INTRODUCTION:

The skin is the largest organ of the human body and one of the most easily accessible for topical application. The skin performs several important functions, including protecting the body from external influences, regulating temperature, participating in metabolism, and sensing external stimuli^1,2,3.

The application of medications topically to the skin, also known as topical application, is a widely accepted treatment for a variety of conditions and diseases. This may include the use of creams, gels, ointments, lotions, patches, and other forms intended for use on the skin⁴.

Gels are a soft dosage form that has a number of advantages over other forms. Gels ensure rapid absorption of active substances through the skin or mucous membranes, which allows you to quickly achieve the desired effect. This is especially important and convenient in cases where it is necessary to provide quick relief in the treatment of local problems such as joint pain, muscle pain, skin diseases, and other symptoms. Gels are easy and convenient to apply to the skin. This is especially useful in treating local problems such as joint pain, muscle pain, or skin diseases⁵. Gels provide local action for medicinal substances, minimizing systemic effects on other organs and systems of the body^6,7.

When developing the composition of creams, gels, ointments, lotions, patches, and other forms intended for use on the skin, it is necessary to take into account the requirements for soft dosage forms in order to achieve comfortable conditions when applied to the skin. This can be achieved by a rational selection of excipients in the composition of a soft dosage form¹. Pharmaceutical excipients are used as structure the dosage form. The main application of excipients to dosage forms for topical use is to control the extent of absorption, maintain viscosity, improve stability, as well as organoleptic properties, and increase the volume of the drug⁴. Rheological parameters (viscosity, thixotropy) are the main requirements that are the criterion for evaluating the quality of gels both during production and their storage⁸^,⁹.

Modern research on active substances in plants leads to the discovery of new potential medicines. This stimulates the pharmaceutical industry to develop plant-based drugs and integrate them into modern medical practice^10,11.

Currently, in many countries of the world, herbal medicines occupy a priority part of the general range of medicines and are being increasingly introduced into use every day^12,13.The advantage of medicines based on herbal raw materials is relative safety, low toxicity in the prevention and treatment of chronic diseases⁸^,14,15.

One of the promising sources of biologically active substances is the plant Portulaca oleracea L. Since ancient times, Portulaca oleracea L. has been used in folk medicine. Depending on its chemical composition, it exhibits various pharmacological effects, such as antioxidant, antitumor, anti-inflammatory, antimicrobial, antiviral, hypoglycemic, hepatoprotective, antipyretic, and diuretic^16,17.

The aim of the study is to develop a technology for obtaining a soft dosage form of a gel with the conditional name PortoGel. The active ingredient in a soft gel dosage form is an ultrasonic ethanolic extract of Portulaca oleracea L. in its original composition with gelling agents and excipients. Considering the need to develop new drugs with high efficiency and safety, the development of a gel based on an ethanolic extract of plant origin, Portulaca oleracea L., seems to be a promising and relevant area of research.

MATERIALS AND METHODS:

Materials:

Sapineo Derm (hydroxyethyl acrylate/sodium acryloyldimethyl taurate) (France), sodium alginate (Xi'an Youth Biotech, China), lecigel (Lucas Meyer, France), guar gum (Premcem Gums, India), glycerin (Pharmacia 2010 LLP, Kazakhstan), boric acid (Tandem Distribution LLP, Kazakhstan), 0.1% Tea Tree oil (Aromatika LLC, Russia), purified water.

Within the framework of this study, 5 models were developed. Sodium alginate and Sepineo Derm in equal concentrations were selected as gelating agents.

Obtaining the extract:

Plants of Portulaca oleracea L. were collected in the flowering phase in the Zhambyl region of the Republic of Kazakhstan, in July-August 2022. After collecting the above-ground parts of Portulaca oleracea L., they were washed with running water to clear debris. For better drying, the raw materials were cut into pieces of 3-5 cm, and the raw materials were dried in a well-ventilated area. The dried raw materials were crushed using an electric grinder (Retsch SM 300, Germany) to a fraction of 0.2–0.5mm. Portulaca oleracea L. extract was obtained in an ultrasonic bath (PS-20AD 2.8 L, China), 70% ethanol was used as an extractant, and the raw material-extractant ratio was 1:10. The resulting extract was filtered through an ashless paper filter, purified by settling, and evaporated at a temperature of 400°C on a rotary evaporator under vacuum (STEGLER RI-213, Russia) to a ratio of 1:1¹⁸. We used an ultrasonic ethanolic extract of Portulaca oleracea L. with a conditional name - POUS extract.

