Tampon for medical and hygienic purposes and methods for its manufacture

Description

Field of invention

[0001] The invention relates to a tampon for vaginal use for medical and hygienic purposes and a method for its manufacture. Background of the invention

[0002] Tampons for hygienic applications usually consist of a mixture of cotton and rayon, to which swelling agents may be added to increase fluid absorption capacity.

[0003] Similarly, medical suppositories for vaginal use are also known, but their function is not to absorb bodily fluids, but to release active ingredients. This method takes advantage of the fact that active ingredients can be delivered very effectively and directly into the bloodstream via the vaginal mucosa.

[0004] From EP 0 415 087 A1 a tampon for medical or hygienic purposes is known which comprises a tampon sheath made of hardened collagen or gelatin foam impregnated with active ingredients.

[0005] In an article in The Guardian on May 28, 2019, entitled "Are 'weed tampons' the answer to period pain?", author Arwa Mahdawi reports on suppositories containing cannabidiol.

[0006] US 2004 / 043071 A1 represents the next state of the art. Description of the invention

[0007] Menstrual cramps are often associated with pain and spasms. Therefore, the object of the invention is to develop a product that combines a medical suppository and a tampon, absorbing bodily fluids on the one hand and relieving menstrual cramps on the other.

[0008] This problem is solved by a tampon for vaginal use for medical and hygienic purposes having the features of claim 1, and by a method for manufacturing such a tampon having the features of claim 6. Preferred embodiments are set forth in the remaining claims.

[0009] The tampon according to the invention for vaginal use for medical and hygienic purposes, comprising an inserter, a middle section, and a retrieval end, includes a tampon core made of a fluid-absorbing, pressed fiber composite material, a retrieval device, preferably a retrieval thread extending from the retrieval end beyond it, preferably an external lubricating coating applied to the tampon core in certain areas, and an active ingredient, at least in the region of the inserter, which is present in the region of the inserter as a coating or as a lumpy material bonded to the tampon core. The active ingredient comprises a hydrogenated fat as a carrier substance and an active substance comprising at least one chemical substance from the group of cannabinoids, in particular cannabidiol.

[0010] The tampon according to the invention thus fulfills two functions simultaneously: the usual fluid-absorbing effect and, after insertion, the release of the active ingredient containing cannabinoids, which has a pain-relieving and antispasmodic effect. The active ingredient must be manufactured in such a way that it melts only at body temperature and can then be absorbed by the body. The melting point of the active ingredient is adjusted, among other things, by selecting hydrogenated fat as the carrier substance.

[0011] The amount of active substance per tampon ranges from 25 to 300 mg, preferably between 50 mg and 300 mg. The chemical substance is primarily cannabidiol (CBD). Cannabidiol is the most important representative of the cannabinoid group, of which the cannabis plant contains at least 113 scientifically studied chemical compounds. The proportion of tetrahydrocannabinol (THC) depends on whether and to what extent a psychoactive effect is desired. If this is not desired, THC should only be present in trace amounts in the active ingredient. THC is the psychoactive substance contained in the cannabis plant, to which the majority of the psychoactive effect is attributed.

[0012] According to a preferred embodiment of the invention, the fiber composite material is organic cotton fiber material.

[0013] Cotton fiber has the advantage over the synthetic fabrics most commonly used in conventional tampons of being a natural product. During vaginal insertion and use, a small amount of fiber loss always occurs, which is why commercially available tampons are usually coated, often with hardened collagen foam or gelatin foam containing nourishing agents, to counteract this fiber loss. Since fiber loss cannot be completely avoided, it is advantageous to use organic cotton fiber as a composite material. The term "organic cotton fiber composite" refers to non-genetically modified cotton from organic farming that has not been treated with synthetic agricultural chemicals such as pesticides and fertilizers.

[0014] Preferably, a pH-influencing substance is present in a volume fraction of about 2% in the active substance and is further preferably a pH buffer substance comprising lactic acid.

[0015] In the pharmaceutical field, lactic acid is used as a pH buffer. However, lactic acid has the additional advantage of already being known to strengthen the vaginal environment in suppositories. The use of lactic acid thus has the dual function of stabilizing the active ingredient and simultaneously providing a soothing and regulating effect when the tampon is used.

[0016] According to a non-inventive embodiment of the invention, the active substance comprises a chemical substance from the group of cannabinoids, predominantly cannabidiol, which is contained in oil as a carrier substance. Hemp seed oil, coconut oil, and olive oil are preferably used. Hemp seed oil is particularly preferred because it is rich in omega-3 and omega-6 fatty acids. "Predominantly" here means that cannabidiol is present in the active substance in a volume fraction of at least 50% of the total volume of cannabinoids contained in the active substance.

