Active ingredient composition for direct oral administration without the addition of water and for promoting bowel movements, dosage product and use of an active ingredient composition and / or a dosage product

Abstract

The invention relates to an active ingredient composition for direct oral administration without the addition of water and for promoting bowel movements, wherein the active ingredient composition comprises at least one solid, wherein the active ingredient composition, as solids, comprises at least 60.0 wt. percent polyethylene glycol with a molar mass greater than 3,000 g / mol and at least 3.0 wt. percent inulin. The invention further relates to a dosage product for direct oral administration without the addition of water, for chewing and / or sucking, and to the use of an active ingredient composition and / or a dosage product.

Description

[0001] The invention relates to an active ingredient composition for direct oral administration without the addition of water and for promoting bowel movements, wherein the active ingredient composition comprises at least one solid. Furthermore, the invention relates to a dosage product for direct oral administration without the addition of water, for chewing and / or sucking, and to the use of an active ingredient composition and / or a dosage product.

[0002] Polyethylene glycol (PEG), also known as macrogol, is a well-known laxative used to treat constipation and promote bowel movements. It is also used to quickly empty the bowels before colonoscopies and / or gastrointestinal surgeries. As an active ingredient, polyethylene glycol has water-binding and laxative properties. The increased water binding of polyethylene glycol in the gastrointestinal tract increases stool volume, thereby stimulating bowel activity and softening the stool, thus facilitating bowel movements.

[0003] Polyethylene glycol is usually supplied as a powder for preparing an aqueous solution. The user stirs the contents of a macrogol sachet into water and drinks it. A disadvantage of this method is that the powder must first be completely dissolved in water, and a corresponding volume of water must be consumed. For example, to achieve a mild laxative effect in the case of constipation, this would be approximately 125 ml of water per macrogol sachet.

[0004] Macrogol powder for reconstitution in water is typically combined with salts such as sodium bicarbonate, sodium chloride, and potassium chloride, and / or other substances. Furthermore, known formulations often contain significant amounts of sweeteners, such as saccharin, sugar, and / or starch, to provide a sweet taste to the reconstituted macrogol solution. A disadvantage of adding electrolytes and / or readily digestible sugars and starches is that these can lead to electrolyte imbalances and consequently to kidney problems, as well as alterations in the gut flora (microbiome). Particularly after a complete bowel movement or with long-term use of macrogol for a daily laxative effect, problems with recolonization or dysbiosis of the gut flora can occur, leading to health issues.

[0005] The purpose of the invention is to improve the state of the art.

[0006] The problem is solved by an active ingredient composition for direct oral administration without the addition of water and for promoting bowel movements, wherein the active ingredient composition comprises at least one solid, and the active ingredient composition as solids comprises at least 60.0 wt% polyethylene glycol with a molar mass of greater than 3,000 g / mol and at least 3.0 wt% inulin.

[0007] This provides an active ingredient composition containing the physically laxative polyethylene glycol with a molar mass greater than 3,000 g / mol, in particular 3,350 g / mol, which comprises at least two solid components and can be taken directly orally without the addition of water. It is particularly advantageous that the user can place the active ingredient composition and / or the dosage product directly into the mouth in solid form and thus ingest it orally without having to dissolve the active ingredient composition in water beforehand. Consequently, handling and administration are significantly simplified for the user, especially for self-administration.

[0008] Because the active ingredients are in solid form, they can be dosed much more precisely. Furthermore, due to direct oral administration, the prescribed dosage is not subject to potential user error, as can occur with previously known macrogol solutions that require preparation. In addition, the active ingredient composition and / or the dosage products are more convenient and significantly more palatable for the user. Since at least the two active ingredients, polyethylene glycol (specifically polyethylene glycol 3350) and inulin, are taken directly as solids, the volume to be ingested and swallowed is considerably reduced compared to prepared macrogol solutions.