Obtaining the gel base:

Aqueous solutions of several concentrations were prepared for each gel-forming agent. At the same time, the optimal mode of obtaining a gel-forming solution was determined. As part of the selection of the optimal composition of the gel base, 5 formulations with different concentrations of gelling agents were studied: sodium alginate, sapineo derm, Guar gum, carrageenan, and glycerin. The concentrations of gelling agents were 0.5%, 0.8%, 1.0%, 1.5%, and 2.5%. The glycerin content was 10%, 15%, and 20%, the addition of which increased plasticity and prevented the gel from drying out. A weighed portion of the gelling agents was introduced separately into purified water and left to swell for 20 minutes, then they were separately dispersed in 40 mL of purified water with continuous stirring. After swelling, it was thoroughly mixed, preventing the formation of bubbles, and homogenized until a homogeneous mass was obtained. Stirred at a speed of 1000–2000rpm. Then a glycerin solution was added by weight and mixed with the gelling agent solution.

Comparative assessment of the proposed formulations appearance and homogeneity and spreadability of gel bases:

Samples of 1.0g of each product were placed between two glass plates (10 x 25cm in size), pressed until a homogeneous 0.5 mm thick layer was obtained, and subjected to visual inspection. Heterogeneous compositions with signs of phase separation were excluded. The appearance, color, and odor were checked using organoleptic analysis¹⁹.

Colloidal stability study:

For preliminary testing of physical stability and prediction of stability, samples of 2.0g were centrifuged for 10 minutes in a laboratory centrifuge (MICROFUCE 16, Germany) with a rotation speed of 100 s²⁰.

pH measurement:

Samples of 5.0g from each gel base were heated in 15g of purified water, stirred for one minute, cooled to 20 °C, and filtered through a paper filter. The pH of the aqueous filtrate was measured using a pH meter (827 pH Lab, Switzerland) with a glass electrode. The results given for each base are the average of 5 measurements¹⁹.

Development of gel:

To develop the optimal composition of the gel, POUS extract and excipients were taken, which were introduced by changing the percentage of ingredients in a quantitative ratio. The homogeneity, consistency, and rheological properties of the resulting gels were studied.

For our research, we selected POUS extract as the active ingredient, Sapineo Derm - gelling agent and stabilizer, Sodium alginate - thickener, Glycerin - moisture-saving substance (penetrator), Boric acid and 0.1% Tea Tree oil -as antimicrobial preservatives, purified water - dispersed medium, and solvent. The gel was obtained from the type of solution. The technological process was carried out at room temperature using a laboratory homogenizer (Dlab-500, China). Mixing speed from 1000 to 2000rpm. The POUS extract was added to the resulting base. The volume was adjusted to 100mL with purified water. Preservatives were added to the gel according to their solubility. Everything was thoroughly mixed.

Rheological properties:

The rheological properties of the PortoGel gel were determined on a viscometer (Brookfield HBDV-2, China), rotation speed from 6 to 200rpm. The spindle number corresponded to LO. Before the rheological analysis, the selected gel model was stored at room temperature 20-25°C.

The rheological parameters were studied at temperatures ranging from 20°C to 25°C. For the study, a sample of the experimental specimen (25.0) was taken. The number of experimental points is 20, and the duration of measurement at each point of the curve is 1 second. To study the thixotropic properties of the gel (the composition of the gel models is indicated in Table 1), deformation kinetics curves were constructed in the coordinates “shear rate (Dr) - shear stress (τ)”, in the region of gradient changes from small to large and from large to small (Fig. 12).

Based on the results obtained, graphs were constructed to characterize the change in viscosity from the shear flow rate gradient and the dependence of the shear flow rate gradient on the shear stress.

Microbiological purity:

The total number of viable aerobic microorganisms (bacteria and fungi in total) is no more than 10² per g. The total number of enterobacteria and some other gram-negative bacteria is not more than 10¹ per g. Absence of Pseudomonas aeruginosa in 1 g, Staphylococcus aureus in 1.0 g²¹.

