A system for manufacturing a pharmaceutical formulation for the treatment of diabetes and diabetic neuropathy

Abstract

A system for the manufacture of pharmaceutical formulations for the treatment of diabetes and diabetic neuropathy, comprising: a) an extraction unit for producing an ethanolic extract from shade-dried leaves of Moringa oleifera Lam. and Bacopa monnieri Linn., and defatting the dried, crushed leaves with petroleum ether to remove lipids and chlorophyll; b) a fractionation unit configured to fractionate the ethanolic extract with ethyl acetate to obtain the ethyl acetate fraction; c) a phytosome preparation unit for the production of phytosomes using antisolvens precipitation technology, wherein the phytosome preparation unit comprises the following: • an ultrasonic device for sonicating a mixture of ethyl acetate fraction and phosphatidylcholine, • a heating device configured to heat the sonicated mixture below 40 °C, and • a condensation device configured to condense solvents into a complex film; and d) a formulation unit configured to incorporate the phytosomes into pharmaceutical dosage forms.

Description

AREA OF INVENTION

[0001] The present disclosure relates to a system for producing a pharmaceutical formulation for the treatment of diabetes and diabetic neuropathy. In particular, the present invention relates to a system for producing the pharmaceutical formulation for the treatment of diabetes and diabetic neuropathy. BACKGROUND OF THE INVENTION

[0002] Diabetes mellitus is a widespread metabolic disease, affecting approximately 529 million people worldwide in 2021. Projections indicate 643 million affected individuals by 2030 and 783 million by 2045. In India alone, 77 million people suffered from diabetes in 2019; this number is expected to rise to over 134 million by 2045. Diabetic neuropathy, nerve damage, affects approximately 50% of people with type 1 and type 2 diabetes, impacts all peripheral nerves, and can potentially damage all organ systems.

[0003] Current treatment methods primarily focus on blood sugar control but may not adequately address accompanying conditions such as diabetic neuropathy. There is currently no cure for diabetic neuropathy; existing systems only alleviate symptoms such as pain and swelling. The progressive nature of the disease increases the risk of foot injuries, ulcers, and, in the worst case, amputations due to loss of sensation.

[0004] Conventional pharmaceutical manufacturing processes for diabetes treatment face several limitations. Plant extract-based systems suffer from low bioavailability, water insolubility, and a bitter taste, which negatively impacts patient adherence. Traditional extraction and formulation methods do not sufficiently improve the absorption of bioactive compounds across biological membranes, thus limiting therapeutic efficacy.

[0005] Phytosome technology has established itself as a promising approach to improving the bioavailability of plant extracts by binding individual components to phosphatidylcholine. Several well-known systems have attempted to treat diabetes and neuropathy using various plant sources. One established method involves the production of phytosomes from Murraya carica Lam. leaves for the treatment of diabetic neuropathy. Another state-of-the-art approach involves the production of herbal preparations containing curcumin oil and boswellia oil for the treatment of numbness in diabetic neuropathy. A further state-of-the-art approach involves the production of phytosomes from Murraya carica Lam. koenigii extract for diabetes prevention.

[0006] However, existing systems reach their limits when simultaneously treating hyperglycemia and diabetic neuropathy. There remains a need for an integrated pharmaceutical formulation system capable of producing compounds with improved bioavailability, increased water solubility, neutral taste, and dual therapeutic activity against both diabetes and diabetic neuropathy.

[0007] Research has shown that Moringa extracts from Oleifera can inhibit the harmful effects of oxidative stress and inflammation while improving glucose and insulin sensitivity. Bacopa Monnieri has demonstrated antinociceptive effects in models of neuropathic pain. However, to date, no system exists that combines these specific plant sources in a phytosome-based formulation specifically designed for the simultaneous treatment of diabetes and diabetic neuropathy.

