Starch-based dosage form and method for the production thereof

Abstract

A casting compound for producing dosage forms using a mogul method has a swellable component in the form of swellable particles, as well as syrup, water, acid and active ingredient. The swellable particles are present in an evacuated state. The proportion of swellable particles is in the region of 5-25 wt.%, the water content is in the region of 15-27 wt.%, and the proportion of active ingredients is in the region of 0.01-30 wt.%.

Description

[0001] Dosage form based on starch and manufacturing process

[0002] Cross-reference

[0003] The present patent application claims the priorities of Swiss patent application No. 000808 / 2024 of 26 July 2024 entitled "Dosage form based on starch and method for its production", Swiss patent application No. 000807 / 2024 of 26 July 2024 entitled "Device for creating a multi-component mass and method for producing a multi-component mass", and Swiss patent application No. 000806 / 2024 of 26 July 2024 entitled "Device and method for producing a multi-component mass, and a system comprising the device", the contents of which are hereby incorporated in full into this application by reference.

[0004] Technical field

[0005] The present invention relates to casting compounds and dosage forms based on a swelling component and a method for producing the same using Mogul technology.

[0006] Technological background

[0007] The traditional mogul method, also known as the starch or powder coating method, is used to produce soft confectionery, especially gummy candies such as the well-known "fruit gum" products.

[0008] During production, along the mogul line, powder boxes are filled with molding powder consisting of native starch at the stamping station. The molding forms are then stamped or stamped into this powder, and the casting compound is poured into these forms at the subsequent casting station using a casting machine. The boxes move along the line one after the other, as the line advances in sync with the casting cycle. During the pouring process, the boxes pause briefly and then continue, or a parallel casting machine is used.

[0009] The casting machine is supplied batchwise from a preheated and heated hopper / storage container with cooked, hot casting compound, and this compound is poured, using a multitude of identical pistons, into the molds stamped into the molding powder in a single pouring cycle. From the storage container to each individual piston stroke, the retention time of the casting compound exhibits a relatively wide range of residence times.

[0010] Depending on its size and the size of the cast products, a casting machine has several hundred such pistons, arranged regularly. Throughputs are typically around 1 to 5 tons per hour.

[0011] The poured, gel-like casting compound cools slowly in the molding powder and solidifies through gelation. The boxes containing the products are then stored for a period of time under suitable climatic conditions, during which further solidification of the products occurs through drying. A unique feature of the Mogul technology is that the molding powder used for the casting mold also acts as a desiccant, as this powder, or starch powder, can absorb water from the products. Furthermore, the molding powder is reusable.

[0012] Originally, gelatin-based casting compounds were processed using Mogul technology. With the trend towards vegetarian products, casting compounds based on starch, pectin, carrageenan, gum arabic, or agar-agar have also become common.

[0013] In all cases, the casting compound is obtained by boiling, typically at over 100 °C, with the various gelling agents, such as gelatin, starch, pectin, carrageenan, gum arabic, or agar-agar, present in dissolved form. These casting compounds are produced in batches, then stored at a temperature that depends on the gelling agent and is typically in the range of approximately 60 °C to 90 °C, and cast at this temperature. Crucial for the phase transition from the liquid to the gel-like state is gelation through cooling.

[0014] During the production of the casting compound, air bubbles can be introduced into the highly viscous mixture when the various components are blended. These are difficult to remove from the casting compound and can therefore remain permanently in the solid final product, which is generally undesirable for various reasons.

[0015] To avoid this, for example, in the production of gelatin-based fruit juice gummies in JP 2004 / 329009 A, a previously cooked liquid mixture of sugar, starch syrup, and fruit juice is kneaded with water-soaked gelatin during the preparation of the casting compound, whereby this kneading process can take place at reduced pressure. This causes any existing air bubbles to expand and be kneaded out more easily.

[0016] In another manufacturing process for gelatin-containing fruit gums, as shown, for example, in JP 2011 / 172524 A, the sugar and starch syrup are boiled at reduced pressure. Any gas bubbles and dissolved gases still present in the highly viscous liquid can thus be efficiently driven off.

[0017] Originally, Mogul technology was used exclusively for the production of confectionery. Later, some pharmaceutical applications were added, where pharmaceutical agents were incorporated into the casting compounds, particularly for applications in the throat and pharynx.

[0018] More recently, Mogul products loaded with active ingredients from the nutraceutical field, such as vitamins, minerals, plant substances or fish oil, have become important, and vegetarian options are often desired in such products.

[0019] The manufacture of such products is described, for example, in WO 03 / 088755 A1. An edible dosage form for active ingredients comprises a matrix of carbohydrates, sugar, hydrocolloid, water, and other ingredients. In a specific embodiment, a gelatin-based casting compound containing the dietary supplement creatine as a functional component is processed using a conventional mogul method.

[0020] Thus, in addition to tablets, effervescent tablets, soft capsules and hard capsules, Mogul products have developed into a new dosage form that is becoming increasingly popular because it is easy to take, even with swallowing difficulties and can even be enjoyed.

[0021] The problem with the known Mogul processes is that the high temperatures typically exceeding 100 °C used during cooking, and the still high temperatures of 60–90 °C at which the casting compounds are stored before pouring, can damage or even inactivate temperature-sensitive ingredients or additives. Therefore, there is a need for a gentler process that can be carried out at lower temperatures.

[0022] Another problem arises from the batch process, which is common in the production of the casting compound. On the one hand, the consistency and uniformity of the products suffer, as they then have an individual history due to the different curing times of the respective casting compound, and fluctuations in the products occur, especially in the case of sensitive active ingredients.

[0023] On the other hand, continuous processes are generally more uniform, easier to control, easier to document, easier to automate, and ultimately more cost-effective in terms of production. These advantages are particularly important for high-quality, active-ingredient products. Therefore, there is a need for a continuous process.

[0024] Gelatin products have a characteristic and very popular rubbery texture, but gelatin is of animal origin. Pectin results in a different texture than gelatin, exhibiting little rubberiness and a so-called short texture. Such products often stick to the teeth. Carrageenan is controversial due to health concerns, and agar-agar is an expensive niche product that is rarely used. Gum arabic leads to relatively hard products, and the raw material is problematic in terms of both procurement and quality.

[0025] Existing starch-based products are not very elastic and have a sticky consistency when eaten, and, accepting the aforementioned disadvantages, must be manufactured at very high temperatures. The products stick strongly to the teeth, which is not only unpleasant but also detrimental to dental health.

[0026] There is therefore also a need for vegetarian products with a rubbery-elastic texture or at least less sticky properties, especially based on starch, with the aim of solving the problems with existing starch-based products.

[0027] WO 2007 / 128150 A1 of the same applicant describes a low-temperature mogul process where particulate starch is used in the casting compound, i.e., where the casting compound is not boiled. The starch particles in the casting compound swell over time and are only present in a swollen form in a phase after casting.

[0028] The resulting products, while similar in texture to rubbery gelatin products, are significantly too hard overall. The market demands softer products. Another problem is that mixing in the starch powder introduces air into the liquid mixture, which is detrimental. To remove these air bubbles from the highly viscous casting compound, the resulting mixture is subjected to vacuum pressure. This is time-consuming.

[0029] These products are designed for the confectionery market and are not adapted to the requirements for dosage forms of active ingredients. The described processes are not continuous. While continuous incorporation of the particulate starch is mentioned as another possibility, it is not explained how this should be implemented in practice.

[0030] These products are also manufactured using fractionated powders of particulate starch, i.e., starch powders with narrow particle size distributions. This is technically complex because sieving processes are required, and expensive because fractions outside the desired particle size range cannot be used. The particulate starches used in these products are extruded and contain short-chain starches and / or plasticizers such as glycerin and / or an additional hydrocolloid such as xanthan gum. However, such products are not generally available on the market and must be specially manufactured, resulting in comparatively very high costs. WO 2010 / 072847 A2 of the same applicant also describes a low-temperature mogul process in which particulate starch is used in the casting compound.A crucial aspect of the process concerns the residence time of the particulate starch in the continuous process, i.e., the time the starch particles are in contact with the liquid phase, which should be as short as possible. As soon as the starch particles come into contact with the liquid, water-containing phase, they begin to swell, increasing the viscosity until it is so high that the casting compound is no longer pourable.

[0031] Even with this method, the products are still too firm to meet market demands. While active ingredients are mentioned, the necessary characteristics of the formulations are not disclosed. The process is geared towards confectionery and filled products, such as those containing a more or less liquid filling.