[0009] Furthermore, it is particularly advantageous that inulin has a prebiotic effect and is metabolized in the gut as an energy source by bacteria, especially bifidobacteria, thereby promoting the targeted enrichment and / or recolonization of beneficial bacteria in the gut. Thus, the desired laxative effect is achieved through its active composition, while simultaneously counteracting undesirable changes in the existing gut microbiome and / or promoting the selective enrichment of beneficial bacteria. In addition to polyethylene glycol, inulin also increases stool volume because, as a dietary fiber, it swells physically and absorbs water.

[0010] A key aspect of the invention is that the active ingredient composition, consisting of at least two solids, can be taken directly orally in its dry state without the need for time-consuming dissolution in water or the consumption of additional water or other liquids during oral administration. Furthermore, the inclusion of inulin in the active ingredient composition allows the stool-volume-enhancing effect of polyethylene glycol to be synergistically enhanced. Simultaneously, despite the laxative effect, which always involves the removal of intestinal bacteria from the gut, the intestinal flora is preserved, rapidly recolonized, and / or its composition is selectively and positively influenced. The effect on the intestinal flora depends particularly on the dosage of the active ingredient composition and the ratio of the weight percentages of polyethylene glycol and inulin to each other.Thus, known potential negative effects of laxatives on the intestinal flora can be reduced or prevented, or even the existing intestinal flora can be improved. Furthermore, the solid absorption form of the active ingredient prevents kidney overload due to a large volume of fluid that needs to be filtered.

[0011] The following terms will be explained:

[0012] An "active ingredient composition" is, in particular, a preparation consisting of at least two ingredients that is suitable for influencing a physiological function. The preparation contains, in particular, at least two solids and / or active ingredients. Furthermore, the active ingredient composition may contain other ingredients, such as a flavoring, sweetener, acidifier, anti-caking agent, filler, and / or excipients. The active ingredient composition has, in particular, laxative and optionally prebiotic effects. The active ingredient composition is, in particular, a medical device. A medical device is understood to have, in particular, a primary intended effect that is physical and / or physicochemical and thus, unlike medicinal products, is not primarily pharmacological, metabolic, and / or immunological.The active ingredient composition can also be a medicinal product and thus serve to treat and / or prevent human diseases. It could also be a dietary supplement. The solids and / or ingredients of the active ingredient composition are of pharmaceutical quality. In principle, the active ingredient preparation and / or its dosage forms could also be administered to an animal. Preferably, the active ingredient composition is taken orally by the user in a specific dosage form. Of course, the solid active ingredient composition itself can also be taken directly into the mouth by the user using a spoon.

[0013] The term "solid" refers specifically to a substance that is in a solid state of matter. Specifically, "solid" also means that the substance is solid at a temperature of 20 °C. The solid is present in a multitude of particles, for example, as a powder and / or granules. The solid is dry and therefore not permeated by moisture, such as water, nor wetted or covered on its surface. The solid only contains moisture and / or water content that arises physically from the humidity of the ambient air and / or the surrounding cleanroom air. The active ingredient composition and the solid are free of added water.

[0014] "Polyethylene glycol" (PEG, also "macrogol") is in particular a water-soluble and non-toxic polymer with the general molecular formula C 2n H 4n+2 O n+1Polyethylene glycol is, in particular, a linear polymer with a repeating unit (-CH₂-CH₂-O-) and a molar mass of 44 g / mol per repeating unit. Polyethylene glycol with a molecular mass above 1,000 g / mol is, in particular, a solid. Polyethylene glycol can, in particular, be in powder form and / or in a flaky state. Polyethylene glycol with a molar mass greater than 3,000 g / mol, in particular 3,350 g / mol, is, in particular, a laxative. It should be emphasized that, in principle, any polyethylene glycol with a molar mass > 3,000 g / mol, and thus any polyethylene glycol in the solid state, can be used. For example, a polyethylene glycol with a molar mass in the range of 3,000 to 6,000 g / mol, in particular 4,000 g / mol, can be used. Preferably, the active ingredient composition comprises polyethylene glycol with a molar mass of 3,350 g / mol. Polyethylene glycol with a molar mass of 3.350 g / mol is also abbreviated as polyethylene glycol 3350 or PEG 3350. By weight, PEG 3350 constitutes the main active ingredient in the formulation. Polyethylene glycol binds water after oral administration, primarily increasing stool volume and softening the stool. Thus, polyethylene glycol exhibits water-binding and laxative properties. Polyethylene glycol is particularly effective in cases of impaired digestion, such as slowed intestinal transit and / or constipation. Polyethylene glycol acts primarily through physical mechanisms and is not absorbed or metabolized itself. Polyethylene glycol is excreted unchanged in the stool.

