Domestic Drugs Research Articles

Improving access to domestic innovative medicines: characteristics and trends of approved drugs in China 2010-2024.

China has initiated drug regulatory reforms since 2015. Here, we analyze the characteristics and trends of domestic innovative drugs approved for marketing in China from January 2010 to May 2024 to explore the effectiveness of drug regulatory reform. Overall, 219 drugs were approved, with growth in chemicals and therapeutic biologics post-reform. Single-arm trials as an important option for clinical trial design of antineoplastic agents increased. The time for each link from investigational new drug (IND) to new drug application (NDA) has been shortened post-reform. Moreover, the time for access to medical insurance for approved drugs has been shortened and price reductions have been increased. China's drug regulatory reforms have made progress in improving the accessibility of domestic innovative drugs.

Modern Russian drugs for the treatment of neurodegenerative diseases

Neurodegenerative diseases are characterized by progressive death of nerve cells of certain types with concomitant atrophy of the corresponding parts of the spinal cord or brain, which is symptomatically manifested by severe neurological and cognitive impairment. These diseases can manifest at any age and be caused by both genetic predisposition and inflammatory and autoimmune processes. Diseases of this group are a common cause of disability and mortality. Thus, the development of new effective domestic drugs for their treatment is an important task for the healthcare system of the Russian Federation. In this review is devoted to the analysis of Russian original and bioanalog organic and genetically engineered drugs for the treatment of neurodegenerative diseases that have been registered in recent years or are currently undergoing clinical trials in Russia.

Efficacy and safety of bioregulatory peptides in the treatment of prostate diseases: a review

The article describes the risk factors, pathogenetic mechanisms of development of various prostate diseases and highlights the problems in their treatment. Information on regulatory peptides and their mechanism of action is presented. Clinical studies proving the high effectiveness of bioregulatory peptides in the treatment of chronic prostatitis, chronic pelvic pain syndrome and benign prostatic hyperplasia are presented. The analysis was carried out and evidence of the effectiveness of domestic drugs Prostatex and Prostateks Plus in the treatment of prostate diseases was presented.

Use of domestic biological drugs in reproduction of cattle

purpose of the work was to analyze the use of domestic biodrugs in the reproduction of cattle. In the scientifi c and economic experiment, three groups of dry cows (control, 1st and 2nd experimental) were formed according to the principle of analog groups, taking into account the clinical and physiological condition, age and live weight. In the 2nd series of the experiment, 3 groups of newborn heifers were formed in accordance with the groups of dams. The work scientifi cally substantiates and experimentally proves the eff ectiveness of using complex immunomodulatory biodrugs consisting of two main active components (yeast cells and vitamins) Salus-PE and Bovistim-K, in the technology of cow reproduction and calf rearing. It has been established that the use of biodrugs in late pregnant cows improved the course of the calving and postpartum periods, increased milk productivity and colostrum quality, forms stable colostral immunity in newborn calves, reduced the risks of respiratory and gastrointestinal diseases in young animals, contributing to better live weight gains. The tested complex immunomodulatory biodrugs activate hematopoiesis, compensatory mechanisms of the body, the population of immune cells in the blood, increased protein metabolism, the expression profi le of cellular and humoral factors of non-specifi c resistance. The use of the developed biodrugs during decornuation stimulated tissue regeneration, accelerated the process of scab formation, normalized the level of γ-globulins, activated the synthesis of α- and β-globulins, oxidation-reduction processes and metabolism, which ensured an increase in the immune status of the body of calves in the neonatal period. The economic effi ciency of using the biodrugs Salus-PE and Bovistim-K in the technology of cow reproduction in the 1st and 2nd experimental groups based on 1 ruble of additional costs was 2.63 and 4.50 rubles, and in the technology of raising calves 6.85 and 11.20 rubles, respectively.

