Compositions comprising active ingredients derived from fungi

Abstract

The invention relates to a composition comprising ingredients derived from fungi, and at least a dicarboxylic acid alkyl ester to combat human ectoparasites. The invention furthermore relates to the process to produce these compositions, namely a process for the preparation of a composition to combat human ectoparasites, wherein fungi are being extracted using an extraction agent comprising at least a dicarboxylic acid alkyl ester, and a formed extract is used as active ingredient in the composition.

Description

[0001] COMPOSITIONS COMPRISING ACTIVE INGREDIENTS DERIVED FROM FUNGI

[0002] Field of the invention

[0003] The present invention generally relates to a composition comprising fungi for combatting human ectoparasites. It furthermore relates to a process for producing such compositions, whereby the active ingredients are extracted from fungi. In addition, the invention relates to the use of ingredients derived from fungi to combat human ectoparasites.

[0004] Background of the invention

[0005] Human ectoparasites and pests are widely present. Head lice (Pediculus humanus capitis), one of the most common ectoparasites globally, affects hundreds of millions of people each year, particularly children aged 3 to 11 . The problem is particularly prevalent in children that go to school, often leading to infestations within their families as well. Head lice infestation is caused by the common head louse Pediculus humanus capitis, and typically causes itching of the scalp. As the lice feed on human blood, they may cause lesions to develop on the scalp, swollen glands on the neck or under arms, or other symptoms. Head lice infestation causes serious problems due to the negative social implications of the infestation. Body lice are also bothersome to humans and carry the additional hazard of being the vectors of certain diseases, such as exanthematic or epidemic typhus and recurrent fever.

[0006] Other examples of ectoparasitic infestations on humans are, for example, scabies, a parasitic infestation caused by tiny mites that burrow into the skin and lay eggs, causing intense itching and a rash. Scabies can lead to skin sores and serious complications like septicemia (a bloodstream infection), heart disease and kidney problems. Ticks are also notorious vectors of diseases. Tick bites themselves can cause local irritation, redness, and itching, and improper removal can lead to skin infections. More importantly, ticks are vectors of serious diseases such as Lyme disease, tick-borne encephalitis, and babesiosis, which can cause long-term health issues if untreated. Pubic lice, or crab lice, are ectoparasites that infest humans, caused by Pthirus pubis. They typically inhabit coarse body hair in the pubic region but can also be found in armpits, chest hair, and eyelashes. Scratching may lead to secondary infections, and while pubic lice do not transmit diseases, they can cause emotional distress and social stigma for those affected. Bed bugs are another group of ectoparasites that can negatively impact human health and well-being. Like scabies, lice, and ticks, bed bugs are small, wingless ectoparasites that feed on human blood. Bed bug bites cause itchy, red welts, which may lead to scratching and secondary skin infections. Although they do not transmit diseases, bed bugs can cause significant anxiety, sleep disturbances, and emotional stress for affected individuals and families.

[0007] Numerous products are available in the market for killing human ectoparasites. However, these products are generally toxic to humans, and harmful to the environment. Lice infestations, particularly in children, are commonly treated with compositions containing pesticides like malathion or permethrin, silicones such as dimethicone and cyclomethicone, or plant oils like tea tree oil. However, pesticides are associated with toxic effects on humans, including carcinogenic risks and endocrine disruption due to estrogen-mimicking properties. Additionally, human ectoparasites have developed resistance to these pesticides, reducing their effectiveness over time. While silicones and plant oils offer alternative treatments, they come with their own risks. Silicones and oils can cause skin irritation, and are notoriously difficult to remove from the hair, leaving it persistently greasy, or with an unpleasant odour. Moreover, these substances can create safety hazards, as they are often flammable and can make surfaces like bathroom floors or other products dangerously slippery, increasing the risk of accidents. Also, many plant extracts are associated with allergies and skin irritation.