[0032] In the described process, the highly viscous casting compound, produced from the mixture of starch powder with the liquid phase (i.e., the liquid sugar mass or syrup), is subsequently degassed under reduced pressure using a kneader or screw conveyor. This process causes the air bubbles to enlarge, making them easier to remove from the compound. However, this method is insufficient to adequately extract the air bubbles that inevitably form when the powder is mixed into the liquid, particularly in large-scale production. Furthermore, the throughput required for cost-effective production can only be achieved to a limited extent with this method, as the process is time-consuming.

[0033] There is therefore a general need for improvements in this area.

[0034] Description of the invention

[0035] One object of the invention is to provide casting compounds and methods for producing dosage forms using a mogul process, which counteract at least one of the aforementioned disadvantages and / or other disadvantages.

[0036] A further object of the invention is to provide dosage forms in the form of active ingredient-containing mogul products that can be manufactured industrially efficiently and cost-effectively using a low-temperature process, and thus gently, using a continuous process.

[0037] Another object of the invention is to provide casting compounds that are readily processable at low temperatures and from which products can be obtained that best meet customer needs regarding product texture and its associated behavior in the mouth. This means a soft and more or less rubbery texture that can be chewed quickly and effortlessly. The requirements of the active ingredients, the demands of a low-temperature process, and the specific requirements of large-scale industrial implementation must also be taken into account as effectively as possible.

[0038] The invention therefore aims to provide a robust, highly automated, continuous, and industrially applicable process with a throughput in the range of 500–5,000 kg / h, thereby enabling low production costs. In particular, it should also make it possible to obtain products that are effectively free of air bubbles.

[0039] These and other problems are solved by an inventive casting compound, an inventive manufacturing process, and inventive dosage forms according to the independent claims. Further advantageous embodiments are given in the dependent claims.

[0040] Conventional casting compounds are boiled, which dissolves the main texturizing component, consisting of macromolecules. These compounds are produced in batches and must then be stored at high temperatures until they can be poured, also at high temperatures. This is because, upon cooling, these casting compounds thicken due to gelation and become unusable. During the production of the casting compound, air is introduced into the mixture, particularly through the addition of various powdered components. This air can be easily and completely removed during boiling. This is because the viscosity is low, and also because water evaporates during boiling, which draws air bubbles out of the mixture, especially when a vacuum is used.

[0041] To enable the gentle processing of Mogul products at low temperatures, the macromolecules of the texturizing component in the casting compound according to the invention are not used in dissolved form, but rather as a swellable component containing swellable particles of the macromolecules. These particles of the swellable component are suspended in the casting compound. When the macromolecules are dissolved, they determine the viscosity, and the higher the molecular weight of the macromolecules, the higher the viscosity. In fact, it increases disproportionately with molecular weight. However, when the macromolecules are not dissolved but bound in particles, the viscosity of the casting compound is only minimally affected by the presence of the particles, and the viscosity is independent of the molecular weight.

[0042] Thus, in their bound form, macromolecules of high and very high molecular weight, which are very advantageous for the product properties, can also be used and processed, whereas such macromolecules would be difficult or impossible to process in dissolved form due to excessive viscosity.

[0043] When the macromolecules, encapsulated within the particles, are used in this bound form, a comparatively low viscosity of the casting compound can be obtained even at low temperatures, independent of the molecular weight of the macromolecules. Furthermore, the casting compound cannot thicken through gelation, as gelation requires the macromolecules to be dissolved beforehand.

[0044] The thickening of the casting compound occurs through the swelling of the swellable component, which is a slow process, especially at lower temperatures (room temperature or below), because liquid must diffuse into the particles of the swellable component. It takes many hours for the casting compound to thicken into a solid mass as a result of swelling, whereas in the continuous process for producing the casting compound according to the invention, the residence time of the particles in the casting compound is only on the order of minutes. Thus, at the time of casting, the particles are in a state that is not yet substantially swollen. When the powder of the swellable component is mixed in, air is inevitably incorporated. At the low temperatures of the process, where the viscosity is comparatively high and no water can be boiled off (which would help to remove the air bubbles from the compound), this air cannot be extracted from the compound to the required extent.Thus, the low-temperature process, which is advantageous on the one hand, has the consequence that air bubbles are present in the products to a greater extent, which is unacceptable.

[0045] Therefore, a previously unknown method, deemed impossible by experts, was employed: the powder is continuously dosed from one vacuum into another and mixed under vacuum. This is because if air is not introduced in the first place, it does not need to be extracted.

[0046] In this context, a vacuum is understood to mean a state of reduced pressure. An evacuated powder or a swellable particle in an evacuated state refers to a powder, particularly swellable particles, that has been pretreated under vacuum, with the reduced pressure conditions specified below being decisive. In this process, air (or an air mixture, or in special cases another gas or gas mixture) is generally not removed from the particles themselves, but rather from the powder, i.e., from between the particles, as much as possible. This occurs before the particles are mixed with a liquid or other components, or suspended in a liquid.

[0047] This makes it possible for the swellable component to be present in the casting compound in an evacuated form, thus obtaining a casting compound that is effectively free of air bubbles from the outset. This means that, according to the invention, the air is removed from the particles and between the particles in a pretreatment step, so that when the powdered, and in particular swellable, component is added, no or as little air or gas is introduced into the liquid or liquid mixture. Consequently, a subsequent, more complex degassing of the viscous casting compound is advantageously unnecessary.

[0048] The inventive solution can be further improved by various embodiments, each advantageous in itself and, unless otherwise described, combinable with one another. These embodiments and their associated advantages are discussed below. A first aspect of the invention relates to a casting compound according to the invention for the production of dosage forms using a mogul process.

[0049] A casting compound according to the invention comprises a swellable component in the form of swellable particles, as well as syrup, water, acid and active ingredient, wherein the swellable particles are in an evacuated state; the proportion of swellable particles is in the range of 5 - 25 wt.%; the water content is in the range of 15 - 27 wt.%; and the proportion of active ingredients is in the range of 0.01 - 30 wt.%.

[0050] In the context of this invention, "syrup" refers to either a sugar-containing syrup or a sugar-free syrup. A sugar-containing syrup is a liquid mixture consisting essentially of water, sugars (monosaccharides and disaccharides such as fructose, glucose, sucrose, allulose, palatinose, isomaltulose, etc.), and / or oligosaccharides. A sugar-free syrup is a liquid mixture consisting essentially of water and suitable sweeteners, in particular sugar alcohol syrups such as those containing sorbitol, mannitol, isomalt, maltitol, lactitol, xylitol, or erythritol, and mixtures thereof. Maltitol syrup is a particularly suitable sugar-free syrup. Combinations of sugar-containing and sugar-free syrups are also possible.

[0051] In an advantageous embodiment of a casting compound according to the invention, the swelling component is starch, wherein the starch is in the form of gelatinized particles.

[0052] Advantageously, such a casting compound according to the invention comprises starch, syrup, water, acid, and active ingredient, and: the starch in the casting compound is present in the form of gelatinized, evacuated particles; the starch content is in the range of 8–25 wt.%; the water content is in the range of 15–27 wt.%; the weight ratio of starch to syrup is in the range of 0.13–0.29; and the active ingredient content is in the range of 0.01–30 wt.%. In a casting compound according to the invention, the syrup is advantageously a sugar-free syrup.

[0053] A particularly advantageous aspect of such casting compounds is the weight ratio of starch to syrup in the range of 0.15 - 0.31.

[0054] In an advantageous embodiment of a casting compound according to the invention, the swelling component is a hydrocolloid.

[0055] Advantageously, the hydrocolloid is selected from a group consisting of gelatin, pectins, carrageenans, alginates, gum arabic and agar-agar, and combinations thereof.

[0056] A particularly advantageous aspect of such a casting compound is that the hydro-collide it contains is present in a form that is at least partially already gelled.

[0057] Advantageously, in a casting compound according to the invention, the proportion of swellable particles below 0.05 mm is less than 40 wt.% in terms of particle size distribution of the swellable particles, even more advantageously less than 35 wt.%, even more advantageously less than 30 wt.%, even more advantageously less than 25 wt.% and even more advantageously less than 20 wt.%.

[0058] Limiting small particles significantly improves viscosity stability during processing, meaning the pourability window is extended. This is advantageous for a stable process.

[0059] In an advantageous embodiment of a casting compound according to the invention, the particle size distribution has an upper limit, wherein the upper limit is at 0.700 mm, preferably at 0.600 mm, even more advantageously at 0.500 mm, even more advantageously at 0.400 mm, even more advantageously at 0.350 mm, and even more advantageously at 0.300 mm.

[0060] This selection limits the negative impact of large particles on sensory perception in the mouth.

[0061] Furthermore, round particles are even more advantageous than long or angular ones. Such particles are obtained by spraying. In an advantageous embodiment of the casting compound according to the invention, the proportion of powder with a particle size of more than 0.200 mm is less than 25 wt.%, even more advantageously less than 20 wt.%, even more advantageously less than 17 wt.%, even more advantageously less than 14 wt.%, even more advantageously less than 12 wt.%, and even more advantageously less than 10 wt.%.