Directions of improving management of innovative activities in pharmaceutical companies

The purpose of the work is to substantiate theoretical provisions and practical recommendations for improving the management of innovative activities of pharmaceutical companies (PC) for the implementation of strategic tasks regarding innovative development and increasing competitiveness. Materials and methods. To achieve the goal of the study, scientific sources on innovation management and intellectual property management and the peculiarities of the organization of innovation processes in pharmacy were analyzed. When conducting research, methods of information search, systematization, comparison, and generalization were used, as well as the method of expert evaluations, taxonomic analysis, and a graphic method to increase the clarity of the presentation of the material. The results. The main directions and features of innovative activity in pharmacy have been studied. A generalized algorithm for managing innovative activities in pharmaceutical companies is given. The relevance of evaluating and managing the innovative potential of PC to achieve a synergistic effect from the use of resources involved in innovative activities is substantiated. A structural model of the innovative potential of PC is proposed, which considers the peculiarities of the flow of innovative processes in pharmacy, related to the development and introduction of new pharmaceuticals to the market. A methodical toolkit for quantitative and qualitative evaluation of the innovative potential of PC has been defined. To improve the management of the PC's innovative activity, a methodology for determining the range of management decisions is proposed based on the results obtained in the framework of creating a report on the patent landscape. Conclusions. In order to achieve the provision of effective and safe domestic drugs to the population of Ukraine, it is necessary to intensify research in the direction of the formation of an effective system of management of the innovative activity of pharmaceutical companies (PC), focused on their gradual transition to an innovative development model. The conducted analysis showed that despite a sufficiently large number of publications devoted to the problems of innovation management, issues related to the problem of forming an effective system of managing the innovative activity of PCs, as well as choosing an effective toolkit for evaluating and managing their innovative potential, taking into account the specifics of the flow of innovative processes in pharmacy, remain insufficiently disclosed and require further research. The proposed structural model of the innovative potential of the FC, a justified methodological toolkit for its assessment, as well as the construction of a cognitive map to determine the most appropriate key components and directions for further improvement and development of the innovative potential will contribute to increasing the efficiency of the innovative activities of enterprises and the implementation of the goals of the innovation strategy. The developed algorithm of preventive management of innovative activity of the PC, aimed at improving the quality of decisions made on innovation management thanks to the use of patent landscape tools, will also contribute to the faster entry into the market of domestically produced innovative medicinal products

Marketing analysis of the Russian pharmaceutical market of oxaliplatin

Relevance. Colon and ovarian cancer occupy leading positions in the structure of morbidity and mortality among malignant neoplasms in Russia. One of the widely used drugs for the treatment of these nosologies is oxaliplatin, but there is no relevant information to assess its availability and share among other antitumor drugs.Objective. Analysis of the Russian pharmaceutical market for oxaliplatin drugs among other antitumor drugs in 2015–2022.Materials and methods. For the analysis, reports from marketing agencies DSM Group and IMS were used, both in value and in physical terms.Results. During the period under study, significant changes occurred in the Russian pharmaceutical market of antitumor drugs: the volume of sales and consumption increased, which was also accompanied by a decrease in the cost of drug units per package (all antitumor drugs) and course of use (oxaliplatin). At the same time, the share of Russian manufacturers of antitumor drugs has increased. In relation to oxaliplatin, during the study period there was almost complete displacement of the original drug from the market by generic drugs. An intensive process of import substitution was also observed: the share of domestic drugs increased by the end of the study period in value and volume terms to 93 and 95%, respectively.Conclusion. Identified changes in the Russian pharmacological market for 2015–2022 reflect an increase accompanied by an increase in the availability of antitumor drugs and, in particular, oxaliplatin.

Modern gene therapy drugs

Gene therapy is a modern and effective approach for treating diseases previously considered incurable by traditional methods. Its main strategy is to transfer the genetic material into the patient’s somatic cells to inhibit or promote the expression of a target gene/protein associated with disease development. This type of therapy is used in patients with few or no alternative treatment options.
 Over the past two decades, gene therapy has produced promising clinical results, with many products approved for treating severe oncologic, hematologic, infectious, orphan, and/or inherited diseases, including monogenic and metabolic diseases. The scope of clinical indications and tissue targets for gene therapy is expanding every year.
 This review examines new genetically engineered drugs recently introduced in global and domestic markets. These drugs are based on molecules of small interfering RNA (siRNA), mRNA, antisense nucleotides, and viral and plasmid vectors. Each group of drugs is unique and has its mechanism of action, depending on the purpose of the therapy.

