Current trends in the standardization of the quality for phytochemical-directed medicinal products

Abstract

The article discusses theoretical and practical aspects of standardization of medicinal products in pharmacy. The concept of standardization in pharmacy and its purpose, which is to ensure stable quality, safety and effectiveness of medicines, are considered. The importance of the regulatory framework in the process of standardization of medicinal products is emphasized. Examples of regulatory documents (Pharmacopoeias, state and international standards), such as the European Pharmacopoeia (Ph. Eur.)), the US Pharmacopeia (USP), the World Health Organization (WHO) Guidelines, are given.

Aim. To determine and provide a comprehensive approach of the features of the drug standardization from the perspective of pharmacognosy, taking into account the principles of pharmacy and pharmacology.

Materials and methods. The materials of the study were the publications of representatives of the domestic pharmacognostic doctrine and the works of foreign scientists. Regulatory documents at the level of the countries of the European Union, the USA, and the WHO have been analyzed. These documents include the European Pharmacopoeia (Ph. Eur.), Monograph 2034 “Herbal Drug Preparations”, the US Pharmacopeia (USP), three regulations (law-making acts) – the WHO Technical Report Series No.1010 (2018), the WHO Guidelines on Good Manufacturing Practices (GMP) for Herbal Medicines and the WHO Guidelines for assessing the quality of herbal medicines with reference to contaminants and residues, which are guiding for use in all member countries of the WHO.

Results. The peculiarities of the drug standardization through the prism of the science of pharmacognosy, as well as related sciences, such as pharmaceuticals and pharmacology, have been determined. It has been found that current standardization trends involve the introduction of innovative technologies, in particular biotechnological methods, pharmacogenomics and artificial intelligence. It has been determined that the standardization of medicinal products can be called a multicomponent process, which differs depending on the boundaries (the WHO or a specific country and its pharmacopoeia) and the purpose of this process, but has as its ultimate goal the creation of uniform, transparent, open standards before obtaining a marketing authorization for a medicinal product, which takes place exclusively within the framework of the legal field.

Conclusions. The standardization of medicinal products is a key process of pharmaceutical control that guarantees their quality, safety and effectiveness. It is based on international and national regulations, such as the European Pharmacopoeia, the US Pharmacopoeia and the WHO Guidelines. Improving standardization methods is the key to increasing the effectiveness and safety of medicines, which, in turn, contributes to improving the quality of medical care.