[0008] There is a need for a composition that effectively treats human ectoparasites while being safe, user-friendly, and both environmentally and economically sustainable. In particular, the composition should be non-flammable and non-toxic, require only a short treatment time, and be easily removable from both hair and treated surfaces. Furthermore, there is a need for a composition that is biodegradable and ecologically sustainable, while remaining technically simple and economically viable. There furthermore exists a need for a composition which can treat body and head lice, but which is safe to use, particularly on children. of the invention

[0009] It is an objective of the invention to address one or more of the disadvantages faced in the prior art. It is another objective of the invention to provide an alternative to the existing over-the-counter products for treating of human ectoparasites. A particular objective is to provide an efficient composition and process for the production of that composition to combat head lice. It is a further objective to use a natural and mild active ingredient in a safe, user-friendly, and both environmentally and economically sustainable formulation.

[0010] Accordingly, the present invention relates to a composition comprising ingredients derived from fungi, and at least a dicarboxylic acid alkyl ester to combat human ectoparasites.

[0011] The present invention further relates to a process for the preparation of a composition to combat human ectoparasites, wherein fungi are being extracted using an extraction agent comprising at least a dicarboxylic acid alkyl ester, and a formed extract is used as active ingredient in the composition.

[0012] The present invention also relates to a composition comprising ingredients derived from fungi, and at least a dicarboxylic acid alkyl ester for use as a medicament.

[0013] Applicants have surprisingly found that fungi comprise ingredients that can combat human ectoparasites. If these ingredients are isolated and blend into the composition for combatting human ectoparasites, the treated human ectoparasites are suffocated and killed within minutes. The ingredients from the fungi can at least partly replace the harmful ingredients that are currently present in the over-the-counter products to combat, for example, head lice.

[0014] Detailed description of the invention

[0015] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0016] The invention relates to a composition comprising ingredients derived from fungi, and at least a dicarboxylic acid alkyl ester to combat human ectoparasites. More specifically, it relates to compositions comprising ingredients derived from fungal matter, including mycelium and / or its fruiting body (i.e. mushroom), to combat human ectoparasites. A unique property of the current invention is that the fungal extract suffocates head lice in a way similar to other products based on substances from natural origin such as tea tree oil. Tea tree oil, widely used in products such as those from Australian Bodycare, have long been used for the treatment of head lice.

[0017] As described in for example US6342253 and US6784211 , tea tree oil works by physically coating and immobilizing insects, blocking their respiratory systems, and leading to suffocation. However, their terpenes, while effective against lice, are known to cause skin irritation and can be harmful to humans if ingested or inhaled, contributing to its toxicity. It has been shown that tea tree oil can cause skin irritation and allergic reactions, especially when used undiluted or in high concentrations. Some cases have reported severe allergic dermatitis following topical application. In more serious instances, exposure to tea tree oil has been associated with hormonal effects, including gynecomastia and premature breast development in children. Furthermore, tea tree oil is toxic if swallowed, with symptoms ranging from confusion and loss of coordination to more serious outcomes like coma. Besides these health risks, products containing tea tree oil as their active ingredient require multiple applications due to their lower efficacy. Moreover, as such products are oil-based, tea tree oil leaves a greasy residue that is notoriously difficult to remove from the hair and surfaces it is in touch with, hereby dramatically extending the time needed per treatment with such products.

[0018] Fungi do not contain these substances. According to the present invention, it is believed that the lethal effect of the ingredients derived from fungi on human ectoparasites can be attributed not to toxic terpenes, but rather to the isolated lipids with a low molecular weight. These lipids are known to have a creeping effect and reduce the specific viscosity. It is assumed that the lipids are able to deeply penetrate the breathing system of both head lice and their eggs, hereby blocking their breathing channels resulting in suffocation. As a result, it is believed that these are the candidate substances for the effect of the head lice remedy according to the present invention. It is preferred that the at least a dicarboxylic acid alkyl ester present in the composition is used to subtract the ingredients from the fungi to obtain the ingredients that are active in the suffocation of the human ectoparasites. The composition then comprises the extract of ingredients derived from fungi obtained by exposing the fungi to at least a dicarboxylic acid alkyl ester, and the extract is active in combatting human ectoparasites.

