Preformulation

In preformulation, relevant physico-chemical properties of drug substances are determined, for example solubility or stability, that are important criteria to select the right substances for development. After oral application, only the substances with sufficient solubility can be absorbed by the digestive tract and into the body, where they become effective. Stability is important, as a drug substance must remain stable during handling, formulation, storage and administration of the drug product.

Formulation

For application and testing of new drug substances in animals and humans, suitable dosage forms are required that enable easy administration and dosing. In research, small-scale standard formulations are prepared for tests in pharmacology, where the therapeutic effect of the drugs is studied. A microsuspension, for example, is a suitable type of formulation for small amounts of substances for in vivo testing. A microsuspension contains very small particles, in the micrometer range, that enables faster dissolution and improved up-take of low water-soluble drug substances by the digestive tract. Microsuspensions are prepared by a standardized small-scale wet-milling process useful for low water-soluble solid compounds.