The best route28 Nov 2021 12:25
All very logical to me as to why Tim should pursue the capsule route. Tim and co in a better position to make these decisions. Just a very brief outine below.AbstractA majority of new active pharmaceutical ingredients in development exhibit low aqueous solubility and poor dissolution and, thus, poor oral bioavailability.A number of approaches have been used to improve aqueous solubility and bioavailability. These have included particle size reduction; creation of amorphous solid dispersions (ASDs); use of solubilization formulations; crystal modification; and chemical modification. Amorphous Spray Dried Dispersions (SDDs) are molecularly dispersed mixtures of amorphous drug, polymers, and optionally, other excipients and are commonly used to increase apparent solubility and dissolution rate, thereby affording superior bioperformance for poorly soluble drugs. Spray-drying is a mature, robust and scalable technology that has been successfully applied to a number of commercial products and a large number of compounds under clinical development.This chapter addresses the formulation, process development, scale-up, and drug product considerations for preparing spray dried dispersions (SDDs). From Sareum RNS the following'• Development of improved drug product underway for first clinical studies; decision made to develop potentially higher-value capsule formulations rather than orally dosed solutions or suspensions means this stage is expected to complete during H1 2022.'Now why would you go through at great effort and create the crystallisation of a compound then compromise in any way shape or form when capsule formulations are clearly advantageous over a tablet product? All things being equal, is it any wonder that competitors products have such a failure rate in clinical trials. Attention to detail. This does not just mean what a compound can do, but also and of the upmost importance is where it may fall down, and rectify these issues before clinical trials go ahead.Most Tyk 2 inhibitors inhibit IL-6. Why is ours better and currently indicative of being far more successful with regards to efficacy and safety profile? Regards