[0015] Inulin (also known as elecampane starch) is a water-soluble dietary fiber. It is a mixture of polysaccharides composed of fructose units with a chain length of 100 monomers and a terminal glycosidic residue. Inulin belongs to the fructans and occurs as a storage substance in many plants, such as members of the Asteraceae and Apiaceae families, including Jerusalem artichokes, chicory, artichokes, dandelions, and others. Inulin has the molecular formula C 6n H 10n+2 O 5n+1 Inulin is a white, crystalline solid. It is not absorbed in the small intestine, but is subsequently broken down in the large intestine by bacteria, such as bifidobacteria, into short-chain fatty acids. Therefore, inulin has a prebiotic effect. This can promote a healthy gut flora.

[0016] The term "weight percent" (also mass fraction) refers specifically to the relative proportion of a substance's mass to the total mass of the active ingredient composition. The determination of the weight percentages of the ingredients in the active ingredient composition is carried out, in particular, in the dry state. Similarly, each ingredient is weighed out in a dry state to prepare the mixed active ingredient composition.

[0017] In another embodiment, the active ingredient composition comprises polyethylene glycol with a molar mass greater than 3,000 g / mol in a range of 60.0 to 85.0 percent by weight.

[0018] Thus, the strength of the laxative effect of the active ingredient can be specifically adjusted according to the mass fraction of polyethylene glycol in the active ingredient composition.

[0019] To enable the prebiotic effect of the active ingredient composition, the active ingredient composition can contain inulin in a range of 3.0 to 15.0 percent by weight.

[0020] Consequently, depending on the mass fraction of PEG, particularly PEG 3350, and inulin relative to each other, a stronger laxative effect, a prebiotic effect, or a largely balancing effect on the intestinal flora can be achieved. In principle, the active ingredient composition can also consist solely of the two solids polyethylene glycol (> 3000 g / mol) and inulin.

[0021] In another embodiment, the active ingredient composition comprises, as further solids, a flavoring agent, a sweetener, an acidifying agent, an excipient, a filler and / or an anti-caking agent, which together constitute a maximum of 37.0 percent by weight of the active ingredient composition.

[0022] In order to enable a solid dosage form that is palatable in terms of taste and / or sensory properties, the active ingredient composition may contain the flavoring agent in a range of 0.3 to 2.5% by weight, the sweetener in a range of 0.02 to 0.10% by weight, the acidifying agent in a range of 0.5 to 5.0% by weight, the excipient in a range of 0.5 to 10.0% by weight, the filler in a range of 5.0 to 35.0% by weight and / or the anti-caking agent in a range of 0.65 to 5.0% by weight.

[0023] In another formulation of the active ingredient composition, the sweetener sucralose, the acidifier citric acid, the excipient potato starch, the filler sorbitol and / or the separating agent magnesium stearate are included.