[0019] Other than against human ectoparasites, existing literature describes the insecticidal activity of extracts derived from edible mushrooms against agricultural pests including the soybean weevil and the Colorado potato beetle. Studies have indicated that mushroom extracts prepared using polar solvents (methanol / water mixtures) demonstrate a slow and limited toxicological effect on agricultural pests, as well as animal ectoparasites. In contrast, the present invention provides a composition containing fungal-derived active agents extracted specifically with a dibasic acid alkyl ester as solvent to combat human ectoparasites. Unlike the slow, partial toxic effects shown in existing literature, this invention demonstrates suffocating the human ectoparasites within minutes, thus making it an effective remedy, for, for example, combating head lice.

[0020] In a further embodiment, the composition furthermore comprises at least one extraction agent, more preferably water, an alcohol, a glycol, an oil, a fat, a wax and / or another ester, even more preferably a glycol, an oil, a fat, a wax, and / or another ester. The another ester might be selected from the group of dicarboxylic acid alkyl esters.

[0021] Preferably, the dicarboxylic acid alkyl ester is selected from dibasic esters of malonic, phthalic, terephthalic, azelaic, sebacic, adipic, succinic, or glutaric acid or mixtures thereof, more preferably dibasic esters of adipic, succinic, or glutaric acid, or mixtures thereof. These dicarboxylic acid alkyl esters function primarily as extraction agents and extract mainly the targeted ingredients for combatting human ectoparasites according to the present invention. Furthermore, dibasic esters are ideal for use in child-friendly medical applications and for dissolving low molecular weight lipids due to the following properties: (1 ) low toxicity - dibasic esters are safe for use in products intended for children as it has low toxicity; (2) effective solubility - dibasic esters have excellent solubility properties for low molecular weight lipids, which is preferred for the stability and effectiveness of the composition; (3) mild odour - dibasic esters have a mild odour, which is advantageous for child-friendly products; and (4) environmentally friendly - dibasic esters are biodegradable and have a low environmental impact, which contributes to sustainable production processes.

[0022] In another embodiment, the composition furthermore comprises at least one solvent, more preferably a solvent out of the group of water, alcohols, glycols, oils, fats, waxes, surfactants and / or esters. Depending on the concentration of the fungal extract, more or less dilution might be needed and it is preferred to come to the ideal concentration by using these solvents.

[0023] In a preferred embodiment according to the current invention, the fungi are impaired to increase the amount of active ingredients and / or change the composition of the active ingredients. This process is akin to negative allelopathy, where stress-induced changes in plants lead to the production of bioactive ingredients that can have detrimental effects for their herbivores. Negative allelopathy is a process where plants produce toxic substances that are activated after being eaten by herbivores. These compounds, stored in an inactive form, become toxic when plant tissue is damaged, deterring further feeding and protecting the plant from future attacks. Fungi, similar to plants, synthesize a variety of bioactive molecules as a defense response to mycophages.

[0024] In a further embodiment, the fungi are impaired by mechanically damaging the fungi. This is done to increase the amount of active ingredients and / or change the composition of the active ingredients even further. It is thereby preferred to mimic the damage caused by mycophages in order to induce a negative allelopathic response, as it is assumed that mimicking induces the greatest response. Mechanically damaging might be done in various ways, amongst others by using sharp objects such as needles or knives. Thus, explained in more detail, the fungal material is subjected to targeted mechanical damage suitably prior to extraction. This damage is applied in order to induce the production or release of specific bioactive ingredients through a defensive (allelopathic) response mechanism. In particular, it is believed that the mechanical disruption mimics mycophagous or herbivore-like attack, as such stimuli are known to activate the fungus’s secondary metabolic pathways. Mechanical damage might be applied using sharp or puncturing tools (e.g., needles, scalpels, or microblades), scoring the surface or slicing through fungal tissue in a manner that simulates biological predation. This approach is inspired by observations in the literature, where mechanical injury to fungal tissues activates biosynthetic responses. For example, Li et al. (2022) report that targeted wounding of Pleurotus Ostreatus mycelia leads to significant changes in gene expression, demonstrating a stress-induced metabolic shift. A similar principle is applied here to preferably increase the concentration of insecticidal actives prior to solvent extraction, preferably with a dicarboxylic acid alkyl ester.

[0025] It is preferred that the fungi belong to the class Agaricomycetes, more preferably to the order of Agaricales. It is further preferred that the fungi belong to the family of Pleurotaceae and / or to the family of Omphalotaceae. Most preferred is that the fungi are oyster mushrooms or shiitake. These have demonstrated to be the most effective in delivery of ingredients for combatting human ectoparasites, are easily available in the market, and easy to grow.

