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Pharmacy & Pharmacology

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Vol 13, No 3 (2025)
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https://doi.org/10.19163/2307-9266-2025-13-3

RESEARCH ARTICLE

142-156 49
Abstract

Rhinitis medicamentosa (RM) is a common complication of prolonged use of nasal decongestants, leading to structural changes in the nasal mucosa. Despite the effectiveness of intranasal glucocorticosteroids, their use may be accompanied by side effects.

Tha aim. To investigate the efficacy and safety of the original combined intranasal therapy consisting of mometasone furoate and dexpanthenol as the main active ingredients in experimental animals.

Materials and methods. An efficacy research was conducted on 18 Chinchilla Soviet rabbits: 3 individuals without RM (control) and 15 individuals with induced RM. The model of induced RM was confirmed by histological examination of the nasal mucosa of 3 randomly selected out of 15 animals after necropsy. The remaining 12 rabbits with RM were divided into 4 groups (n=3): untreated, as well as those with induced RM without treatment, those treated with 5% dexpanthenol, those treated with 0.05% mometasone furoate, and those receiving combination therapy with the two above drugs. RM was induced by administration of 0.1% xylometazoline for 14 days. The safety assessment experiment was conducted on 80 outbred rats (4 groups of 10 females and 10 males each: 3 groups with combined therapy at doses of 50, 200 and 800 µl, respectively, and 4 group (control) with saline) with 28-day intranasal administration. To assess the effectiveness, histological analysis (assessment of structural changes in the nasal mucosa) and photoplethysmography (assessment of the microcirculation of the nasal cavity by cold sampling) were used. To assess the safety of combination therapy, the clinical condition of animals, hematological and biochemical studies, assessment of the hemostasis system, and histological analysis of internal organs were performed.

Results. The histological examination revealed pronounced dystrophic changes in the nasal mucosa in animals with induced MR without treatment, moderate inflammation with dexpanthenol monotherapy and structural restoration in the mometasone furoate monotherapy and combination therapy groups. The best efficacy was observed in the combination therapy group, in which the histological pattern fully corresponded to the structure of the nasal mucosa of healthy animals, in contrast to mometasone furoate monotherapy, where histological signs of incomplete repair were observed. It should be noted that photoplethysmography also confirmed a statistically significant improvement in microcirculation in the combination therapy group compared with the control (p <0.05), approaching the indicators of healthy animals. The results of the study also proved the safety of the original intranasal combination. 

Conclusion. The drug combination has demonstrated superiority over monotherapy by the individual components included in its composition, providing hydration and restoration of the nasal mucosa, as well as normalization of microcirculation in it. The photoplethysmography method has shown its effectiveness for noninvasive assessment of blood flow in the nasal mucosa. The data obtained substantiate the prospects for further study of the above-mentioned combination therapy with intranasal administration to assess the efficacy and safety of MR treatment in clinical trials.

157-170 22
Abstract

The development of innovative antipsychotic drugs is one of the key tasks of modern pharmacology. Due to their unique chemical properties, benzimidazole derivatives demonstrate diverse neuropsychotropic effects, highlighting their high potential as antipsychotic agents. Bioinformatics methods enable optimization of the process of identifying compounds with high affinity for target receptors.

The aim. To identify and evaluate benzimidazole derivatives with atypical antipsychotic activity using QSAR analysis and pharmacophore modeling, followed by in vivo experimental testing in preclinical models of psychotic disorders.

Materials and methods. QSAR models were constructed based on data from 2615 compounds from the ChEMBL database. Pharmacophore modeling was performed based on the structure of the 5-HT2A receptor (PDB ID: 6A94). The antipsychotic activity of the most promising compound was assessed in vivo using tests with apomorphine in rats and mice.

Results. Machine learning models were developed and tested to predict the antipsychotic activity of benzimidazole derivatives. The Neural Networks (MAE=0.019) and Random Forest (MAE=0.020) algorithms demonstrated the highest prediction performance. Pharmacophore modeling of interaction with the 5-HT2A receptor identified a promising compound for further testing. Compound RU-31 demonstrated significant reduction (p <0.05) in climbing behavior in mice (ED80=10.16 mg/kg intraperitoneally) and high efficacy when administered with low presynaptic doses of apomorphine (yawning frequency decreased by 49,3% compared to control, p  <0.05).

Conclusions. Compound RU-31 showed activity in the climbing test and in the test with low presynaptic doses of apomorphine, suggesting potential atypical antipsychotic effects. Benzimidazole derivative RU-31 is a promising candidate for further investigation in the development of novel atypical antipsychotics.

