News of Pharmacy

Optimization of the content of excipients in tablets

O. V. Kutova — 2025-03-21

When developing a tablet drug technology, there is a need to find the optimal quantitative content of a number of excipients that should provide a set of required pharmacopeial characteristics. The quantitative composition of excipients affects several pharmaco-technological parameters under study, which leads to the need to solve the problem of multicriteria optimization.

Materials and methods. To determine the optimal amount of three excipients, the amount of which is fixed in the tablet, we used the method of mathematical modeling with the application of statistical analysis and a multicriteria optimization. The following software tools were used to process the experimental data and perform calculations MS Excel and Mathcad 14.

Results and discussion. A methodical approach to determining the optimal solution using statistical methods in pharma-technological research with quantitative factors is proposed in the example of establishing the optimal content of excipients with a fixed total amount in the development of tablet technology. The issues of building mathematical models that characterize the effect of the quantitative content of excipients on a number of pharma-technological parameters of tablets based on experimental data are considered. Attention is focused on the peculiarities of using static methods for processing experimental data in the case when the studied factors are correlated, which can lead to negative consequences when evaluating the results of regression analysis. A generalized optimization criterion is proposed that contains unit vectors - Y(X)=F(y1(X), y2(X), ..., yi(X)), where X=f(x1,x2,...xn) and is a multidimensional vector function. Minimization of this function leads to the determination of the coordinate of the point in the admissible decision domain that satisfies the condition of equal approximation of all individual criteria to their optimal values.

Conclusions. The optimal number of excipients with a fixed total amount in the composition of tablets was determined, which will ensure the maximum approximation of the pharmacological and technological parameters of tablets under the study conditions.

Determination of rheological parameters of gels used in the treatment of dermatological skin diseases

O. V. Shtrimaitis — 2025-03-21

Aim. To study the rheological parameters of medicinal and cosmetic products that are available in the Ukrainian
pharmaceutical market in the form of a gel for the treatment of dermatological diseases (acne) in order to determine
the acceptability criteria when assessing the rheological properties of gels.
Materials and methods. The study objects were medicines containing retinoids (adapalene and tretinoin) and a
cosmetic product (a therapeutic and preventive gel). The rheological properties of the gel samples were assessed using a Rheolab QC rotational rheometer (Anton Paar) equipped with a C-CC27 / SS coaxial cylinder system.
Results. The results of rheological studies depend on the experimental conditions and the equipment used.
The challenge in assessing rheological properties lies in the absence of specific values for soft dosage forms, which
makes it difficult to assess the values obtained and determine compliance. Therefore, due to the lack of universal
criteria for assessing rheological parameters and the necessity to determine acceptable rheological property ranges
in the development of soft dosage forms containing retinoids, it became essential to establish acceptable rheological
parameter ranges on the example of existing gel forms for treating acne. Analyzing the shear stress range values, in
which the flow curves are located, it can be determined that acceptable ranges for the new drug being developed are
the shear stress range of 25–100 Pa under similar or approximate experimental conditions. The initial viscosity of the
gels studied ranges from 30 to 100 Pa·s.
Conclusions. The experimental studies have demonstrated that the gels presented in the study exhibit high
thixotropic properties, indicating significant structural recovery after mechanical deformation caused by the measuring
system inner cylinder. The acceptable shear stress range for the new drug being developed should be within 25–100 Pa under
similar or approximate experimental conditions. The gels have been identified as pseudoplastic dispersed systems.
As the initial viscosity of the gels studied ranges from 30 to 100 Pa·s, it must be considered when developing a new
pharmaceutical product for the treatment of dermatological diseases

Peculiarities of functioning of logistics systems of pharmaceutical enterprises in crisis situations

R. V. Sahaidak-Nikitiuk — 2025-03-21

In the conditions of martial law, domestic pharmaceutical enterprises are faced with an acute issue of timely provision of the population with the necessary high-quality medicines in the right place in full at an affordable price.
Aim. To study the problems and peculiarities of the functioning of the logistics system of a pharmaceutical enterprise in crisis conditions, as well as to form directions for overcoming the problems identified.
Materials and methods. The research materials were scientific works and Internet sources on the issues studied.
The research methods applied were methods of analysis and synthesis, generalization, expert method. The expert
method was used to determine the problems of managing logistics systems of pharmaceutical enterprises in Ukraine
in crisis conditions. The minimum permissible number of experts was determined taking into account the maximum
permissible relative error. The total number of respondents who participated in the expert study was 25 managers of
pharmaceutical enterprises. The results of the survey were significant and convergent; the concordance coefficient
was 0.83, the calculated Pearson’s χ2-test exceeded the tabular value, taking into account the number of degrees of
freedom and the significance level (p=0.05). The assessment of the degree of significance of logistics system management problems was carried out on a ten-point scale where 1 point was the least significant factor, and 10 points was
the most significant factor.
Results and discussion. The problems of managing logistics systems of pharmaceutical enterprises in Ukraine
in crisis conditions have been identified. The definition of crisis logistics, its goals, objectives and features has been
proposed. The phases of functioning of crisis logistics at pharmaceutical enterprises have been summarized.
Conclusions. In the course of their operation, pharmaceutical enterprises are constantly faced with the challenging external environment, which makes it necessary to introduce modern methods and approaches to management;
one of these approaches is the introduction of crisis logistics.