[0008] Therefore, there is a need for a comprehensive system for the production of pharmaceutical formulations that addresses the challenges of the bioavailability of plant compounds while enabling effective treatment of diabetes and diabetic neuropathy with improved patient-friendly properties such as taste neutrality and water solubility. SUMMARY OF THE INVENTION

[0009] The present disclosure relates to a system for the preparation of a pharmaceutical formulation for the treatment of diabetes and diabetic neuropathy. The invention relates to a system for the preparation of a composition for the treatment of diabetes and diabetic neuropathy comprising a novel formulation of phytosomes obtained from the leaves of Moringa oleifera Lam. and Bacopa monnieri Linn., which enables safe and effective control of blood glucose levels and diabetic neuropathy. Preferably, the present invention relates to a system for the preparation of an antidiabetic pharmaceutical composition comprising: phytosomes from Moringa oleifera Lam. and Bacopa monnieri Linn. leaves with improved bioavailability.

[0010] The present disclosure relates to a system for the manufacture of pharmaceutical formulations for the treatment of diabetes and diabetic neuropathy. The system comprises: a) an extraction unit for the manufacture of an ethanolic extract from shade-dried leaves of Moringa oleifera Lam. and Bacopa monnieri Linn.and degrease the dried, crushed leaves with petroleum ether to remove lipids and chlorophyll; b) a fractionation unit for fractionating the ethanolic extract with ethyl acetate to obtain the ethyl acetate fraction; c) a phytosome preparation unit for producing phytosomes by antisolvene precipitation, the phytosome preparation unit comprising: an ultrasonic unit for sonicating a mixture of the ethyl acetate fraction and phosphatidylcholine, a heating unit for heating the sonicated mixture to below 40 °C, and a condensation unit for condensing solvents to form a complex film; and a formulation unit for incorporating the phytosomes into pharmaceutical dosage forms.

[0011] The subject of this disclosure is a system for the manufacture of pharmaceutical formulations for the treatment of diabetes and diabetic neuropathy.

[0012] Another objective of the present disclosure is to provide a pharmaceutical composition containing phytosomes from ethyl acetate fractions of Moringa oleifera Lam. and Bacopa monnieri Linn. leaves for the treatment of diabetes and diabetic neuropathy.

[0013] Another objective of the present disclosure is to improve the bioavailability and absorption of phytoconstituents from Moringa oleifera and Bacopa monnieri by phytosome formulation with phosphatidylcholine in a 1:1 ratio.

[0014] Another objective of the present disclosure is to offer a safe, effective, tasteless and aromaless antidiabetic composition that overcomes the limitations of existing treatments by improving efficacy and reducing toxicity.

[0015] However, another objective of the present disclosure is the control of blood sugar levels and the prevention of the progression of diabetic neuropathy by using plant-derived phytosomes as an alternative to synthetic drugs.

[0016] To further clarify the advantages and features of the present disclosure, the invention is described in more detail with reference to specific embodiments illustrated in the accompanying drawings. It is understood that these drawings merely show typical embodiments of the invention and are therefore not to be understood as limiting its scope of protection. The invention is described and explained in more detail and with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE IMAGES

[0017] These and other features, aspects and advantages of the present disclosure will be better understood when the following detailed description is read with reference to the accompanying drawings, in which identical symbols represent identical parts, wherein: Fig. Figure 1 shows a block diagram of a system for the manufacture of a pharmaceutical formulation for the treatment of diabetes and diabetic neuropathy according to an embodiment of the present disclosure; Fig. Figure 2 shows a table with an oral liquid formulation containing phytosomes (F1) according to an embodiment of the present disclosure; Fig. Figure 3 shows a table of the oral liquid formulation containing a leaf extract (F2) according to an embodiment of the present disclosure; and Fig. Figure 4 shows a table of oral liquid formulations without extract / phytosomes according to an embodiment of the present disclosure.