[0062] It is also advantageous that, in a casting compound according to the invention, the particles of the swellable component suspended therein are essentially not yet swollen.

[0063] The expert recognizes that this is significant at the time of casting, that is, in the unstored state of the casting compound, which is particularly advantageous during the mixing process.

[0064] An advantageous feature of a casting compound according to the invention is that it is essentially free of air bubbles. An indicator of unwanted air in the casting compound is its turbidity or low transparency.

[0065] Commercially available starch powder typically has a bulk density of about 0.5 kg / l. According to the invention, the bulk density of the starch powder is >0.5 kg / l, preferably between 0.55 kg / l and 0.9 kg / l, and particularly preferably between 0.6 kg / l and 0.9 kg / l.

[0066] Particularly advantageous is a casting compound according to the invention having a relative proportion of air bubbles in the total volume of the casting compound of less than 5 vol.%, even more advantageously of less than 0.5 vol.%, even more advantageously of less than 0.1 vol.%, even more advantageously of less than 0.05 vol.%, and even more advantageously of less than 0.01 vol.%.

[0067] A second aspect of the invention relates to a dosage form for the active ingredient.

[0068] A dosage form according to the invention has been obtained with a casting compound according to the invention and with a mogul process, wherein the dosage form has been cast in powder molds.

[0069] Advantageously, such a dosage form according to the invention has a unit weight in the range of 1.0–4.5 g. A third aspect of the invention relates to a method for producing a dosage form based on a swellable component using a mogul casting process.

[0070] In a method according to the invention, the swelling component is continuously dosed from a second vacuum region into a third vacuum region via a connection, where the swelling component is homogeneously mixed under vacuum with continuously dosed syrup in a mixing region for the swelling component and the syrup, wherein the second and third vacuum regions have a pressure of less than 500 mbar.

[0071] Advantageously, in a method according to the invention, the second vacuum region is supplied batchwise with a swellable component via a lock from the first vacuum region, wherein the first vacuum region is filled with a swellable component at normal pressure and then evacuated to the low pressure in the second vacuum region before the swellable component from the first vacuum region is transferred to the second vacuum region after the lock is opened.

[0072] Alternatively or additionally, in a method according to the invention, the swelling component can advantageously be dosed continuously in a gravimetrically controlled manner.

[0073] It is particularly advantageous in the phases in which the first vacuum area is at normal pressure, to dose the swelling component volumetrically.

[0074] In an advantageous embodiment of a method according to the invention, the second vacuum region is fluidically connected to a third vacuum region via a force compensator during the transition to that third vacuum region.

[0075] The second and third vacuum zones are particularly advantageous when connected by a pressure equalization line. This line can be a flexible hose, for example, a flexible plastic hose.

[0076] In another advantageous embodiment of a method according to the invention, syrup is continuously dosed into a mixing chamber for the swelling component and the syrup. Advantageously, the syrup is dosed using a progressive cavity pump, the pump being particularly advantageously controlled by a flow meter for the syrup.

[0077] In a further advantageous variant of a method according to the invention, the mixture is continuously discharged from the mixing area for the swelling component and the syrup.

[0078] The discharge is advantageously achieved using a progressive cavity pump. The mixing zone for the swelling component and the syrup is particularly advantageous, designed as the pump's mouth chamber.

[0079] In yet another advantageous variant of a method according to the invention, the discharge is carried out using an eccentric screw pump, wherein the continuous mass flow from the eccentric screw pump is controlled by a Coriolis flow meter.

[0080] The Coriolis flow meter is advantageously equipped with at least two measuring tubes. The Coriolis flow meter is particularly preferred when operated with at least two excitation frequencies.

[0081] Advantageously, in a method according to the invention, the active ingredient in the form of an active ingredient-containing mixture is continuously introduced into the continuous mass flow of swelling component and syrup.

[0082] Even more advantageous is the continuous conveyance of the active ingredient mixture using an eccentric screw pump, and the mass flow is particularly advantageously regulated with a flow meter.

[0083] Advantageously, in a method according to the invention, aroma is continuously introduced into the continuous mass flow of the mixture containing the active ingredient.

[0084] Even more advantageous is the continuous conveyance of the active ingredient mixture using an eccentric screw pump, and the mass flow of aroma is particularly advantageously regulated with a flow meter.

[0085] In yet another advantageous variant of a method according to the invention, after the mass flow of the swelling component and syrup has been combined with the mass flow of the active ingredient-containing mixture, which may optionally be flavored, the resulting mass flow is mixed, for example with a static mixer.

[0086] Advantageously, in a process according to the invention, at least one pulsation dampener is present in the course of the process path after the mixing of the swelling component and syrup up to the casting machine.

[0087] It is advantageous to have at least one pulsation dampener on the process path from the point where the various mass flows are combined to the casting machine.

[0088] The at least one pulsation dampener is advantageously designed as a pressure-resistant hose. Even more advantageous is the at least one pulsation dampener being designed as a pressure-resistant and expandable hose.

[0089] In a further advantageous variant of a method according to the invention, the casting compound, which is continuously fed to a casting machine, is supplied to the casting machine via a compound distributor.

[0090] In another advantageous embodiment of a method according to the invention, the absolute pressure in the mass flow before the mass distributor (40) or in the mass distributor pulsates in a range of -1 - 3 bar, particularly advantageously in a range of -0.3 - 2 bar.

[0091] Advantageously, in a method according to the invention, the casting machine is designed according to the First in First out principle.

[0092] A further advantage of a method according to the invention is that the casting machine has a torque per metering piston in the range of 0.01 - 0.1 Nm.

[0093] The casting compound is advantageously cast in a process according to the invention at a temperature in the range of approximately 15–55 °C. A lower temperature of 1°C or an upper temperature of 60°C is possible for special applications.

[0094] In a process according to the invention, the casting compound advantageously comprises swellable particles, syrup, water, acid and optionally an active ingredient.

[0095] A particularly advantageous proportion of swellable particles is in the range of 5–25 wt.%. In the aforementioned processes according to the invention, the swellable particles are advantageously selected from a group consisting of gelatin, pectins, carrageenans, alginates, gum arabic, agar-agar, and combinations thereof.

[0096] Alternatively, in the aforementioned inventive process, the swellable particles are gelatinized starch.

[0097] In yet another advantageous variant of a process according to the invention, a portion of the syrup of the casting compound is dosed into the process together with the mixture containing the active ingredient.

[0098] Particularly advantageous is the proportion of syrup in wt.%, which is dosed into the process with the active ingredient-containing mixture, lying between A and B, where these values ​​are given as follows: A = 0.0029*x + 10; B = 0.0029*x + 20; with x = proportion in wt.% of the active ingredient-containing mixture in the casting mass.

[0099] In the aforementioned methods according to the invention, the throughput of casting material is advantageously in the range of 500 kg / h - 5,000 kg / h, and the casting machine has a casting rate of 15 - 35 boxes per minute.

[0100] In the aforementioned processes according to the invention, the cast products are also advantageously dried at a temperature in the range of 35 - 65 °C and at a relative humidity of 10 - 50%, and the products have a unit weight of 0.5 - 4.5 g in the packaging-ready state.

[0101] A fourth aspect of the invention relates to a dosage form.

[0102] Such a dosage form according to the invention is produced according to a method according to the invention.

[0103] Further aspects of the present invention will also become apparent from the following description.

[0104] The invention also includes individual features shown in the figures, even if they are shown there in conjunction with other features and / or are not mentioned above. Furthermore, the term "comprises" and derivatives thereof does not exclude other elements or steps. Likewise, the indefinite article "a" or "an" and derivatives thereof does not exclude a plurality. The functions of several features listed in the claims can be fulfilled by a single unit. The terms "essentially," "approximately," "about," and the like, in conjunction with a property or value, also define precisely that property or value. All reference numerals in the claims are not to be understood as limiting the scope of the claims.

[0105] Brief description of the drawings

[0106] For a better understanding of the present invention, reference is made below to the drawings. These show only exemplary embodiments of the invention. The same reference numerals are used in the following figures and the accompanying description for identical or similarly functioning parts.

[0107] Figure 1 schematically shows the production of the casting compound as a flowchart.

[0108] Figure 2 schematically shows the essential aspects of the manufacturing process according to the invention and a corresponding plant.

[0109] Implementation of the invention

[0110] Fabrics

[0111] Hydrocolloids

[0112] Hydrocolloids, as used here, are defined as hydrocolloids that, when in solution, can form gels upon cooling. These include, in particular, gelatin, pectins, carrageenans, alginates, agar-agar, gum arabic, and combinations thereof. Starch is not included in this group.