[0024] An "aroma compound" is, in particular, a chemically defined substance with flavor-imparting properties. An aroma compound can be, in particular, a natural, nature-identical, or artificial flavoring compound. In addition to one aroma compound, the active ingredient composition can also contain, in particular, two or more aroma compounds, and thus the active ingredient composition can also have various aromas. Flavorings are, in particular, products that are added to the active ingredient composition to give it a particular smell and / or taste. An aroma compound can also be an aroma extract. In principle, any type of aroma compound can be used in the active ingredient composition. An aroma compound can be any flavoring compound approved for use in food and / or pharmaceuticals.For example, the flavoring agent could be a natural and / or artificial strawberry flavor. Similarly, the active ingredient composition could include a peppermint, lemon, orange, or plum flavor, or another flavor and / or aroma.

[0025] A "sweetener" is, in particular, a substitute for sugar. A sweetener can be a natural sweetener and / or a sugar substitute. A sweetener is, in particular, a natural or synthetic sugar substitute. A sweetener has a particularly intense sweet taste. In principle, a sweetener can be any sweetener approved for use in food and / or pharmaceuticals. Examples of natural sweeteners include aspartame or sucralose, and examples of sugar substitutes include mannitol or xylitol.

[0026] An "acidifying agent" is, in particular, a substance that imparts a sour taste to an active ingredient and / or increases its acidity. Specifically, an acidifying agent produces a sour and / or refreshing taste. An acidifying agent is, in particular, one that is approved for use in food and / or pharmaceuticals. Examples of acidifying agents include citric acid and malic acid.

[0027] An "adjuvant" is, in particular, a substance that supports the processing of the active ingredient composition into a dosage product. An adjuvant can, for example, be used to stabilize the active ingredient composition during processing. An adjuvant can be, for instance, a starchy substance, potato starch, and / or maltodextrin. In this case, the adjuvant, such as potato starch, can act as a binder between the solid components of the active ingredient composition. In principle, an adjuvant can be any adjuvant approved for use in food and / or pharmaceuticals.

[0028] A "filler" (also called a bulking agent) is a substance that increases the volume and / or stability of the active ingredient composition. The filler does not affect the efficacy and / or other properties of the active ingredient composition. The filler also simplifies the manufacturing of the dosage product by increasing the volume of the active ingredients. A pharmacologically and / or toxicologically inert substance can be used as a filler. For example, sorbitol can be used as a filler, which can also serve as a sugar substitute and / or humectant. In principle, any filler approved for use in food and / or pharmaceuticals can be used. The filler and / or sorbitol can be in granular form.

[0029] A "release agent" is, in particular, a substance that keeps adjacent ingredients separable. A release agent can also be a flow aid or a mold release agent. In principle, any release agent approved for use in food and / or pharmaceuticals can be used. For example, a release agent can be a hydrophobic, wax-based, and / or fat-based substance. Magnesium stearate can be a particularly suitable release agent. Due to its lubricating properties, magnesium stearate can be used as a release agent in tablet pressing. Magnesium stearate adheres to the surface of the other particles in the active ingredient composition and reduces friction between them and against external surfaces.

[0030] In another aspect of the invention, the problem is solved by a dosage product for direct oral administration without the addition of water, for chewing and / or sucking, wherein the dosage product has a previously described active ingredient composition.

[0031] In a further embodiment of the dosage product, the dosage product comprises polyethylene glycol with a molar mass greater than 3,000 g / mol in an amount in the range of 1.0 g to 9.0 g, in particular from 2.0 to 7.0 g, preferably from 3.0 to 5.0 g.

[0032] This ensures that the dosage product is in a suitable portion. Therefore, the dosage product contains the desired amount of PEG, in particular PEG 3350, to achieve a sufficient laxative effect with a single and / or precisely dosable dose.

[0033] To provide a solid and dry dosage product, the dosage product is free of added water.

[0034] This ensures that the dosage product retains its solid form and / or solid state even over extended storage periods and can only be taken directly orally by the user in a solid state. Preferably, no water is intentionally added during or after the manufacturing process; instead, the dosage product contains only the water naturally bound in the active ingredients due to the manufacturing and environmental conditions.