[0026] The composition of the invention is used to combat human ectoparasites. It is preferred that the human ectoparasites are one or more out of the group of lice, mites, bed bugs, and ticks, more preferably, the human ectoparasites are head lice. Lice, mites, bed bugs, and ticks are closely related to the test model species, specifically head lice, as they share several key biological traits, including survival strategies, developmental life cycles, host-dependent behaviour, cuticle structure, and modes of locomotion.

[0027] Suitably, the composition furthermore contains one or more of the following substances: a) one or more cosmetically and / or pharmaceutically active substances; b) biocidal substances, preferably insecticides or acaricides, more preferably pyrethrum extracts, macrocyclic lactones, phenylpyrazoles, alkyl phosphates, and / or carbamates; c) plant extracts or plant oils, preferably tea tree oil, azadirachta indica, grapefruit, lavender, and / or a plant extract from a quassia species; d) fatty acids of the mono- or diglyceride, preferably lauric acid, oleic acid, or stearic acid, and / or the esterification of these fatty acids; e) mineral oils; and / or f) silicones, preferably dimethicone. These are all substances found in a variety of formulations as a solution or shampoo to combat lice.

[0028] Suitably, the composition is being formulated as a solution, a shampoo, a foam, a gel, a powder, a spray, and / or a paste and used as a spray solution, an apply-and-leave on solution and / or a washing solution for the organisms or materials to be treated.

[0029] The ingredients for combatting human ectoparasites derived from fungi and dissolved in dicarboxylic acid alkyl esters, are also called active fungal extract. Suitably, the composition comprises in the range of from 0.10 up to 50 wt% of the active fungal extract, preferably in the range of from 0.50 up to 25 wt%, more preferably in the range of from 1.0 up to 15 wt%, based on the total weight of the composition.

[0030] The fungal extract described herein may be formulated with a range of auxiliary substances depending on the intended use and application. In a further embodiment of the invention, the composition comprises in the range of from 0.10 up to 90 wt% of water, preferably in the range of from 30 to 80 wt% of water, and / or in the range of from 0.10 up to 40 wt% of surfactants, preferably in the range of from 5.0 to 25 wt%, and / or in the range of from 0.10 to 5.0 wt% of preservatives, preferably in the range of from 1.0 to 3.0 wt%, based on the total weight of the composition. These quantities are illustrative and serve to exemplify stable and effective formulations for practical use. The inclusion, exclusion, or variation of such auxiliary components does not alter the core inventive concept. The example formulation should not be construed as limiting, as a broad range of excipients may be used to complement the fungal extract without departing from the scope of the invention. These components make it a composition that is optimally stable, user-friendly and effective.

[0031] The current invention is also directed to the process for the preparation of a composition to combat human ectoparasites, wherein fungi are being extracted using an extraction agent comprising at least a dicarboxylic acid alkyl ester, and a formed extract is used as active ingredient in the composition. Dibasic esters have not been previously used for the extraction of natural substances from fungi. It was not known that dibasic esters are suitable for extracting the ingredients from fungi that are highly effective in combatting human ectoparasites. Preferably, the extraction agent furthermore comprises at least one out of the group of water, an alcohol, a glycol, an oil, a fat, a wax and / or another ester, more preferably a glycol, an oil, a fat, a wax and / or another ester. Suitably, the dicarboxylic acid alkyl ester is selected from dibasic esters of malonic, phthalic, terephthalic, azelaic, sebacic, adipic, succinic, or glutaric acid or mixtures thereof, preferably dibasic esters of adipic, succinic, or glutaric acid, or mixtures thereof. These extraction agents specifically extract the low molecular weight lipids from the fungi, which are the targeted active ingredients for combatting the human ectoparasites.

[0032] In a further embodiment of the invention the fungi are being dried, more preferably to a weight of at most 30% of the original weight, even more preferably to at most 20% of the original weight, even more preferably to at most 10% of the original weight of the fungi. Drying of the mushrooms, preferably at temperatures below 40°C, has the effect that the induced compounds are preserved. Also, drying helps concentrate the bioactive ingredients and makes the extraction process more efficient.