171-183 17
Abstract

Today, there is an annualincrease in the prevalence of obesityandoverweightworldwide.Thisproblem is becomingparticularlyrelevant,sincetheseconditionsserve as keyriskfactors for the development of anumber of cardiovascularandmetabolicdisorders,including type 2diabetesmellitus(T2DM).On the territory of the Russian Federation, drugswerepresentedasagonists of glucagon-like peptide of the first type (GLP-1)receptors, the activesubstance of which was producedexclusively by biotechnologicalmeans. It is important to notethat solid-phasechemicalsynthesisisalsooneof the alternativemethods for obtainingGLP-1analogues. A significantadvantage of thismethodoverbiotechnologicalsynthesisis the exclusion of spontaneousamino acid substitutionsand the absence of impuritiescharacteristicofthismethod.

The aim. Evaluation of the biological activity of the domestic medicinal product liraglutide (Enligria®, solution for subcutaneous administration, 6 mg/ml, PROMOMED RUS LLC), obtained by chemical synthesis, and a foreign reference drug (Saxenda®,solutionforsubcutaneousadministration,6 mg/ml,NovoNordiskA/C),obtainedbiotechnologically.

Materials and methods. The effectiveness of liraglutide preparations was evaluated using a model of induced metabolic syndrome in CBA×C57BL/6 SPF mice (n=36,age6months)according to changes in body weight,feedintake,bloodglucoseandlipid levels, and adiposetissuemass.

Results. According to the results of the study, it was shown that Enligria® and Saxenda® drugs have comparable efficacy parameters and statistically significantly (p < 0.05) reduce body weight (13.6±2.1% and 13.3±3.3%, respectively), glucose levels (18 ± 3% and 16 ± 9%), triglycerides (32 ± 12% and 40 ± 18 %) and cholesterol (16 ± 7% and 18 ± 9%) in the blood. Enligria® reduced the mass of structural subcutaneous fat by 32 ± 3% (p < 0.0001), and visceral fat by 34 ± 4% (p < 0.0001). The studiedliraglutidepreparationsshowed a pronouncedhypoglycemiceffect,observedinalldoseranges. The observedhypoglycemiceffectwasdose-dependent.

Conclusion. The results of the work indicate the high effectiveness of the synthetic drug Enligria®, which is expressed in reducing body weight and improving metabolic parameters.

184-201 26
Abstract

One of the key factors in ensuring the availability of modern treatments and choosing the optimal therapy for patients is the clinical and economic characteristics of new medical technologies.

The aim: to assess the clinical and economic feasibility of using sonidegib in widespread clinical practice.

Materials and methods. General scientific research methods were used as a methodological basis. A "decision tree" model was developed to conduct a clinical and economic assessment. The clinical and economic assessment of the use of sonidegib was carried out from the perspective of the healthcare system of the Russian Federation: the costs of systemic drug therapy for the 1-line of patients with locally advanced basal cell carcinoma (BCC) were taken into account.

Results. A comparative analysis of efficacy based on the progression-free survival (PFS) criterion revealed the advantage of sonidegib over vismodegib: the odds ratio (OR) of disease progression in patients with locally advanced BCC 12 months after the start of therapy was 0.27778 (95% CI 0.125–0.618; p=0.0017; Z=3.1423). The reduction in the risk of progression when using sonidegib compared to vismodegib was 59.1% (OR= 0.409; 95% CI 0.229–0.732, p=0.0026, Z=3.013). The results of testing the hypothesis about the equality of the proportion of patients with locally advanced BCC without disease progression 12 months after the start of therapy also confirmed the presence of statistically significant differences in efficacy between the two treatments in favor of sonidegib (χ2=9.2007, df=1, p=0.002419, 95% CI 0.09312–0.432132). The use of sonidegib in the 1-line of therapy, 2.53 million rubles per year will be required per 1 patient, which is 10.86% lower than the use of vismodegib, and corresponds to an absolute saving of 308.55 thousand rubles. The "cost-effectiveness" indicator (CER) for sonidegib was 114,627 rubles versus 220,295 rubles for vismodegib. The incremental cost-effectiveness ratio (ICER) is 175,050 rubles per additional month of PFS. Sensitivity analysis showed the stability of the results when changing key parameters.

Conclusion. Based on the results of the study, the hypothesis about the clinical and economic benefits of sonidegib in the treatment of locally advanced BCC was confirmed, and data were obtained on the clinical and economic feasibility of using sonidegib in widespread clinical practice.

REVIEW

202-238 83
Abstract

The aim. In this review, information obtained through a comprehensive scan of scientific resources on recent developments in the field of health regarding boric acids and BCCs is brought together, and current and future perspectives are presented.

Matherial and methods. The literature studies on boron were collected using multiple databases (WOS, PubMed, Scopus, Science Direct, SciVerse, SciELO, Cochrane Library, Embase and Google Scholar). The health effects of boric acids and BCCs used in preclinical and clinical studies were systematically compiled.