[0035] Because the active ingredient composition and / or dosage form are free of added water, and the dosage form is taken orally in solid form, additional water intake is unnecessary. This results in less water being ingested compared to state-of-the-art products, and the reduced water volume places less strain on the kidneys' filtration capacity. Therefore, this dosage form is particularly suitable for users with renal insufficiency.

[0036] In another embodiment, the dosage product is free of added electrolyte.

[0037] This also relieves the filtration capacity of the kidneys, avoids electrolyte imbalances, and, in particular, prevents excessively high electrolyte concentrations in a short period of time after ingestion due to the absence of added electrolytes.

[0038] To enable optimal direct ingestion of the dosage product in solid form, the dosage product can be designed as a chewable tablet.

[0039] In another embodiment of the dosage product, the chewable tablet has a hardness of a maximum of 200 N, in particular a maximum of 150 N.

[0040] Thus, the chewable tablet has a hardness and / or firmness that is easy for the user to chew. The chewable tablet can be packaged individually, for example in a plastic wrapper, or several chewable tablets can be packaged in a tube or container, such as a tin or stand-up pouch.

[0041] To provide different dosage forms depending on the user's preference, the active ingredient composition is supplied loose in a stick, sachet or can.

[0042] A stick or sachet contains a single dose of the active ingredient for direct oral administration. Alternatively, the active ingredient can also be provided in a container, allowing the user to measure out the appropriate dose using a measuring spoon or a conventional teaspoon and / or tablespoon and take it directly by mouth. This allows a single dose of the active ingredient to be provided in a sachet, a small package in the form of a pouch or bag. Consequently, the active ingredient is packaged in a dose-appropriate manner in a sachet, stick, or pouch. A stick (also called a stick pack) is specifically a long, narrow, sealed pouch containing a single dose. The stick or pouch is sealed at one or more edges. It may also have a tear strip.

[0043] Table 1 lists an example formulation of a chewable tablet with the solid components of its active ingredient composition and their possible weight percentage ranges, which can be implemented in other formulations. Similarly, Table 2 lists an example formulation of a direct powder stick with the solid components of its active ingredient composition and their possible weight percentage ranges in other formulations. The direct powder stick is specifically formulated so that the active ingredient mixture reacts quickly with the moisture in the mouth after direct oral ingestion, providing the user with a melting sensation (so-called "fast melt"). Table 1: Active ingredient composition of one chewable tablet solid function Recipe , weight percent Possible area in weight percent Polyethylene glycol 3,350 Main active ingredient 78,12 % 60 - 85 % Inulin Active ingredient 5,0% 3,0 - 15 % Aroma (e.g., peppermint) Flavoring 0,50 % 0,30 - 2,5 % potato starch Aids 1,0 % 0,50 - 10,0 % Magnesium stearate Release agent %0,50 0,65 - 5,0 % Sorbitol Filler 14,88 % 5,0 - 35,0 % Table 2: Active ingredient composition of a direct powder stick solid function Recipe , weight percent Possible area in weight percent Polyethylene glycol 3,350 Main active ingredient 78,12 % 60 - 85 % Inulin Active ingredient 5,0 % 3,0 - 15 % Aroma (e.g., plum) Flavoring 1,50 % 0,50 - 2,50 % Sucralose sweetener 0,05 % 0,02 - 0,10 % citric acid Acidulant 0,80 % 0,50 - 5, 0 % Magnesium stearate Release agent 0, 16 % 0,10 - 0,50 % Sorbitol Filler 19, 37 % 10 - 35 %

[0044] In another aspect of the invention, the problem is solved by using a previously described active ingredient composition and / or a previously described dosage product to promote bowel movements and colonization with intestinal bacteria, particularly in cases of renal insufficiency.

