Development of technological complex for production of compounded infusion admixtures in hospital pharmacies

The modern model of infusion pharmacotherapy in hospitals involves a process-based approach, the most important "input" of which is the manufacturing of infusion admixtures and the control of infusions preparation. In Russian hospitals, production of drug admixtures is carried out by nursing staff in inappropriate conditions and with equipment unappropriated for this type of activity. In accordance with the normative documentation, manufacturing of infusion admixtures should be reserved for hospital pharmacies. Only in pharmacies it is possible to organize a manufacture complex of infusion admixtures of adequate quality under aseptic conditions. For the extemporaneous manufacturing of infusion admixtures in hospital pharmacies of the Russian Federation we have developed technological complex, which included: development of information database "Interaction of injectable drugs"; development of technological schemes of manufacturing of infusion mixtures; selection of necessary equipment; development of a system of quality control of infusion admixtures. The information database is a search engine that allows to estimate the composition of the recipe on the compatibility of components. The typical scheme of production areas of hospital pharmacy allows you to place required for aseptic manufacturing equipment with minimal costs. Step by step instruction on mixing the components of the recipe eliminates contamination in product. The system of quality control confirms the high quality of infusion admixtures. Overall, this technological complex ensures quality, efficiency and safety provided to patients of the hospital infusion therapy

Off-Label Prescribing in Paediatric Cardiology: Regulatory Aspects and Safety Assessment by Spontaneous Reporting

In paediatrics, it is a common practice to use pharmaceuticals outside the approved Summary of Product Characteristics (i.e. off-label). According to the literature, up to 45% of inpatient paediatric prescriptions and 10–20% of outpatient ones are for off-label uses. It is essential to analyse such uses, as it helps medical practitioners act reasonably and professionally.The aim of the study was to explore the possibility of using spontaneous reports to assess the risks of the off-label use of cardiac medicinal products in children in the Irkutsk region.Materials and methods. The authors analysed 25 reporting forms on adverse drug reactions (ADRs) in paediatric cardiac patients from the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region and regional data from the Automated Information System (AIS) of the Federal Service for Surveillance in Healthcare of the Russian Federation (Roszdravnadzor) submitted in 2009–2020. The inclusion criterion for reporting forms was a causal relationship between the off-label use of a medicinal product and the ADR that was scored as “possible” or higher on the Naranjo probability scale.Results. According to the reporting forms, the off-label use of cardiac medicinal products in children was associated with ADRs, such as angiooedema, cutaneous symptoms, and bronchospasm. The majority of ADRs (84%) were considered severe. The medicinal products were prescribed for heart failure, arterial hypertension, and cardiac arrhythmias. The majority of ADR reports (75%) were submitted by inpatient medical organisations.Conclusions. The analysis of spontaneous ADR reporting databases is a simple and informative method for studying the safety of medicinal products. It is necessary to raise awareness of ADRs associated with off-label prescribing amongst paediatric cardiologists in order to reduce the incidence of ADRs. The following contributions will improve the quality of medical care: all parties involved with pharmaceuticals should adhere to good pharmacovigilance practices, medical practitioners should be actively involved in treatment safety monitoring, and the professional training curricula of paediatric cardiologists and paediatricians should include specific units on the practical functioning of pharmacovigilance

Nanоbiocomposite based on dihydroquercetin and arabinogalactan in the form of a gel for external use as a means for the treatment of chronic venous insufficiency in an experiment

Background. Due to the high prevalence of chronic venous insufficiency among the population, with a decrease in the quality of life of patients and their early disability, there is a need to develop modern effective and safe means for the prevention and treatment of this pathology. We have developed the optimal composition and technology of a gel for external use based on a nanobiocomposite of dihydroquercetin and arabinogalactan, which has a venoprotective effect. The article presents data on the results of a preclinical study of the safety and specific activity of the gel.The aim. To study the specific activity (decongestant, antitranssudative action) and safety of a gel for external use based on nanobiocomposite of dihydroquercetin and arabinogalactan used for the treatment of chronic venous insufficiency in the framework of preclinical studies.Materials and methods. The object of the study was a gel for external use based on dihydroquercetin and arabinogalactan nanobiocomposite. The study was conducted on 32 white male rats of the same age, for 15 days. The study of the pharmacological activity of a gel based on a nanobiocomposite of dihydroquercetin and arabinogalactan, was carried out on a model of acute venous stagnation in the tail of a rat (edema of non-inflammatory genesis), the dynamics of tail volume growth in the experimental and control group of animals was evaluated. The irritant effect of the gel on the skin of animals was also determined, the permeability of the capillaries of the skin was determined.Results. When studying the pharmacological activity of the gel on a model of acute venous stagnation in the tail, it was shown that a soft dosage form for external use developed on the basis of nanobiocomposite of dihydroquercetin and arabinogalactan has decongestant and antitranssudative activity. The presence of a locally irritating effect in the gel under study has not been established in the framework of the experiment.Conclusion. In the course of preclinical study of the gel of the nanobiocomposite dihydroquercetin and arabinogalactan on laboratory animals, its antitranssudative activity and safety have been proven