[0033] In an even further embodiment of the invention, the fungi are dried, followed by extraction of the dried fungi at a temperature in the range of from 0°C up to 100°C, preferably at a temperature in the range of from 10°C up to 80°C, more preferably at a temperature in the range of from 20 up to 50°C. Drying of the fungi might take place at different temperatures from the extraction temperature. Drying might take place in special equipment, but if circumstances allow it, drying might even take place outside in the sun.

[0034] Suitably, the amount of dried fungi is in the range of 1 to 75%, preferably in the range of 1 to 50%, more preferably in the range of from 1 to 40%, even more preferably in the range of from 1 to 30% relative to the total amount of the extraction agent.

[0035] In another preferred embodiment of the invention, the extraction of the dried fungi takes place at a pressure in the range of 1000 to 5000 hPa, preferably at a pressure in the range of 1000 to 3000 hPa, more preferably 1000 to 2000 hPa. These pressure ranges are suitable for general production facilities, ensuring compatibility with standard equipment while maintaining efficiency in the extraction process. Suitably, extraction techniques such as ultrasonic extraction, maceration or percolation may be applied. Ultrasonic extraction uses high-frequency sound waves to enhance solvent penetration and accelerate the release of bioactive compounds from fungal biomass. Percolation involves passing solvents continuously through the fungal material to improve extraction efficiency. The selection of the extraction method depends on specific requirements regarding yield, speed, and scalability.

[0036] Suitably, the dried fungal matter is macerated. Maceration is defined as an extraction technique that involves breaking down solid material to rupture its cell structures, thereby exposing internal chemical constituents for extraction with solvents. Preferably, the dried fungal matter is macerated in the solvent for a duration up to 72 hours at a temperature in the range of from 20 up to 50°C. Preferably, the solvent is dicarboxylic acid alkyl ester, more preferably, the solvent is selected from dibasic esters of malonic, phthalic, terephthalic, azelaic, sebacic, adipic, succinic, or glutaric acid or mixtures thereof, preferably dibasic esters of adipic, succinic, or glutaric acid, or mixtures thereof.

[0037] Suitably, the fungi are being pressed and filtered to obtain an extract. To do so, preferably a fine mesh filter is used. This way the extract is stabilized by removing solid particles that might settle over time, while retaining the active ingredients essential for the product’s effectiveness.

[0038] Preferably, the fungi are impaired to increase the amount of targeted active ingredients, more preferably before drying of the fungi. Preferably, the fungi are impaired by mechanically damaging the fungi, more preferably by using sharp or puncturing tools (e.g., needles, scalpels, or microblades), scoring the surface or slicing through fungal tissue in a manner that simulates biological predation.

[0039] To optimize the yield of active fungal extract, it is preferred that the fungi that are impaired are left for at least one hour before being harvested and dried, more preferably for at least two hours before being dried, and for at most 72 hours. The fungi are then allowed the time needed to produce a sufficient defensive response, being the synthesis of negative allelopathic compounds in response to the impairment.

[0040] Suitably, the composition furthermore comprises at least one solvent, more preferably a solvent out of the group of water, alcohols, glycols, oils, fats, waxes, surfactants and / or esters. Suitably, the fungi belong the class Agaricomycetes, more preferably to the order of Agaricales, even more preferably to the family of Pleurotaceae and / or to the family of Omphalotaceae, even more preferably the fungi are oyster mushrooms or shiitake. These fungi have demonstrated to be the most effective in delivery of ingredients for combatting human ectoparasites, are easily available in the market, and easy to grow.

[0041] Suitably, the human ectoparasites are one or more out of the group of lice, mites and ticks, preferably head lice.

[0042] The invention is furthermore directed to a composition comprising ingredients derived from fungi, and at least a dicarboxylic acid alkyl ester for use as a medicament.

[0043] Preferably, for use, the ingredients derived from fungi are being formulated as a solution, shampoo, foam, gel, powder, spray and / or paste, and used as a spray solution, an apply-and-leave on solution or a washing solution for the organisms or materials to be treated.

[0044] Suitably, the formula consists of a blend of solvents, surfactants, the active ingredient (fungal extract), and preservatives, or, depending on the specific application, a combination of these individual components.