Research on the development of quality control methods for a solid soap for treating psoriasis

I. V. Honcharov — 2025-03-21

Products in the form of soap are a relevant addition to the complex therapy of dermatological diseases, including
psoriasis. The skin affected by psoriasis requires “soft” care, so the use of a hygienic product that has a moisturizing
and exfoliating effect will have a positive impact on the course of the disease, complementing the effect of the main
therapeutic agents. In view of this, based on the results of previous studies, we have proposed three compositions
of solid soaps, for which it is advisable to conduct a study of the main quality indicators at this stage of development.
Aim. To develop the quality control methods for model samples of the solid soap obtained.
Materials and methods. The study materials were model samples of the solid soap containing palm kernel, coconut, avocado, almond, olive, castor oils, as well as citric, salicylic acid and lactobionic acid. The study of organoleptic
properties, solubility, as well as characteristics affecting the soap quality (pH, chlorides and other substances insoluble
in ethanol, hydroxides of free fatty acids or alkali metals, the fatty acid content), such parameters as “Acid number” and
“Iodine number” was carried out. The active ingredients were identified.
Results. The resulting soaps are solid to the touch, without deformations, cracks and mechanical inclusions, white
or slightly yellowish in color, odorless or with a peculiar smell. They are soluble in water and ethanol (96 %) and have
a pH in the range from of 6.5 to 8.5. When determining the content of chlorides and other substances insoluble in ethanol, the residue weight was not more than 0.15 g in all samples studied. When determining the content of hydroxides of free
fatty acids or alkali metals, no more than 0.8 ml of 0.1 M sodium hydroxide solution was used for titration. The content
of fatty acids was more than 40 %; the acid number was no more than 205; the iodine number was not less than 83.
The results of identification reactions were positive.
Conclusions. The results of the study indicate compliance with the requirements for the main quality indicators of
the solid soap samples proposed by us.

The effect of extraction conditions on the quantitative content of flavonoids in peppermint leaf extracts (Mentha Piperitae folium)

O. O. Dobrovolnyi — 2025-03-21

Aim. To investigate the influence of key parameters of peppermint leaf extraction (Mentha Piperitae folium) on the quantitative content of flavonoids in the obtained extracts and to determine the optimal process conditions.

Materials and methods. The object of the study was powdered dried leaves of Peppermint. As extraction solvents 93%, 70%, 40% ethyl alcohol solution (vol.) and purified water were used. As the extraction method filtration extraction was used. In the studied samples of extracts the dry residue, the yield of extractable matter and the quantitative content of the sum of flavonoids were determined. Assay was performed by absorption spectrophotometry on a PerkinElmer Lambda 35 spectrophotometer.

Results and discussion. Based on the data obtained it can be said about effectiveness of the applied experimental model. Achieving effective mass transfer of bioactive substances from the extracted material was ensured by continuous supply of fresh extraction solvent and its steady rate movement through the raw material layer at a constant speed. Since the conditions of the starting raw material, the extraction method and the speed the extractant were the same for all experiments the change in the polarity of the extraction solvent and the dynamics of the DER served as evaluation factors of the overall efficiency of the process. It was established that the extracts obtained under the conditions of using ethanol within 40-70% and a DER 1:7-9 were characterized by the most optimal and balanced ratio of flavonoid content and the yield of extractable matter. The use of 93% ethanol is effective in terms of quantitative characteristics of the extract but the least effective in terms of the yield of extractable matter. In turn, the aqueous extractant allows achieving the highest yields of extractable matter with a relatively low content of flavonoids in such extracts.

Conclusions. It has been determined that the efficiency of flavonoid extraction and product yield significantly depend on the polarity of the extractant used and DER. It has been proven that the use of filtration extraction ensures uniform dynamics of mass transfer of extractable matters from the extracted raw materials and a stable content of flavonoids in the studied samples. It has been found that peppermint leaf extracts obtained under the conditions of using ethanol within 40-70% and DER 1:7-9 are characterized by the most optimal and balanced quantitative indicators. It has been experimentally found that under optimal process conditions the average yield of extractable matter is within 20% and the content of the sum of flavonoids is within 9%.

