matrix. Unlike crystalline drug formulations, amorphous drugs exhibit higher energy states and greater molecular mobility. By preventing drug recrystallisation and maintaining a high-energy amorphous state, ASDs enhance drug solubility, dissolution kinetics, and absorption.
At Eurofins CDMO, we have in-house expertise to produce ASDs via spray-drying and bead-coating technologies.