RESULTS AND DISCUSSION:

In the modern pharmaceutical industry, the selection of raw materials and excipients plays a key role in the creation of high-quality and functional medicines. Natural gelling agents such as Sodium alginate, Guar gum, and Carrageenan are often used as effective thickeners. The structural viscosity of some gel compositions increases due to synergy between the components. The ratio of a particular component may vary depending on the specific formulation of the gel and its intended use^22-25.

A study of the properties of the selected gelling agents showed that the optimal combination for this pharmaceutical development is Sodium alginate and Sapineo Derm in an equal concentration of 1%. The resulting gel had a pleasant consistency, elasticity, was easily spread, was not greasy, and did not disperse when applied to the skin.

Model samples of the gel base:

In order to select a base for the gel, models of biodegradable polymers and plasticizers of natural and synthetic origin, representing different ratios of gelling agents and plasticizers, were studied.

To obtain a stable system with the introduction of POUS extract, 5 gel base compositions were tested. Glycerin was used as a plasticizer and solubilizer²⁶, which ensures the resorption of medicinal substances through biological membranes. The compositions of the studied compositions are presented in Table 1.

The selection criteria at the initial stage were satisfactory appearance, homogeneity, odor, plasticity, stability and pH.

Appearance and homogeneity of gel bases:

All compositions have a pleasant, shiny, homogeneous appearance, a rich beige color and a characteristic smell. They have an optimal consistency for application to the skin. All model samples were subjected to further research.

Determination of the pH of the gel bases:

The pH value of the gel base significantly affects the interaction between the related ingredients under the conditions used in its production. For topical use, the pH value of pharmaceuticals should be in the range of 4.5–8.5. It is recommended to use products with a pH of 5.0–5.5, close to the pH, that is considered physiological for the skin^5,27,28.

The pH of the gels was measured on five gel samples. The results are presented in Table 2.

Table 2. pH of the gel bases

Gel samples	After preparation	After storage at a temperature of 20⁰C - 25⁰C
Model 1	5.8±0.01	5.8±0.01
Model 2	6,5±0.02	6.42±0.01
Model 3	6.8±0.03	6.7±0.02
Model 4	7.0±0.01	7.19±0.02
Model 5	5.5±0.02	5.5±0.02

In the studied gel bases, a decrease in pH of 0.7 units was observed for formulations containing Lecigel (Model 1 compared to Model 2), and by 0.4 units for formulations containing carrageenan (Model 4 compared to Model 3). The additional introduction of 1.5% Sapineo Derm into the composition (Model 4) causes an increase in the pH value by more than 1.2 units (Model 4 compared to Model 1) or by 1.5 units for the same concentrations of sodium alginate and Sapineo Derm (Model 5 compared to Model 4). Measurements show that the combination of sodium alginate and Sapineo Derm stabilizes the pH system, which is not subject to changes during storage, and corresponds to the required range (Model 5). These results indicate the need to select and combine components in the formulation of gel bases, taking into account their effect on the pH and stability of the system.

Thus, as a result of research on the development of the optimal composition of the base, we selected model 5 of the following composition: Sodium alginate (1.0), Sapineo derm (1.0), Glycerin (10.0), and purified water up to 100.0.

Model gel samples:

The gel was obtained by dissolving the components at room temperature using a laboratory homogenizer, stirring speed 1000 – 2000 rpm. The POUS extract was added to the resulting base, and the volume was adjusted to 100.0 g with solvent. Preservatives were added to the gel according to their solubility. Model gel compositions are presented in Table 3.

Table 3. Composition of model gel samples with POUS extract

No.	Main Components	Functional purpose	Model No. 1	Model No.2	Model No.3	Model No.4	Model No.5
1	POUS Extract	Active substance	8.0	8.0	8.0	8.0	8.0
2	Sodium alginate	Gelling agent, stabilizer, thickener	1.0	1.0	1.0	1.0	1.0
3	Sepineo Derm	Thickener, stabilizer and texturizing agent	1.0	1.0	1.0	1.0	1.0
4	Glycerin	Emollient	10.0	10.0	10.0	10.0	10.0
5	Tea Tree oil	Preservative			0.2		0.2
6	Boric acid	Preservative				1.0	1.0
7	Citric acid	Preservative		0.5
8	Stearic acid	Stabilizer	0.5
9	Purified water	Solvent	till 100.0	till 100.0	till 100.0	till 100.0	till 100.0