[0113] The hydrocolloids mentioned are widely used in the production of mogul products. Gelatin and pectin are the most common. Traditionally, the hydrocolloids are dissolved in the casting compound, and the casting compounds are boiled to prepare the necessary solutions. Temperatures of approximately 90 to typically well over 100 °C are used for this process. These casting compounds are poured at temperatures above the gelling temperature, as gelation is only desired after pouring and would otherwise render the casting compound unusable. The pouring temperature is above 60 °C, typically well above 60 °C.

[0114] According to the invention, the hydrocolloids used are employed as swellable powders. Within the powder particles, the hydrocolloids are present at least partially in a gelled form. Such powders are obtained, for example, by dissolving the hydrocolloids and then drying the solutions. Advantageously, at least partial gelation occurs during this process.

[0115] Strength

[0116] The starch used is in the form of gelatinized starch. This means that the semi-crystalline structure of native starch has been transformed into a substantially amorphous structure. The starch has thus been converted into a swellable form, as required for the present invention.

[0117] Gelatinized starch is also known as precooked starch, cold-soluble starch, or instant starch. This type of starch is obtained by the action of water and temperature, and optionally mechanical energy, followed by drying, particularly roller drying or spray cooking, and by comminution, resulting in a specific particle size distribution.

[0118] In an advantageous embodiment, the starch is used in a modified form. Modification by substitution, for example by hydroxypropylation or acetylation, is particularly preferred, as this improves the stability of the products. The substitution can also be combined with crosslinking, for example in the form of distarch phosphate or distarch adipate. Even more advantageously, hydroxypropylated distarch phosphate is used.

[0119] Furthermore, starches that are partially degraded in molecular weight, for example by acid or enzymes, possibly in combination with substitution and / or cross-linking, are also suitable. Oxidized starches can also be used. The selection of starches allows for the creation of various textures, such as those closely resembling the texture of gelatin or those closer to that of pectin products. This enables the product to meet diverse market demands.

[0120] In terms of origin, tapioca starches are advantageous because they are available in a particularly pure form and result in good storage stability. Pea starches or potato starches are also advantageous, especially for softer, less elastic textures.

[0121] In an advantageous embodiment, the weight mean of the molecular weight distribution of the starch in g / mol is at least 500,000, more advantageously at least 2,700,000, more advantageously at least 3,300,000, more advantageously at least 5,500,000, more advantageously at least 8,000,000 and more advantageously at least 11,000,000.

[0122] Particle size distribution of the hydrocolloids and the starch

[0123] The particle size of the powder and its distribution influence both the kinetics of the swelling process and thus the viscosity of the casting compound. Smaller particles swell faster than larger ones, and therefore larger particles are preferable to maintain a consistent viscosity or one that increases only slowly over time. On the other hand, large particles result in an unfavorable sensory experience in the mouth, while smaller particles are more advantageous for a homogeneous product structure with homogeneous properties and a uniformly distributed active ingredient. A balanced particle size distribution can meet these various requirements.

[0124] In an advantageous embodiment, the proportion of powder with a particle size of less than 0.050 mm in wt.% is less than 40%, even more advantageously less than 35%, even more advantageously less than 30%, even more advantageously less than 25% and even more advantageously less than 20%.

[0125] Limiting the quantity of small particles significantly improves viscosity stability during processing, thus extending the pourability window. This is advantageous for a stable process. In a preferred embodiment, the particle size distribution has an upper limit, with the upper limit being 0.700 mm, preferably 0.600 mm, more advantageously 0.500 mm, 0.400 mm, 0.350 mm, 0.300 mm, 0.250 mm, and 0.200 mm.

[0126] This selection limits the negative impact of large particles on sensory perception in the mouth.

[0127] In an advantageous embodiment, the proportion of powder with a particle size of more than 0.200 mm in wt.% is less than 25%, even more advantageous is less than 20%, even more advantageous is less than 17%, even more advantageous is less than 14%, even more advantageous is less than 12% and even more advantageous is less than 10%.

[0128] This selection has a positive influence on the sensory experience in the mouth and on storage stability.

[0129] In an advantageous embodiment, the particle size distribution comprises a range extending at least from PA to PB. The value for PA in mm is 0.060, more advantageously 0.050, 0.040, 0.030, 0.020, and 0.010. The value for PB in mm is 0.150, 0.170, 0.180, 0.190, 0.200, 0.210, and 0.220.

[0130] A wide particle size distribution results in a uniform texture and good storage stability.

[0131] syrup

[0132] In principle, syrups can be used that are typically used in the confectionery industry for the production of mogul products.

[0133] A sugar syrup is a liquid mixture consisting primarily of water, sugars (monosaccharides and disaccharides such as fructose, glucose, sucrose, allulose, palatinose, etc.), and / or oligosaccharides. Specifically, it refers to sugar syrups obtained from a combination of dissolved sugar and glucose syrup. The sugar-to-glucose syrup ratio can vary widely, and glucose syrup can exhibit a broad spectrum of oligosaccharide composition. Generally, the term "glucose syrup" refers to a syrup that, in addition to glucose, contains a more or less significant proportion of oligosaccharides.

[0134] On the other hand, sugar-free syrups can also be used, as are typically found in Mogul products. This category includes, for example, sugar alcohol syrups such as those containing sorbitol, mannitol, isomalt, maltitol, lactitol, xylitol, or erythritol, and mixtures thereof. Maltitol syrup is a particularly suitable sugar-free syrup. Combinations of sugar-containing and sugar-free syrups are also possible.

[0135] Isomaltulose and fructose syrups and mixtures thereof with other syrups are also suitable.

[0136] With regard to the Brix value in °Brix, the syrups preferably have a value in the range of 60 - 90, even more advantageously 65 - 85, even more advantageously 70 - 80, and even more advantageously 72 - 79.

[0137] acid

[0138] In principle, any acid used in the confectionery, nutraceutical, and pharmaceutical industries can be used. Fruit acids and combinations thereof are preferred. Suitable acids include, for example, citric acid, malic acid, tartaric acid, fumaric acid, lactic acid, metatartaric acid, phosphoric acid, ascorbic acid, adipic acid, salts of citric acid, salts of lactic acid, and combinations thereof.

[0139] buffer

[0140] Buffering agents and acidity regulators commonly used in the confectionery, nutraceutical, and pharmaceutical industries can also be employed. Examples include citrates such as trisodium citrate and triammonium citrate; tartrates, acetates, ascorbates, lactates, carbonates, maleates, adipates, polyphosphates, sulfates, and hydroxides; as well as combinations thereof. Flavorings.

[0141] Flavorings commonly used in confectionery, nutraceuticals, and pharmaceuticals can also be employed. The selection of flavorings is virtually limitless. Fruit flavorings and flavorings of natural origin are particularly advantageous.

[0142] Additive

[0143] Additives commonly used in the confectionery, nutraceutical, and pharmaceutical sectors can also be employed. Examples include emulsifiers, stabilizers, antioxidants, preservatives, natural sweeteners with high sweetness such as stevia and luo han guo, artificial sweeteners with high sweetness such as aspartame, advantame, acesulfame, cyclamate, neotame, saccharin, sucralose, and thaimatin, and sugar substitutes such as lucuma and yacon.

[0144] Active ingredient

[0145] A very wide range of substances and combinations thereof can be considered as active ingredients, all of which have a desirable, supportive effect on the body. These include, in the broadest sense, dietary supplements, nutraceuticals, and even pharmaceuticals. The desired effect encompasses, for example, health benefits and support in the most general sense, effects related to lifestyle, effects related to cosmetic aspects, and effects in relation to a balanced and varied diet.

[0146] The dosage form according to the invention represents an alternative to effervescent tablets, tablets, soft capsules and hard capsules, which is why, in principle, active ingredients as formulated with these classic dosage forms are also suitable for the dosage form according to the invention.

[0147] These include, in particular, vitamins, both of natural and synthetic origin, such as vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, and vitamin K. An important group of active ingredients are minerals such as calcium, magnesium, cobalt, iron, iodine, copper, selenium, and zinc.

[0148] Further examples of active ingredients include omega-3 fatty acids, both of animal (fish oil) and plant origin, carotenoids such as astaxanthin, beta-carotene, lutein, zeaxanthin, polyphenols, coenzyme Q10, prebiotics, probiotics, flavonoids, quercetin, caffeine, collagen, keratin, hyaluronic acid, glucosamine, L-carnitine, melatonin, colostrum, lactase, glucans, beta-glucan, Ester C, ceramides, hydrogenated guar gum, xylooligosaccharides, various plant extracts such as ginger, ashwagandha, tomato extract, ginseng, maca root extract, acerola fruit extract, green tea extract, bamboo extract, saffron, lemon verbena, theanine, flavonoids, hesperidin, turmeric, pomegranate, grapefruit seeds, and mixtures thereof.