Results and conclusion. Different natural and synthetic boron-containing compounds (BCCs) are increasingly used in the healthcare sector. To date, five BCCs drugs (bortezomib, crisaborole, ixazomib, tavaborole and vaborbactam) have been approved by the Food and Drug Administration, for diverse clinical applications. It is also understood that more than ten boron-based compounds (alabostat, sodium borocaptate, voromycin, TOL-463 and others) are being investigated in different clinical trial phases. In addition, it is seen that clinical studies are continuing for combinations of various drugs with BCCs for use in new indications. In addition, it is observed that boron and boron-containing compounds are widely used as supplements. This review also provides an overview of recent advances in the pharmacological activities of boric acids and BCCs, including antioxidant, anti-inflammatory, anti-atherosclerotic, anticancer, antimicrobial, antiparasitic, antiviral, antiprotozoal, cardioprotective, hepatoprotective, neuroprotective, osteoprotective, antidiabetic, anti-apoptotic, anti-obesity, ferroptosis properties, effects on immune system, antiepileptic, anti-Parkinson, and anti-Alzheimer’s activities and the mechanisms of action involved, obtained from both in vitro and in vivo studies.

EDITORIAL

239-240 25
Abstract

Referred to by: Butranova O.I., Gorbacheva A.A., Zyryanov S.K., Ni O.G. Microbiological landscape and parameters of antibiotic resistance of pathogens in patients of neonatal intensive care units. Pharmacy & Pharmacology. 2024;12(6):378-393. https://doi.org/10.19163/2307-9266-2024-12-6-378-393

We hereby inform readers that in the final version of the article changes were made in Russian and English.

In the published article “Microbiological landscape and parameters of antibiotic resistance of pathogens in patients of neonatal intensive care units”, there was an error. In the authors' affiliations did not include all institutions and positions held: Butranova O.I. – Research Fellow of IPCE RAS, Moscow, Russia; Gorbacheva A.A. – Research Engineer IPCE RAS, Moscow, Russia; Zyryanov S.K. – Chief Research Fellow of IPCE RAS, Moscow, Russia.

Correct version:

O.I. Butranova1,2, A.A. Gorbacheva1,2,3, S.K. Zyryanov1,2,4, O.G. Ni3

1 Peoples’ Friendship University (RUDN University),

6 Miklukho-Maklaya Str., Moscow, Russia, 117198

2Institute of Physical Chemistry and Electrochemistry of Russian Academy of Sciences,

bldg. 4, 31, Russia, Leninsky Prospekt, Moscow, 119071

3 Kommunarka Center,

8/3 Sosenskiy Stan Str., Moscow, Russia, 108814

4 City Clinical Hospital No. 24,

10 Pistsovaya Str., Moscow, Russia, 127015

 

О.И. Бутранова1,2, А.А. Горбачева1,2,3, С.К. Зырянов1,2,4, О.Г. Ни3

1Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов имени Патриса Лумумбы»,

Россия, 117198, г. Москва, ул. Миклухо-Маклая, д. 6

2 Федеральное государственное бюджетное учреждение науки Институт физической химии и электрохимии им. А.Н. Фрумкина Российской академии наук,

Россия, 119071, г. Москва, Ленинский проспект, д. 31, корп. 4

3 Государственное бюджетное учреждение здравоохранения города Москвы «Московский многопрофильный клинический центр «Коммунарка»

Департамента здравоохранения города Москвы»,

Россия, 108814, г. Москва, ул. Сосенский Стан, д. 8/3

4 Государственное бюджетное учреждение города Москвы «Городская клиническая больница № 24 Департамента здравоохранения города Москвы»,

Россия, 127015, г. Москва, ул. Писцовая, д. 10

 

AUTHORS

Olga I. Butranova – Candidate of Sciences (Medicine), Assistant Professor of the Department of General and Clinical Pharmacology of the Medical Institute, Peoples' Friendship University (RUDN University); Research Fellow of IPCE RAS. ORCID ID: 0000-0001-7729-2169. E-mail: butranova-oi@rudn.ru

Anastasiia A. Gorbacheva – Assistant Lecturer of the Department of General and Clinical Pharmacology of the Medical Institute, Peoples' Friendship University (RUDN University); Research Engineer IPCE RAS;  Clinical Pharmacologist of Kommunarka Center (Moscow, Russia). ORCID ID: 0009-0003-9721-6931. E-mail: gorbacheva_aa@pfur.ru

Sergey K. Zyryanov – Doctor of Sciences (Medicine), Professor, Head of the Department of General and Clinical Pharmacology of the Peoples' Friendship University (RUDN University); Chief Research Fellow of IPCE RAS; Deputy Chief Physician of the City Clinical Hospital No. 24 (Moscow, Russia). ORCID ID: 0000-0002-6348-6867. Е-mail: zyryanov_sk@rudn.university

Oksana G. Ni – Head of the Department of Clinical Pharmacology of the Kommunarka Center (Moscow, Russia). ORCID ID: 0000-0003-0994-0579. E-mail: ni.oksana@gmail.com

 

Due to a technical error on part and without any malicious intent, it was stated in the "Funding" section that "This study did not have financial support from third-party organizations."

