Introduction. Despite the fact that the range of industrial drugs on the shelves of pharmacies is a large part, the extemporal medicines increasingly occupy a worthy niche in the provision of medicines to the population, this is because the production of medicines according to individual prescriptions has its advantages. In addition to taking into account the individual characteristics of the patient, the selection of the composition of medicinal substances and their dosage, as well as the dosage form, the extemporal preparation has a number of advantages. One of the main ones is the absence of side effects. The latter is due to the fact that, in contrast to the reagy-made medicines, the extemporal ones are applied immediately after preparation, and therefore is designed for a short shelf life. Excipients (preservatives, stabilizers, emulsifiers, form-building, etc.) are introduced into their composition in the minimum quantity, if necessary [1, 3-5]. Allergic reactions rarely occur with the use of the extemporal drugs, which is especially important in the treatment of children. Compared to ready-made drugs extemporal medicines are cheaper; it plays an important role in treating the poor, for example, pensioners.
Therefore, the extemporal compounding has the right to exist and must be developed as an alternative form of treatment. However, there are a number of problems that need to be solved. To date, not all pharmacies have the conditions for the preparation of extemporal drugs (production departments). One of the main problems is the limited range of active pharmaceutical ingredients on the market, especially produced domestically; some of the imported substances do not quite meet the quality requirements. Certain difficulties exist in matters of profit from the sale of these drugs.
Despite the foregoing, in recent years, the number of production pharmacies in Ukraine is growing. Large pharmacy chains, for example, in Kharkov, such as Leda, Prana, Pharmacy 195, Pharmacy 200, and other pharmacy institutions of “Kharkiv CP Pharmacy” have their own production pharmacies that provide the network with extemporal intra-pharmacy products. The nomenclature of extemporal prescriptions and intra-pharmacy products that are produced in such pharmacies is diverse and depends on the pharmacy, the profile of the medical institutions that are close to it, and the needs of the population.
In recent years, Ukraine has paid particular attention to the development of a regulatory framework for the preparation of extemporal drugs in pharmacies. Articles on the extemporal formilation are included in the new edition of the State Pharmacopoeia of Ukraine, orders of the Ministry of Health of Ukraine, etc. [1, 3, 4]. Thus, the revival of the extemporal compounding and the expansion of its range in pharmaceutical practice is currently highly relevant.
One of the directions of the scientific work of the Department of Pharmaceutical Technology of Drugs of the National University of Pharmacy is the expansion of the range of extemporal drugs that can be prepared in pharmacies, the development of their regulatory documentation.
Aim of the study. The aim of this work is to study the range of extemporal formulations, which are produced in a pharmacy for the treatment of vegetovascular dystonia and neurosis in children; development of the composition and technology of extemporal formulation for the treatment of this pathological condition; preparation of regulatory documentation for intra-pharmaceutical product.
Materials and methods. With the help of modern pharmacotechnological, physicochemical and statistical methods, the composition, technology and methods of identifying the ingredients that are in the composition of the drug were developed, as well as the quantitative method of rapid analysis of the obtained drug [1, 3, 4].
Results and discussion. One of the most common diseases in pediatric practice is vegetodistonia, neuroses that often develop in children. Since modern ready-made drugs can cause allergic reactions in children, irritation of the gastrointestinal tract and other side effects [2], when developing the composition of the intra-pharmacy products, it was necessary to exclude the possibility of the occurrence of complications from its usage, which was one of the important criteria. We have chosen a mixture as the dosage form, since it is convenient for use in pediatric practice, can mask the unpleasant taste of medicinal substances, and has a number of other advantages [4]. Considering the pharmacological action of medicinal substances, caffeine-sodium benzoate, sodium bromide, magnesium sulfate, glucose, tincture of valerian were introduced into the composition of the medicinal product. As a solvent for the preparation of medicine purified water was used, as it meets all the basic requirements applied to excipients (good solubility of substances, indifference, etc.) of the workpiece, it was necessary to eliminate the possibility of complications from its use, which was one of important criteria. To increase the shelf life of the intra-pharmaceutical products, a solution of citral was added to its composition.
The technology of the intra-pharmacy products in pharmaceutical conditions is the following: since the drug will be used in pediatric practice, it must be prepared under aseptic conditions using freshly distilled boiled purified water. If there is no aseptic block in the pharmacy, it is allowed to prepare the medicine in a laminar block. [4]. In the auxiliary container, glucose is dissolved in the measured purified water, the obtained solution is filtered. To speed up the manufacturing process of the intra-pharmacy product concentrated solutions of caffeine-sodium benzoate 10 %, sodium bromide 20 % and magnesium sulfate 25 % are used. In the absence in the pharmacy of these concentrated solutions, the substances can be used in a dry form. In this case, taking into account the rules of dissolution of medicinal substances, firstly the potent caffeine-sodium benzoate and then all other substances are dissolved. In the last turn, solution of citral and valerian tincture is added. The prepared intra-pharmacy product is packed in a container for dispensing of dark glass. Container is labeled with the main label “Mixture” or “Internal” with additional warning signs “Keep in a dark, cool place”, “Shake well before use”, “Keep away from children”, “Prepared aseptically”.
Conclusion. The composition and technology of a children’s medicine in the form of an opalescent mixture for the treatment of vegetative-vascular dystonia and neurosis in children has been developed The use of the drug helps to improve the overall condition of the organism, cardiovascular and nervous systems. Methods of qualitative and quantitative rapid analysis of the drug have been developed, the results of which will be presented in the following publications.
References.
- Державна фармакопея України / ДП «Науковий фармакопейний центр якості лікарських засобів». – 2-е вид. – Х.: ДП «Науковий фармакопейний центр якості лікарських засобів», 2014. – Т. 3. – 732 с.
- Дрововоз, С. М. Фармакология в помощь студенту, провизору и врачу: Учебник-Справочник / С. М. Дрововоз [и др.]. 2-е изд. перераб. и доп.– Х.: Титул, 2018. – 640 с.
- Справочник экстемпоральной рецептуры / Под ред. А. И. Тихонова. – К.: МОРИОН, 1999. – 496 с.
- Стандарт МОЗ України «Вимоги до виготовлення нестерильних лікарських засобів в умовах аптек» СТ-Н МОЗУ 42 – 4.5: 2015 // За ред. О. І. Тихонова і проф. Т. Г. Ярних. – Київ, 2015. – 109 с.
- Уидани, Басcам. Анализ и технология экстемпоральной рецептуры для фармакотерапии сердечно-сосудистых заболеваний / Басам Уидани, Е. Е. Богуцкая // Инновации в медицине и фармации – 2017: матер. дистанционной науч.-практ. конф. студентов и молодых ученых; под ред. А. В. Сикорского, О. К. Дорониной. – Минск: БГМУ, 2017. – С. 681–684.