[0149] Regarding pharmaceutical agents, those that have an effect in the mouth and throat and in the stomach are particularly noteworthy examples.

[0150] Mixtures of 2 to many active ingredients from the same group of active ingredients, as well as from different groups of active ingredients, are also possible.

[0151] Casting compound based on various

[0152] To enable a process that eliminates the need to boil the casting compound, allowing the procedure to be carried out at low temperatures, the macromolecules are used in the form of a swellable component. The swelling behavior of the swellable particles in the swellable component is determined by the parameters of the overall formulation, with the proportion of the swellable component and the water content being of particular importance.

[0153] With cooked casting compounds, the formulation has little significant influence on further processing. This is different with low-temperature processes, meaning the formulation must be optimally adapted to the process. For example, there are formulations that would yield good products, but because the swellable component swells too quickly, e.g., because the proportion of swellable particles is too high, such formulations are not suitable for industrial processing. This means the formulation must also take the requirements of the process into account and, in particular, enable the slowest possible increase in viscosity. This also makes the process robust. If continuous production stops due to any disruption, the casting compound should remain pourable for as long as possible.

[0154] Surprisingly, the many different and sometimes conflicting requirements regarding product properties and process requirements can be met, resulting in a robust and cost-effective high-throughput process.

[0155] According to the invention, casting compounds for the production of dosage forms using the mogul process comprise a swellable component in the form of swellable particles, as well as syrup, water, acid and active ingredient, wherein a) the swellable particles are in an evacuated state; b) the proportion of particles is in the range of 5 - 25 wt.%; c) the water content of the casting compound is in the range of 15 - 27 wt.%; d) the proportion of active ingredients is in the range of 0.01 - 30 wt.%.

[0156] In an advantageous embodiment, the lower limit for the proportion of the swellable component in the casting compound, in wt.%, is 5.5, even more advantageously 6.0, 6.5, 7.0, 7.5, 8.0, and 8.5. In an advantageous embodiment, the upper limit for the proportion of the swellable component in the casting compound, in wt.%, is 24, 23, 22, 21, 20, 19, 18, 17, 16, and 15.

[0157] The advantageous proportion of the swellable component achieves, on the one hand, an advantageous texture and matrix properties for the encapsulation of the active ingredients, and on the other hand, good processability, i.e., an advantageous balance between viscosity and slow increase in viscosity due to the swelling of the swellable component.

[0158] In an advantageous embodiment, the lower limit for the water content of the casting compound in wt.% is 15, even more advantageously 16, even more advantageously 17, even more advantageously 17.5, even more advantageously 18.0, even more advantageously 18.5, and even more advantageously 19.0. In an advantageous embodiment, the upper limit for the water content of the casting compound in wt.% is 27, even more advantageously 26.5, even more advantageously 26.0, even more advantageously 25.5, even more advantageously 24.0, even more advantageously 23.5, and even more advantageously 23.0.

[0159] The water content consists of the water contained in the swelling component, the water contained in the syrup, and the water added to the recipe as water.

[0160] The water content is needed for the swelling of the swellable component; the lower the water content, the slower the swelling process, which is advantageous for the process, and the less water there is in the recipe, the shorter the drying times.

[0161] The lower water content according to the invention must be maintained to ensure the required swelling behavior. Conversely, increasing the water content reduces the viscosity and improves the homogenization of the components. With the advantageous water content, favorable processing is achieved, i.e., a favorable balance between viscosity and the slow increase in viscosity due to the swelling of the swellable component. This also results in advantageously short drying times for the cast products and favorable behavior with regard to minimal adhesion of molding powder to the products during drying. Furthermore, water plays an important role in providing the active ingredient-containing mixture. The advantageous range represents a particularly favorable balance of all these aspects.

[0162] In a preferred embodiment, the lower limit for the proportion of the active ingredient in wt.% is 0.01%, even more preferred 0.05%, even more preferred 0.1%, even more preferred 0.5%, even more preferred 1.0%, even more preferred 1.5%, even more preferred 2.0%, even more preferred 2.5%, even more preferred 3.0%, and even more preferred 3.5%. In a preferred embodiment, the upper limit for the proportion of the active ingredient in wt.% is 29%, even more preferred 28%, even more preferred 27%, even more preferred 26%, and even more preferred 25%.

[0163] On the one hand, depending on the dosage form, the aim is to achieve the largest possible amount of active ingredient; on the other hand, the active ingredient content affects the product's texture and, in many ways, its processing. Conversely, there are also active ingredients that are administered in very small quantities because they already produce the desired effect in very small amounts. Within these limits, advantageous products are possible with advantageous processes.

[0164] In an advantageous embodiment, the lower limit for the proportion of syrup in wt.% is 30%, even more advantageous at 33%, even more advantageous at 36%, even more advantageous at 39%, even more advantageous at 42%, even more advantageous at 45% and even more advantageous at 48%. In an advantageous embodiment, the upper limit for the proportion of syrup in wt.% is 80%, even more advantageous at 77%, even more advantageous at 74%, even more advantageous at 71%, even more advantageous at 68% and even more advantageous at 66%.

[0165] The syrup content is important for the properties of the resulting products as well as for their processability. The advantageous ranges represent a balance between various processing and product characteristics and are particularly important for storage stability.

[0166] In an advantageous embodiment, the lower limit for the ratio of swelling component to syrup is 0.08, even more advantageous at 0.09, even more advantageous at 0.10, even more advantageous at 0.11, even more advantageous at 0.11, even more advantageous at 0.12, even more advantageous at 0.13, and even more advantageous at 0.14. In an advantageous embodiment, the upper limit for the ratio of swelling component to syrup is 0.28, even more advantageous at 0.27, even more advantageous at 0.265, even more advantageous at 0.260, even more advantageous at 0.255, even more advantageous at 0.250, even more advantageous at 0.245, and even more advantageous at 0.240.

[0167] By selecting the advantageous range for the ratio of swelling component to syrup, important texture properties and storage stability are advantageously determined, and, as with water content, a whole range of interconnected effects and requirements for processability and product are selected within an advantageous range.

[0168] In an advantageous embodiment, the proportion of powder with a particle size of less than 0.050 mm is less than 40% by weight, more advantageously less than 35%, less than 30%, less than 25%, and less than 20% by weight. In an advantageous embodiment, the lower limit for the proportion of acid is 0.40% by weight, more advantageously 0.50%, 0.60%, 0.70%, and 0.80% by weight. In an advantageous embodiment, the upper limit for the proportion of acid is 3.0% by weight, more advantageously 2.8%, 2.6%, 2.4%, and 2.2% by weight.

[0169] In an advantageous embodiment, the casting compound has a buffer, and the lower limit for the buffer content in wt.% is 0.20%, even more advantageously 0.30%, 0.40%, 0.45%, and 0.50%. In an advantageous embodiment, the upper limit for the buffer content in wt.% is 2.0%, 1.9%, 1.8%, 1.7%, 1.6%, 1.5%, and 1.4%.

[0170] The casting compound may contain additives.

[0171] In an advantageous version, the syrup is a sugar-free syrup.

[0172] In an advantageous embodiment, the casting compound has a temperature in °C of less than 55, more advantageously less than 50, even more advantageously less than 47, even more advantageously less than 44, even more advantageously less than 42, even more advantageously less than 40, and even more advantageously less than 38. A lower limit for the temperature of the casting compound in °C is advantageously 15, even more advantageously 17, even more advantageously 20, even more advantageously 23, and even more advantageously 25.

[0173] As the temperature decreases, the viscosity increase slows down advantageously over time, making the process more robust, especially in the event of disturbances and interruptions. Conversely, higher temperatures lead to lower viscosity, which then increases more rapidly. (Starch-based casting compounds)

[0174] In an advantageous embodiment of the casting compound for the production of dosage forms for active ingredients, the swellable component is starch and the starch is present in the form of gelatinized particles.

[0175] This allows for the creation of vegetarian dosage forms with a rubbery-elastic texture, similar to either gelatin or pectin, depending on the chosen strength. Such textures can therefore be obtained using a gentle low-temperature process.

[0176] To obtain starch-based dosage forms with a rubbery-elastic texture, a pleasant mouthfeel, and no stickiness to the teeth, particularly high molecular weights of the starch are necessary. If the starch were boiled, its viscosity would be far too high for the mass to be poured. For the aforementioned products, suitable processing is only possible by using the starch in particle form.

[0177] Using starch as a swelling component allows for the production of products that would otherwise be impossible, with the added advantage that high temperatures are not required. This makes it particularly advantageous to process sensitive, expensive active ingredients, and because they are less thermally degraded, they can be dosed at lower levels.