Table 6. Result of microbiological examination of gel

The name of indicators	Regulatory document on test methods	Requirements of the regulatory document	Result	Temperature, C° Humidity, %
Microbiological purity: -total number of aerobic bacteria, CFU/g	State Pharmacopoeia of the Republic of Kazakhstan vol. 1, p. 2.6.12, p. 2.6.13	no more than 10⁵	Less than 10	21 С° 64%
-total number of fungi, CFU/g		no more than 10⁴	Less than 10
-enterobacteria, CFU/g		no more than 10³	Less than 10
-Salmonella in 10g		absence	absence
E. coli in g		absence	absence

Table 7. Results of studying the rheological properties of gel

Speed Rotation spindle, RPM/SP*	Shear rate y, with *(0.82•RPM)**	Ascending		Descending
Speed Rotation spindle, RPM/SP*	Shear rate y, with *(0.82•RPM)**	Shear stress, mPa λ=η•у)	Viscosity, η, mPa•s	Shear stress, mPa λ=η•у)	Viscosity, η, mPa•s
6	7,32	6015,4	821,7	8913,3	1217,6
10	12,2	9615,8	788,1	12733,3	1043,7
12	14,6	11811,2	806,7	14709,2	1004,7
20	24,4	19143,9	784,5	20066	822,3
30	36,6	26037,5	711,4	26081,4	712,6
50	61	35741,2	585,9	34511,7	565,7
60	73,2	37761	515,8	36663,2	500,8
100	122	47289	387,6	45796,1	375,3
120	146,4	51987,2	355,1	52689,7	359,9
200	244	45620,5	186,9	45620,5	186,9

Note: * coefficient for the used LO spindle, sample volume 25.0 mL

Research on the rheology of gel:

Consistency is one of the most important properties of gels, creams, and ointments, which has a significant impact on such technological and consumer indicators as packaging and extrusion from tubes, convenience, and ease of application to the skin²⁹. The rheological properties of soft dosage forms—plasticity, elasticity, structural viscosity, and thixotropy—allow the preparation, distribution, and packaging of these forms³⁰. Thixotropy means a decrease in viscosity caused by the deformation of the medium and its rest after the removal of the external load³¹. At low shear rates, the gel structure is destroyed and completely renewed. As the shear rate increases, the destruction of the gel structure begins to prevail over renewal, and the viscosity decreases. At high shear rates, the structure is completely destroyed, and the system begins to flow³². The results of studying the rheological properties of the PortoGel gel are presented in Table 7.

According to the results of the study, the resulting deformation kinetics curve of the PortoGel gel reveals significant “hysteresis loops”, while the “ascending” curve, which characterizes the destruction of the system, differs from the “descending” curve, which characterizes the renewal of the system, and is explained by the preservation of residual deformation after severe weakening of the structure under the influence of previously applied stress. The dynamic viscosity of the sample is presented in Figures 1 and 2. Figure 1 shows a graph of the dependence of viscosity on the shear flow velocity gradient.

Figure 1. Dependence of viscosity on shear flow velocity gradient

From Figure 1, it can be seen that with an increase in the shear flow rate gradient, a gradual decrease in the viscosity of the test gel is observed. Garg T. et al.⁴ note that gelling agents are used in concentrations of 0.5–10% to easily add to the active drug to form a gel and maintain the viscosity of the gelling agents in the range from about 1000 cP to about 100,000 cP . The consistency of the sample is satisfactory, and the viscosity values of the obtained samples fall within the acceptable range of 200 to 1200 mPas. The data obtained confirm the presence of structure formation in the studied gel. This system has a Newtonian type of flow, since the viscosity remains constant when the shear rate changes. Figure 2 presents graphs for assessing the hysteretic effects that occur during forward and reverse changes in the velocity gradient, depending on the shear stress. In the graph, the descending curve together with the ascending one form a hysteresis loop, which confirms the thixotropy of the system under study. The presence of thixotropic properties characterizes the good spreadability and ability to squeeze out the PortoGel gel from tubes.

Figure 2. Dependence of the gradient of the shear flow velocity on the shear stress.

To achieve the desired rheological properties, cellulose-based polymers or synthetic polymers are added to gels for external use³³. The results of the study show that all bases showed optimal values of structural viscosity. In the presence of a hysteresis loop, the descending and ascending curves after the study practically merge and return to one point. This may indicate that the gel exhibits rheological behavior such as "pseudoplasticity" or "elastic-plasticity," which is typical for gels containing complex structures such as polymer networks or colloidal particles, which can provide both elasticity and plasticity depending on mechanical conditions³⁴.