Modern aspects of external application and prospects of using the secretome of mesenchymal stem cells (review)

Introduction. The secretome of mesenchymal stem cells (SMSC) is widely used in medicine. It is most often used due to its immune-modulating and regenerative properties in the treatment of autoimmune, immuno-mediated and other diseases due to its anti-inflammatory, neuroprotective and regenerating action. In many studies, exosomes isolated from SMSC are used as a therapeutic agent. In recent years, the interest in the development of products containing SMSC for external use has increased. Similar drugs are planned to be used in the treatment of diabetic wounds, for skin regeneration, the treatment of inflammatory diseases, as well as alopecia. There are multiple studies on increasing collagen secretion and reducing skin photosensitivity in preclinical studies, which confirms the significant potential for the use of SMSC in dermatology and cosmetology. The purpose of this review was to study the potential of using conditioned medium in medicines for external use, approaches to standardization of SMSC as a pharmaceutical substance and methods of increasing percutaneous delivery.Text. SMSC as an active pharmaceutical ingredient is a transparent liquid from yellow to orange in color with a characteristic odor. The pH of the ready-to-use SMSC composition ranges from 7.0 to 7.5, which allows it to be used in topical and external applications without the addition of stabilizers or pH correctors. Problems of delivery of SMSC through the epidermis are most often solved by placing the secretome in hydrogels, using exosomes or technology using microneedles. Since 2022, after legislative changes, measures have been taken to register and introduce into clinical practice domestic drugs based on cellular products. However, as the analysis showed, it will take some time before the appearance of original medicines based on SMSC, and today in the Russian Federation only products related to cosmetics and veterinary drugs, as well as zoocosmetics, are produced so far.Conclusion. SMSC may also prove to be a safer and more effective substance for the potential treatment of a wide range of acute and chronic diseases. But despite the large number of positive results of using SMSC for wound healing in animals, as well as clinical studies on skin regeneration, there are no studies of its safety and effectiveness, as well as standardization of the production process.

In Vivo Bioequivalence Study of Drug: An Analysis of Bidding in Vietnam Period 2018 - 2022

To promote the development of bioequivalent drugs, the Ministry of Health of Vietnam has classified a separate bidding group for bioequivalent drugs. According to the results of bidding for bioequivalent drugs in the period 2018 - 2022 has achieved very encouraging results, the ratio of domestic bioequivalent drugs compared to foreign bioequivalent drugs winning bids is from 2.13 to 3.63 times higher. Regarding active pharmaceutical ingredients of bioequivalent drugs, bioequivalent drugs with the highest total winning value (including all dosage forms, concentrations,...) focus mainly on antibiotics (cefuroxime, cefixime,…), anti-diabetic drugs (gliclazide, metformin,...), high blood pressure drugs (amlodipine), antipyretic and pain relievers (paracetamol). The winning drug dosage forms are still mainly conventional dosage forms (tablets, film-coated tablets, capsules) and their active ingredients are almost single. In particular, several multi-component bioequivalence drugs have a large total winning value but do not belong to the pharmaceutical group on the list of mandatory bioequivalence test reports when registering the drug, such as the combination of Gliclazide + Metformin; Glibenclamide + Metformin; Glimepiride + Metformin. The trend of selecting pharmaceutical substances/groups of pharmaceutical substances that manufacturers focus on researching/registering bioequivalent drugs in Vietnam is focused on drugs on the list of drugs covered by health insurance.