[0178] Other processes and casting compounds using dissolved hydrocolloids exist for hydrocolloids, but these do not offer the advantage of a low-temperature process. Furthermore, the textures obtained with hydrocolloids and the inventive process deviate from the known standard, making them particularly interesting for the market as new variants.

[0179] In an advantageous embodiment of the casting compound for the production of dosage forms for active pharmaceutical ingredients, it comprises starch, syrup, water, acid, and active ingredient, wherein: a) the starch is present in the casting compound in the form of evacuated, gelatinized particles; b) the starch content is in the range of 8–25 wt.%; c) the water content is in the range of 15–27 wt.%; d) the starch-to-syrup ratio is in the range of 0.13–0.29; e) the active ingredient content is in the range of 0.01–30 wt.%. Such casting compounds can be either sugar-containing or sugar-free. A sugar-containing or sugar-free syrup is used accordingly.

[0180] The starch content determines the firmness of the products and their behavior in the mouth within a desired range. More starch results in harder products that are more difficult to chew, while less starch leads to products that are not sufficiently dimensionally stable and can deform and become sticky during storage.

[0181] The advantageous water content range allows for very slow swelling of the starch particles, resulting in a very gradual increase in viscosity and enabling a robust process at low pressures, where process interruptions can occur without causing problems or casting failure. The comparatively low water content also allows for complete swelling after casting and is advantageous in terms of shorter drying time, as less water needs to diffuse from the product into the starch powder. Despite the low starch content, the low water content also leads to a comparatively high viscosity that increases only slightly over time, ensuring that the active ingredients in the casting compound remain stable once homogenized.

[0182] The discovered ratio of starch to syrup results in an optimal texture, good storage properties, and provides a particularly suitable matrix for the active ingredient, which can also be highly loaded.

[0183] This matrix can therefore be used with a wide range of active ingredients and concentrations while still meeting the texture requirements.

[0184] Requirements b) to d) indirectly involve the active ingredient content, as this is typically a solid and must be prepared in a suspension, thus requiring a liquid phase primarily supplied by water and syrup. During the process, this suspension is then mixed with a mixture of starch and syrup. Therefore, the water and syrup content cannot be chosen independently of the active ingredient content and must be optimally adjusted accordingly. For advantageous product properties for the consumer and during storage, as well as for fulfilling the process requirements, combining conditions a) to e) is particularly beneficial.

[0185] The use of modified starch is advantageous, as it ensures product stability during storage. Unmodified starch leads to retrogradation, causing products to harden over time and become crumbly in the mouth, which is undesirable.

[0186] Because the starch particles suspended in the casting compound are advantageously not substantially swollen, the process becomes particularly robust and the casting behavior remains constant, even during process interruptions.

[0187] Casting compounds that are as free of air bubbles as possible are advantageous, because these are visible on the products depending on their size and number, which is undesirable.

[0188] For the areas selected as advantageous, the reasons mentioned for the casting compound for various swelling components also apply, which are in principle independent of the type of swelling component.

[0189] In an advantageous embodiment, the lower limit for the proportion of the swellable component in the casting compound, in wt.%, is 8.0, even more advantageously 8.5, even more advantageously 9.0, even more advantageously 9.5, even more advantageously 10.0, even more advantageously 10.5, and even more advantageously 11.0. In an advantageous embodiment, the upper limit for the proportion of the swellable component in the casting compound, in wt.%, is 25, even more advantageously 24, even more advantageously 23, even more advantageously 22, even more advantageously 21, even more advantageously 20, and even more advantageously 19.

[0190] In a preferred embodiment, the lower limit for the water content of the casting compound in wt.% is 15, even more preferred at 16, even more preferred at 17, even more preferred at 17.5, even more preferred at 18.0, even more preferred at 18.5, and even more preferred at 19.0. In a preferred embodiment, the upper limit for the water content of the casting compound in wt.% is 27, even more preferred at 26.5, even more preferred at 26.0, even more preferred at 25.5, even more preferred at 24.0, even more preferred at 23.5, and even more preferred at 23.0. The water content comprises the water contained in the swelling starch, the water contained in the syrup, and the water added to the formulation.

[0191] In a preferred embodiment, the lower limit for the proportion of the active ingredient in wt.% is 0.01%, even more preferred at 0.05%, even more preferred at 0.1%, even more preferred at 0.5%, even more preferred at 1.0%, even more preferred at 1.5%, even more preferred at 2.0%, even more preferred at 2.5%, even more preferred at 3.0%, and even more preferred at 3.5%. In a preferred embodiment, the upper limit for the proportion of the active ingredient in wt.% is 29%, even more preferred at 28%, even more preferred at 27%, even more preferred at 26%, and even more preferred at 25%.

[0192] In an advantageous embodiment, the lower limit for the proportion of syrup in wt.% is 30%, even more advantageous at 33%, even more advantageous at 36%, even more advantageous at 39%, even more advantageous at 42%, even more advantageous at 45% and even more advantageous at 48%. In an advantageous embodiment, the upper limit for the proportion of syrup in wt.% is 80%, even more advantageous at 77%, even more advantageous at 74%, even more advantageous at 71%, even more advantageous at 68% and even more advantageous at 66%.

[0193] In an advantageous embodiment, the lower limit for the ratio of swelling component to syrup is 0.130, even more advantageous at 0.140, 0.150, 0.160, 0.165, 0.170, 0.115, and 0.180. In an advantageous embodiment, the upper limit for the ratio of swelling component to syrup is 0.29, 0.28, 0.27, 0.265, 0.260, 0.255, 0.250, 0.245, and 0.240.

[0194] In an advantageous embodiment, the proportion of powder with a particle size of less than 0.050 mm in wt.% is less than 40%, even more advantageously less than 35%, even more advantageously less than 30%, even more advantageously less than 25% and even more advantageously less than 20%.

[0195] In a particularly advantageous embodiment, the lower limit for the acid content in wt.% is 0.40%, even more advantageously 0.50%, even more advantageously 0.60%, even more advantageously 0.70%, and even more advantageously 0.80%. In a particularly advantageous embodiment, the upper limit for the acid content in wt.% is 3.0%, even more advantageously 2.8%, even more advantageously 2.6%, even more advantageously 2.4%, and even more advantageously 2.2%.

[0196] In an advantageous embodiment, the casting compound has a buffer, and the lower limit for the buffer content in wt.% is 0.20%, even more advantageously 0.30%, 0.40%, 0.45%, and 0.50%. In an advantageous embodiment, the upper limit for the buffer content in wt.% is 2.0%, 1.9%, 1.8%, 1.7%, 1.6%, 1.5%, and 1.4%.

[0197] The casting compound may contain additives.

[0198] In an advantageous embodiment, the casting compound has a temperature in °C of less than 55, more advantageously less than 50, even more advantageously less than 47, even more advantageously less than 44, even more advantageously less than 42, even more advantageously less than 40, and even more advantageously less than 38. A lower limit for the temperature of the casting compound in °C is advantageously 15, even more advantageously 17, even more advantageously 20, even more advantageously 23, and even more advantageously 25.

[0199] Sugar-free casting compounds based on starch

[0200] Sugar-free products have gained in importance and their significance continues to increase, which is why sugar-free casting compounds are advantageous.

[0201] In an advantageous embodiment, the lower limit for the proportion of the swellable component in the casting compound in wt.% is 10.0, even more advantageous is 10.5, even more advantageous is 11.0, even more advantageous is 11.5, even more advantageous is 12.0, even more advantageous is 12.5, and even more advantageous is 13.0. In an advantageous embodiment, the upper limit for the proportion of the swellable component in the casting compound is 27% by weight, even more advantageously 26%, 25%, 24%, 23%, 22%, and 21% by weight. In an advantageous embodiment, the lower limit for the ratio of swellable component to syrup is 0.150%, 0.160%, 0.170%, 0.180%, 0.185%, 0.190%, 0.195%, and 0.200% by weight.In an advantageous embodiment, the upper limit for the ratio of swelling component to syrup is 0.31, even more advantageous is 0.30, even more advantageous is 0.29, even more advantageous is 0.285, even more advantageous is 0.280, even more advantageous is 0.275, even more advantageous is 0.270, even more advantageous is 0.265 and even more advantageous is 0.260.

[0202] The advantageous ranges for water content, active ingredient content, syrup content, particle size, acid content, buffer content and the temperature of the casting compound are otherwise the same as listed above for starch-based casting compounds.

[0203] Production of the casting compound

[0204] The production of the casting compound according to the invention is schematically illustrated as a flowchart in Figure 1, which is referred to below.

