As always, APIs with poor aqueous solubility have been a big problem in development of new drug products. One attractive solution is the use of an amorphous form of the drug substance. This is because amorphous phases are much more soluble than their crystalline counterparts, and can often be formulated to be physically and chemically stable throughout the shelf life of the drug product.
SARA PHARM has numerous techniques to search for and stabilize amorphous forms of drug substance, which is a strict requirement. ASDs are a good solution to be considered for carrying out the first animal tox studies to determine the maximum tolerated dose (MTD) when dealing with a poor soluble API. A rather limited amount of material, up to 1g, is required to carry out such an ASD screen.