Polymorph and Salt Screening and Selection
Available from Triclinic Labs, Inc
The Search for Optimal Solid Form Properties:
Our Services and Approach for Pharmaceutical and Fine Chemical Development and Crystallization
Different crystalline solid forms of an active pharmaceutical ingredient (API) can have very different physico chemical properties. Those differences can impact bioavailability, solubility, dissolution rate, first pass metabolism, side effect incidence, stability, API and drug product manufacturability, and other important parameters. The vast majority of APIs can exist in multiple solid forms, including polymorphs, hydrates, solvates, salts, cocrystals, and non-crystalline forms. The goal in screening and selection is to produce an optimal solid form based on parameters such as crystallinity, stability, solubility, hygroscopicity, and ease of production ("manufacturability"). Understanding the crystallization process is paramount for reproducibility.
Triclinic has extensive experience in solid-state and solid form screening & selection and in devising and conducting studies to improve your drug's physico-chemical properties.
If you are searching for a developable form of your API we can determine polymorphism, a most stable form, as well as develop salts, cocrystals, and non-crystalline materials.
If your API has poor aqueous solubility, solid forms can be found and patented that will lead to improved solubility.
If your drug has poor stability or handling properties, Triclinic can recommend approaches to improve those properties.