[0017] According to an alternative embodiment of the invention, which is not according to the invention, the active substance comprises a chemical substance from the group of cannabinoids, predominantly cannabidiol, which is contained in a paste whose melting point is higher than 25 °C and preferably higher than 27 °C. Such pastes are already available on the market, so that the process of extraction or cold pressing, or the production in a bioreactor, starting from cannabis plants, and in particular the Cannabis sativa L. plant with a high natural cannabidiol content, no longer needs to be described.

[0018] Since it is desirable that the active substance be used in the purest possible form, according to the invention the active substance comprises at least 90% by volume cannabidiol, which is present as isolate or distillate. Furthermore, the volume fraction of the active substance in the active ingredient is between 20% and 80%.

[0019] In the production of a distillate, the desired active substance is concentrated to the highest possible level, whereas after the production of an isolate, only the desired chemical substance and possibly traces of other substances remain in the active substance. Cannabidiol isolates and distillates are commercially available in crystalline or solid, pressed form.

[0020] Depending on the form in which the active substance is contained within the tampon, the volume fraction of the active substance can be either small or significant. This allows the individual dose of cannabinoids, and in particular cannabidiol, per tampon to be adjusted to the desired target value.

[0021] In a preferred embodiment, the hydrogenated fat is present in the active ingredient substance in a volume fraction of between 20% and 80% and preferably comprises vegetable glycerides. Such a hydrogenated fat is marketed, for example, as a hard fat under the trade name Witepsol in the product lines S, E, and W. The selection of the appropriate hydrogenated fat is based on the melting points specified in the data sheets and a suitable mixture of hydrogenated fats, should further fine-tuning be required.

[0022] In general, it is preferable to use only substances or preparations in the manufacture of the active ingredient that are listed in the pharmacopoeia and whose use for vaginal application is assured.

[0023] Preferably, the volume fraction of psychoactive tetrahydrocannabinol (THC) is below 0.2 vol.%.

[0024] The inventive method for producing a tampon as described above comprises the steps of providing a tampon core, preferably produced by pressing fibrous material into a fiber composite, producing the active ingredient substance, and either coating the insert end of the tampon core with the active ingredient substance by immersing at least the insert end in a heated bath containing the active ingredient substance or by spraying on a defined amount of the active ingredient substance, or attaching a defined amount of the active ingredient substance to the insert end of the tampon core by means of an adhesive bond and / or a mechanical bond.

[0025] Regardless of whether the active ingredient is placed by immersion, spraying, sticking on or by mechanical attachment to the insert end of the tampon core, it is important to ensure that exactly reproducible conditions are in place so that identical amounts of the active substance and the chemical substance contained therein are applied each time.

[0026] According to a preferred embodiment of the invention, a defined amount of active ingredient is attached to the insertion end of the tampon core by means of a mechanical connection, by locally heating the active ingredient and passing the retrieval device through the active ingredient in the locally heated area.

[0027] The retrieval device is generally a thread made of organic cotton. By passing the thread through the active ingredient, the active ingredient is attached to the tampon core as long as the active ingredient is still in solid form, i.e., until after the insertion of the tampon according to the invention.

[0028] All embodiments have in common that the insertion end of the tampon is smooth due to the hydrogenated fat as a carrier substance for the active ingredient, which facilitates the intended insertion of the tampon. Brief description of the drawings

[0029] Figure 1 schematically shows a tampon according to the invention with a mechanical connection between the active ingredient substance and the tampon core; Figure 2 schematically shows a tampon according to the invention with a connection between the active ingredient substance and the tampon core produced by coating; Figure 3 schematically shows a variant of the tampon according to the invention; and Figure 4 schematically shows a further variant of the tampon according to the invention. Ways to implement the invention

[0030] At the in Fig. 1 In the illustrated embodiment, the active ingredient 12 is attached to the tampon core 14 of the tampon 10 by forming the desired amount of the active ingredient, comprising hard fat as a carrier substance, optionally lactic acid as a pH buffer, and the active substance, which includes cannabidiol as a chemical compound, into an ovoid form. An antioxidant, preferably vitamin E, may also be included in the carrier substance.

[0031] At the insertion point 16 of the tampon, the ovoid body containing the active ingredient 12 is connected to the tampon core 14. For this purpose, the ovoid body containing the active ingredient 12 is pressed into the tampon core 14.