At low shear rates, the rate of structure disintegration is less than the rate of their restoration; therefore, viscosity does not depend on shear, and the system acquires a Newtonian type of flow. As can be seen from the presented figures, the sample of the PortoGel gel under study has thixotropy and plasticity, which confirms the satisfactory fluidity of the system during the technological process and during application to the skin surface.

Over the past few years, herbal medicines have been gaining popularity in both developing and developed countries. According to research conducted by the World Health Organization, more than 80% of the world's population relies on traditional medicine systems³⁵. Medicinal plants have been shown to play an important role in the treatment of skin diseases such as cuts and burns^1,30.

It is reported that the authors, Snehal D. Sandokar et al. An ointment composition with Anogeissus latifolia extract was developed, and a quality assessment was carried out⁸. A team of authors, Swapnil S. Chopade et al.¹⁹, reported the development of tenoxicam nanogel using Noveon AA-1 polycarbophil and eucalyptus oil as a penetration enhancer, which proved useful as a topical gel for the treatment of edema and rheumatoid arthritis. In their work, Maher Al-Absi et al.³⁰ present the results of a study on the creation of an ointment base using available local ingredients from pomegranate peel extract with optimal rheological properties. Denny Satria et al. reported that a gel with ethanol extracts of binahong leaves and mobe leaves has an effect on increasing the proliferation of fibroblasts and osteocytes during wound healing after tooth extraction in Wistar rats³⁶.

These works fit well with the results of our study on the development of a gel with purslane extract.

Plants are a natural source of bioactive substances and continue to play a critical role in healthcare³⁷.

CONCLUSION:

This study aimed to create a gel with available local plant resources as ingredients (POUS extract). Gel with the ultrasonic ethanolic extract Portulaca oleracea L., passes all indicators of physico-chemical assessment and shows significant results. Thus, this gel can become a medium for effective and easy use of its medicinal properties in a simple dosage form. Further research is needed to determine the therapeutic efficacy of the gel. A gel base with specified rheological properties can be used for further work as a matrix for the inclusion of extracts for cosmetic and pharmaceutical purposes.

CONFLICT OF INTEREST:

The authors declare that there are no conflicts of interest regarding the publication of this article.

ACKNOWLEDGMENTS:

This research has been funded by the Committee of Science and Higher Education of the Ministry of Science and Higher Education of the Republic of Kazakhstan, Grant No. АР14971256.

The authors thank the staff of the control and analytical laboratory of the S.D. Asfendiyarov Kazakh National Мedical University, for their help in conducting experiments.

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Received on 06.06.2024 Revised on 24.09.2024

Accepted on 06.12.2024 Published on 28.01.2025

Available online from February 27, 2025

Research J. Pharmacy and Technology. 2025;18(2):691-698.

DOI: 10.52711/0974-360X.2025.00102

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Model Number	The components of the base,%
Model Number	Sodium Alginate	Guar gum	Carrageenan	Sapineo Derm	Lecigel	Glycerin	Purified water
1	1.5				1.0	-	97.5
2	2.5		1.0			-	96.5
3	1.0		1.0	1.0		20.0	77.0
4	-	0.2		1.5		15.0	84.4
5	1.0			1.0		10.0	88.0

Model No.	Indicator
Model No.	Colour	Homogeneity	Transparency	Consistency	рН	Colloidal stability
1	Beige color	uniform	Opalescence	Dense	6.1±0.01	Stable
2	Rich beige color	uniform	Opalescence	Dense	5.8 ±0.01	Stable
3	Light brown	uniform	nontransparent	Dense	6.3±0.02	Stable
4	Light brown	uniform	nontransparent	Dense	6.2±0.02	Stable
5	Rich beige color	uniform	nontransparent	Dense	5.5±0.02	Stable

No.	Main Components	Content, %	Functional purpose
1	POUS Extract	8.0	Active substance
2	Sepineo Derm	1.0	Thickener, stabilizer and texturing agent
3	Sodium alginate	1.0	Gelling agent, stabilizer, thickener
4	Glycerin	10.0	Moisture-saving substances (emollient)
5	Boric acid	1.0	Antimicrobial preservative
6	Tea Tree oil	0.2	Antimicrobial preservative
7	Purified water	Up to 100.0	Dispersed medium, solvent