[0045] The use of the inventive composition is preferably directly on the infested human. It may also be applied to furniture, blankets, pillows, mattresses, clothing, headgear such as caps or helmets, especially in cases of lice infestation, and / or floors such as carpets, e.g., in cases of mite infestation. The inventive composition can also be processed into a bait paste or similar baits with suitable additives.

[0046] The following, non-limiting examples are provided to illustrate the invention.

[0047] The effectiveness of fungi was tested on head lice and nits. The effect of both untreated and treated fungi was investigated. The untreated fungi were used immediately. The treated fungi were treated as follows: the fungi were damaged using needles by lightly scratching and stabbing the outer wall. We then waited 12 hours, so that the impaired fungi were allowed sufficient time for the desired stress response to be activated.

[0048] As fungi, shiitake and oyster mushrooms were used.

[0049] Next the untreated and treated fungi were dried until a decrease of 93% in weight was reached. The dried mushroom material was then finely ground to a powder. Subsequently, the pulverized mushroom material was macerated in a dibasic esters-mixture, comprising of dimethyl adipate, dimethyl glutarate and dimethyl succinate. This solvent works excellently in extracting the ingredients from dried fungi. To prepare the extract, 30 wt% dried mushroom powder (vs. the amount of DBE) was soaked in the DBE mixture for 24 hours at 40°C, after which it is pressed and filtered.

[0050] This resulted in 4 extracts; untreated oyster mushroom (1 a), untreated shiitake (2a), treated oyster mushroom (1 b) and treated shiitake (2b).

[0051] About 10 wt% of the extracts, based on the total weight of the total solution, were dissolved in a mixture of water, cocam idopropyl betaine, lauric acid, lauryl glucoside, polyglyceryl-3 polyricinoleate, polyglyceryl-3 disintegrates, sulfated castor oil, polyglyceryl-3 caprate, dicaprylyl ether, lauryl alcohol, benzyl alcohol, benzoic acid and sorbic acid. A control group without the fungal extract (so with the DBE mixture, but without it containing the targeted active ingredients derived from dried fungi) was also composed (3) of water, cocam idopropyl betaine, dimethyl glutarate, lauric acid, dimethyl adipate, lauryl glucoside, polyglyceryl-3 polyricinoleate, polyglyceryl-3 disintegrates, sulfated castor oil, polyglyceryl-3 caprate, lauryl alcohol, benzyl alcohol, benzoic acid, dimethyl succinate and sorbic acid.

[0052] Lastly, a water control (4) was included.

[0053] Head lice and nits were collected from the heads of infected children and were immersed in each of the 6 extracts for 10 minutes. After a 10-minute treatment, the lice and nits were rinsed thoroughly with water, leaving them free from any residue, after which they were observed.

[0054] The head lice were observed under a strong digital microscope (Bysameyee 4K 3840 x 2160P) at intervals of 0.5 hour, 1 hour, 2 hours and 4 hours after treatment. The formula is considered effective (read: lethal) against head lice if they are dead or immobile. Immobile means that internal (intestines) or external movement (twitching of legs / antennae) may still be present, but signs of sustainable life and remaining chance of reproduction are undeniably excluded. In some cases, the ‘abdominal’, the gastrointestinal tract of the louse, still moves after some time, which indicates life, but which ultimately always ends in the complete death of the louse. The percentages in Table 1 represent the proportion of dead and / or immobile lice relative to the total number of treated lice and nits.

[0055] Because of the 10-day hatching period of the nits, it is assumed that the treated nits can still hatch up to 10 days after treatment. Therefore, they were directly stored in a conditioned incubator (30°C with a humidity of 75%) after rinsing - hereby simulating the human scalp and accurately mimic their natural hatching process - after which they were checked for signs of hatching / life every day for up to 10 days after treatment.

[0056] The results in the tables below show the percentage of dead head lice and nits compared to the total test group.

[0057] Table 1 : the percentage of dead head lice compared to the total for the different formulations Table 2: the percentage of dead nits compared to the total for the different formulations

[0058] From the above experiments can be concluded that oyster mushroom and shiitake, both untreated and treated, clearly show effectiveness in the rapid killing of both head lice and nits.

