Dermal pharmaceutical composition
The dermal pharmaceutical composition with silver-modified bentonite addresses the limitations of conventional treatments by achieving rapid and effective healing of skin and nail conditions, enhancing treatment success and skin health.
Patent Information
- Application Number
- PCT/EP2025/060831
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-04-22
- Filing Date
- 2025-04-21
- Publication Date
- 2025-10-30
AI Technical Summary
Conventional dermal pharmaceutical compositions for treating skin and nail diseases and injuries often lead to limited treatment success and require prolonged periods for noticeable improvement.
A dermal pharmaceutical composition comprising a pharmaceutically acceptable carrier material and pharmaceutically compatible silver-modified bentonite, which is applied directly to the skin or nails, allowing for rapid absorption and effective treatment of a wide range of conditions, including wounds, scars, and skin diseases.
The composition achieves significant healing success within a short period, typically a few days to a few weeks, effectively treating various skin and nail conditions, including wounds, scars, and skin diseases, with silver-modified bentonite providing improved healing and skin elasticity.
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Abstract
Description
[0001] DERMAL PHARMACEUTICAL COMPOSITION
[0002] TECHNICAL AREA
[0003] According to a first aspect, the present invention relates to a dermal pharmaceutical composition comprising the following components: a) a pharmaceutically acceptable carrier material, and b) pharmaceutically acceptable silver-modified bentonite incorporated into the pharmaceutically acceptable carrier material.
[0004] According to a second aspect, the present invention relates to a dermal pharmaceutical composition for use in the treatment of wounds, scars, athlete's foot, nail fungus, neurodermatitis, psoriasis, leg ulcers, rosacea, urticaria, herpes, open toes, pressure sores, burns, chemical burns, abrasions, pimples, acne, impure skin, rashes, dry skin, dandruff, sunburn, dandruff, and / or insect bites, and / or in the preparation, execution, and / or aftercare of tattooing, wherein the dermal pharmaceutical composition comprises the following components: a) a pharmaceutically compatible carrier material, and b) pharmaceutically compatible silver-modified bentonite incorporated in the pharmaceutically compatible carrier material.
[0005] According to a third aspect, the present invention relates to a method for producing a dermal pharmaceutical composition, wherein the method comprises the following process steps: providing a pharmaceutically compatible carrier material, and incorporating a pharmaceutically compatible silver-modified bentonite into the pharmaceutically compatible carrier material.
[0006] According to a fourth aspect, the present invention relates to a pharmaceutical composition obtainable by the method according to the third aspect.
[0007] TECHNICAL BACKGROUND AND TASK STATEMENT
[0008] A large number of patients suffer from a wide variety of skin and nail diseases and injuries, such as wounds, scars, athlete's foot, nail fungus, neurodermatitis, psoriasis, leg ulcers, rosacea, urticaria, herpes, open toes, pressure sores, burns, chemical burns, abrasions, pimples, acne, impure skin, rashes, dry skin, dandruff, sunburn, scalp dandruff, and insect bites, as well as redness and inflammation after getting tattoos.
[0009] Current treatment methods for the corresponding diseases and injuries of the skin or nails involve the application of various dermal pharmaceutical compositions. These compositions contain a wide range of active ingredients in various carrier materials and are typically applied to the affected areas of the skin or nail as ointments, creams, gels, oils, or lanolin. The various active ingredients in these conventional dermal pharmaceutical compositions are absorbed through the patient's skin or nails, thereby exerting their effect.
[0010] However, conventionally used dermal pharmaceutical compositions often lead to only limited treatment success, so there is a need to develop dermal pharmaceutical compositions that can not only be used for a wide variety of diseases and wounds of the skin or nail, but also lead to noticeable treatment success in a short period of time in order to improve the patient's health.
[0011] The present invention therefore aims to provide a dermal pharmaceutical composition which can be advantageously used to treat a wide variety of diseases and wounds of the skin or nails of patients.
[0012] DESCRIPTION OF THE INVENTION
[0013] Surprisingly, it was found within the scope of the present invention that the use of pharmaceutically compatible silver-modified bentonite in a dermal pharmaceutical composition in the treatment of various diseases and wounds of the skin or nail has led to a significant improvement in the healing success within a short healing period.
[0014] According to a first aspect, the present invention relates to a pharmaceutical composition, wherein the pharmaceutical composition is a dermal pharmaceutical composition, and wherein the dermal pharmaceutical composition comprises the following components: a) a pharmaceutically acceptable carrier material, and b) pharmaceutically acceptable silver-modified bentonite incorporated into the pharmaceutically acceptable carrier material.