[0032] Alternatively or additionally, the ovoid body can also be bonded to the tampon core 14 using the active substance 12, whereby any pharmacologically approved adhesive can be used which remains inert to the active substance and does not penetrate to any significant extent into the fiber composite of the tampon core 14.

[0033] Based on the typical dimensions of an example tampon with a diameter of 15 mm and a length of 450 mm, the ovoid body containing active ingredient 12 can have a length of 18 mm and a diameter of 12 mm, corresponding to the three principal axes with dimensions of 18 mm, 12 mm, and 12 mm. The active ingredient therefore has a volume of 1.36 cm³.

[0034] A further, additional fixation of the ovoid body to the active ingredient 12 can be achieved by threading the retrieval thread 18 through the ovoid body. For this purpose, the ovoid body is locally heated and liquefied using nozzles or a laser beam before being attached to the tampon core 14, so that the retrieval thread 18 can be threaded through the lumpy active ingredient 12. The locally heated active ingredient then solidifies again and closes tightly around the retrieval thread. After the active ingredient 12 is attached to the tampon core 14 by pressing and / or gluing, the retrieval thread is guided through the tampon core 14 to the retrieval end 20 and out of it, extending beyond the retrieval end 20 of the tampon 10 in a known manner.

[0035] In the embodiment according to Fig. 2The active ingredient 12 containing cannabidiol is applied to the insertion point 16 of the tampon 10 by either immersing the tampon core 14 in heated active ingredient 12 or by spraying the active ingredient locally onto the tampon core in the insertion point of the tampon.

[0036] Figs. 3 and 4 further alternatives for the arrangement of active substance 12 on the tampon core are shown. In this case, the

[0037] embodiment according to Figure 3 the active substance is applied in a ring shape in the area of ​​the inserter 16, while according to the embodiment after Fig. 4 Additionally, longitudinally extending areas 22 of the tampon core are provided with an active ingredient, which have the advantage of facilitating tampon insertion due to improved lubricating properties. The schematic in Figure 4The arrangement of the longitudinally extending areas 30 shown is only an example with regard to number and length.

[0038] In the case of coating the insert 16 of the tampon core 14 with active ingredient 12 by immersing the insert 16 in a heated bath containing the active ingredient 12, the dosage and thus the amount of active ingredient 12 can be determined by precisely defined and reproducible procedures and conditions during the immersion of the insert 16 into the bath containing the active ingredient 12. The temperature of the heated liquid in the bath, the immersion time, the immersion depth, and, if applicable, the number of repetitions must be taken into account. The temperature of the liquid is adjusted depending on its melting point and is between 30 °C and 42 °C.

[0039] To prevent the absorbent tampon core 14 from absorbing the active ingredient 12 and thereby undesirably increasing its volume, it is important to ensure that the active ingredient 12 in the heated bath has a temperature at which it is not thin but has a creamy, highly viscous consistency. This has the advantage that the active ingredient 12 does not penetrate the tampon core 14 to any significant extent, but essentially remains on its surface and hardens there after subsequent cooling.

[0040] When the active ingredient 12 is applied to the tampon core 14 by spraying, precisely calibrated and reproducible procedures are also required to ensure that the same amount of active ingredient is applied to each tampon core. This involves coordinating the spray duration and the diameter of the nozzle(s). During spraying, the tampon core is either rotated around its axis or the nozzle(s) are moved around the tampon core. Alternatively, several nozzles can be used, arranged around the tampon. When manufacturing the tampon by spraying the active ingredient, the temperature of the active ingredient must also be raised sufficiently so that it is above its melting point and can therefore be pumped and dispensed through the nozzle(s).

[0041] Both embodiments share the common features of alternative methods for producing the active ingredient. Depending on the form in which the active ingredient is contained within the active ingredient, the same predetermined, effective amount of cannabidiol is present. If the cannabidiol is used as an isolate, the volume fraction of the active ingredient is lower, for example, between 20% and 80%, while in the case of an oil or paste containing the active ingredient, comprising at least one chemical substance from the cannabinoid group, the volume fraction of the oil or paste in the active ingredient can be up to 95%. In this way, the single dose of cannabinoid, and in particular cannabidiol, per tampon is adjusted to a desired target value.However, it is preferred that, in addition to cannabidiol, other chemical substances from the group of cannabinoids are also contained in the active substance, since other chemical substances from the group of cannabinoids also have positive effects and, moreover, some chemical substances from the group of cannabinoids also work synergistically together.