The study of the physicochemical properties of rectal cream samples with the carrot extract and rutin

The modern arsenal of drugs aimed at eliminating pathological processes of the anorectal zone, as a rule, consists of suppositories and soft drugs. When using suppositories, hemorrhoidal nodes may be injured, uneven distribution of the drug along the walls of the anal canal may be observed. In addition, with external and combined hemorrhoids, there is a need to apply the drug not only to the walls of the anal canal, but also to the perianal skin. Therefore, preference is given to the use of soft drugs since the process of their introduction is as easy as possible. Today, the pharmaceutical market of Ukraine has a wide range of products for the treatment of diseases of the anorectal zone, but the constant increase in the number of patients indicates that this problem has not been solved. Therefore, the study on the creation of a new rectal soft medicine that will have a complex effect on pathological processes and expand the range of domestic drugs for use in proctology is relevant. Aim. To substantiate the type of base for a soft rectal medicine by studying the organoleptic and physicochemical properties of the experimental samples. Materials and methods. The study objects were samples of a soft dosage form of various compositions and the reference drug “Procto-Glivenol Cream” (VAMPHARMA S.R.L., Italy). Samples on different carrier bases were examined by their organoleptic and textural properties; their colloidal and thermal stability, viscosity and pH were studied. Results and discussion. It has been found that the use of a sample on a gel base with Aristoflex does not ensure the presence of an optimal adhesive layer between the mucous membrane of the anorectal zone and the dispersion medium of the drug. The proxanol-188 sample does not have satisfactory thermal and colloidal stability indicators. The use of an emulsion base provides the necessary ability to spread over the surface, adhesion and cohesion. Conclusions. Therefore, for further research, it is advisable to use a sample of the rectal cream, which is an emulsion system.

Marketing research of the ukrainian pharmaceutical market of medicines for cognitive impairment

The war in Ukraine causes people constant nervous tension and stress, as a result, there is an increase in the number of cases of diseases of the nervous system. It has been established that worsening of cognitive impairment is more often diagnosed, so there is a need for proper rational pharmacotherapy. The presence of cognitive impairment occurs in almost 30% of patients with post-COVID syndrome and in 70% of patients in the first 6 months after a stroke. Nootropic drugs are increasingly being used to restore and improve cognitive function. The aim of our research was to study the range of drugs of the ATC group N06B X «Various psychostimulants and nootropics», which are presented on the pharmaceutical market of Ukraine as of February 2024 for formation of needed offers of domestic and foreign drugs during wartime, optimization of meeting the needs of patients with cognitive impairment, and relevance of drugs development by domestic manufacturers. In order to conduct marketing research, an analytical review of information sources on the reference group of drugs registered on the Ukrainian market (psychostimulants and nootropics) was used: The State Register of Drugs, the Compendium, instructions for the use of drugs. The methods of our research were information search, generalization, marketing research, graphical and mathematical and statistical methods. The results of the analysis of the ATC of group N06B X «Various psychostimulants and nootropics» showed that 17 active pharmaceutical ingredients are registered in the modern pharmaceutical market of Ukraine, which are represented by 156 trade names (TN). We conducted a study of the range of drugs ATC of the N06B X group «Various psychostimulants and nootropics» depending on the country of manufacture. It has been established that the drugs of this group are represented by 12 countries. Analysis of the nomenclature in the pharmaceutical market of Ukraine showed that 95 TN are produced by 24 Ukrainian manufacturers, 61 TN – by 20 foreign manufacturers. It was found that pramiracetam and phenylpiracetam preparations are represented only by foreign manufacturers, which indicates the need to introduce to the market new drugs of domestic production. In the studied assortment of drugs of the reference group, 90% of the total number are monocomponent drugs. The most common forms of drugs in this group are solutions for injection (40%) and tablets (35). The largest share of such dosage forms as solutions for injection and tablets is represented by cytocoline and piracetam preparations, which indicates a high need for such dosage forms of this group of drugs in the treatment of cognitive impairment. The results of the study may be relevant in the formation of the necessary assortment of drugs in pharmacies to meet the needs of patients with cognitive impairments.