[0015] This achieves the technical advantage that effective treatment of a wide variety of skin and nail diseases and injuries can be achieved in a large number of patients within a short period of time, i.e., a few days or a few weeks.
[0016] The dermal pharmaceutical composition, as described in the first aspect, can be applied directly to the patient's skin and / or nails. The pharmaceutically compatible silver-modified bentonite is absorbed through the skin and / or nails and, as an active ingredient, leads to successful treatment of a variety of diseases and injuries, such as wounds, scars, athlete's foot, nail fungus, neurodermatitis, psoriasis, leg ulcers, rosacea, urticaria, herpes, open toes, pressure sores, burns, chemical burns, abrasions, pimples, acne, impure skin, rashes, dry skin, dandruff, sunburn, dandruff, insect bites, and redness and inflammation after tattooing.
[0017] The silver in pharmaceutically acceptable silver-modified bentonite can be essentially unbound, particularly chemically unbound, i.e., present as an atom and not as an ion of a silver compound. The silver in pharmaceutically acceptable silver-modified bentonite can be unbound, particularly chemically unbound, in concentrations of 80 wt.% to 100 wt.%, preferably 95 wt.% to 99 wt.%. Unbound silver means that the silver is present essentially in its pure form and not as silver oxide, not as silver nitride, and / or not as any other silver compound or silver salt.
[0018] According to an advantageous embodiment, the pharmaceutically compatible carrier material is selected as a base gel, which preferably comprises paraffin and polyethylene, wherein the base gel is particularly preferably present in a weight range of 80 wt.% to 99.9 wt.%, preferably from 90 wt.% to 99.9 wt.% based on the total weight of the pharmaceutical composition, most preferably in a weight range of 96 wt.% to 98 wt.%.
[0019] This achieves the technical advantage that the pharmaceutically compatible carrier material selected as the base gel provides a dermal pharmaceutical composition in the form of an ointment, which can be conveniently applied to the patient's skin or nails. An ointment based on the base gel spreads particularly well on the patient's skin and penetrates crevices, making it especially beneficial for the treatment of nail fungus and / or crusting.
[0020] In particular, the base gel includes base gel 3021 (manufacturer Caesar & Loretz GmbH), which consists in particular of 95 wt% paraffin (CAS No. 8042-47-5) and 5 wt% polyethylene (CAS No. 9002-88-4).
[0021] According to an advantageous embodiment, the pharmaceutically compatible carrier material is selected as a wound oil, which is particularly selected as argan oil, wherein the wound oil preferably comprises at least one fatty acid and / or vitamin E, wherein the fatty acid is further preferably selected from the group comprising oleic acid, palmitic acid, stearic acid, linoleic acid and mixtures thereof, wherein the wound oil is particularly preferably present in a weight range of 80 wt.% to 99.9 wt.%, preferably from 95 wt.% to 99.9 wt.% based on the total weight of the pharmaceutical composition, most preferably in a weight range of 96 wt.% to 98 wt.%.
[0022] This achieves the technical advantage that the pharmaceutically compatible carrier material selected as a wound oil can be conveniently applied to the patient's skin or nails. A wound oil spreads particularly well on its own across the patient's skin and penetrates crevices, making it especially beneficial in the treatment of nail fungus, scalp psoriasis, and / or crusting.
[0023] In particular, argan oil (manufacturer Bioadorates Product Sari) is used as a wound oil, which specifically comprises 44% by weight oleic acid (Omega 9), 13% by weight palmitic acid, 5% by weight stearic acid, and 30% by weight linoleic acid (Omega 6). The argan oil also contains 8% by weight other biological components of the argan fruit, which primarily include sterols. Vitamin E has been added to the argan oil, specifically at a concentration of 60 mg per 100 mg.
[0024] According to an advantageous embodiment, the pharmaceutically compatible carrier material is selected as a wound petrolatum, which preferably comprises petrolatum and / or eucalyptus oil, wherein the wound petrolatum is particularly preferably present in a weight range of 80 wt.% to 99.9 wt.%, preferably from 95 wt.% to 99.9 wt.% based on the total weight of the pharmaceutical composition, most preferably in a weight range of 96 wt.% to 98 wt.%.
[0025] This achieves the technical advantage that the pharmaceutically compatible carrier material selected as wound petroleum jelly can be advantageously applied to the patient's skin.
