Dr Sanjay Boldhane, PhD
Associate Vice-President, Formulation Development
“The goal of the formulation team is always to produce the best product that will allow a drug to be absorbed well in the body and achieve the best therapeutic response. Often we think we have a great formulation but are disappointed when the clinical results do not come up to expectations. Our experience with the Surge Dose approach changed that completely, as every Surge Dose tablet developed showed faster and more consistent absorption in vivo.”
“Imaginot worked as part of the project team to effectively transfer the technology to our scientists. They were very supportive, providing expert input and guidance throughout the formulation and process development steps through to the clinical studies.”
“Comparative quantitative dissolution data guided our development and allowed us to identify the lead formulations for the biostudies very quickly. The Surge Dose tablets achieved faster disintegration and dissolution in vivo leading to rapid onset of absorption through higher early exposure and a shorter Tmax. Importantly, Surge Dose reduced subject-to-subject absorption variability without the multiple peaks and delayed absorption frequently seen in some subjects.”
“We used the Surge Dose approach for several molecules demonstrating that when you improve the in vitro dissolution, then dissolution and absorption will be improved in vivo. The in vitro – in vivo correlation gave our formulation team great confidence in this formulation approach. For drugs which need rapid onset of action with higher peak plasma concentrations quickly and reproducibly with low subject-to-subject variability, then the Surge Dose approach would be our first choice in the future.“
“The Surge Dose tablet formulations were easy to develop with reduced development times and fewer biostudies needed. They use standard GRAS excipients which are safe, readily available and lower cost compared many commonly used diluents so that there is no impact on COGS. If stored at temperatures below 30˚C, Surge Dose tablets can be packed in Alu-Alu blisters.”