Economic analysis of the use of drugs for the treatment of hemophilia A, B and Willebrand's disease

Relevance. Therapy of hemophilia A, B and Willebrand's disease is carried out under the program of 14 VZN due to the use of federal budget funds. The use of funding is increasing in line with the growth of the total number of patients. In 2022,85.99 billion rubles were allocated, which corresponds to a 1.5‑fold increase in funding compared to 2018. The aim of the study was to conduct an economic analysis of the use of drugs for the therapy of hemophilia A, B and Willebrand's disease. Methods. The materials for the analysis were the dosing regimen of LPs selected on the basis of clinical recommendations, the availability of LPs in the 14 VZN program, and the prices for LPs from the State Register of maximum selling prices for VED drugs. Costs of on demand prophylaxis and treatment regimens for hemophilia A, B and Willebrand's disease according to clinical recommendations for each INN for all trade names (TN) were assessed. Results. For hemophilia A the number of submitted drugs by INN is 7;IN — 14; of them domestic drugs were submitted — 1. The minimum cost of LPs for prophylaxis is 2 584 764,00 rubles. Coit-DVI (Grifols Therapeutics LLC, USA), and the maximum cost is RUR 9,955,517.21. Advait (Takeda Manufacturing AG, Austria). Forhemophilia B, the number of represented PL — 2 INN; INN — 6; domestic drugs — 2. The minimum cost is RUR 1,559,376.00. Innonafactor (AO Generium, Russia), maximum — 3 079 319,88 rubles for a year course of prophylaxis LP Immunin (TakedaManufacturing, Austria). To stop bleeding in patients with inhibitor form use anti-inhibitor coagulant complex (Feiba, Austria), which is necessary on average 9100 units per 1 patient, and the average cost of application — 430 863,52 rubles or eptacog alpha(activated) (Coagil-VII, Russia) at multiple administration to the patient 6 times a day — maximum cost — 2 739 803,64 rubles or once a day — 293 550,35 rubles. Conclusion. In the structure of drug supply for patients with hemophilia, domestic drugs are represented by 5 names: Octofactor (JSC "Generium", Russia); Agemfil B (FGBU "NMIC Hematology" of the Ministry of Health of Russia, Russia) and Innonafactor (JSC "Generium", Russia); ArioSaven (LLC "PSK Pharma", Russia) and Coagil-VII (JSC "SG Biotech", Russia). There are no domestic drugs available for the therapy of Willebrand's disease.

Analysis of drug list used in E Hospital in 2021

Objective: General analysis and analysis according to ABC/VEN of drugs list (DL) used at Hospital E (HE) from January 1, 2021 to December 31, 2021 by retrospective analysis. Research subjects and methods: Descriptive and retrospective study of all DL used at Hospital E from January 1 to December 31, 2021, drug use report of Hospital E in 2021 and related documents regarding DL of Hospital E from January 1 to December 31, 2021. Exploiting data at the Faculty of Pharmacy Hospital E, combined with exploiting the DL management software of the Faculty of Pharmacy, Hospital E in 2021. Results: The structure of DL HE in 2021 includes 566 drugs divided into 28 groups of pharmacological effects (PE), foreign drugs dominate over domestic drugs, single-component drugs account for a larger proportion, parenteral drugs, infusion predominates. According to ABC analysis: Group A accounted for 77.38% of value with 112 drugs divided into 19 groups of physical exercise. Group B accounted for 15.03% of value with 113 drugs divided into 22 groups PE. Group C accounted for 7.59% of value. According to VEN analysis: the vital drugs (V) have 105/566 drugs, accounting for 18.55% of the items. Essential drugs (E) have 401/566 drugs, accounting for 70.85% of items. Non-essential drugs (N) have 60/566 drugs, accounting for 10.60% of the items. According to the ABC/VEN matrix: The most important group (I): including AV, AE, AN, BV, CV: 35.87% items, 80.55% value. The important group (II): including BE, BN, CE: 58.65% items, 18.55% value. The less important group (III): CN: 5.48% items and 0.90% value. Key words: Drugs List (DL); Hospital E (HE); ABC/VEN matrix; Original brand name medicine (OBNM).