[0026] In particular, petroleum jelly with eucalyptus oil (manufacturer The Inked Army GmbH) is used, which comprises petroleum jelly (CAS No. 8009-03-08) as its main ingredient in a range of 75% to 99.9% by weight, and in particular may contain up to 2% by weight of eucalyptus oil (CAS No. 84625-32-1).
[0027] According to an advantageous embodiment, the pharmaceutically compatible silver-modified bentonite is present in a weight range of 0.1 wt.% to 20.0 wt.%, preferably 0.2 wt.% to 10.0 wt.% based on the total weight of the pharmaceutical composition, more preferably in a weight range of 0.2 wt.% to 8.0 wt.%, and even more preferably in a weight range of 0.2 wt.% to 4.0 wt.%.
[0028] This achieves the technical advantage of ensuring a sufficient concentration of pharmaceutically compatible silver-modified bentonite is present in the dermal pharmaceutical composition for the treatment of a wide range of skin conditions and injuries. Furthermore, the pharmaceutically compatible silver-modified bentonite increases skin elasticity and results in softer skin.
[0029] According to an advantageous embodiment, the pharmaceutically compatible silver-modified bentonite comprises silver, cetrimonium bromide and / or bentonite minerals, in particular comprising montmorillonite.
[0030] This achieves the technical advantage that the aforementioned components of the silver-modified bentonite provide an effective dermal pharmaceutical composition and also serve skin care, as the skin remains soft.
[0031] In particular, bentonite comprises a mixture of various clay minerals, especially montmorillonite, and serves as an effective carrier for silver and optionally zinc present in the dermal pharmaceutical composition, and also enhances the effect of the active substances silver and / or cetrimonium bromide.
[0032] In particular, cetrimonium bromide enhances the effect of the components of the silver-modified bentonite.
[0033] In particular, the montmorillonite is present in the bentonite in a weight range of 60 wt.% to 80 wt.%.
[0034] According to an advantageous embodiment, silver is present in the silver-modified bentonite in a weight range of 0.5 wt.% to 5 wt.% based on the weight of the silver-modified bentonite, preferably in a weight range of 1.0 wt.% to 3 wt.%, more preferably in a weight range of 1.5 wt.% to 2.5 wt.%, and most preferably in a weight range of 1.7 wt.% to 2.1 wt.%.
[0035] This achieves the technical advantage that the specified weight range of silver provides an effective dermal pharmaceutical composition.
[0036] According to an advantageous embodiment, cetrimonium bromide is present in the silver-modified bentonite in a weight range of 0.1 wt.% to 50 wt.%.
[0037] This achieves the technical advantage that the specified weight range of cetrimonium bromide provides an effective dermal pharmaceutical composition.
[0038] According to an advantageous embodiment, the pharmaceutical composition further comprises the following component: pharmaceutically acceptable zinc oxide, wherein the pharmaceutically acceptable zinc oxide is preferably present in a weight range of 0.1 wt.% to 4.0 wt.% based on the total weight of the pharmaceutical composition, more preferably in a weight range of 0.2 wt.% to 2.0 wt.%, more preferably in a weight range of 0.3 wt.% to 1.5 wt.%, and most preferably in a weight range of 0.4 wt.% to 1.2 wt.%.
[0039] This achieves the technical advantage that the use of zinc oxide improves the efficacy and / or the range of application of the pharmaceutical composition. Particularly in the treatment of nail fungus, the pharmaceutically compatible zinc oxide promotes the transport of the active ingredients. According to an advantageous embodiment, the pharmaceutical composition further comprises the following component: pharmaceutically compatible silver chloride applied to titanium dioxide, wherein the pharmaceutically compatible silver chloride applied to titanium dioxide is preferably present in a weight range of 0.5 wt.% to 4.0 wt.% based on the total weight of the pharmaceutical composition, more preferably in a weight range of 0.6 wt.% to 3.5 wt.%, more preferably in a weight range of 0.65 wt.% to 3.0 wt.%, and most preferably in a weight range of 0.7 wt.% to 2.7 wt.%.
[0040] This achieves the technical advantage that the use of silver chloride applied to titanium dioxide improves the effectiveness or the range of application of the pharmaceutical composition.
