Farmaciya (Pharmacy)

Introduction. Dihydroquercetin (DHQ) is a flavonoid that is characterized by limited bioavailability, that particularly associates with low solubility in water under normal conditions. Previously, DHQ was combined with the proteinogenic amino acid L-lysine to create a composition that exhibited strong anti-inflammatory and wound healing effects in models of grade III burn injuries in rats.

Objective: To obtain and characterize solid monophasic systems based on DHQ and L-lysine using a complex of physico-chemical methods.

Material and methods. To obtain DHQ compositions containing L-lysine, grinding techniques were used with the following lyophilization or drying of the aqueous solution at 65 °C. Scanning electron microscopy was employed to examine the microstructure of the resulting objects. The structure and properties of the solid phase were characterized using X-ray powder diffraction and thermal analysis methods. The chemical composition was analyzed using infrared spectroscopy and nuclear magnetic resonance methods. Quantitative analysis was performed using high performance liquid chromatography (HPLC).

Results. Coamorphous modifications based on DHQ and L-lysine, in the form of films and mesoporous lyophilizates, have been obtained and characterized using physico-chemical methods. No formation of new covalent bonds between the components during the preparation of these modifications was observed. A glass transition effect at a temperature of 64 °C was detected for the films. To monitor the quantitative composition of the components, a method based on HPLC with pre-column derivatization using o-phthalaldehyde and UV-detection was developed.

Conclusion. Thus, the obtained objects are coamorphous systems in the form of glass-like film and porous materials formed through intermolecular interactions between DHQ and L-lysine. In the future, it will be interesting to develop dosage forms based on these objects.

Key words: dihydroquercetin, amino acids, HPLC, NMR ¹H, coamorphous modifications.

Introduction. Common raspberry (Rubus idaeus L.) is one of the representatives of the genus Rubus L., belonging to the Rosaceae family, which is widespread and cultivated in the Russian Federation. The fruits and leaves of common raspberry, due to their rich chemical composition (flavonoids, phenylpropanoids, saponins, organic acids and tannins), are used in folk practice as an anti-inflammatory, antipyretic and diaphoretic agent. Common raspberry leaf was included in the British Pharmacopoeia, but in the Russian Federation there is no regulatory documentation that regulates the quality of common raspberry leaves.

The aim of the work was to develop methods for the qualitative and quantitative determination of the amount of flavonoids in common raspberry leaves.

Material and methods. The object of the study is the leaves of common raspberry, harvested during the flowering phase in different areas of the Samara region in June – July 2024. Qualitative determination of flavonoids was carried out by thin-layer chromatography (TLC) using chromatographic carriers of Sorbfil brand plates (PTLC-AF-A-UV). To separate the substances, a solvent system was used: n-butyl alcohol – glacial acetic acid – water in a ratio of 4:1:2. Quantitative determination of the amount of flavonoids in aqueous-alcoholic extracts of common raspberry leaves was carried out by differential spectrophotometry on a Specord 40 device (AnalytikJena AG, Germany) calculated on standard sample of rutin.

Results and discussion. The developed method of quantitative determination was used to calculate the content of total flavonoids in common raspberry leaves, which varied from 2.08±0.06 to 2.11±0.06%. A validation assessment of the developed method was carried out. The error of a single determination with a confidence probability of 95% is ±2.86%.

Conclusion. A method of quantitative determination of total flavonoids in common raspberry leaves by differential spectrophotometry was developed. A method of qualitative determination of flavonoids in common raspberry leaves was developed using thin-layer chromatography in the solvent system n-butyl alcohol – glacial acetic acid – water in a ratio of (4:1:2) with a witness substance, a standard sample of rutin. The obtained research results can be used in the development of regulatory documentation for a promising type of raw material «Common raspberry leaves» for introduction into the State Pharmacopoeia of the Russian Federation.

Introduction. The optimal solution for effective wound treatment is the creation of minimally invasive dosage forms that combine prolonged delivery of drugs and high adhesion to the site of application. The creation of a combined dosage form in the form of a film with a gel applied to it allows to increase the duration of the agent's presence on the affected area, providing a stable effect of the active component on cells and tissues.