[0045] The invention will now be explained in more detail using exemplary embodiments. These will show... Fig. 1. A highly schematic representation of a dosage product in the form of a chewable tablet, Fig. 2 a highly schematic representation of an alternative dosage product in the form of a direct powder stick, Fig. 3 a schematic representation of a flow diagram of a manufacturing process of an active ingredient composition, and Fig. 4 A highly schematic representation of a flow diagram of the production of the dosage product as a chewable tablet and as a direct powder stick.

[0046] A dosage product 101 for direct oral administration without the addition of water, to promote bowel movements and to support intestinal flora, is designed as a chewable tablet 103. After direct oral ingestion without water, the chewable tablet 103 is chewed and / or sucked by the user in the mouth. The chewable tablet 103 has a circular cross-section ( Fig. 1).

[0047] In an alternative formulation of the dosage product 101, it is designed as a direct powder stick 105. A packaging tube of the direct powder stick 105 is sealed at the top and bottom edges by means of a seal 113 and has a non-in Fig. 2. Tear opener shown. For direct oral administration, the packaging of the direct powder stick 105 is torn open and the active ingredient composition contained therein is placed directly into the mouth.

[0048] In a manufacturing process 201, the respective active ingredient composition 120 contained in the chewable tablet 103 or the direct powder stick 105 is assembled. Fig.3) In the case of the chewable tablet 103, polyethylene glycol 3350 (107) is weighed out as the main active ingredient at 78.12% by weight, as specified in Table 1 above as the formulation (step 203). Likewise, inulin 109 is weighed out as the active ingredient at 5.0% by weight, as well as the following additional ingredients: 111 peppermint flavor at 0.50% by weight, potato starch at 1.0% by weight, magnesium stearate at 0.50% by weight, and sorbitol at 14.88% by weight. In the case of the direct powder stick, as specified in Table 2 above for the formulation, polyethylene glycol 3.350 (107) is also weighed out at 78.12 wt%, inulin 109 at 5.0 wt%, and as further ingredients 111, the plum flavoring specified in Table 2 at 1.50 wt%, sucralose at 0.05 wt%, citric acid at 0.80 wt%, magnesium stearate at 0.16 wt%, and sorbitol at 19.37 wt% (step 203). The polyethylene glycol 3.350 (107), Inulin 109 and the other ingredients 111 are each present as solids.

[0049] After weighing 203 of these raw materials, a horizontal wave mixer is filled 205. Depending on the size of the horizontal wave mixer and its mixing intensity, mixing 207 is usually carried out for a duration of between 3 and 20 minutes. After mixing 207, the horizontal wave mixer is emptied 209, with the mixed active ingredient composition 120 being collected in a specially manufactured container. Subsequently, the respective dosage product 101 is manufactured 221. Fig. 4).

[0050] In the case of chewable tablet 103, a compound containing the active ingredient composition 120 (according to the formulation in Table 1) is prepared (step 223). The compound, contained in a container, is then docked to a tablet press via a docking device, and the container is opened so that the compound flows into the tablet press. In the tablet press, the compound is compressed 225 to form chewable tablets 103. The chewable tablets 103 can then be individually packaged in a foil pack, or several chewable tablets 103 can be filled directly into packaging tubes and automatically sealed with a stopper (filling 227). Depending on the size and desired firmness of the manufactured chewable tablet 103, a compression force between 15 and 120 kN (kilonewtons) is used during compression 225.

[0051] In the production of the direct powder stick 105 as a dosage product 101, the active ingredient composition 120 is prepared according to the formulation in Table 2 (step 233). Likewise, a film for the direct powder sticks 105 is provided via a roll storage system in a stick pack machine (step 235). Using individual dosing units of the stick pack machine, the active ingredient composition 120 is dosed as a single dose into the film formed into the stick packaging (step 237), whereby the individual sticks are sealed 239 and subsequently cut 241, so that individual direct powder sticks 105 filled with the loose active ingredient composition 120 are available.