[0018] Furthermore, those skilled in the art will recognize that the elements in the drawings are simplified and not necessarily drawn to scale. For example, the flowcharts illustrate the process by highlighting the main steps to facilitate understanding of this disclosure. With regard to the construction of the device, one or more components may be represented in the drawings by conventional symbols. The drawings may show only those specific details relevant to understanding the embodiments of this disclosure, so as not to clutter the drawings with details that are already apparent to those skilled in the art from the description contained herein. DETAILED DESCRIPTION:

[0019] To facilitate understanding of the principles of the invention, reference is made below to the embodiment illustrated in the drawings, which is described using specific terms. It is understood, however, that this does not limit the scope of protection of the invention. Rather, modifications and further developments of the illustrated system, as well as further applications of the inventive principles depicted therein, are conceivable, insofar as they would typically occur to a person skilled in the art in the field of the invention.

[0020] It will be clear to those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not to be understood as a limitation thereof.

[0021] References to “an aspect”, “another aspect”, or similar phrases in this description mean that a particular feature, structure, or property described in connection with the embodiment is included in at least one embodiment of the present disclosure. Therefore, phrases such as “in one embodiment”, “in another embodiment”, and similar expressions in this description may, but do not necessarily, all refer to the same embodiment.

[0022] The terms "includes," "comprehensive," or similar expressions denote non-exclusive inclusion. Thus, a procedure or method containing a list of steps does not only include those steps but may also include further steps not explicitly listed or inherent in the procedure or method. Likewise, the statement "includes..." for one or more devices, subsystems, elements, structures, or components, without further limitations, does not preclude the existence of other devices, subsystems, elements, structures, or components.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meanings generally known to those skilled in the art in the field to which this invention belongs. The systems, methods, and examples described herein serve only for illustration and are not to be understood as limiting.

[0024] Embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

[0025] Fig. Figure 1 shows a block diagram of a system for the manufacture of a pharmaceutical formulation for the treatment of diabetes and diabetic neuropathy according to an embodiment of the present disclosure.

[0026] According to Fig. 1 The system (100) comprises an extraction unit (102) for the production of an ethanolic extract from shade-dried leaves of Moringa oleifera Lam. and Bacopa monnieri Linn.and degrease the dried, crushed leaves with petroleum ether to remove lipids and chlorophyll; a fractionation unit (104) for fractionating the ethanolic extract with ethyl acetate to obtain the ethyl acetate fraction; a phytosome preparation unit (106) for producing phytosomes by antisolvens precipitation, the phytosome preparation unit (106) comprising: an ultrasonic unit (106a) for sonicating a mixture of the ethyl acetate fraction and phosphatidylcholine, a heating unit (106b) for heating the sonicated mixture to below 40 °C, and a condensation unit (106c) for condensing solvents to form a complex film; and a formulation unit (108) for incorporating the phytosomes into pharmaceutical dosage forms.

[0027] In one embodiment, the phytosome preparation unit (106) is configured to produce phytosomes with a mixture of ethyl acetate fraction and phosphatidylcholine in a 1:1 ratio.

[0028] In one embodiment, the extraction unit (102) comprises a Soxhlet extractor configured to extract the dried, crushed leaves with ethanol for 72 hours.

[0029] In one embodiment, the fractionation unit (104) is configured to fractionate using a separating funnel in a 1:1 ratio under periodic shaking.

[0030] In one embodiment, the ultrasonic device is configured to sonicate the mixture in an aprotic solvent for 15-20 minutes.

[0031] In one embodiment, the heating device comprises a microsynthesis device configured to heat the mixture.

[0032] In one embodiment, the phytosome preparation unit (106) is configured to produce phytosomes with an average size of 718 nm.

[0033] In one embodiment, the formulation unit (108) is configured to produce dosage forms from the group consisting of powders, granules, tablets, capsules, oral liquid preparations, beverages and functional foods.