The authors regret that the following statement was missed out due to oversight in the Funding section in the version of this article initially published: "The research was carried out at the expense of the Russian Science Foundation No. 23-73-30004, https://rscf.ru/project/23-73-30004 /".

Correct version:

FUNDING

The research was carried out at the expense of the Russian Science Foundation No. 23-73-30004, https://rscf.ru/project/23-73-30004/

 

The error does not change the essence of the data presented in the article, does not violate their perception by readers or interpretation.

The authors would like to apologize for any inconvenience caused. The authors declare no conflict of interest.

The original article has been updated in online-version: https://www.pharmpharm.ru/jour/article/view/1667

241 40
Abstract

Referred to by: Garankina R.Yu., Ryazhenov V.V., Maksimkina E.A., Fisenko V.S., Alekhin A.V., Tarasov V.V., Chizhov K.A., Samoschenkova I.F., Bekhorashvili N.Yu., Zakharochkina E.R. Problems and Solutions of Pharmaceutical Packaging in Bulk. Pharmacy & Pharmacology. 2025;13(2):128-138. https://doi.org/10.19163/2307-9266-2025-13-2-128-138

We hereby inform readers that in the final version of the article changes were made in Russian.

In the published article "Problems and Solutions of Pharmaceutical Packaging in Bulk", the authors found an error: accidentally, due to a technical error on our part and without any malicious intent, source No. 17 was incorrectly indicated in the "References" section of the Russian-language version of the article:

  1. Фисенко В.С., Соломатина Т.В., Фаррахов А.З., Юрочкин Д.С., Мамедов Д.Д., Мальченкова С.С., Голяк Н.С. Современное состояние экстемпорального изготовления лекарственных средств в Федеративной Республике Германия // Вестник фармации. - 2022. - № 3(97). - С. 44-56. https://doi.org/10.52540/2074-9457.2022.3.44

The authors regret that, due to oversight, the indicated source of literature was incorrectly cited in the originally published version of this article.

Correct version:

  1. Мальченкова С.С., Голяк Н.С. Современное состояние экстемпорального изготовления лекарственных средств в Федеративной Республике Германия // Вестник фармации. - 2022. - № 3(97). - С. 44-56. https://doi.org/10.52540/2074-9457.2022.3.44

The error occurred due to the fault of the entire team of authors, but does not change the essence of the data presented in the article, does not violate their perception by readers or interpretation.

The authors would like to apologize for any inconvenience. The authors declare no conflict of interest.

The original article has been updated in online-version:  https://www.pharmpharm.ru/jour/article/view/1685

242 41
Abstract

Referred to by: Ryazhenov V.V., Maksimkina E.A., Fisenko V.S., Alekhin A.V., Tarasov V.V., Raisyan M.G., Zakharochkina E.R., Chizhov K.A., Garankina R.Yu. Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia. Pharmacy & Pharmacology. 2024;12(5):324-337. https://doi.org/10.19163/2307-9266-2024-12-5-324-337

 

We hereby inform readers that in the final version of the article changes were made in Russian and English.

In the published article " Regulation in the sphere of circulation of extemporaneously compounded medicines under modern conditions of Russia", the authors found an error: accidentally, due to a technical error on part and without any malicious intent, еhe regulatory document was incorrectly specified in table 1 (p.330):

Resolution of the Government of the Russian Federation No. 546 “On Approval of the Regulations on Licensing of Pharmaceutical Activities” dated March 31, 2022.

The authors regret that, due to an oversight, the cited regulatory document was incorrectly numbered (No. 546)  in the originally published version of this article.

Correct version:

Resolution of the Government of the Russian Federation No. 547 “On Approval of the Regulations on Licensing of Pharmaceutical Activities” dated March 31, 2022.

The error occurred due to the fault of the entire team of authors, but does not change the essence of the data presented in the article, does not violate their perception by readers or interpretation.

The authors would like to apologize for any inconvenience. The authors declare no conflict of interest.

The original article has been updated in online-version:  https://www.pharmpharm.ru/jour/article/view/1664



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ISSN 2307-9266 (Print)
ISSN 2413-2241 (Online)