Research objective. to create a combined dosage form in the form of a film with an applied mucoadhesive gel containing an antibacterial and wound-healing component, respectively.

Material and methods. Film samples were prepared on the basis of gelatin, samples based on MC, Na-CMC, Na-alginate, carbopol 940 were obtained as mucoadhesive gels. In order to provide antibacterial action, the polyvalent bacteriophage Sextaphag was introduced into the composition of the films and gels. L-arginine was added to the dosage form as a reparation stimulator.

Results. Application of the gel increases the film thickness, reduces the strength characteristics, but significantly increases the extensibility of the material. The mucoadhesiveness indices are significantly improved when using gels based on carbopol. The moisture absorption and vapor permeability indices have satisfactory values, which indicate the maintenance of a favorable environment for wound healing. An experiment on laboratory animals showed an increase in the wound defect regeneration index when using the developed composition compared to the traditional product (Levomekol).

Conclusion. The developed combined dosage form has the necessary characteristics for effective wound treatment. This combination provides increased fixation on the wound surface and a prolonged therapeutic effect. The presence of a bacteriophage in the composition of the developed product provides reliable protection against infections.

Introduction. In the context of the development of a personalized approach in medicine, extemporaneous medicines are of particular importance, in the creation of which the most convenient type of dosage form and acceptable excipients can be selected taking into account the age, allergy status, the presence of concomitant diseases and other individual characteristics of the patient. Pharmaceutical development of an extemporaneous medicines is usually the responsibility of a pharmacist-technologist of a production pharmacy. To optimize this process, it is important to develop methodological approaches to the pharmaceutical development of extemporaneous medicines.

Objective: substantiation of the methodological scheme for the pharmaceutical development of extemporaneous suspensions for oral administration for children within the framework of the Quality by Design (QbD) concept using the example of furazidin suspension.

Material and methods. The study used content analysis of scientific literature and regulatory documents and systems analysis based on the QbD concept.

Results. Based on the quality target product profile, the optimal extemporaneous dosage form of furazidin for children is powder for preparation of oral suspension. Critical quality indicators for pharmaceutical development of bulk powder are description (taste), particle size, sedimentation stability, viscosity, dosing uniformity; for dosed powder – description (taste), dosing uniformity. Bulk powder should contain a stabilizer and a sweetener, while dosed powder must contain only a sweetener. Critical parameters of the manufacturing process of powders for preparation of oral suspension include grinding time of furazidin tablets and mixing time of ingredients.

Conclusion. In the course of the conducted study, a methodological scheme for the pharmaceutical development of extemporaneous suspensions for oral administration for children was developed, which can be introduced into the routine practice of production pharmacies to optimize the process of manufacturing and dispensing children's extemporaneous dosage forms.

Introduction. The Strategy of Actions in the Interests of Senior Citizens in the Russian Federation until 2025 has been approved on the territory of the Russian Federation. One of the main areas of this document is providing senior citizens with medicines and medical products. The document notes that this assistance should be personalized. The discrepancy between the provided, desired, and expected information leads to information asymmetry and reduces the level of pharmaceutical assistance. All of the above determined the purpose of this study.

Objective. To study the information support of geriatric consumers of pharmacy organizations to optimize the information process.

Material and methods. The study used: content analysis, comparison method, observation, interviewing and graphic method. The study materials were questionnaires of 207 geriatric consumers and questionnaires of 117 employees of these pharmacy organizations.

Results. The study examined the main features of providing information to geriatric patients and identified the knowledge of pharmacy employees about the information needs of this group of consumers. Analysis of the obtained research results allowed us to identify 4 types of research gaps based on the theory of gaps in service in the following areas: a list of necessary information for geriatric patients, compliance of the information provided with the requirements of regulatory documents, reasons for the purchase made in the pharmacy, a list of information for the algorithm for pharmaceutical consulting.

Conclusion. The study identified four types of gaps in service in information provision, which indicated the main areas of information asymmetry in the provision of pharmaceutical care to geriatric patients. Based on the results, recommendations were formed for conducting pharmaceutical consultations.