The assessment of environmental measures in healthcare institutions as a factor in improving the economic efficiency of production activities

V.V. Vinohradsky — 2025-03-21

In recent years, Ukraine has accumulated a number of urgent environmental problems, including the disposal of
medical and pharmaceutical waste. This problem has appeared before society as one of the global ones, which threatens to increase the waste accumulation and its negative impact on the environment and human health.
Aim. To analyze and assess environmental measures implemented in healthcare institutions in order to determine
their impact on improving the economic efficiency of production activities. The study aims to identify the relationship
between implementing environmental initiatives and optimizing costs, increasing productivity, and improving the overall sustainability of healthcare institutions.
Materials and methods. Analytical, statistical, systemic structural-logical and calculation methods, as well as the
materials of the internal reporting documentation of the departments of the healthcare institution under study were
used in the work.
Results. The article determines the share of capital expenditures in the total amount of expenditures for environmental protection measures and the rational use of natural resources in the healthcare institution under study, as well
as the share of expenditures for the destruction and neutralization of solid and liquid medical waste in the total amount
of expenditures for environmental protection measures and the rational use of natural resources. Based on these
indicators, the structure of the enterprise’s environmental costs has been analyzed, and the dynamics of changes in
these expenditures has been traced.
Conclusions. A set of environmental measures in a healthcare institution to improve an effective environmental
protection system has been proposed, which will contribute to improving the economic efficiency of production and
undoubtedly improve the environmental situation in the country. Obtaining environmental, economic and social effects
from the complex developed and organizational and technological actions implemented in the healthcare institution
has been proven.

The substantiation of the composition and pharmaco-technological studies of the herbal medicine for the complex therapy of post-traumatic stress disorder

M. V. Buryak — 2025-03-21

Post-traumatic stress disorder (PTSD) is a mental condition that can develop after experiencing or being present
at a traumatic event (war, natural disasters, violence, accidents or other stressful situations). Over the past two years,
the number of patients with this diagnosis in the electronic healthcare system has significantly increased. Therefore, it
is urgent to create safe, including for long-term use, medications to help patients with PTSD.
Aim. To study the potential of the plant raw material for the development of herbal medicines intended for the
treatment of post-traumatic stress disorder, as well as to develop the composition of a new original medicinal product
of natural origin.
Materials and methods. The study object was the raw material of Gaillardia pulchella L. Herba, Ocīmum basilīicum,
L Herba, Hyperіcum perforatum L. Herba, Chamomilla recutita L. flos, Melissa officinalis L. Herba, Ginkgo biloba L. Folia.
NEWS OF PHARMACY 1 (109) 2025 ISSN 2415-8844 (Online) 41
The pharmaco-technological indicators were studied according to the standard methods of the State Pharmacopeia
of Ukraine (SPhU).
Results. The main place in the phytotherapy of PTSD is given to plant components that have various complexes
of biologically active substances (BAS), which exhibit antidepressant, anxiolytic, nootropic, angioprotective, antispasmodic, metabolic, venotonic effects. The combination of selected types of the raw material creates favorable conditions for the manifestation of the pharmacological activity of the drug due to the fact that its components affect different
parts of the body, enhancing the expected therapeutic effect. Such a multifaceted effect of the components of the
herbal medicine not only improves its therapeutic effectiveness, but also minimizes the risk of side effects. The study
of pharmaco-technological indicators allows us to find out that the values of loss on drying for the samples of the medicinal plant raw material (MPRM) studied are in the range from (5.11 ± 0.20) to (7.24 ± 0.20) %, which corresponds to
the current standards of the SPhU for plant materials. The specific gravity values vary in the range from (1.380 ± 0.021)
to (1.580 ± 0.022) g/cm³, which indicates a decrease in the probability of stratification of the raw material in herbal
medicine compositions during mixing of ingredients. The bulk density parameters for the components of the herbal
medicine ranges from (0.476 ± 0.012) to (0.724 ± 0.020) g/cm³, which indicates the presence of significant differences
in this indicator for different samples of the MPRM. In addition, the bulk density indicators of the raw material in the
herbal medicine developed changed almost twice – from (0.114 ± 0.007) to (0.231 ± 0.002) g/cm³. This difference was
taken into account when developing the technological process for the production of the herbal medicine in order to
ensure uniform distribution of components in the finished product.
Conclusions. Modern scientific data on the spread of PTSD, as well as on the pharmacological properties, chemical composition and botanical characteristics of the MPRM and the herbal medicine have been analyzed and systematized. A theoretical and experimental substantiation of the composition of the herbal medicine for the complex therapy
of PTSD has been developed. The influence of various pharmaco-technological characteristics of the MPRM and the
herbal medicine on their quality has been studied. The combined herbal medicine proposed, the components of which
mutually enhance and complement their pharmacological properties during the complex treatment of PTSD will not
only increase the effectiveness of pharmacotherapy, but also reduce the risk of side effects associated with the use of
synthetic drugs. It should be noted that the research of the drug being created is still ongoing. In the future, it is planned
to study in detail the composition of BAS, develop methods for their analysis, study the effect of these substances on
the pharmacological action, as well as expand the range of dosage forms for this product.