[0034] In one embodiment, the produced phytosomes are water-soluble and tasteless, and the formulation unit (108) is configured to combine the phytosomes with pharmaceutically acceptable excipients.

[0035] The present invention relates to a system for the production of pharmaceutical formulations for the treatment of diabetes and diabetic neuropathy. The system comprises an integrated arrangement of units for the production of phytosome-based compositions with improved bioavailability and therapeutic efficacy.

[0036] The system comprises an extraction unit for producing ethanolic extracts from shade-dried leaves of Moringa oleifera Lam. and Bacopa monnieri Linn. The extraction unit defatts the dried, crushed leaves with petroleum ether to remove lipids and chlorophyll. A fractionation unit fractionates the ethanolic extract with ethyl acetate to obtain flavonoid-rich ethyl acetate fractions. A phytosome preparation unit uses the antisolvens precipitation technique to produce phytosomes by combining the ethyl acetate fraction with phosphatidylcholine in a 1:1 ratio. The mixture is sonified, heated to below 40 °C, and condensed to form a complex film. A formulation unit incorporates the produced phytosomes into various pharmaceutical dosage forms.

[0037] The phytosomes produced with this system contain approximately 40 to 60 wt% ethyl acetate and phosphatidylcholine. The resulting phytosomes have an average size of 718 nm and are characterized by water solubility and tastelessness. This makes them suitable for incorporation into powders, granules, tablets, capsules, liquid dosage forms, beverages, and functional foods.

[0038] This system overcomes the limitations of conventional herbal extract preparations by eliminating solubilizers and offering a safe and effective formulation for blood glucose control and the treatment of complications of diabetic neuropathy. The water-soluble and tasteless phytosomes significantly improve patient adherence compared to bitter-tasting conventional extracts.

[0039] The present invention relates to a system for producing compositions for the treatment of diabetes and diabetic neuropathy, wherein the system is configured to produce novel formulations of phytosomes from the leaves of Moringa oleifera Lam. and Bacopa monnieri Linn., which enable safe and effective control of blood glucose levels and diabetic neuropathy. Preferably, the present invention relates to a system for producing antidiabetic pharmaceutical compositions containing phytosomes from Moringa oleifera Lam. and Bacopa monnieri Linn. leaves with improved bioavailability.

[0040] According to the present invention, the system is configured to produce compositions with phytosomes obtained from plant leaves, containing the ethyl acetate fraction of an ethanolic extract of Moringa oleifera Lam. and Bacopa monnieri Linn. leaves. The leaves of Moringa monnieri Linn. contain approximately 40 to 60 wt.%, preferably 50 wt.%, and phosphatidylcholine also approximately 40 to 60 wt.%, preferably approximately 50 wt.%. According to the present invention, the effective concentration of the ethyl acetate fraction of the ethanolic extract of Moringa monnieri Linn. oleifera Lam. and Bacopa monnieri Linn. leaves and phosphatidylcholine is maintained, more precisely, in a 1:1 ratio.

[0041] The present invention relates to a system for the production of pharmaceutical compositions for diabetes and diabetic neuropathy, comprising the following steps: drying the leaves; preparing the crude drug material for extraction; extraction; fractionation; production of phytosomes; and mixing the phytosomes into dosage forms.

[0042] The extraction unit is designed for processing Moringa oleifera and Bacopa leaves. The harvested and shade-dried *Monnieri* leaves are crushed using a mill and stored in an airtight container. The extraction unit includes a degreasing unit that defats the dried, crushed leaves in a Soxhlet extractor using petroleum ether to remove lipids and chlorophyll. The extraction unit also includes a drying unit for drying the pomace and an extraction unit that extracts the dried pomace for 72 hours using 99% ethanol in a Soxhlet extractor. The extraction unit is designed to allow for the natural evaporation of the ethanolic extract.