[0042] Accordingly, the volume fraction of hydrogenated fat in the active ingredient also varies, ranging from 5% to 93%, and can even reach up to 95%. The upper value is only relevant if the cannabidiol is used as an isolate and the active substance comprises only about 5% by volume in the active ingredient. The use of hard fat under the trade name Witepsol, from product lines S, E, or W, has proven suitable as a hydrogenated fat. The hard fats sold under the trade name Witepsol are particularly suitable for the production of the active ingredient because they are white or nearly white and odorless. Furthermore, these hard fats consist primarily of glycerides of vegetable origin. Since no additives are included, these hard fats can be used in pharmaceutical applications.

[0043] The selection of the appropriate hydrogenated fat is based on the desired melting point of the active ingredient, which should be between 30°C and 38°C and preferably between 34°C and 36°C, and can be adjusted accordingly.

[0044] If fiber loss during insertion and use of the tampon is to be reduced, in addition to the application in the insertion area, the central cut and / or the retrieval end of the tampon core can also be coated with the active ingredient or with a further coating, for example made of hardened collagen foam or gelatin foam with nourishing agents.

[0045] Organic cotton fiber is the preferred material used as a fiber composite.

[0046] Lactic acid is used as an optional pH-influencing substance in a volume fraction of approximately 2% of the active ingredient, which stabilizes the active ingredient and simultaneously has a caring and regulating effect during the use of the tampon.

[0047] From the large group of cannabinoids with over 100 different substances, the following additional cannabinoids, besides cannabidiol (CBD), are found in an active ingredient substance produced by extraction or cold pressing: Cannabigerolsäure (CBGA) Cannabigerolsäure Monomethylether (CBGAM) Cannabigerol (CBG) Cannabigerol Monometylether (CBGM) Cannabigerovarinsäure (CBGVA) Cannabigerovarin (CBGV) Cannabichromensäure (CBCA) Cannabichromen (CBC) Cannabichromevarinsäure (CBCVA) Cannabichromevarin (CBCV) Cannabidiolsäure (CBDA) Cannabidiol Monomethylether (CBDM) Cannabidiol C 4 (CBD-C 4 ) Cannabidivarinsäure (CDBVA) Cannabidivarin (CBDV) Cannabidiorcol (CDB-C 1 ) Delta-9-Tetrahydrocannabinolsäure A (THCA-A) Delta-9-Tetrahydrocannabinolsäure B (THCA-B) Delta-9-Tetrahydrocannabinol (THC) Delta-9-Tetrahydrocannabinolsäure C 4 (THCA-C 4 ) Delta-9-Tetrahydrocannabinol C 4 (THC-C 4 ) Delta-9-Tetrahydrocannabivarinsäure (THCVA) Delta-9-Tetrahydrocannabivarin (THCV) Delta-9-Tetrahydrocannabiorcolsäure (THCA-C 1 ) Delta-9-Tetrahydrocannabiorcol (THC-C 1 ) Delta-7-cis-Isotetrahydrocannabivarin Delta-8-Tetrahydrocannaninolsäure (Δ 8< -THCA) Delta-8-Tetrahydrocannaninol (Δ 8< -THC) Cannabicyclolsäure (CBLA-C 5 )Cannabicyclol (CBL-C 5 ) Cannabicyclovarin (CBLV) Cannabinol Methyl Ether (CBNM) Cannabinol-C 4 (CBN-C 4 ) Cannabivarin (CBV) Cannabinol-C 2 (CBN-C 2 ) Cannabiorcol (CBN-C 1 ) Cannabinodiol (CBND) Cannabinodivarin (CBVD) Cannabitriol (CBT) 10-ethoxy-9-hydroxy-delta-6°-tetrahydrocannabinol 8,9-dihydroxy-delta-6°-tetrahydrocannabinol Cannabitriolvarin (CBTV) Ethoxy-cannabitriolvarin (CBTVE) Dehydrocannabifuran (DCBF) Cannabifuran (CBF) Cannabichromanone (CBCN) Cannabicitran (CBT) 10-Oxo-delta-6a-tetrahydrocannabinol (OTHC) Delta-9-cis-tetrahydrocannabinol (cis-THC) Cannabiglendol (OH-iso-HHCV) Cannabiripsole (CBR) Trihydroxy-delta-9-tetrahydrocannabinol (triOH-THC).

[0048] The most important substances extracted from cannabis are, from the list above, CBG, THC, CBD, CBC, CBGV, THCV, CBDV and CBCV.

