Preformulation - contemporary trend or source of knowledge about drug substance and product. Pharmaceutical companies main challenge is to launch the product on the market as fast as possible hence the need to generate - in reasonably short time - the necessary information allowing to make decisions about the choice of the drug substance and excipients, and about the development of the product at individual stages of development work. Detailed, early evaluation of the drug substance and excipients, dosage forms and technological possibilities is referred to as preformulation. Preformulation tests are carried out by innovation companies, which develop new active substances having the expected action and by generic companies, which introduce on the market the products containing active substances of known action and use. In both cases, the preformulation tests are conducted differently. Innovation companies spend a lot of time on tests and determining the properties of the drug substance. Generic companies focus on three areas: analysis of the reference product, confirmation and determination of physicochemical properties of the drug substance, and development of generic products.

Keywords: preformulation, preformulation test, generic products, drug.