[0043] The fractionation unit is configured so that the residue is suspended in water and fractionated with ethyl acetate in a 1:1 ratio in a separatory funnel under periodic shaking. The solvents can mix and then separate again, as they are immiscible. The fractionation unit collects the ethyl acetate extracts, which represent the flavonoid-rich fraction and form the upper layer in the separatory funnel. The unit includes a collection device for the separate collection of the layers and a drying device for drying the ethyl acetate fractions.

[0044] The phytosome preparation unit is configured for the production of phytosomes via antisolvens precipitation. It includes an ultrasonic unit for sonicating a mixture of extract and phosphatidylcholine (1:1 ratio) for 15–20 minutes in an aprotic solvent. Sonication causes a size reduction, resulting in phytosomes with an average size of 718 nm. The unit also includes a heating unit with a microsynthesis unit that heats the sonicated mixture to below 40 °C for approximately 20 minutes. A condensation unit condenses the solvents into a complex film in a round-bottom flask. The unit further includes a separation unit for removing the complex film with n-hexane, and a filtration and drying unit for filtering and drying the complex film to obtain the desired phytosomes.

[0045] The formulation plant is configured to produce pharmaceutical formulations in various dosage forms, such as powders, granules, tablets, capsules, or beverages, together with suitable, pharmaceutically acceptable excipients. Furthermore, the formulation plant is configured to incorporate phytosomes into functional foods, which may contain various nutrients, vitamins, minerals, flavorings (including synthetic and natural flavorings), colorings and flavor enhancers, pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, pH regulators, stabilizers, preservatives, glycerol, alcohols, or carbonating agents as permitted food additives. Example 1: Configuration of the extraction unit for Moringa oleifera and Bacopa monnieri processing

[0046] The extraction unit is designed for processing Moringa oleifera and Bacopa monnieri leaves. The harvested leaves are dried in the shade, then crushed in a mill and stored in an airtight container. The extraction unit includes a weighing device for the dried, crushed leaves, and a degreasing unit with a Soxhlet extractor for removing lipids and chlorophyll from the leaves using petroleum ether. The extraction unit also includes a drying unit for drying the pomace and an extraction unit with a Soxhlet extractor for extracting the dried pomace with 99% ethanol for 72 hours. Example 2: Configuration of the fractionation unit

[0047] The fractionation unit is configured so that the residue is suspended in water and fractionated with ethyl acetate in a 1:1 ratio in a separatory funnel under periodic shaking. The solvents can mix and then separate again, as they are immiscible. The fractionation unit collects the ethyl acetate extracts, which represent the flavonoid-rich fraction and form the upper layer in the separatory funnel. The unit includes a collection device for the separate collection of the layers and a drying device for drying the ethyl acetate fractions. Example 3: Configuration of the phytosome preparation unit

[0048] The phytosome preparation unit comprises an ultrasonic unit for sonicating a mixture of extract and phosphatidylcholine (1:1 ratio) for 15–20 minutes in an aprotic solvent. It also includes a heating unit with a microsynthesis unit for heating the sonicated mixture to below 40 °C for approximately 20 minutes. Furthermore, the unit includes a condensation unit for condensing the solvents into a complex film in a round-bottom flask. Finally, the unit includes a separation unit for separating the complex film with n-hexane, and a filtration and drying unit for filtering and drying the complex film to obtain the desired phytosomes.

[0049] Fig. Figure 2 shows a table with an oral liquid formulation containing phytosomes (F1) according to an embodiment of the present disclosure.

[0050] Fig. Figure 3 shows a table with an oral liquid formulation containing an extract from leaves (F2) according to an embodiment of the present disclosure.