The substantiation of the technology of the cream with lespedeza extracts

K. E. Kiselyova — 2025-03-21

Aim. To study the dependence of the properties of a cream with lespedeza extracts on the technological parameters
of its manufacture and to develop the technology of the cream.
Materials and methods. The study object was an emulsion-based cream with bicolor lespedeza extracts. The experimental samples of the cream were emulsified using an MI-2 mixer at the speed range from 1000 to 3000 rpm in
increments of 500 rpm for 5-20 min in increments of 5 min for each sample. The quality of the manufactured samples
was assessed by appearance, thermal stability, colloidal stability, and the degree of dispersion of particles of the dispersed phase and viscosity indicators.
Results. According to the results of the experimental studies, the parameters of the technological process have
been substantiated, the manufacturing technology has been developed, and control points in the production of an
emulsion cream with lespedeza extracts for the treatment of infectious and inflammatory skin diseases have been
determined. The development of the cream technology was based on the results of the previous experimental studies
of the cream composition containing a liquid alcohol lespedeza extract and an oil lespedeza extract. Standard equipment used in the production of soft drugs was applied to produce the emulsion-based cream. The cream technology
consists of the stage of auxiliary work, several stages of the technological process (preparation of the aqueous phase,
preparation of the oil phase, preparation of the cream, preparation and homogenization of the cream), the stage of
packaging in containers, packaging in packs and group packaging for shipment to the finished product warehouse. To scale
the laboratory technology of the emulsion cream “Lespedin” into industrial production, critical production points and
conditions of the technological process have been determined, which will allow obtaining products that will meet the
requirements of the current regulatory documentation.
Conclusions. The parameters of the technological process for the production of an emulsion cream with extracts
of bicolor lespedeza have been experimentally substantiated. The technological process for manufacturing the emulsion cream with the conditional name “Lespedin” has been developed. The critical technological parameters for obtaining a soft dosage form have been determined.

The isolation of Venlafaxine from the biological material by hydrophilic solvents

S. V. Baiurka — 2025-03-21

Aim. To determine the Venlafaxine recovery from biological tissues using generally accepted methods of drug
isolation by the extraction with acidified water and acidified ethanol.
Materials and methods. The studies were performed on model samples of the animal liver spiked with Venlafaxine. The drug was isolated by the extraction with water acidified with oxalic acid according to the A. O. Vasylieva
method, ethanol acidified with oxalic acid by the Stas-Otto method, water acidified with sulfuric acid according to the
V. P. Kramarenko method. The extracts obtained were subjected to the additional cleanup procedure by the back-extraction and TLC. Detection and the quantitative determination of Venlafaxine in the extracts obtained were performed
by TLC and UV spectrophotometry.
Results and discussion. While extracting Venlafaxine from the biological material with water acidified with oxalic
acid, ethanol acidified with oxalic acid and water acidified with sulfuric acid, the recovery values were 44 ± 2 %, 36
± 3 % and 28 ± 3 %, respectively. The quantitative determination of the drug in extracts was performed by the UVspectrophotometric method at λmax 277 nm according to the equation of the calibration curve y=(0.00368 ± 2×10-5)×x,
which showed linearity in the range of the analyte concentrations of 25.00-300 μg/mL.
Conclusions. 1. The recovery values of Venlafaxine from the biological material using generally accepted methods have been determined. The highest recovery was obtained while extracting with water acidified with oxalic acid,
which was 44 ± 2 %, which provided its suitability for the sample preparation during the non-directed toxicological examination. 2. The inclusion of the additional cleanup procedure by the back-extraction and TLC into the pretreatment
process made possible to apply the UV spectrophotometric method, which was linear within the range of the expected
lethal concentrations of Venlafaxine in the biological material. 3. The method of the Venlafaxine isolation from the liver
tissue by extracting with acidified water with oxalic acid followed by the additional optimized cleanup procedure can
be recommended for the forensic toxicological examination of the biological material for the presence of Venlafaxine

The feasibility of developing an original anti-inflammatory drug for topical use

N. V. Rybak — 2025-03-21

Aim. To determine the feasibility of developing an original anti-inflammatory drug for topical use by analyzing the
range of the pharmaceutical market of Ukraine.
Materials and methods. A review of literature sources using the method of analysis and generalization of the data
obtained, as well as the assortment analysis of the segment of local anti-inflammatory drugs in the pharmaceutical
market of Ukraine were conducted.
Results. The classic representatives of drugs with the anti-inflammatory activity are the group of non-steroidal
anti-inflammatory drugs. They are represented by 5 dosage forms: gel, ointment, cream, transdermal patch, and spray
for external use. Most of the drugs of the group of nonsteroidal anti-inflammatory drugs are made in Ukraine, but there
are also representatives of Indian, German, Estonian production, etc. Diclofenac sodium is the most commonly used
drug among them. In addition, there are steroid drugs with the anti-inflammatory activity – topical corticosteroids. They
are available in 7 dosage forms: gel, emulsion, cream, ointment, lotion, solution and spray for external use. Most often,
the country of origin is Ukraine, but there are also products from Croatia, the USA, Germany, etc. The active pharmaceutical ingredients are usually hydrocortisone or prednisolone.
Conclusions. Anti-inflammatory drugs for topical use have an extremely wide range of products in the pharmaceutical market of Ukraine. However, because of the significant shortcomings that accompany the use of these drugs,
the development of new safe anti-inflammatory drugs for topical use is still relevant.

