Jadwiga Mielcarek, Paweł Grobelny, Tomasz Osmałek

Trwałość fotochemiczna substancji leczniczych i gotowych postaci leków. Część II. Sposoby oceny fotowrażliwości leków i ochrony przed rozkładem

Photostability of drug substances and dosage forms. Part 2. Drugs photostability evaluation methods and decomposition preventing. It is known that many drugs as well as nonpharmaceutically active compounds decompose when exposed to light. It was also proven that photodegradation of an active compound results in several side-effects such as phototoxic, photoallergic or carcinogenic reactions. Even small amounts of possible photoproducts can be dangerous during pharmacotherapy. Though our knowledge about photolabile drugs is still quite sparse, recent surveys show that this problem cannot be ignored. For several years there had been no strict standards about how to correctly evaluate photochemical properties of drugs. In 1998 ICH (International Conference on Harmonization) formulated internationally accepted Guideline for Drug Photostability Testing. It contains essential principles and clues for researchers such as precise comparison of light sources, characteristic of chambers, description of analytical procedures