[0205] The continuously produced casting mass is obtained by continuously combining a continuously produced homogeneous mixture 3 of swelling component 1 and syrup 2 with a mixture 6, which consists of an active ingredient-containing mixture 4 and optionally further components such as aroma 5, to form a homogeneous overall mixture 7, which is poured as casting mass with a casting machine 8 on a mogul line at a specific pouring rate.

[0206] The aroma component 5 can, in principle, be continuously mixed into the mixture 3 consisting of swelling component 1 and syrup 2, into the active ingredient-containing mixture 4, or into the mixture 7 resulting from these two mixtures.

[0207] The aroma component 5 is advantageously mixed continuously into the active ingredient component 4, so that the active ingredient component 4 and the aroma component 5 together 6 can then be introduced into the main stream of starch mass 1 and syrup mass 2 and mixed with the static mixer.

[0208] Alternatively, the flavoring component can be introduced directly into the main stream of starch mass 1 and syrup mass 2, downstream of the progressive cavity pump 34-36 and before the static mixer. Another alternative is that the flavoring component can be mixed into the active ingredient-containing mixture during its preparation (see below for the preparation of the active ingredient component), thus eliminating the need for an additional mixing step.

[0209] The other components – acid, buffer, additives, and color – can be processed analogously to the aroma component. However, it is advantageous to add these components to the process together with mixture 4, which contains the active ingredient.

[0210] The active ingredient is mainly in powder form. To convert this powder into a flowable mixture 4, a liquid phase is required in which the powder can be suspended.

[0211] The active ingredient-containing mixture 4 has, in an advantageous embodiment, the following components:

[0212] 1. Water

[0213] 2. Acid

[0214] 3. Buffer, if necessary

[0215] 4. Syrup

[0216] 5. Color, if applicable.

[0217] 6. Aroma, if desired

[0218] 7. Additives, if applicable

[0219] 8. Active ingredient

[0220] To mix the active ingredient into a free-flowing phase, in an advantageous embodiment, water is first added in which acid and, if necessary, buffer can be dissolved. Syrup is then added to ensure, firstly, that there is a sufficient liquid phase to mix in the powder, and secondly, because syrup has a significantly higher viscosity than water, to obtain a liquid phase with a certain viscosity so that the powder suspended in it is stable and does not sediment, or does not sediment quickly, and the mixture can be kept stable by stirring.

[0221] Thus, in an advantageous embodiment, the syrup is introduced into the casting process via two routes. Firstly, via the mixture of starch and syrup, and secondly, via the active ingredient-containing mixture 4. It is also advantageous that this reduces the proportion of syrup in the starch and syrup mixture, because the increase in viscosity over time of this mixture, and consequently of the entire casting mass, is slower, resulting in a more stable and robust process.

[0222] In an advantageous embodiment, the amount of syrup supplied to the process via mixture 4 is adjusted depending on the proportion of the active ingredient-containing mixture 4 in the overall formulation.

[0223] In an advantageous embodiment, the proportion S of the syrup that is supplied to the process via the active ingredient-containing mixture 4, in wt.% based on the total syrup, is therefore between SA and SB, depending on WA, the proportion of active ingredient-containing mixture 4 in wt.%, wherein

[0224] SA = 0.29*WA + 10 and SB = 0.29*WA + 20.

[0225] In an advantageous embodiment, the active ingredient-containing mixture 4 is produced using a powder mixer. The mixture 4 is contained in a mixing vessel, from which a line leads to a powder mixing system. In this system, powder is continuously mixed into the mass stream, homogenized, and then returned to the mixing vessel. This means the powder is mixed in via a closed loop. A Fristam PM / PMV powder mixer, for example, is suitable for this purpose. Additionally, the mixture 4 is advantageously agitated and mixed within the mixing vessel by an agitator. A jet mixer, for example, is suitable for this purpose.

[0226] In an advantageous embodiment, the active ingredient-containing mixture 4 is degassed at least once during the manufacturing process by applying a vacuum, so that no disturbing air bubbles are introduced into the casting mass by this mixture.

[0227] Method for the continuous production of the casting compound

[0228] An advantageous device for producing casting compounds according to the invention is shown in Figure 2.

[0229] A corresponding apparatus is also disclosed in the Swiss patent application entitled "Device for creating a multi-component compound and method for producing a multi-component compound" filed by the same applicant and with the same filing date as the present patent application, as well as in the Swiss patent application entitled "Device and method for producing a multi-component compound, and a system comprising the device" filed by the same applicant and with the same filing date as the present patent application. The disclosure content of these patent applications is hereby incorporated into the description in its entirety by reference. The devices and methods shown therein enable the particularly advantageous production and processing of casting compounds according to the present patent application.

[0230] Casting compounds are generally produced in batches, or even exclusively so. In continuous processes, flavors, colors, or additives are mixed into an otherwise batch-produced casting compound as it flows into the mold and may be temporarily stored there until it is poured into the finished products. Continuous processes offer the advantage of greater automation and better documentation.

[0231] The casting compounds according to the invention contain a swellable component in the form of particles, which is novel and unusual. Since the advent of the Mogul process, gelling agents in the casting compound have been dissolved by boiling. Gelation then only begins upon cooling. Because, in the inventive process, these particles begin to swell as soon as they are mixed into the casting compound, the gelation or thickening process begins as soon as the particles are incorporated. This significantly reduces the time until casting, which must be taken into account by the process.

[0232] The inventive process is therefore novel in many respects because new requirements had to be taken into account. It is not a variation of known processes, but rather something fundamentally new. The patent applications by the same applicant described in the prior art are to be understood as preliminary stages of this process.

[0233] Various components for the production of the casting compound and the casting compound itself are continuously conveyed. Continuous means that within a short period of 1 minute, the mass flow rate averaged over this period exhibits a deviation from the target value of advantageously less than 16%, even more advantageously less than 13%, even more advantageously less than 10%, even more advantageously less than 7%, even more advantageously less than 5%, and even more advantageously less than 3%.

[0234] When a powder is mixed into a viscous mass, air is always mixed in along with the powder, and removing this air to the required extent is very difficult, time-consuming, and often impossible. Therefore, the inventive method employs the technique of metering the swellable component from a vacuum, thus preventing the introduction of the interfering air in the first place. Implementing this principle then presented a whole series of novel problems that could only be solved with considerable ingenuity.

[0235] In the inventive method for producing a dosage form based on a swellable component, the swellable component is continuously dosed from a vacuum region 48 via a connection 56 into a vacuum region 34, where the swellable component is homogeneously mixed under vacuum with continuously dosed syrup in a mixing region for swellable component and syrup, wherein the two vacuum regions have a pressure of less than 500 mbar absolute.

[0236] The connection 56, through which the swellable component is conveyed from the vacuum area 48 to the vacuum area 34, also ensures that the two vacuum areas can communicate with each other, so that nominally the same vacuum is present in both areas.

[0237] In an advantageous embodiment, an additional connection in the form of a compensating line 55 is used to compensate for small, unexpected differences in vacuum between the two regions 48 and 34, which can arise from the mass flow of swellable component through the connection 56. These small differences can negatively affect the dosing accuracy of the swellable component, and this effect can be eliminated by the compensating line.

[0238] In an advantageous embodiment, the pressure in the two vacuum ranges 48 and 34 is less than 300 mbar absolute, even more advantageously less than 200, even more advantageously less than 150, even more advantageously less than 100, even more advantageously less than 80, even more advantageously less than 60, even more advantageously less than 50, and even more advantageously less than 40.

[0239] In an advantageous embodiment, the pressure difference between the two vacuum zones 48 and 34 is less than 10 mbar, even more advantageously less than 7 mbar, less than 5 mbar, less than 3 mbar, less than 1 mbar, and less than 0.5 mbar.

[0240] In an advantageous embodiment, the swelling component is gravimetrically controlled and dosed from vacuum zone 48 into vacuum zone 34. Compared to volumetric dosing, this allows for significantly better dosing accuracy because it can be continuously monitored and adjusted.

[0241] In an advantageous embodiment, the vacuum region 48 is supplied batchwise with a swellable component from an upstream vacuum region 47 via a lock 50.

[0242] In an advantageous embodiment, the lock 50 is designed as a gate valve. In an advantageous embodiment, the gate valve is sealed by at least one pneumatic seal, wherein this seal is advantageously designed as a tubular seal that seals towards the gate valve when pressurized and whose diameter decreases when the pressure is released, so that the gate valve can then be moved.

[0243] In an advantageous embodiment, the upper vacuum chamber 47 is supplied with a swellable component in batches at normal pressure via the feeder 51 when the slide 49 is open, which is advantageously designed identically to the lower slide 50. That is, the vacuum chamber 47 is replenished with the swellable component until an upper fill level is reached.