The substantiation of the composition of an extemporaneous cream with antipsoriatic and anti-inflammatory effects

Zh. M. Polova — 2025-03-21

Aim. To substantiate an extemporaneous emulsion cream based on purified naphthalan oil for the pharmacotherapy of psoriasis.

Materials and methods. Such methods as system analysis and generalization, as well as organoleptic, physicochemical, structural-mechanical, biopharmaceutical and statistical methods were used in the work.

Results. The composition of an extemporaneous agent in the form of a cream for external use with the antipsoriatic and anti-inflammatory action were substantiated. It contains a purified naphthalan oil, the chamomile oil extract and a 10 % oil solution of vitamin A as active components of the substance of natural origin. Six model samples of the emulsion cream were processed; Tween-80, emulsifier No. 1 and Olivem 1000 were introduced in them as emulsifiers. Glycerol and propylene glycol in the concentration of 10 % were used as structure-forming substances of the hydrophilic phase. Colloidal and thermal stability, pH, structural viscosity and kinetics of the active component release were determined by the agar diffusion method in order to substantiate the excipients in the composition of the emulsion cream.

Conclusions. As a result of the organoleptic, physicochemical, structural-mechanical and biopharmaceutical studies conducted, the composition of an extemporaneous emulsion cream with antipsoriatic and anti-inflammatory effects based on white purified naphthalan oil has been experimentally substantiated.

The study of the analgesic and anti-edematous activity of purified naphthalan oil on the model of psoriasis

I. Yu. Stan — 2025-03-21

Aim. To study the analgesic and anti-edematous activity of test samples of soft dosage forms containing purified naphthalan oil (PNO) on the model of psoriasis-like skin lesions and with additional inflammation induced by carrageenan.

Materials and methods. Psoriasis-like skin lesions were modeled by applying imiquimod to mice on a shaved area of the back skin. Additional inflammation was induced by injecting carrageenan under the plantar aponeurosis of the hind limb. The analgesic and anti-edematous effects of test samples of soft dosage forms containing PNO were studied, namely, an ointment with 10 % purified naphthalan oil and 3 % salicylic acid (PNO-SA), a cream with 10 % purified naphthalan oil and 0.064 % betamethasone dipropionate (PNO-BD), a cream with 10 % purified naphthalan oil and 10 % urea (PNO-U), and a cream with 10 % purified naphthalan oil, 0.064 % betamethasone dipropionate, and 10 % urea (PNO-BD-U). The analgesic effect of the test samples was assessed using the “tail flick” test to determine the pain threshold. The anti-edematous effect was evaluated by measuring the paw volume (standard units) using the plethysmometric method with the subsequent calculation of anti-edematous activity (AEA).

Results. It was found that in mice with psoriasis-like skin lesions, test samples containing PNO did not exhibit algogenic effects or increase the pain sensitivity. The PNO-SA ointment demonstrated a statistically significant higher pain threshold or a tendency toward a higher pain threshold on Day 14 of the treatment. In conditions of additional pain induction by carrageenan, all groups receiving PNO test samples showed an increased pain threshold 4 hours after phlogogen administration. The PNO-SA, PNO-U, and PNO-BD-U test samples also exhibited higher pain threshold values compared to the pathology control group. These findings suggest the analgesic effect of soft dosage forms containing PNO. It was found that the highest anti-edematous effect was observed in the PNO-SA group 2 hours after carrageenan administration (AEA 78.6 %) and in the PNO-U group 4 hours after administration (AEA 91.7 %). At the same time, in the PNO-SA group, unlike the other groups, there was no statistically significant increase in the paw volume during the experiment.

Conclusions. Among the test samples studied, PNO-SA is of the greatest interest taking into account the analgesic and anti-edematous activity. It is advisable to conduct further studies to assess the effectiveness and safety of this dosage form in models of psoriasis-like skin lesions in vitro and in vivo in order to develop a medicinal product for psoriasis treatment.

The substantiation for the selection of excipients in the composition of the topical analgesic foam

M. E. Popova — 2025-03-21

Skin aerosol foams are promising drug delivery systems due to their numerous advantages and ease of use. The application of foam minimizes the need for touching and rubbing the damaged skin, as the foam spreads easily on the skin with minimal to moderate shear force, which is particularly beneficial for treating wounds of various etiologies. Numerous scientific studies have demonstrated that the pharmaceutical combination of dexpanthenol and lidocaine creates an effective formulation for treating skin conditions due to their anti-inflammatory, antipruritic, anesthetic, and antiseptic properties.

The aim of the study was to justify the selection of excipients in the composition of topical analgesic foam to ensure its stability, effectiveness, ease of application, and therapeutic properties.

Results and Discussion

The composition of a topical analgesic foam containing dexpanthenol at a concentration of 50 mg/ml and lidocaine hydrochloride at 15 mg/ml was developed and justified. A technological process for manufacturing the foam was proposed.

