Hong Li, Vice President of Formulation at BioDuro-Sundia, presented her company’s latest solution engine programme. The solution engine is a rapid formulation approach for solubility enhancement using milligrams of API.
Oral administration is the most preferred drug delivery system. However poor oral bioavailability is associated with oral administration. The reason behind poor oral bioavailability is linked to solubility and permeability.
BioDuro-Sundia’s solution engine aims to address this problem by combining silicon modelling, high-throughput in vitro screening, and in vivo PK studies. Li added that silicon modelling is used for polymer screenings. She explained that this combination enables rapid identification of optimal formulation using minimal API amounts for quicker development.
The amorphous stage of drug molecules is critical to achieving higher bioavailability. The higher the apparent solubility and higher dissolution rate of a polymer play a key role in the ASD formulation. The interaction between the API and polymer will prevent the recrystallisation process thus improving the stability of the ASD.
Li also introduced the Solution 2.0 Process which uses silicon modelling without any API required to screen polymers efficiently. Their miniaturised screening process can run between 50 and 80 different combinations of experiments and then conduct an in-house PK study to find out what is the best formulation to move forward with. Li stated that his process just takes 2 – 3 weeks.
To illustrate the key value of these, Li explained that Solution Engine 2.0 brings significant value to client programs especially to accelerate the development of BCS II & IV compounds by salvaging poorly soluble candidates that would otherwise be discarded. Li mentioned that her team conducted both pre-clinical and clinical studies that demonstrate that using polymers (e.g. HPMCAS-L) with surfactants (e.g. E-TPGS) enhances bioavailability.