[0059] Also, the control group (shampoo without fungal extract) demonstrates some efficacy compared to the water control: 55% vs. 0% in lice and 60% vs. 30% in nits. This highlights that at least some of these ingredients also have an impact on head lice and nits. However, the formulation containing fungal content demonstrates significantly higher efficacy rates, which are crucial for a head lice treatment to be effective and reliable in practice.

[0060] Note: 30% of the nits in the water control group appear to have not survived treatment. However, this outcome is not a result of the water immersion itself. Instead, it reflects a common challenge in such experiments: distinguishing between viable and non-viable nits before treatment, as their status often becomes apparent only after hatching conditions have been simulated. The inclusion of dead nits from the outset is an almost unavoidable risk that causes these confusing results.

[0061] The untreated fungal extracts exhibit 80-90% efficacy against head lice, with oyster mushroom demonstrating greater effectiveness than shiitake. Notably, both fungi show a marked increase in efficacy following treatment (mechanical injury), achieving lethality rates of 85-100% against head lice. Once again, the oyster mushroom extract demonstrates superior effectiveness.

[0062] The untreated oyster mushroom and shiitake exhibit equal lethality against nits (85%). Notably, both fungi show a marked improvement in effectiveness after treatment, with the oyster mushroom extract demonstrating superior results. The treated oyster mushroom extract achieves 100% efficacy against both lice and nits, whereas treated shiitake demonstrates 85% effectiveness against lice and 95% against nits.

[0063] From the above, it is concluded that oyster mushrooms and shiitake exhibit inherent efficacy against head lice and their eggs, and that a clear enhancement in effectiveness is observed when the fungi are mechanically injured prior to extraction. This is consistent with existing literature, including studies such as Li et al., which have demonstrated that wounding of fungi activates biosynthetic responses that increase the concentration of insecticidal active ingredients.

Claims

CLAIMS1. A composition comprising ingredients derived from fungi, and at least a dicarboxylic acid alkyl ester to combat human ectoparasites.

2. Composition according to claim 1 , wherein the composition furthermore comprises at least one extraction agent, preferably water, an alcohol, a glycol, an oil, a fat, a wax and / or an ester, more preferably a glycol, an oil, a fat, a wax and / or another ester.

3. Composition according to claim 1 or 2, wherein the dicarboxylic acid alkyl ester is selected from dibasic esters of malonic, phthalic, terephthalic, azelaic, sebacic, adipic, succinic, or glutaric acid or mixtures thereof, preferably dibasic esters of adipic, succinic, or glutaric acid, or mixtures thereof.

4. Composition according to any of the previous claims, wherein the composition furthermore comprises one or more out of the group of water, alcohols, glycols, oils, fats, waxes, surfactants, and / or esters.

5. Composition according to any of the previous claims, wherein the fungi are impaired to increase the amount of active ingredients and / or change the composition of the active ingredients.

6. Composition according to claim 5, wherein the fungi are impaired by mechanically damaging the fungi.

7. Composition according to any of the previous claims, wherein the fungi belong to the class Agaricomycetes, preferably to the order of Agaricales, more preferably to the family of Pleurotaceae and I or to the family of Omphalotaceae, even more preferably the fungi are oyster mushrooms or shiitake.

8. Composition according to any of the previous claims, wherein the human ectoparasites are one or more out of the group of lice, mites, bed bugs, and ticks, preferably the human ectoparasites are head lice.

9. Composition according to any of the previous claims, wherein the composition furthermore contains one or more of the following substances: a) one or more cosmetically and / or pharmaceutically active substances; b) biocidal substances, preferably insecticides or acaricides, more preferably pyrethrum extracts, macrocyclic lactones, phenylpyrazoles, alkyl phosphates, and / or carbamates; c) plant extracts or plant oils, preferably tea tree oil, azadirachta indica, grape fruit, lavender, and / or a plant extract from a quassia species; d) fatty acids of the mono- or diglyceride, preferably lauric acid, oleic acid, or stearic acid, and / or the esterification of these fatty acids; e) mineral oils; and / or f) silicones, preferably dimethicone.