The use of excipients, including solvents, plasticizers, foam boosters, and foam stability stabilizers, was characterized, ensuring the formation of stable foam. The compatibility of aerosol solution components with the propellant was studied under various storage temperatures (2–8°C, 25°C, 37°C). The results confirm that the developed foam composition meets pharmacopoeial requirements for stability, efficacy, and consumer properties. This allows recommending the developed formulation for further research and practical application.

Conclusions

Optimal concentrations of excipients and propellant were justified to ensure appropriate consumer properties. It was determined that a propane-butane content in the range of 33.25–35.0 g provides optimal foam delivery characteristics, including stability (up to 40 minutes) and a high release percentage (over 93%). The pH of the primary solution (5.1–5.5) corresponds to the optimal range for the skin (4–6.5), ensuring patient comfort, minimizing irritation, and promoting wound healing processes. Further studies are aimed at the biopharmaceutical evaluation of the dosage form.

Analysis of the range of medicines for the treatment of the wound process

T. M. Mironchuk — 2025-03-21

Aim. To study the range of medicines that promote wound healing in the pharmaceutical market of Ukraine.

Materials and methods. The study objects were the State Register of Medicines, tabletki.ua website, patient information leaflets. Analytical and statistical methods of analysis were used in the study.

Results. After analyzing the market of wound-healing medicines, it has been found that according to the ATC classification, the group of medicines studied belongs to the ATC group D “Dermatological agents”. The study has found that 81.7 % of medicines are of domestic production, while 18.3 % are of foreign production. The most common are soft dosage forms – 50.4 %; the second position is occupied by liquid dosage forms – 48 %; the least drugs belong to solid dosage forms – 1.6 %.

Conclusions. After analyzing the entire range, it has been found that there are no probiotic medicines for local use in the pharmaceutical market. Therefore, there is a need for further research and development of wound-healing drugs with a probiotic effect for topical use.

The use of the medicinal plant raw material and bee products in the treatment of dermatological diseases

M. A. Tarapata — 2025-03-21

Aim. To analyze the application of natural components in dermatological practice, as well as to study the potential benefits of using extracts from the medicinal plant raw material (MPRM) (Curcuma longa, Aloe vera, Calendula officinalis) and bee products (propolis, bee venom, honey) in the treatment of skin diseases.

Materials and methods. To achieve this aim, methods of logical-content issue formation, content-analysis of publications in scientific and practical-oriented medical and pharmaceutical publications, comparative analysis and graphic tools of visual presentation of the data obtained were used. This study presents the results of scientific and practical work of leading scientists and the own experimental research materials of the authors of the article. Determination and observational studies cover clinical tests that diagnose acne on the skin.

Results. Traditional treatments, including topical retinoids, benzoyl peroxide, and systemic antibiotics, while effective, are not without side effects and limitations, requiring the study of alternative therapies. The combination of bee products and medicinal plant extracts proposed is a potentially synergistic approach to improving acne treatment outcomes. These materials show a clear effect of using natural components in dermatological practice.

Conclusions. The analysis of scientific literature has shown that the plant raw material and bee products have significant therapeutic potential due to a wide range of biologically active substances. The use of honey, propolis and bee venom in the treatment of dermatological diseases, as well as plant extracts that enhance the effect of bee products is of particular interest. The studies conducted have confirmed the effectiveness of the medicinal compositions developed on the basis of the MPRM and bee products for the treatment of dermatological pathologies.

Development of the ointment emulsion base formulation intended for cutaneous application in plantar xerosis

M. I. Fedorovska — 2025-02-26

Plantar xerosis is a feet skin condition characterized by excessive dryness, hyperkeratosis and fissures in the stratum corneum of epidermis. For the treatment and care of the skin with this pathology, drugs in the form of emulsion-based ointments with a high concentration of the hydrophobic phase will be effective.

Aim. Development of the water/oil type emulsion ointment base formulation for cutaneous application in plantar xerosis.

Materials and methods. 9 samples of water/oil type emulsion bases, which contained almond oil and waxes – beeswax, sunflower and rice bran wax. To stabilize the emulsion system, emulsifiers of the second type were used (emulsifier T-2, glyceryl monostearate, sorbitan oleate). To increase colloidal stability, sodium tetraborate was introduced into the formulation.

The samples were prepared using the direct emulsification method and evaluated with the following indicators: organoleptic properties, homogeneity, colloidal and thermal stability, microscopic studies to determine of the emulsion internal phase dispersion, biopharmaceutical studies with the method of release into agar gel, determination of pH and structural viscosity.

Results and discussion. The experiment results of the composition development of water/oil type emulsion bases by determining organoleptic, physical and chemical (colloidal and thermal stability, pH), pharmacotechnological (homogeneity, average size of the dispersed phase, structural viscosity) and biopharmaceutical studies showed that the emulsion bases with combinations of beeswax and glyceryl monostearate (sample No. 2) and sunflower wax and sorbitan oleate (sample No. 4) were characterized with the best properties.

Conclusions. The proposed water/oil type emulsion bases meet the requirements of the main quality indicators and are promising carriers of ointments for cutaneous application in plantar xerosis.

