ARTYKUŁ

Marzena Jamrógiewicz, Aneta Karczewska-Kaliszak, Karolina Milewska

Fotolabilność substancji leczniczych – przegląd aktualnych badań i strategie postępowania
2019-10-31

Podstawowa procedura przeprowadzania badań trwałości substancji leczniczych i produktów leczniczych opisana jest w wytycznych Międzynarodowej Rady Harmonizacji Wymagań Technicznych dla Leków Stosowanych u Ludzi, tzn. ICH (ang. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). Wytyczne te nie zawierają jednak szczegółowych procedur i metodologii eksperymentalnej, których należy przestrzegać podczas przeprowadzania testów stresowych, zwłaszcza dotyczących fotostabilności. Na podstawie najnowszego piśmiennictwa naukowego, w pracy przedstawiono testy i różnorodne badania, które dostarczają informacji o fotolabilnych substancjach leczniczych, strukturze i właściwościach produktów ich degradacji, a także różnych strategiach postępowania.

Słowa kluczowe: fotostabilność, fotolabilność, substancje lecznicze.

© Farm Pol, 2019, 75 (10): 575–583

Light-sensitive medicinal compounds – the latest review of studies and strategies in proceedings

The main procedure for stability testing of Active Pharmaceutical Ingredients (API) and medicinal products is described in the guidelines of the International Council for the Harmonization of Technical Requirements for Human Drugs (ICH). However, these guidelines do not contain specific procedures and methodologies that must be followed in stress testing, especially photostability tests. On the basis of the latest, current research reports which have been published, as well as scientific literature this article provide current information about photolabile medicinal compounds, the structure and properties of their degradation products, as well as various strategies of proceedings.

The ICH Q1B guidelines cover two main types of tests, namely ‘forced degradation’ and ‘confirmatory’ tests for medicinal products and medical devices and supplements. Forced degradation studies are used to explain the mechanisms of photodegradation and to develop procedures for the proper production, packaging, storage, clinical / production use of the active pharmaceutical ingredient and the final product. These studies are also aimed at developing an appropriate analytical method capable of visualizing potential changes occurring in the medicinal product or demonstrating the specificity of an already existing method. The “confirm” test, as the name suggests, is intended to confirm that the recommended storage conditions and packaging of the medicine are adequate and sufficient to protect the medicinal product. Light exposure for confirmatory testing roughly reflects exposure to typical ultraviolet and visible light for 3 months in case of a medicinal product without protective packaging in a pharmacy, warehouse or home (in the United States / Northern Europe). Therefore, for geographical locations with a greater number of hours and greater sunlight intensity, this period is much shorter. Such test guidelines are determined depending on the geographical location (zone) of the country in which they take place.

People believe that product they use and eat are safety while most of the society are convinced that current guidelines concerning quality evaluation of medicinal products are unified and concentrate on verification of stability through determination by particular tests. The purpose of this review is to discuss with criticism all current recommendations referring to the photostability tests performed for pharmaceutical industry mostly connected with human life as pharmacy. The estimation of all existing and obligatory requirements with their gaps are discussed.

Keywords: photostability, photolability, Active Pharmaceutical Ingredient (API).

© Farm Pol, 2019, 75 (10): 575–583

1.11 MB | 11 grudnia 2019