10. Composition according to any of the previous claims, wherein the composition is being formulated as a solution, a shampoo, a foam, a gel, a powder, a spray, and / or a paste and used as a spray solution, an apply-and-leave on solution and / or a washing solution for the organisms or materials to be treated.

11. Composition according to any of the previous claims, wherein the composition comprises in the range of from 0.10 up to 50 wt% of the active fungal extract, preferably in the range of from 0.50 up to 25 wt%, more preferably in the range of from 1 .0 up to 15 wt%, based on the total weight of the composition.

12. Composition according to any of the previous claims, wherein the composition comprises in the range of from 0.10 up to 90 wt% of water, preferably in the range of from 30 to 80 wt% of water, and / or in the range of from 0.10 up to 40 wt% of surfactants, preferably in the range of from 5.0 to 25 wt%, and / or in the range of from 0.10 to 5.0 wt% of preservatives, preferably in the range of from 1 .0 to 3.0 wt%, based on the total weight of the composition.

13. Process for the preparation of a composition to combat human ectoparasites, wherein fungi are being extracted using an extraction agentcomprising at least a dicarboxylic acid alkyl ester, and a formed extract is used as active ingredient in the composition.

14. Process according to claim 13, wherein the extraction agent furthermore comprises at least one out of the group of water, an alcohol, a glycol, an oil, a fat, a wax and / or another ester, more preferably a glycol, an oil, a fat, a wax and / or another ester.

15. Process according to claim 13 or 14, wherein the dicarboxylic acid alkyl ester is selected from dibasic esters of malonic, phthalic, terephthalic, azelaic, sebacic, adipic, succinic, or glutaric acid or mixtures thereof, preferably dibasic esters of adipic, succinic, or glutaric acid, or mixtures thereof.

16. Process according to claims 13 to 15, wherein the fungi are being dried, preferably to a weight of at most 30% of the original weight, more preferably to at most 20% of the original weight, even more preferably to at most 10% of the original weight of the fungi.

17. Process according to claims 13 to 16, wherein the fungi are dried, followed by extraction of the dried fungi at a temperature in the range of from 0°C up to 100°C, preferably at a temperature in the range of from 10°C up to 80°C.

18. Process according to claims 13 to 17, wherein the amount of dried fungi is in the range of 1 to 75%, preferably in the range of 1 to 50%, more preferably in the range of from 1 to 30%, relative to the total amount of the extraction agent.

19. Process according to claims 13 to 18, wherein the dried fungal matter is macerated in the solvent for a duration up to 72 hours at a temperature in the range of from 20 up to 50°C.

20. Process according to claims 13 to 19, wherein the fungi are being pressed and filtered to obtain an extract.

21. Process according to claims 13 to 20, wherein the fungi are impaired to increase the amount of active ingredients and / or change the composition of the active ingredients, preferably before drying of the fungi.

22. Process according to claim 21 , wherein the fungi are impaired by mechanically damaging the fungi.

23. Process according to claim 21 or 22, wherein the fungi that are impaired are left preferably for at least for one hour before being dried.

24. Process according to claims 13 to 23, wherein the composition furthermore comprises at least one out of the group of water, alcohols, glycols, oils, fats, waxes, surfactants and / or esters.

25. Process according to claims 13 to 24, wherein the fungi belong to the class Agaricomycetes, preferably to the order of Agaricales, more preferably to the family of Pleurotaceae and / or to the family of Omphalotaceae, even more preferably the fungi are oyster mushrooms or shiitake.

26. Process according to claims 13 to 25, wherein the human ectoparasites are one or more out of the group of lice, mites and ticks, preferably head lice.

27. A composition comprising ingredients derived from fungi, and at least a dicarboxylic acid alkyl ester for use as a medicament.

28. Use according to claim 27, in the treatment of human ectoparasites, preferably one or more out of the group of lice, mites and ticks, preferably head lice.

29. Use according to claims 27 to 28, wherein the composition is being formulated as a solution, shampoo, foam, gel, powder, spray and / or paste, and used as a spray solution, an apply-and-leave on solution or a washing solution for the organisms or materials to be treated.

30. Use according to claim 29, wherein the formula consists of a blend of solvents, surfactants, the active ingredient (fungal extract), and preservatives, or, depending on the specific application, a combination of these individual components.

Images