The study of the anti-inflammatory properties of original dry extracts of narrow-leaved lavender (Lavandula angustifolia mill.) herb

O. O. Bogatyrova — 2025-03-21

The aim of our work was to conduct experimental studies of the anti-inflammatory properties of original dry extracts of the narrow-leaved lavender herb of Ukrainian origin to justify their introduction into clinical practice.

Materials and methods of the research. The objects of the study were experimental test samples: No. 1 ‒ dry extract of narrow-leaved lavender herb, obtained by extraction with purified water; No. 2 - dry extract of the narrow-leaved lavender herb obtained by extraction with a water-ethanol solution (40% ethanol); No. 3 - dry extract of the narrow-leaved lavender herb, obtained by extraction with a water-ethanol solution (70% ethanol). An experimental study of the anti-inflammatory properties of dry extracts of lavender herb was carried out on various models of acute inflammation in rats with proven mechanisms of development. Test samples were administered at doses of 25, 50, 100, and 150 mg/kg three days before edema modelling, intragastrically in the form of an aqueous suspension stabilized with Tween-80, in a volume of 1 ml/100 g of animal weight, the last administration was carried out half an hour before the administration of phlogogens - carrageenan or zymosan. As comparison drugs, diclofenac sodium (8 mg/kg) and quercetin (50 mg/kg) were used in the form of an aqueous suspension in a volume of 1 ml/100 g of animal weight half an hour before the administration of carrageenan or zymosan. Edema was induced by subplantar injection into the right hind foot of 0.1 ml of 1% carrageenan solution from Sigma (USA) or 2% zymosan suspension. The severity of the local reaction was assessed by the ratio of the paw volume before and after the administration of phlogogen. The volume of the affected paw was measured using a LE7500 plethysmometer (PANLAB, Italy) 1, 3, 4, 6 and 24 hours after the administration of carrageenan or zymosan.

Statistical data processing was performed using the standard STATISTICA program package (version 6.0). The obtained data are presented as the mean value and its standard error or minimum and maximum values. The distribution of data in the studied samples was checked for normality using the Shapiro-Wilko test. In case of non-compliance with the normal distribution of data in the analyzed samples, intergroup differences were determined using the non-parametric Kruskal-Wallis test (analogue of variance analysis). The significance level was p<0.05.

Results and their discussion.

It has been experimentally proven that in the model of acute inflammation caused by the administration of carrageenan, moderate anti-inflammatory properties of the studied test samples of dry extracts of narrow-leaved lavender herb were established. The most active and stable anti-exudative activity was demonstrated by test samples No. 1 at a dose of 100 mg/kg (50%) and No. 2 at a dose of 150 mg/kg (52%). Test sample No. 3 showed moderate activity, and its maximum effectiveness was observed during the first hour of the experiment. Unlike test samples No. 1 and 2, which provided a stable uniform effect throughout the entire observation period, the effect of test sample No. 3 was less long-lasting.

In the model of acute aseptic inflammation caused by zymosan, it was found that dry extracts of lavender herb showed significant antiexudative activity. However, there was no direct dose-dependent effect. The results of the studies show that among the three tested test samples, the most pronounced and stable antiexudative activity at the level of 61% and 71%, respectively, was demonstrated by extracts of lavender herb obtained by extraction (40 and 70% ethanol) at doses of 150 and 50 mg/kg. Their effectiveness was statistically significantly higher compared to quercetin.

Based on the obtained results, certain assumptions can be made about the immunomodulatory properties of lavender extracts. The reduction of edema under the influence of the studied extracts indicates the suppression of excessive inflammatory reaction, which is one of the manifestations of the immunomodulatory effect. The aqueous extract can weaken the activation of the inflammatory response due to antioxidant properties, which reduce oxidative stress in tissues. Water-ethanolic extracts, due to the high concentration of essential oils (linalool and linalyl acetate), can affect the regulation of the production of both pro-inflammatory and anti-inflammatory cytokines (e.g., interleukin-1β, TNF-α, interleukin-10) and modulate the activity of TLR receptors, which is important for the regulation of macrophage activity and inhibition of the inflammatory response. Antiexudative activity, especially in test samples No. 2 and 3, indicates the ability to modulate vascular permeability, which depends on the activity of immune cells, such as macrophages and neutrophils.

Conclusion. The results of the conducted studies indicate that in the carrageenan-induced inflammation model, the moderate effectiveness (52% and 35%) of test samples No. 2 and 3 is likely associated with a higher concentration of linalool, linalyl acetate, lavandulol and camphor - substances that are extracted with ethanol and block the synthesis of leukotrienes and histamine at the initial stage of edema development. In the zymosan-induced inflammation model, among the three studied test samples, the most pronounced and stable antiexudative activity was demonstrated by dry extracts of narrow-leaved lavender (Lavandula angustifolia Mill.), obtained by extraction with water-ethanol solutions (40 and 70% ethanol) in doses of 150 and 50 mg/kg (test samples No. 2 and 3) at the level of 61% and 71%, respectively. Their effectiveness was statistically significantly higher compared to quercetin. The results of the experiments are consistent with previous studies on the antimicrobial and anti-inflammatory properties of dry extracts of the herb Lavandula angustifolia, obtained by extraction with aqueous-ethanol solutions (40 and 70% ethanol), which strengthens the experimental evidence base of their therapeutic value in the treatment of inflammatory conditions.

