Formulation Development

Expertise beyond your expectations.

A great drug cannot work without the right formulation approach. It’s important to get it right the first time so that you get the best performance possible from your drug, allowing your program to proceed efficiently. Our particle engineering and solid dosage form approach enables the development of formulations that overcome a variety of dissolution, solubility, and controlled-release challenges. 

The development process begins in our solid-state laboratory, where we determine a comprehensive understanding of the physicochemical properties of your drug. A variety of modeling and experiments are performed, such as assessment of pKa, LogP, thermal properties, polymorph thermodynamics, solubility, dissolution performance, and chemical/physical stability. Our formulation scientists use this knowledge along with decades of experience to produce small batches of prototype formulations (as small as 100 mg) for further evaluation of in vivo and in vitro performance. These can be further optimized for engineering and GMP production batches.

If you are advancing an asset from discovery into preclinical studies, we can help. We have developed a broad range of fit-for-purpose preclinical formulation methodologies that avoid the typical angst associated with this stage of development. Our approach utilizes a variety of technologies, including simple solutions, lipid vehicles, crystalline suspensions, amorphous dispersions, or nano particulates. We provide a ready-to-dose approach that provides the required performance and stability to enable PK and toxicology assessment with minimal stress.

Our approach enables rapid advancement of your drug into later development stages. Our manufacturing equipment is designed to facilitate scaleup to larger batch sizes and reduce the need for complex equivalency studies.