Formulation Development Articles - Latest

Polyols (aka polyhydroxy co-solvents aka osmolytes) such as sucrose have long been known to impart thermodynamic stability to proteins in solution. Recent advances in biotechnology and in the development of proteins for therapeutic applications has led to an increased interest in these neutral co-solvents (more than 60 % of mAb formulations currently in market have polyhydroxy alcohols as excipients). read more

In general, there is an industry trend toward the need for increased capacity, efficiency, uptime, and utilization – and this trend is certainly prevalent in most tablet production environments. Increasing overall capacity with fewer machines and fewer operators is driving requirements for fast change strategies, which involve multiple turrets, multiple sets of change parts, and streamlined procedures. read more

The well-established successes in combinatorial chemistry and high throughput screening have resulted in the rapid identification of many highly potent lead pharmaceutical compounds with optimized pharmacodynamic properties, but relatively sub-optimal biopharmaceutical characteristics read more

Raman scattering technology has been found to be a very useful tool to aid in the development of well-understood solid dosage forms with appropriate manufacturing controls and storage conditions. read more