REQUIREMENTS OF THE LEADING PHARMACOPEIAS FOR ADAPALENE AND TRETINOIN

Abstract

Creating medicinal products based on active substances not found in the pharmacopeia (SPhU) requires an appropriate approach to determining the substance's properties, conducting quantitative and qualitative analysis, as well as identifying accompanying impurities and storage conditions. The aim of our work was to study the properties of adapalene and tretinoin, taking into account further work on the development of new local and systemic drugs. The objects of the research were substances that belong to the group of retinoids (adapalen and tretinoin). An analysis of available pharmacopoeial articles on the substance of the world's leading pharmacopoeias (USP, British Pharmacopoeia, European Pharmacopoeia) was carried out. A Lumam P1 microscope equipped with a DMC 300 digital eyepiece camera and ScopePhoto software was used to determine the microscopy of active substances. Based on the analysis of the world's leading pharmacopoeias, the pharmacopoeial articles of tretinoin and adapalene substances were studied. The presence of pharmacopoeial articles related to ready-made medicinal forms such as gel, cream and solution was also determined. The obtained data indicate the existence of different approaches to the analysis of active substances in the European (British Pharmacopoeia, European Pharmacopoeia) and American (USP 44) Pharmacopoeias. The main differences are found in the definition of impurities to active substances. It is also important to note that the identification of active substances varies due to the use of different methods for quantification. Storage requirements for substances such as tretinoin and adapalene are determined by the recommendations of all Pharmacopoeias and involve working with them in conditions that protect against exposure to light and moisture. In this regard, the American Pharmacopoeia recommends avoiding exposure to light when working with adapalene. It is important to note the presentation of articles on soft dosage forms in the British and American Pharmacopoeias. Crystal forms for tretinoin and adapalene were determined based on the provided data from microphotographs. Tretinoin has needle-like and platinum-yellow crystals, while adapalene belongs to powders with a cubic crystal system.