[0041] According to an advantageous embodiment, the pharmaceutically acceptable silver-modified bentonite further comprises the following component: pharmaceutically acceptable zinc pyrithione, wherein the pharmaceutically acceptable zinc pyrithione is preferably present in a weight range of 0.01 wt.% to 20 wt.%, preferably from 0.1 wt.% to 0.5 wt.%, more preferably from 0.01 wt.% to 0.5 wt.%, further preferably from 0.1 wt.% to 0.35 wt.%, and more preferably from 0.15 wt.% to 0.25 wt.%, based on the weight of the pharmaceutically acceptable silver-modified bentonite.
[0042] This results in the technical advantage that the use of zinc pyrithione in combination with silver improves the effectiveness or the range of application of the pharmaceutical composition.
[0043] According to a second aspect, the present invention relates to a pharmaceutical composition for use in the treatment of wounds, scars, athlete's foot, nail fungus, neurodermatitis, psoriasis, leg ulcers, rosacea, urticaria, herpes, open toes, pressure sores, burns, chemical burns, abrasions, pimples, acne, impure skin, rashes, dry skin, dandruff, sunburn, dandruff, and / or insect bites, and / or in the preparation, execution, and / or aftercare of tattooing, wherein the pharmaceutical composition is a dermal pharmaceutical composition comprising the following components: a) a pharmaceutically acceptable carrier material, and b) pharmaceutically acceptable silver-modified bentonite incorporated in the pharmaceutically acceptable carrier material.This achieves the technical advantage that effective treatment of a variety of diseases and / or injuries of a patient is possible using the dermal pharmaceutical composition.
[0044] The silver in pharmaceutically acceptable silver-modified bentonite can be essentially unbound, particularly chemically unbound, i.e., present as an atom and not as an ion of a silver compound. The silver in pharmaceutically acceptable silver-modified bentonite can be unbound, particularly chemically unbound, in concentrations of 80 wt.% to 100 wt.%, preferably 95 wt.% to 99 wt.%. Unbound silver means that the silver is present essentially in its pure form and not as silver oxide, not as silver nitride, and / or not as any other silver compound or silver salt.
[0045] All advantageous embodiments mentioned for the pharmaceutical composition according to the first aspect are also advantageous embodiments for the pharmaceutical composition for use according to the second aspect.
[0046] According to a third aspect, the present invention relates to a method for producing a dermal pharmaceutical composition, wherein the method comprises the following process steps: providing a pharmaceutically acceptable carrier material, and incorporating a pharmaceutically acceptable silver-modified bentonite into the pharmaceutically acceptable carrier material.
[0047] This achieves the technical advantage of effective production of the dermal pharmaceutical composition.
[0048] The silver in pharmaceutically acceptable silver-modified bentonite can be essentially unbound, particularly chemically unbound, i.e., present as an atom and not as an ion of a silver compound. The silver in pharmaceutically acceptable silver-modified bentonite can be unbound, particularly chemically unbound, in concentrations of 80 wt.% to 100 wt.%, preferably 95 wt.% to 99 wt.%. Unbound silver means that the silver is present essentially in its pure form and not as silver oxide, not as silver nitride, and / or not as any other silver compound or as a silver salt. All advantageous embodiments mentioned for the pharmaceutical composition according to the first aspect are also advantageous embodiments for the process according to the third aspect.
[0049] According to an advantageous embodiment, the incorporation of the pharmaceutically compatible silver-modified bentonite into the pharmaceutically compatible carrier material comprises the following process steps: incorporating the pharmaceutically compatible silver-modified bentonite into the pharmaceutically compatible carrier material by means of a process carried out under exclusion of air and / or oxygen, and subsequently dispersing the mixture of the pharmaceutically compatible carrier material and the pharmaceutically compatible silver-modified bentonite.
[0050] The incorporation of the pharmaceutically compatible silver-modified bentonite into the pharmaceutically compatible carrier material can be carried out under exclusion of air and / or oxygen using a toothed disc.
[0051] The dispersion of the mixture of the pharmaceutically compatible carrier material and the pharmaceutically compatible silver-modified bentonite can be carried out using a three-roller.
[0052] Through this process, the inventor of the present invention achieves deaeration of the pharmaceutical product and energy enrichment. Both serve to stabilize it, and the energy enrichment additionally ensures high efficacy. The active ingredient, silver-modified bentonite, is finely ground and stabilized by the high energy input. This high energy input ensures that the effect of the silver-modified bentonite is enhanced.