[0051] Fig. Figure 4 shows a table of oral liquid formulations without extract / phytosomes according to an embodiment of the present disclosure. Oral liquid formulation system consisting of phytosomes (F1):

[0052] The formulation unit is configured to produce a liquid oral preparation by mixing the dry powder obtained in Example 3 with the ingredients in Fig. The formulation unit is manufactured using the listed pharmaceutical excipients. Since the phytosomes are water-soluble, the formulation unit is designed to eliminate the need for diluents or suspending agents, thus simplifying the preparation of the liquid oral dosage form. The system is configured to avoid toxicity risks associated with diluents and reduce formulation costs. The formulation unit overcomes the water solubility problems typically encountered with herbal oral dosage forms containing extracts, thereby eliminating the need for diluents. Oral liquid formulation system consisting of leaf extract [EXTRACT FRACTION (EAFMO+EAFBM) FORMULATION] (F2):

[0053] The formulation unit is configured to produce a liquid oral preparation by mixing the dry powder (pure extract) obtained in Example 2 with the ingredients in Fig. The system produces the following three listed pharmaceutical excipients. Since the extract fraction is insoluble in water, CMC is added, necessitating a solubilizer. The system results in a bitter-tasting preparation. Oral liquid formulation without extract / phytosomes [BLANK FORMULATION] (F3):

[0054] The formulation unit is configured to create an oral formulation by adding the ingredients listed in the table. Fig. The formulation unit is produced using the four listed pharmaceutical excipients. It is also configured to contain, for comparison purposes, only the excipients used in F1 and F2 as a blank formulation.

[0055] The characterization unit is configured to investigate the effect of the phytosome composition produced in Example 3 according to an embodiment of the present invention on diabetic neuropathy by observing the blood glucose level.

[0056] Based on the results of the MTT test, the L6 cell line was observed to exhibit cytotoxic activity upon exposure to different concentrations of the sample. Sample EAFBM (IC50 = 1.433 ± 0.16 µg / ml) proved to be more cytotoxic than sample PMOBM (IC50 = 41.62 ± 0.064 µg / ml) and sample EAFMO (IC50 = 320.9 ± 0.089 µg / ml). The IC50 value represents the concentration of an inhibitor / sample / formulation at which the number of viable cells is reduced by half.

[0057] Based on the results, enzyme inhibition (α-amylase) was observed in samples EAFMO (IC50 = 14.23 ± 0.28 µg / ml), EAFBM (IC50 = 1.815 ± 0.31 µg / ml), and PMOBM (IC50 = 20.34 ± 0.12 µg / ml) compared to the standard acarbose (IC50 = 1.03 ± 0.06 µg / ml). The concentrations of 14.23 µg / ml in sample EAFMO, 1.815 µg / ml in sample EAFBM, and 20.34 µg / ml in sample PMOBM correspond to 0.1845 µg / ml of the standard (acarbose). Sample EAFBM showed higher activity than samples EAFMO and PMOBM.

[0058] Based on the results, enzyme inhibition (α-glucosidase) was observed in samples EAFMO (IC50 = 876 ± 0.2062 µg / ml), EAFBM (IC50 = 51.04 ± 0.183 µg / ml), and PMOBM (IC50 = 802.8 ± 0.148 µg / ml) compared to the standard acarbose (IC50 = 4.434 ± 0.09 µg / ml). 876 µg of sample EAFMO, 51.04 µg of sample EAFBM, and 802.8 µg of sample PMOBM corresponded to 4.434 µg / ml of the standard (acarbose). Sample EAFBM showed higher activity than samples EAFMO and PMOBM.

[0059] According to the analysis results, sample A showed in vitro glucose uptake in the L6 cell line. The insulin concentration was 512.22 µg / ml, and the metformin concentration was 530.43 µg / ml. In sample EAFMO, glucose uptake at the IC50 dose was 533.43 µg / ml, in sample EAFBM it was 498.75 µg / ml, and in sample PMOBM it was 480.88 µg / ml. At the lowest IC50 dose, glucose uptake was 76.75 µg / ml, compared to the control (untreated cells) (431 µg / ml).

[0060] According to the analysis results, different insulin concentrations were found in samples EAFMO, EAFBM, and PMOBM. The highest concentration was observed in sample EAFBM (287.09 U / ml lysate) and the lowest in sample PMOBM (273.91 U / ml lysate) compared to the control sample.

