Are you approaching candidate nomination? This is a key milestone in all drug development programs, and often directly linked to your next round of funding. Many times the HCl salt, or the free form of the molecule is taken as a default into toxicology studies. After all, this was what was generated in the medicinal chemistry phase. Unfortunately, many compounds have been rejected due to suboptimal properties, whereas the choice of a different (salt) form might have improved solubility and stability considerably. Don’t let your next compound get rejected in early development due to sub-optimized form.
FormSelect is the Cambridge Major approach to risk-mitigation in the early development phase. Polymorphic behavior and stability of a range of free form(s) and salts are studied in parallel, maximizing your chances of success.
By using only pharmaceutically-acceptable counter ions and solvents, and applying only scalable crystallization methods, a directed experimental program will rapidly generate information to aid in the selection of a “developable” form of your API.
CML employs state-of-the-art crystallization tools and highly experienced experts in drug substance solid state chemistry to drive your program. Make the right choice with FormSelect!
From Discovery through commercial manufacture of active pharmaceutical ingredients – We Deliver
Cambridge Major is organized along five key integrated Centers of Excellence, providing our clients with end-to-end solutions.