[0053] The three-roller process de-aerates the system. This de-aeration reduces the amount of oxygen in the pharmaceutical composition, which could otherwise react with the silver to form silver oxide and thus reduce its efficacy. This de-aeration effect stabilizes the system. During processing, it is crucial that all components, i.e., at least the pharmaceutically compatible carrier material and the pharmaceutically compatible silver-modified bentonite, are processed under vacuum or in the absence of oxygen. This procedure further removes air from the process to prevent oxidation of the silver in the silver-modified bentonite as much as possible. The particle size of the silver-modified bentonite in all the aforementioned embodiments can range from 2.5 pm to 20 pm, preferably from 5 pm to 10 pm.
[0054] This achieves the technical advantage of effective production of the dermal pharmaceutical composition.
[0055] According to a fourth aspect, the present invention relates to a pharmaceutical composition obtainable by the method according to the third aspect.
[0056] This achieves the technical advantage of effective production of the dermal pharmaceutical composition.
[0057] EXAMPLES OF EXECUTION
[0058] Within the framework of the following detailed examples, a large number of dermal pharmaceutical compositions were produced, and their effectiveness in treating a variety of skin diseases or wounds was investigated.
[0059] The following are the components of the dermal pharmaceutical compositions 1a, 1b, 2a, 2b, 2c, 3a, 3b, 3c, 4a, 4b, 5a, 5b and 5c that were investigated below, with the weight percentages of the individual components being varied.
[0060] In dermal pharmaceutical compositions 1a, 1b, 2a, 2b, and 2c, base gel 3021 (manufacturer Caesar & Loretz GmbH) is used as a pharmaceutically compatible carrier material. This base gel primarily comprises paraffin and polyethylene. Specifically, base gel 3021 consists of 95% by weight paraffin (CAS No. 8042-47-5) and 5% by weight polyethylene (CAS No. 9002-88-4). Thus, the corresponding pharmaceutical compositions 1a, 1b, 2a, 2b, and 2c are provided as ointments, which are applied to the skin of the patients being treated.
[0061] The active ingredients in dermal pharmaceutical compositions 1a, 1b, 2a, 2b, and 2c are silver-modified bentonite or silver-modified bentonite and zinc pyrithione. The silver-modified bentonite comprises 0.1 wt% to 50 wt% cetrimonium bromide (CAS 57-09-0) and 0.5 wt% to 5 wt% silver (CAS 7440-22-4), with the remainder of the silver-modified bentonite consisting of bentonite (CAS 1302-78-9) containing montmorillonite (CAS 1318-93-0) as its main component.
[0062] The silver-modified bentonite and zinc pyrithione comprises 0.1 wt.% to 50 wt.% cetrimonium bromide (CAS 57-09-0), 0.5 wt.% to 5 wt.%, preferably 1.7 wt.% to 2.1 wt.% silver (CAS 7440-22-4), and 0.01 wt.% to 0.5 wt.% zinc pyrithione (CAS 13463-41-7), wherein the remainder of the silver-modified bentonite consists of bentonite (CAS 1302-78-9).
[0063] The dermal pharmaceutical composition 1a comprises 96 wt% base gel 3021 and 4 wt% silver-modified bentonite and zinc pyrithione.
[0064] The dermal pharmaceutical composition 1b comprises 96 wt% base gel 3021 and 4 wt% silver-modified bentonite.
[0065] The dermal pharmaceutical compositions 2a, 2b and 2c also include zinc oxide (CAS No. 1314-13-2) and silver chloride on titanium dioxide as additives, which comprises between 10 wt.% and 25 wt.% silver chloride (CAS No. 7783-90-6) and titanium dioxide (CAS No. 13463-67-7) as the remaining component.
[0066] The dermal pharmaceutical composition 2a comprises 98.7 wt% base gel 3021, 0.4 wt% zinc oxide, 0.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite and zinc pyrithione.
[0067] The dermal pharmaceutical composition 2b comprises 97.7 wt% base gel 3021, 0.4 wt% zinc oxide, 1.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite and zinc pyrithione.
[0068] The dermal pharmaceutical composition 2c comprises 95.9 wt% base gel 3021, 1.2 wt% zinc oxide, 2.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite and zinc pyrithione.
[0069] In dermal pharmaceutical compositions 3a, 3b, 3c, 4a, and 4b, argan oil (manufacturer Bioadorates Product Sari) is used as a pharmaceutically compatible carrier material, containing at least one fatty acid and / or vitamin E. The argan oil specifically comprises 44% w / w oleic acid (omega-9), 13% w / w palmitic acid, 5% w / w stearic acid, and 30% w / w linoleic acid (omega-6). The remaining 8% w / w of the argan oil consists of other biological components of the argan fruit, particularly sterols, and vitamin E has been added at a concentration of 60 mg per 100 mg. Thus, the corresponding pharmaceutical compositions 3a, 3b, 3c, 4a, and 4b are provided as wound oils, which are applied to the skin of the patients being treated.