[0061] In various cases, phytosomes improve the solubility, permeability, and bioavailability of active ingredients and inhibit or delay their physical and chemical degradation. They can be used without toxic side effects. Phytosomes offer improved bioavailability by increasing the penetration and bioavailability of phytoconcentrates. The improved absorption leads to a higher absorption rate, thus requiring a lower dosage of the active ingredients to achieve the desired effect. Furthermore, they exhibit fewer toxic side effects, allowing them to be used without adverse effects.

[0062] The drawings and the preceding description illustrate embodiments. Those skilled in the art will recognize that one or more of the described elements can be combined to form a single functional element. Alternatively, certain elements can be divided into several functional elements. Elements of one embodiment can be added to another. For example, the process flows described here can be modified and are not limited to the manner described herein. Furthermore, the actions of a flowchart need not be performed in the sequence shown; nor do all actions necessarily need to be carried out. Actions that do not depend on other actions can be performed in parallel with the other actions. The scope of protection of the embodiments is in no way limited by these specific examples. Numerous variations, whether explicitly stated in the description or not, such as...Differences in structure, dimensions, and materials are possible. The scope of protection of the embodiments is at least as comprehensive as described by the following claims.

[0063] The advantages, other benefits, and problem solutions have been described above with reference to specific embodiments. However, the advantages, benefits, problem solutions, and any components that can effect or enhance an advantage, benefit, or solution are not to be construed as critical, necessary, or essential features or components of the claims. REFERENCES 100 A system for the manufacture of a pharmaceutical formulation for the treatment of diabetes and diabetic neuropathy. 102 extraction units 104 fractionation unit 106 phytosome preparation unit 106a Ultrasound device 106b Heating element 106c Condensation arrangement 108 Formulation unit

Claims

A system for the manufacture of pharmaceutical formulations for the treatment of diabetes and diabetic neuropathy, comprising: a) an extraction unit for the production of an ethanolic extract from shade-dried leaves of Moringa oleifera Lam. and Bacopa monnieri Linn., and degrease the dried, crushed leaves with petroleum ether to remove lipids and chlorophyll; b) a fractionation unit configured to fractionate the ethanolic extract with ethyl acetate to obtain the ethyl acetate fraction; c) a phytosome preparation unit for the production of phytosomes by antisolvens precipitation technique, the phytosome preparation unit comprising: • an ultrasonic device for sonicating a mixture of ethyl acetate fraction and phosphatidylcholine, • a heating device configured to heat the sonicated mixture below 40 °C, and • a condensation device configured to condense solvents to a complex film; and d) a formulation unit configured to incorporate the phytosomes into pharmaceutical dosage forms. System according to claim 1, wherein the phytosome preparation unit is configured to produce phytosomes with a mixture of ethyl acetate fraction and phosphatidylcholine in a 1:1 ratio. System according to claim 1, wherein the extraction unit comprises a Soxhlet extractor configured to extract the dried, crushed leaves with ethanol for 72 hours. System according to claim 1, wherein the fractionation unit is configured to fractionate by means of a separating funnel in the ratio 1:| under periodic shaking. System according to claim 1, wherein the ultrasonic device is configured to sonicate the mixture for 15-20 minutes in an aprotic solvent. System according to claim 1, wherein the heating device comprises a microsynthesis device configured to heat the mixture. System according to claim 1, wherein the phytosome preparation unit is configured to produce phytosomes with an average size of 718 nm. System according to claim 1, wherein the formulation unit is configured to produce dosage forms from the group consisting of powders, granules, tablets, capsules, oral liquid preparations, beverages and functional foods. System according to claim 1, wherein the produced phytosomes are water-soluble and tasteless, and the formulation unit is configured to mix the phytosomes with pharmaceutically acceptable excipients.

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