Edyta Leyk, Marek Wesołowski

Trwałość chemiczna i fizyczna substancji leczniczych

Chemical and physical stability of active pharmaceutical ingredients

The most important issue from the pharmaceutical point of view is a stability of pharmaceutical active ingredients (APIs). In this paper general remarks on chemical and physical stability of APIs have been given. Taking into account diverse molecular structures of APIs, their possible degradation pathways were characterized. There were hydrolysis, decarboxylation, elimination and dehydration, isomerization and recemization, oxidation, fotodegradation and interactions between APIs and API with excipients. These information can be very useful in predicting the chemical instability of APIs based on their molecular structure. The factors affecting stability of APIs were also described. Moreover, physical stability of APIs was considered since the physical state of drug substances determines their physical properties. A special attention was paid on the crystallization of amorphous APIs, transitions in crystalline state and the factors affecting physical stability of drug substances.

Keywords: active pharmaceutical ingredients, chemical stability, physical stability, pathways of APIs degradation.

© Farm Pol, 2017, 73(11): 687-691