[0070] For the characterization of the other components, reference is made to the descriptions of the dermal pharmaceutical compositions 1 a, 1 b, 2a, 2b and 2c.
[0071] The dermal pharmaceutical composition 3a comprises 98.7 wt% argan oil, 0.4 wt% zinc oxide, 0.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite and zinc pyrithione.
[0072] The dermal pharmaceutical composition 3b comprises 97.7 wt% argan oil, 0.4 wt% zinc oxide, 1.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite and zinc pyrithione.
[0073] The dermal pharmaceutical composition 3c comprises 95.9 wt% argan oil, 1.2 wt% zinc oxide, 2.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite and zinc pyrithione.
[0074] The dermal pharmaceutical composition 4a comprises 96.0 wt% argan oil and 4.0 wt% silver-modified bentonite and zinc pyrithione.
[0075] The dermal pharmaceutical composition 4b comprises 96.0 wt% argan oil and 4.0 wt% silver-modified bentonite.
[0076] In dermal pharmaceutical compositions 5a, 5b, and 5c, petrolatum with eucalyptus oil (manufacturer: The Inked Army GmbH) is used as a pharmaceutically compatible carrier material. The main component of this composition is petrolatum (CAS No. 8009-03-08) in a concentration ranging from 75% to 99.9% by weight, with eucalyptus oil (CAS No. 84625-32-1) being present in concentrations of up to 2% by weight. Thus, the corresponding pharmaceutical compositions 5a, 5b, and 5c are provided as creams that are applied to the skin of the patients being treated. For the characterization of the other components, please refer to the descriptions of dermal pharmaceutical compositions 1a, 1b, 1c, 2a, 2b, and 2c.
[0077] The dermal pharmaceutical composition 5a comprises 99.10 wt% petrolatum, 0.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite.
[0078] The dermal pharmaceutical composition 5b comprises 98.1 wt% petrolatum, 1.7 wt% silver chloride on titanium dioxide and 0.2 wt% silver-modified bentonite.
[0079] The dermal pharmaceutical composition 5c comprises 96.0 wt% petrolatum and 4.0 wt% silver-modified bentonite.
[0080] The dermal pharmaceutical compositions 1a, 1b, 2a, 2b, 2c, 3a, 3b, 3c, 4a, 4b, 5a, 5b and 5c are manufactured by providing the respective pharmaceutical carrier material and subsequently incorporating the pharmaceutically compatible silver-modified bentonite and / or the pharmaceutically compatible silver-modified bentonite and zinc pyrithione, as well as, if applicable, the zinc oxide or the silver chloride on titanium dioxide. This incorporation is carried out primarily using a toothed disc. Finally, the mixture of the respective pharmaceutical carrier material and the additives is dispersed using a three-roller to provide the respective dermal pharmaceutical compositions 1a, 1b, 2a, 2b, 2c, 3a, 3b, 3c, 4a, 4b, 5a, 5b and 5c, some of which were subsequently applied to the skin or nail of the patient being treated.
[0081] The particle size of the silver-modified bentonite in all the preceding embodiments can range from 2.5 pm to 20 pm, preferably from 5 pm to 10 pm.
[0082] Use of dermal pharmaceutical compositions in the treatment of patients
[0083] As already stated, the dermal pharmaceutical compositions of the present invention are suitable for use in the treatment of a variety of diseases or wounds in patients, in particular for use in the treatment of wounds, scars, athlete's foot, nail fungus, neurodermatitis, psoriasis, leg ulcers, rosacea, urticaria, herpes, open toes, pressure sores, burns, chemical burns, abrasions, pimples, acne, impure skin, rashes, dry skin, dandruff, sunburn, scalp dandruff, and insect bites, as well as in the preparation, execution, and aftercare of tattooing.
[0084] The results of using dermal pharmaceutical compositions 1a, 1b, 2a, 3a, 4a, and 4b for the treatment of psoriasis, open wounds, nail fungus, chemical burns, and aftercare of tattoos are examined in Table 1 below. The effectiveness of the treatment was examined qualitatively with regard to the healing success of the disease or wound, where "++" describes a very good healing success, "+" describes a good healing success, "0" describes a moderate healing success, and "≤" describes a poor healing success.