Prospects for development of the domestic hemostatic drugs market based on analysis of B02BC group sales

Prospects for development of the domestic hemostatic drugs market based on analysis of B02BC group sales

The scientific achievements of the pharmacologists from the Republic of Moldova between years 1988–2024

The main areas and directions of the scientific research are revealed, with a brief description of the most important outcomes obtained as a result of their implementation in medical practice, recognized and confirmed in various ways: scientific publications, patents, domestic drugs developed and authorized, published monographs and textbooks, scientific theses, state programs, scientific projects and grants obtained, various national and international scientific forums – all aimed at ensuring rational, effective and harmless pharmacotherapy. The discipline "Clinical Pharmacology" has been included in the university curriculum; the specialty "Pharmacologist-clinician" has been implemented in the Public Medical-Health Institutions of the Republic of Moldova; the concept of rational use of drugs and the Pharmaco-therapeutic Formulary System have been developed and implemented; the scientific support dedicated to the "Clinical Pharmacology" service has been edited.

Инсектоакарицидная эффективность современного отечественного антипаразитарного препарата OKVET® EXPRESSTABS®

Currently, there is an urgent issue about import substitution with highly effective domestic drugs used in veterinary medicine for the treatment of diseases of parasitic etiology: ixodidosis, aphonipterosis, trichodectosis, otodectosis, sarcoptic mange and others. The article presents data on the study of the insectoacaricidal effectiveness of the modern domestic antiparasitic drug OKVET® EXPRESSTABS ® tablets on dogs spontaneously infested with Ixodes ricinus, Ixodes persulcatus, Dermacentor reticulatus, Ctenocephalides canis, Trichodectes canis, Otodectos cynotis and Sarcoptes spp. As a result of the studies, it was found that the acaricidal effectiveness of the drug OKVET® antiparasitic tablets for ixodidosis lasts 35 days, the insecticidal effect against Ctenocephalides canis and Trichodectes canis in dogs was observed already 2 days after use and lasts 42–45 days, and an acaricidal effect was also established against scabies mites Otodectos cynotis and Sarcoptes spp., since scabies mites were not diagnosed in dogs on the 28th day after application. These studies indicate high effectiveness OKVET® antiparasitic tablets, which are not inferior to imported analogues.

Перспективи внутрішньоутробного лікування запальних змін евентрованих органів при гастрошизисі у плодів (огляд літератури)

Gastroschisis (GS) - is one of the most severe defects of newborns, which is characterized by congenital eventration of the abdominal organs outside the anterior abdominal wall into the amniotic fluid, due to a through defect of the anterior abdominal wall. The defect is adjacent to the normal, unaltered umbilical cord, usually to the right of the umbilicus, the umbilical ring is split, the eventrated organs are not covered by embryonic membranes or their remains. The frequency of gastroschisis is 0.31-4.72 per 10,000 births. Although, with the development of modern surgical approaches over the past 15 years, the mortality of newborns with gastroschisisis dynamically decreasing, however, this pathology remains a significant problem in neonatal and pediatric surgery, as it requires early surgery, associated with a significant risk of disability in children due to short bowel syndrome, abdominal cancer and recurrent esophageal disease, adhesive intestinal obstruction, etc. Purpose - to analyze, according to the literature, the prospects for the use of cellular technologies for the in utero treatment of inflammatory changes in the enteric organs in fetal GS in experimental conditions. The main reason for the unsatisfactory results of GS treatment is the pathological changes of the eventrated organs and their consequences. Therefore one of the ways to reduce mortality in GS is intrauterine treatment and the prevention of inflammatory changes of the eventrated organs in the fetuses. Modern regenerative medicine offers several new approaches for the treatment of fetal malformations, including the use of cell technology. Stem cells, from various sources, are one of the alternative therapies that can inhibit inflammatory processes in tissues, activate endogenous reparative mechanisms, and, ultimately, together with the implementation of preventive measures, reduce perinatal mortality and disability. The availability of domestic cell drugs, the development of technologies for their transplantation, and methods of delivery of pregnant women with GS in the fetus, with proven clinical efficacy, will significantly improve the comprehensive treatment of patients with congenital malformations, which is significant social and economic importance. Therefore, the study of regenerative potential and assessment of the prospects for the use of stem cells in obstetrics and perinatal medicine from various sources is of great scientific and practical interest. No conflict of interests was declared by the authors.