The formulation of the concept of internal transfer as a stage for assessing the process scalability on the example of the scheme for obtaining substance 6-methyluracil

O. M. Tarasenko — 2025-03-21

Aim. To introduce the concept of internal (laboratory) transfer, in which the transferring party is a pharmaceutical development specialist, and the receiving party is a technology transfer specialist. The study involved determining the main directions of laboratory scaling, searching for visual approaches to its implementation, as well as performing calculations for increased raw material loads using conversion factors.

Materials and methods. The study object when determining the transfer algorithm was substance 6-methyluracil, which synthesis was in the conditions of the pharmaceutical enterprise JSC “Farmak”. During the internal transfer of the active pharmaceutical ingredient (API), the approved laboratory method for obtaining API 6-methyluracil was tested (scaled). The methodological approach was applied to evaluate the effectiveness of technology transfer processes at various stages, including development, transfer, and adaptation of technologies to production conditions. The reporting documentation of production sites was analyzed.

Results. To ensure proper scaling and testing of the technology, key research areas for the technology transfer were identified, including the adaptation of laboratory process parameters to scaling conditions, reproduction of the laboratory methods for obtaining the substance under laboratory scaling conditions, and evaluation of the process efficiency, including cost-effectiveness. As a result of laboratory scaling with the integrated use of these approaches, the finished product was obtained. This product met the qualitative and quantitative requirements established during the pharmaceutical development and matched the quality of the laboratory sample of the finished product. Based on the data obtained, the efficiency of the scaling process was assessed by comparing (before and after) with the data from the laboratory method. It was determined that during laboratory scaling, the consumption rates per kilogram of the product decreased compared to the laboratory development data, resulting in a reduced cost of the final product.

Conclusions. The technological process for obtaining 6-methyluracil is suitable for scaling under laboratory transfer conditions. All technological parameters identified at the pharmaceutical development stage and adapted for the scalable process were successfully confirmed during the laboratory transfer. The laboratory equipment that maximally simulated production conditions was selected for the transfer process. Additionally, the quantitative yield of the product with reduced consumption rates was confirmed. The target product obtained fully complies with the target quality profile defined during the pharmaceutical development.

Marketing and pharmacoeconomic studies of statin drugs

S. V. Zhadko — 2025-03-21

Aim. To conduct a marketing and pharmacoeconomic analysis of statin drugs and study consumption trends of this group of drugs based on sales indicators from pharmacies.

Materials and methods. The paper used methods of desk marketing research, economic and statistical method, methods of pharmacoepidemiological and pharmacoeconomic research (formal VN-analysis, cost minimization method). Consumption of monocomponent statin drugs was studied according to sales data for 2024 at 1746 pharmacies, which are part of three pharmacy chains. The physical availability of statins was studied according to penetration indicators in pharmacies, economic availability — according to the solvency adequacy ratio.

Results and their discussion. The State Register found 253 records of registration of statins with the following INNs: simvastatin, atorvastatin, rosuvastatin, and pitavastatin. The largest number of drugs, trade names, domestic and foreign manufacturers are represented in the rosuvastatin and atorvastatin segment. Simvastatin drugs are represented by only one domestic manufacturer, and there are no domestic pitavastatin drugs on the market. According to the results of the formal VN analysis, only simvastatin belongs to category V, which is present in all analyzed regulatory and medical-technological documents. Simvastatin, which consumers can receive with reimbursement, occupies only 18.11% in terms of the number of DDs sold. The largest share in statin consumption by DD is occupied by rosuvastatin (56.31%) and atorvastatin (25.39%). All simvastatin drugs have high economic availability for the population; among atorvastatin and rosuvastatin drugs, there are drugs with both high and medium economic availability; all pitavastatin drugs have medium economic availability. Among the simvastatin, atorvastatin, and rosuvastatin drugs, most DDs released belong to foreign manufacturers.

Conclusions. The Ukrainian statin market has revealed a predominance of foreign manufacturers in terms of the number of registered drugs, trade names, and the share of DDs sold from pharmacies. The drugs that lead in sales volume, in most cases, have high physical availability, but are not the cheapest treatment options. Currently, there is a possibility of reimbursement for the cost of treatment only with simvastatin, which is classified as a low-effective statin. Ukrainian consumers can choose atorvastatin and rosuvastatin drugs from domestic and foreign manufacturers in a wide price range (except for certain dosages), however, some drugs with high economic availability have very low penetration rates in pharmacies. The low physical availability of the only domestic drug of the simvastatin group and the lack of domestic drugs of the pitavastatin group may limit patients' access to more affordable treatment options. The high proportion of consumption of rosuvastatin and atorvastatin, which are not subject to reimbursement, makes it urgent to expand the reimbursement program to increase access to modern statin therapy for more patients.