[0085] Within the framework of the data shown in Table 1, a large number of diseases or wounds in different patients, including psoriasis, open wounds on the nose and leg, nail fungus, chemical burns of the hand, and open leg ulcers, showed poor or at best only moderate success in treatment with conventional pharmaceutical compositions over a long period of several months to several years (see Table 1, “previous product”, “time”, and “success”).
[0086] Within the framework of the treatment using the pharmaceutical compositions of the present invention, the previously described dermal pharmaceutical compositions 1a, 1b, 2a, 3a, 4a, and 4b were used as a follow-up treatment for the corresponding pretreatments, with the frequency of application, the exposure time, and the amount applied being taken from Table 1. As can be seen from the "Healing Period" and "Success" columns of Table 1, a very good or at least good healing success was observed within a few days or a few weeks.
[0087] As part of the treatment using the pharmaceutical compositions of the present invention, the previously described dermal pharmaceutical composition 1b was used in a treatment following tattooing, and here too a significant reduction in inflammation and redness was achieved within one week (Table 1, column “Success”).
[0088] As shown in Table 1 above, the dermal pharmaceutical compositions 1a, 1b, 2a, 3a, 4a, and 4b can be advantageously used to treat a variety of a patient's diseases and / or wounds, or for aftercare following tattooing, and allow for a [benefit] compared to conventional [treatments].
[0089] These methods promote beneficial healing within a very short time. In particular, the use of wound oils allows for the effective treatment of conditions in hard-to-reach areas, such as nail fungus, psoriasis on the scalp, or wounds with scabs.
Claims
REQUIREMENTS 1. Pharmaceutical composition, wherein the pharmaceutical composition is a dermal pharmaceutical composition, and wherein the dermal pharmaceutical composition comprises the following components: a) a pharmaceutically acceptable carrier material, and b) pharmaceutically acceptable silver-modified bentonite incorporated into the pharmaceutically acceptable carrier material.
2. Pharmaceutical composition according to claim 1, wherein the silver in the pharmaceutically acceptable silver-modified bentonite is substantially unbound, in particular chemically unbound.
3. Pharmaceutical composition according to claim 1 or 2, wherein the pharmaceutically compatible carrier material is selected as a base gel which preferably comprises paraffin and polyethylene, wherein the base gel is particularly preferably present in a weight range of 80 wt.% to 99.9 wt.%, preferably from 90 wt.% to 99.9 wt.% based on the total weight of the pharmaceutical composition, and most preferably in a weight range of 96 wt.% to 98 wt.%.
4. Pharmaceutical composition according to claim 1 or 2, wherein the pharmaceutically compatible carrier material is selected as a wound oil, which is preferably selected as argan oil, wherein the wound oil further preferably comprises at least one fatty acid and / or vitamin E, wherein the fatty acid is further preferably selected from the group comprising oleic acid, palmitic acid, stearic acid, linoleic acid and mixtures thereof, wherein the wound oil is particularly preferably present in a weight range of 80 wt.% to 99.9 wt.%, preferably 95 wt.% to 99.9 wt.% based on the total weight of the pharmaceutical composition, and most preferably in a weight range of 96 wt.% to 98 wt.%.
5. Pharmaceutical composition according to claim 1 or 2, wherein the pharmaceutically compatible carrier material is selected as a wound ointment, which preferably comprises petrolatum and / or eucalyptus oil, wherein the wound ointment is particularly preferably in a weight range of 80 wt.% to 99.9 wt.%, preferably from 95 wt.% to 99.9 wt.% based on the total weight of the pharmaceutical The composition is present, and most preferably in a weight range of 96 wt.% to 98 wt.%.
6. Pharmaceutical composition according to any of the preceding claims, wherein the pharmaceutically compatible silver-modified bentonite is present in a weight range of 0.1 wt.% to 20.0 wt.%, preferably 0.2 wt.% to 10.0 wt.% based on the total weight of the pharmaceutical composition, more preferably in a weight range of 0.2 wt.% to 8.0 wt.%, and even more preferably in a weight range of 0.2 wt.% to 4.0 wt.%.
7. Pharmaceutical composition according to any of the preceding claims, wherein the pharmaceutically acceptable silver-modified bentonite comprises silver, cetrimonium bromide and bentonite minerals, in particular comprising montmorillonite.
