Expectorant phytomucolytic syrups are widely used pediatric OTC-medicines. Physicians, pediatricians, and pharmacists are traditionally concerned with the efficacy of the active ingredients in cough syrups, and rarely consider the safety aspects of excipients that however are not absolutely “inactive” and are proved to initiate some negative reactions and interactions with other drugs. This paper presents a review, categorization, and comparative analysis of the safety profile of excipients contained in the 22 best-selling OTC pediatric phytomucolytic syrups available in pharmaceutical markets in Ukraine and Germany and proposes an approach to the consideration of the excipients’ safety risks for a pharmacist in the process of pharmaceutical care. The study has revealed that only one of the twenty-two analyzed syrups does not contain any potentially harmful excipients. The results of this analysis were used for developing a specific decision tool for pharmacists that can be used for minimizing excipient-initiated reactions when delivering OTC phytomucolytic syrups for children.

Мета роботи. Оптимізація та удосконалення фармацевтичної опіки для забезпечення раціональної фітотерапії пацієнтів при симптоматичному лікуванні кашлю із застосуванням рослинних препаратів, отриманих за оригінальною технологією фітонірингу. Матеріали і методи. Методологічну основу дослідження складають принципи об’єктивності і системності. У роботі використано комплекс загальнонаукових та спеціальних методів: теоретичний, метод узагальнення, систематизації даних, порівняння, методи вивчення літературних джерел і аналізу та ін. Результати й обговорення. У роботі висвітлено основні принципи фармацевтичноїопіки пацієнтів із кашлем. Актуалізовано роль фітотерапії в симптоматичному лікуванні кашлю та обґрунтовано раціональний вибір оптимального препарату з позицій доказової медицини. Представлено алгоритм фармацевтичної опіки пацієнтів при симптоматичному лікуванні кашлю як одного з характерних симптомів запальних захворювань дихальних шляхів та алгоритм фармацевтичної опіки при виборі та відпуску стандартизованих фітопрепаратів у лікарській формі сиропу для симптоматичного лікування кашлю в дітей. Висновки. Під час проведення фармацевтичної опіки пацієнтів із кашлем першорядна рекомендація фармацевтом стандартизованих рослинних лікарських засобів ґрунтується на вагомих даних доказової медицини щодо їх ефективності і безпеки, а також прийнятності для застосування різними категоріями споживачів, включно дітей.

Due to the specificity of the composition and production of herbal medicines, ensuring their quality is particularly important, but at the same time an extremely difficult task. Purpose - to review the key problems, principles and aspects of the quality of herbal medicines and generalize advanced approaches to ensure their quality using the example of a phytoneering drug for the treatment of cough in acute bronchitis and inflammatory diseases of the respiratory tract. The concept of the quality of the phytoneering drug was considered and analyzed. The central role belongs to the well-founded choice of starting plant material, the use of cultivated subspecies of plants and own seed material, which is of critical importance for ensuring the optimal and stable phytochemical composition of the extracts. In addition, the quality of the phytoneering medicines is determined by strict compliance with the GACP guideline, a standardized production process in accordance with GMP using the latest patented technologies, leading procedures for continuous quality control and the possibility of analyzing the multicomponent composition of the obtained extracts. Thus, the concept of phytoneering provides a thorough and comprehensive methodological basis for establishing quality at each stage of the life cycle of the drug and the reproducibile and consistent quality of extracts from batch to batch. Together with a thorough evidence base of preclinical and clinical research all this is an absolute competitive advantage of the phytoneering medicine over other herbal drugs. No conflict of interests was declared by the authors.

Diseases of the respiratory system occupy an important place in the structure of morbidity in the population of Ukraine, being only second to diseases of the cardiovascular system in prevalence. Patients with a respiratory pathology make up a significant part of the pharmacy visitors. In most cases, at the first symptoms of such diseases, patients begin to be treated on their own with the help of non-prescription drugs, and quite often the first person they turn to is a pharmacist. A striking example of the effectiveness and safety of herbal medicine is the symptomatic treatment of cough as one of the most characteristic symptoms of the respiratory tract pathology. The use of herbal products with the antitussive, expectorant, mucolytic action has a long history, and currently it does not lose its significance. The clinical efficacy of herbal products is determined by the mechanism of their specific action, and the rational choice of the optimal drug taking into account the cause of the cough, its nature and the characteristics of the course of the inflammatory process in the respiratory organs, allows eliminating cough or effectively managing it. Bronchipret® is a herbal product of “Bionorica SE” company, which is one of the most studied and widely used in medical practice. The drug is indicated for the treatment of respiratory tract diseases accompanied by cough and sputum formation, including acute and chronic bronchitis. The main and well-studied pharmacological effects of Bronchipret® are secretolytic/mucolytic, anti-inflammatory, antiviral, antimicrobial and bronchospasmolytic ones. The pharmacological effects listed are due to a complex of biologically active substances (BAS) of such plants as the root of spring primrose, thyme herb, ivy leaf. All medicinal plants that make up the “active core” of the drug have a long history of their use in folk medicine. Moreover, their various beneficial effects on the human body in different diseases and conditions have been confirmed by empirical experience. The drug is produced in three dosage forms (drops, syrup, tablets), and it determines the targeting of its prescription to different categories of patients. The drug has a high evidence base and has been studied at the cellular and molecular levels. Conclusions. In the case of choosing a herbal medicine for responsible self-medication, drug consumers can rely on their own experience, but most of them trust the knowledge of a pharmaceutical professional, and this fact increases the pharmacist’s responsibility for the treatment prescribed. Therefore, it should be the choice of a drug with an optimal efficacy/safety ratio, which is determined from the standpoint of evidence-based medicine. It is precisely these requirements that the phytoneering drug Bronchipret® meets.