[0049] In addition to cannabidiol (CBD), some cannabinoids can be desirable accompanying substances. Cannabigerol (CBG), cannabigerolic acid (CBGA), cannabichromene (CBC), and cannabidiolic acid (CBDA), for example, possess antibiotic effects, while cannabigerol and delta-9-tetrahydrocannabinol (THC) also have analgesic and anti-inflammatory effects. The antifungal properties of cannabigerol can also have a positive additional effect. Example Product description for a CBD tampon with 100mg of active CBD ingredient

[0050] Approximately 10 grams of Witepsol E76 pastilles are placed in a glass container along with approximately 5 grams of CBD paste (50% CBD content) and approximately 0.3 grams of lactic acid (Lacidum Lacticum). The mixture is then slowly heated and stirred until a smooth, creamy emulsion is formed. At a temperature between 30°C and 40°C, the active ingredient has a viscosity that ensures ideal processing.

[0051] 612 mg of the active ingredient should be applied to each tampon tip. The active ingredient consists of 400 mg Witepsol E76 as a carrier substance (65%), 200 mg CBD paste (33%), and 12 mg lactic acid (2%). Two different application methods were investigated: 1) Application of the active ingredient with a nozzle: The active ingredient is then applied evenly around the tampon tip using a thin nozzle. The nozzle diameter and the temperature of the substance must be selected so that the active ingredient is not absorbed by the tampon core. Instead, the active ingredient should spread evenly on the surface of the tampon core in the insertion area (tampon tip). 2) Application of the active ingredient using the immersion method: In this method, the tampon tip is briefly immersed in a basin containing the active ingredient. It is important to ensure that the viscosity of the active ingredient is high enough so that it has a creamy consistency. This has the advantage of preventing excessive absorption by the tampon core.To control the dosage of the applied active ingredient, the tampon core can be cooled to accelerate the hardening of the active ingredient. The overall immersion time of the tampon core in the active ingredient bath also plays a role. Dosage can also be achieved through multiple, interval-like immersions. With the tampon core at room temperature and the active ingredient warmed to 30°C to 40°C, three to five immersions, each lasting one to two seconds, have proven effective.

Claims

1. A tampon for vaginal use for medical or hygienic purposes with an insertion end (16), a middle section and a retrieval end (20), comprising: - a liquid-absorbing tampon core (14); - a retrieval apparatus, preferably a retrieval thread (18), which extends from the retrieval end (20) beyond it; - optionally, an external lubricant coating, applied to the tampon core (14) in certain areas; and - an active drug substance (12) at least in the area of the insertion end (16), which is present in the area of the insertion end (16) as coating or as lumpy material, that is connected to the tampon core (14), wherein - the active drug substance comprises: - an active substance, comprising at least one chemical substance from the group of cannabinoids; and - a hydrogenated fat as a carrier substance, characterized in that - the tampon core (14) consists of a pressed fibre composite material; - the active substance, comprising at least one chemical substance from the group of cannabinoids, comprises at least 90 vol % cannabidiol, which is present as an isolate or distillate; and - the active substance is present in a volume fraction of 20% to 80% of the active drug substance (12).

2. The tampon according to claim 1, characterized in that the fibre composite material is organic cotton fibre.

3. The tampon according to claim 1 or 2, further comprising: - a pH-value-influencing substance in a volume fraction of approximately 2% of the active drug substance (12); wherein - the pH-value-influencing substance is preferably a pH-buffer substance, which comprises lactic acid.

4. The tampon according to any one of the preceding claims, characterized in that the hydrogenated fat in the active drug substance (12) is present in a volume fraction between 20% and 80% and preferably comprises vegetable glycerides.

5. The tampon according to any one of the preceding claims, characterized in that the active drug substance (12) is in a lumpy form and is connected to the tampon core (14) in such a way that the active drug substance (12) forms the insertion end (16) of the tampon (10).

6. A method for manufacturing a tampon (10) according to any one of the preceding claims, comprising the steps: (a) providing a tampon core (14); (b) manufacturing the active drug substance (12); and either (c1) coating at least the insertion end (16) of the tampon core (14) with the active drug substance (12) by immersing the insertion end (16) in a heated bath, containing the active drug substance (12), or by spraying on a defined quantity of the active drug substance (12); or (c2) attaching a defined amount of active drug substance (12) to the insertion end (16) of the tampon core (14) by means of an adhesive bond and / or a mechanical bond.

7. The method according to claim 6, wherein, in step (c2), the active drug substance (12) is locally heated, and the retrieval apparatus (18) is passed through the active drug substance (12) in the locally heated area.