Analysis and Evaluation of Prospects for the Development of New Drugs Derived from Benzodiazepines

Introduction. The use of drugs derived from benzodiazepine for the treatment of various diseases continues to be relevant. Benzodiazepines are approved by most regulatory authorities around the world. Despite the large number of side effects and non-medical use, they are becoming more promising in emergency care for prolonged seizures and epileptic status.Aim. To analyze the existing medicines on the market of the Russian Federation based on benzodiazepine derivatives and assess the prospects for development in this direction.Materials and methods. The study was conducted on the basis of regulatory legal acts in the field of healthcare and the circulation of medicines, publications of Russian and foreign authors, the results of scientific research using situational, comparative, structural-logical and content analysis methods. The information base of the study was the online database "State Register of Medicines" (grls.minzdrav.gov.ru), databases of peer-reviewed publications: PubMed and Scopus.Results and discussion. Data were obtained on the range of medicines derived from benzodiazepines according to the following indicators: international nonproprietary names, trade names, medicines, manufacturing countries and enterprises, dosage forms. The problem of "medicinal sovereignty" is discussed. Promising niches have been found for the development of innovative drugs derived from benzodiazepines.Conclusion. It has been established that mainly domestic benzodiazepine-type drugs are represented on the Russian pharmaceutical market, while there is a certain shortage of pharmaceutical substances. In Russia, such dosage forms as films, transdermal plasters and preparations for the inhalation use of benzodiazepine derivatives are not registered. It is important to create innovative dosage forms capable of providing a fast, non-invasive and socially acceptable method of use and a high rate of adherence to treatment by patients.

The Effect of Original Russian Neurotropic Drugs on Organic Anion Transporting Polypeptides OATP1B1 and OATP1B3.

In experiments on HepG2 cells, we studied the effect of the original domestic neurotropic drugs omberacetam, fabomotizole, and ethylmethylhydroxypyridine succinate (EMHPS) (1-500 μM) on the activity and content of organic anion transporting polypeptides OATP1B1 and OATP1B3. It was shown that omberacetam (500 μM) increased the content of OATP1B1 and OATP1B3, fabomotizole did not affect the level of both transporters, and EMHPS (500 μM) increased the content of OATP1B1 compared to the control and did not affect the level of OATP1B3. The tested substances also reduced the OATP1B1/OATP1B3 ratio, as evidenced by a decrease in the penetration of atorvastatin, a substrate of the transporters, into HepG2 cells in the presence of omberacetam (100-500 μM), fabomotizole (500 μM), and EMHPS (10-500 μM). Evaluation of clinical significance of the obtained results, according to the FDA approach based on the calculation of the Cmax/IC50 ratio, showed that the effect of the tested substances on OATP1B1/OATP1B3 is clinically insignificant.

Response of Mouse Ovaries to Stimulation witch ihe FSH-SU-PER Drug

Hormonal preparation of female egg donors is one of the first stages in obtaining genetically modified animals by microinjected zygote transplantation. A large number of embryos synchronized in development can be obtained by a superovulation procedure based on treating female animals with gonadotropins. As a rule, drugs from different manufacturers differ markedly in terms of their efficacy. In the context of sanctions imposed on the Russian Federation, attention should be paid to domestic hormonal drugs, thus substantiating their objective assessment. It was shown that different batches of the FSH-SUPER drug, used mainly for hormonal treatment of farm animals, differed in stimulating effect on superovulation in female mice. At the same time, the efficacy of this drug surpassed that of Follimag (Mosagrogen, Russia).