[0052] Thus, the following dosage products are provided: a chewable tablet 103 and a direct powder stick 105, which have the respective active ingredient composition 120 and can be taken directly by a user in a simple, convenient and sensorially enjoyable way, without the need for prior addition of water. Reference symbol list 101 Dosage product 103 chewable tablets 105 direct powder sticks 107 Polyethylene glycol 3,350 109 Inulin 111 other ingredients 113 Sealing 120 active ingredient composition 201 Manufacturing processes 203 Weighing 205 Filling a mixer 207 Mixing 209 Emptying the mixer 221 Manufacturing of the medicinal product 223 Providing a pressing compound 225 Compressed into chewable tablets 227 Filling into packaging tubes 233 Providing the active ingredient composition 235 Providing a foil for sticks 237 Single dose of the active ingredient composition in sticks 239 Sealing the Sticks 241 Cutting the sticks

Claims

Active ingredient composition (120) for direct oral administration without the addition of water and for promoting defecation, wherein the active ingredient composition (120) comprises at least one solid, characterized in that the active ingredient composition (120) comprises as solids at least 60.0 wt% polyethylene glycol (107) with a molar mass of greater than 3,000 g / mol and at least 3.0 wt% inulin (109). Active ingredient composition (120) according to claim 1, characterized in that the active ingredient composition (120) comprises polyethylene glycol (107) with a molar mass greater than 3,000 g / mol in a range of 60.0 to 85.0 percent by weight. Active ingredient composition (120) according to claim 1 or 2, characterized in that the active ingredient composition (120) comprises inulin (109) in a range of 3.0 to 15.0 percent by weight. Active ingredient composition (120) according to one of the preceding claims, characterized in that the active ingredient composition (120) comprises as further solids (111) a flavoring agent, a sweetener, an acidifying agent, an excipient, a filler and / or a separating agent, which together constitute a maximum of 37.0 percent by weight of the active ingredient composition. Active ingredient composition (120) according to claim 4, characterized in that the active ingredient composition (120) comprises the flavoring agent in a range of 0.3 to 2.5 wt%, the sweetener in a range of 0.02 to 0.10 wt%, the acidifying agent in a range of 0.5 to 5.0 wt%, the auxiliary agent in a range of 0.5 to 10.0 wt%, the filler in a range of 5.0 to 35.0 wt% and / or the release agent in a range of 0.65 to 5.0 wt%. Active ingredient composition (120) according to one of the preceding claims, characterized in that the sweetener is sucralose, the acidifier is citric acid, the excipient is potato starch, the bulking agent is sorbitol and / or the anti-caking agent is magnesium stearate. A dosage product (101) for direct oral administration without the addition of water, for chewing and / or sucking, characterized in that the dosage product (101) comprises an active ingredient composition (120) according to one of claims 1 to 6. The dosage product (101) according to claim 7, characterized in that the dosage product (101) comprises polyethylene glycol with a molar mass greater than 3,000 g / mol in an amount in the range of 1.0 g to 9.0 g, in particular from 2.0 g to 7.0 g, preferably from 3.0 g to 5.0 g. Dosage product (101) according to claim 7 or 8, characterized in that the dosage product (101) is free of added water. Dosage product (101) according to one of the preceding claims, characterized in that the dosage product (101) is free of added electrolyte. Drug product (101) according to one of the preceding claims, characterized in that the drug product (101) is designed as a chewable tablet (103). Dosage product (101) according to claim 11, characterized in that the chewable tablet (103) has a hardness of a maximum of 200 N. Dosage product (101) according to one of claims 7 to 10, characterized in that the active ingredient composition (120) is present loosely in a stick (105), bag or can. Use of an active ingredient composition (120) according to one of claims 1 to 6 and / or a dosage product (101) according to one of claims 7 to 13 for promoting bowel movements and colonization with intestinal bacteria, particularly in cases of renal insufficiency.

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