8. Pharmaceutical composition according to claim 7, wherein silver is present in the silver-modified bentonite in a weight range of 0.5 wt.% to 5 wt.% based on the weight of the silver-modified bentonite, preferably in a weight range of 1.0 wt.% to 3 wt.%, more preferably in a weight range of 1.5 wt.% to 2.5 wt.%, and most preferably in a weight range of 1.7 wt.% to 2.1 wt.%.
9. Pharmaceutical composition according to claim 6 or 7, wherein cetrimonium bromide is present in the silver-modified bentonite in a weight range of 0.1 wt.% to 50 wt.%.
10. Pharmaceutical composition according to any one of the preceding claims, wherein the pharmaceutical composition further comprises the following component: pharmaceutically acceptable zinc oxide, wherein the pharmaceutically acceptable zinc oxide is preferably present in a weight range of 0.1 wt.% to 4.0 wt.% based on the total weight of the pharmaceutical composition, more preferably in a weight range of 0.2 wt.% to 2.0 wt.%, more preferably in a weight range of 0.3 wt.% to 1.5 wt.%, and most preferably in a weight range of 0.4 wt.% to 1.2 wt.%.
11. Pharmaceutical composition according to any one of the preceding claims, wherein the pharmaceutical composition further comprises the following component: Pharmaceutically compatible silver chloride applied to titanium dioxide, wherein the pharmaceutically compatible silver chloride applied to titanium dioxide is preferably present in a weight range of 0.5 wt.% to 4.0 wt.% based on the total weight of the pharmaceutical composition, further preferably in a weight range of 0.6 wt.% to 3.5 wt.%, further preferably in a weight range of 0.65 wt.% to 3.0 wt.%, and most preferably in a weight range of 0.7 wt.% to 2.7 wt.%, 12. Pharmaceutical composition according to any of the preceding claims, wherein the pharmaceutically acceptable silver-modified bentonite further comprises the following component: pharmaceutically acceptable zinc pyrithione, wherein the pharmaceutically acceptable zinc pyrithione is preferably present in a weight range of 0.01 wt.% to 20 wt.%, preferably from 0.1 wt.% to 0.5 wt.%, more preferably from 0.01 wt.% to 0.5 wt.%, further preferably from 0.1 wt.% to 0.35 wt.%, more preferably from 0.15 wt.% to 0.25 wt.%, based on the weight of the pharmaceutically acceptable silver-modified bentonite.
13. Pharmaceutical composition for use in the treatment of wounds, scars, athlete's foot, nail fungus, neurodermatitis, psoriasis, leg ulcers, rosacea, urticaria, herpes, open toes, pressure sores, burns, chemical burns, abrasions, pimples, acne, impure skin, rashes, dry skin, dandruff, sunburn, scalp dandruff, and / or insect bites, and / or in the preparation, execution, and / or aftercare of tattooing, wherein the pharmaceutical composition is a dermal pharmaceutical composition, the pharmaceutical composition comprising the following components: a) a pharmaceutically acceptable carrier material, and b) pharmaceutically acceptable silver-modified bentonite incorporated into the pharmaceutically acceptable carrier material.
14. Pharmaceutical composition according to claim 13, wherein the silver in the pharmaceutically acceptable silver-modified bentonite is substantially unbound, in particular chemically unbound.
15. A method for producing a dermal pharmaceutical composition, wherein the method comprises the following process steps: providing a pharmaceutically compatible carrier material, and incorporating a pharmaceutically compatible Compatible silver-modified bentonite in the pharmaceutically compatible carrier material.
16. Method according to claim 15, wherein the silver in the pharmaceutically acceptable silver-modified bentonite is substantially unbound, in particular chemically unbound.
17. The method of claim 15 or 16, wherein the incorporation of the pharmaceutically acceptable silver-modified bentonite into the pharmaceutically acceptable carrier material comprises the following process steps: incorporating the pharmaceutically acceptable silver-modified bentonite into the pharmaceutically acceptable carrier material under exclusion of air and / or oxygen, and subsequently dispersing the mixture of the pharmaceutically acceptable carrier material and the pharmaceutically acceptable silver-modified bentonite.
18. Method according to claim 17, wherein the incorporation of the pharmaceutically compatible silver-modified bentonite into the pharmaceutically compatible carrier material is carried out under exclusion of air and / or oxygen by means of a toothed disc.
19. Method according to claim 17 or 18, wherein the dispersion of the mixture of the pharmaceutically acceptable carrier material and the pharmaceutically acceptable silver-modified bentonite is carried out using a three-roller.
20. Pharmaceutical composition obtainable by the method according to any one of claims 15 to 19.
Citation Information
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