The interchangeability of drugs from line items of pharmaceutical compliance and clinical efficiency and safety

Questions of replacement of original medicines with generic are discussed. The sintesation of identical medicine is a complex challenge from the technological point of view. It is caused by distinctions in production of substances, influence of the variable pharmaceutical factors giving change of the size of particles, a different amorphous forms, a deviation of structure and quantitative content of impurity. Auxiliary substantion characteristics of a production process of ready dosage forms matter. Data on pharmacokinetic equivalence of each generic to original are necessary. For carrying out pharmacotherapy original medicine which receive as a result of the researches executed under the regulated protocol needs data on comparative therapeutic efficiency and shipping the generic of drugs

Влияние гепа-мерца на содержание аденозиндифосфата в эритроцитах крови больных с тяжелым течением острого гепатита В

Обстежено 160 хворих на гострий гепатит В (ГГВ) тяжкого перебігу. Усіх хворих поділено на наступні вікові групи: 1) 20-39 р., 2) 40-49р., 3) 50-59р., 4) 60 років і старші. Кожній віковій групі відповідала одновікова група донорів. Хворі на ГГВ (n=80) отримували базисну терапію, хворим в групі порівняння (n=80) до базисної терапії додавали гепа-мерц. В результаті проведених досліджень встановлено, що ГГВ тяжкого перебігу супроводжується зниженням вмісту аденозинтрифосфата (АДФ) в еритроцитах крові. Глибина виявлених змін залежить від віку і статі хворих. Лікування хворих на ГГВ тяжкого перебігу із застосуванням гепа-мерцу призводило до відновлення рівня АДФ у крові хворих всіх вікових групах.There were investigated 80 patients with AHB aged from 20 to 60 and older who were divided into four age groups. Each age group corresponded to a group of donors of the same age. The studies found that acute hepatitis B of the severe course was accompanied by a decrease in the content of AMP in red blood cells. The depth of the detected changes depends on the age and sex of the patients. Hepa-Merz application had of a positive influence on the content of AMP in erythrocytes in severe AHB. After treatment with Hepa-Merz the AMP content in the blood was significantly higher than the similar indices in patients who were not added Hepa-Merz to a common scheme. Higher content of AMP was observed in female patients, especially in the first and second age groups.Было обследовано 160 больныхс острым гепатитом В (ОГВ) тяжелого течения. Всех больных разделили на следующие возрастные группы: 1) 20-39 л., 2) 40-49л., 3) 50-59 л., 4) 60 лет и старше. Каждая возрастная группа подразделена по полу. Каждой возрастной группе соответствовала одновозрастная группа доноров. Больные ОГВ основной группы (n=80) получали базисную терапию, больным в группе сравнения (n=80) к базисной терапии добавляли гепа-мерц. В результате проведенных исследований установлено, что ОГВ тяжелого течения сопровождается снижением содержания аденозинтрифосфата (АДФ) в эритроцитах крови. Глубина выявленных изменений зависит от возраста и пола больных. Лечение больных ОГВ тяжелого течения с применением гепа-мерца приводило к восстановлению уровня АДФ в крови во всех возрастных группах больных

Growth and filling regularities of filamentary channels in non-metallic inorganic coatings under anodic oxidation of valve metals. Mathematical modeling

Theoretical models are developed for growth and filling processes in filamentary channels of nanostructured non-metallic coatings produced by anodizing and microplasma oxidation. Graphical concentration distributions are obtained for channel-reacting anions, cations, and sparingly soluble reaction products depending on the time of electric current transmission and the length of the filamentary channel. Graphical distributions of the front moving velocity for the sparingly soluble compound are presented. The resulting model representation increases the understanding of the anodic process nature and can be used for a description and prediction of porous anodic film growth and filling. It is shown that the character of the filamentary channel growth and filling causes a variety of processes determining the textured metal – nonmetallic inorganic coating phase boundary formation

Growth and filling regularities of filamentary channels in non-metallic inorganic coatings under anodic oxidation of valve metals. Mathematical modeling

Theoretical models are developed for growth and filling processes in filamentary channels of nanostructured non-metallic coatings produced by anodizing and microplasma oxidation. Graphical concentration distributions are obtained for channel-reacting anions, cations, and sparingly soluble reaction products depending on the time of electric current transmission and the length of the filamentary channel. Graphical distributions of the front moving velocity for the sparingly soluble compound are presented. The resulting model representation increases the understanding of the anodic process nature and can be used for a description and prediction of porous anodic film growth and filling. It is shown that the character of the filamentary channel growth and filling causes a variety of processes determining the textured metal – nonmetallic inorganic coating phase boundary formation