[0244] Then the slide 49 is closed and the upper vacuum zone 47 is regulated to the same vacuum as the lower vacuum zone 48. When a lower fill level of the fill material is reached in the vacuum zone 48, the airlock 50 is opened and the fill material falls from the upper vacuum zone 47 into the lower vacuum zone 48, after which the airlock is closed again. In an advantageous embodiment, during the phase in which the swellable component falls from the upper vacuum zone 47 into the lower vacuum zone 48 and while the upper vacuum zone is not at the same vacuum as the lower zone, i.e., during the times when the vacuum zone 47 is being refilled with the swellable component, the swellable component is metered in volumetric mode.

[0245] In an advantageous embodiment, the connection 56 from the vacuum area 48 to the vacuum area 34 is equipped with a force decoupling 43, which ensures that the gravimetric dosing of the swelling component is not affected by the vibrations of the progressive cavity pump 34-36.

[0246] In an advantageous embodiment, the syrup is continuously dosed into the mixing area 34 of the swellable component and the syrup, where the two continuously arriving substances, the swellable component and the syrup, are homogeneously mixed.

[0247] In an advantageous embodiment, syrup is continuously dosed using an eccentric screw pump 22-24, wherein the continuous syrup dosing is advantageously controlled via a flow measurement 25 of the syrup flow.

[0248] In an advantageous embodiment, the supply of the syrup to the mixing area 34 is equipped with a force decoupling 44, wherein this force decoupling is advantageously implemented as a hose.

[0249] In an advantageous embodiment, the line in which the mass flow of swelling component and syrup is carried away after the progressive cavity pump 34-36 is equipped with a force decoupling 45, wherein this force decoupling 45 is advantageously realized as a hose.

[0250] The reason for this force decoupling 45 is that, in an advantageous embodiment, the progressive cavity pump 34-36 rests on load cells that measure the weight of this progressive cavity pump. This weight measurement serves to determine and, if necessary, regulate the fill level in the throat chamber 34 of the progressive cavity pump 34-36. For consistent and effective homogenization of starch and syrup in the throat chamber 34, a fill level that can be regulated within certain limits is necessary. In a preferred embodiment, the throat chamber 34 of the progressive cavity pump 34-36 is enlarged compared to a conventional throat chamber of such a progressive cavity pump in order to provide sufficient space for homogenizing the swelling component and syrup.In a preferred embodiment, the screw in the throat chamber 34 is equipped with at least one additional helix, which on the one hand promotes homogenization and on the other hand increases the pressure with which the mass is forced from the throat chamber into the area of ​​the rotor-stator 36 of the progressive cavity pump 34-36. This is advantageous because the vacuum in the throat chamber 34 makes feeding the rotor-stator more difficult.

[0251] In an advantageous embodiment, the progressive cavity pump 34-36 is designed with respect to the throat chamber 34 and the screw located therein in such a way that the progressive cavity pump normally used for conveying can simultaneously be used as a mixer.

[0252] In an advantageous embodiment, the mixture of swelling component and syrup is continuously discharged by the progressive cavity pump 34-36, wherein the continuous mass flow of swelling component and syrup is controlled via a flow meter 37.

[0253] In an advantageous embodiment, the flow meter 37 is a Coriolis flow meter. In an advantageous embodiment, the Coriolis flow meter is equipped with at least two measuring tubes and is even more advantageously operated with at least two excitation frequencies.

[0254] In an advantageous embodiment, the active ingredient-containing mixture is continuously introduced into the mass flow of the swelling component and syrup. In another advantageous embodiment, the active ingredient-containing mixture is metered via a progressive cavity pump 27-29, the mass flow being advantageously controlled by a flow meter 30.

[0255] In an advantageous embodiment, the aroma component is continuously dosed, and the aroma mass flow is advantageously controlled by a flow measurement 33.

[0256] In an advantageous embodiment, the aroma component is introduced into the mass flow of the active ingredient-containing mixture after the flow measurement 33 and before the introduction of the active ingredient-containing mixture into the mass flow of swelling component and syrup.

[0257] In an advantageous embodiment, after introducing the active ingredient-containing mixture into the mass flow of the swelling component and syrup, the total mass is mixed. In an advantageous embodiment, this mixing is carried out using a static mixer 39.

[0258] The aforementioned solution has the advantage that the swelling process in the pharynx (34) occurs more slowly. In the pharynx, the mixture has a residence time spectrum, meaning that some swellable particles can remain there longer. This causes the particles to swell slightly, increasing the viscosity of the mixture. Since particle swelling is highly sensitive to water content, and the syrup has a lower water content than the active ingredient component, the starch particles in the aforementioned variant swell more slowly because they are only in contact with the syrup. Consequently, the viscosity increases more slowly.

[0259] Alternatively, the active ingredient component, and optionally the flavor component, can be dosed directly into the throat area 34, similar to the syrup, and mixed there. This has the advantage of resulting in a particularly good mixture. The static mixer 39 can then be omitted if no further components are added after the eccentric pump.

[0260] However, it should be noted that with such a solution, the mass in throat chamber 34 thickens more quickly during process interruptions due to the higher water content. While the viscosity initially drops significantly when the active ingredient component is added, because this component is thin and aqueous, the viscosity then increases more rapidly.

[0261] The casting compound, ready for pouring after mixing, is conveyed to casting machine 41 of the Mogul line. While this casting compound is produced continuously, the casting machine can only pour it discontinuously. This is because the casting machine fills the casting compound into powder boxes via a multitude of several hundred pistons. A filled powder box is then moved along the line, and the next powder box is moved under the casting machine for filling. Furthermore, the casting machine can only receive casting compound when the pouring pistons are raised, i.e., filled with casting compound. When the casting compound is being poured, the casting machine cannot receive any more. This discontinuous pouring process follows the pouring cycle, which, measured as the number of boxes poured per minute, is typically in the range of 10–35, advantageously in the range of 15–35.This means that intervals of up to a few seconds occur during which casting compound arrives at the casting machine, but cannot be drawn off. As a result, the pressure of the casting compound rises during the phases when the machine cannot draw off any compound, and then drops during the phases when compound is drawn off. This creates strong pressure pulsations.

[0262] In an advantageous embodiment, a pulsation dampener 57 is used in the section from the static mixer 39 to the casting machine 41. In an advantageous embodiment, this pulsation dampener consists of a variable volume through which fluid flows, the variability of which can be achieved, for example, by a movable piston. In a further advantageous embodiment, this pulsation dampener consists of a hose whose elasticity enables the variable volume. Advantageously, the hose has a length in meters of at least 1, advantageously at least 2, and even more advantageously at least 3.

[0263] In an advantageous embodiment, the casting machine 41 is equipped with a mass distributor 40, which distributes the flow of casting material arriving at the casting machine evenly across the width of the casting machine.

[0264] In an advantageous embodiment, the casting machine 41 is designed according to the first-in, first-out (FIFO) principle. This means that the casting compound leaves the casting machine in the same order in which it enters the machine. This is achieved structurally by avoiding dead spaces within the flow channels of the casting machine, along which the casting compound flows. This ensures that no parts of the casting compound remain in the casting machine for an extended period and thicken there due to the swelling of the starch particles.

[0265] The casting compound according to the invention is typically more viscous than conventional casting compounds, such as those poured by Mogul casting machines. Therefore, the forces required to eject the casting compound through the respective nozzles with the casting pistons are greater than usual. Furthermore, these forces must also be sufficient to eject thickened casting compound if, due to a malfunction, the casting compound remains in the casting machine longer than usual. These forces are provided, for example, by at least one servo motor. In an advantageous embodiment, the casting pistons are moved by four servo motors. The forces are specified as torque in Nm.

[0266] In a preferred embodiment, the torque in Nm available per casting piston as a continuous load is greater than 0.005, advantageously greater than 0.001, even more advantageously greater than 0.015, even more advantageously greater than 0.020, even more advantageously greater than 0.025, even more advantageously greater than 0.030, even more advantageously greater than 0.035, and even more advantageously greater than 0.040. Typical casting machines operate with several hundred pistons.

[0267] For cost-effective production, the highest possible mass throughput is advantageous. In a particularly advantageous embodiment, the throughput of casting material in kg / h is 900–5,000, even more advantageous 1,400–5,000, and still more advantageous 1,700–5,000. The described process according to the invention enables such throughputs.

[0268] The casting compound is poured into powder molds located in so-called boxes. These boxes are moved along the Mughal line in a continuous pouring cycle beneath the casting machine, where the casting compound is poured by the numerous pistons of the machine into the many molds stamped or embossed into the powder. The boxes have a length and width that roughly correspond to the length and width of the casting machine and a depth of a few centimeters. The molding powder in the boxes consists of a powder made from native starch.

[0269] The water content of this powdered starch is an important parameter for good products. Ideally, the water content (in wt.%) of the powdered starch should be a maximum of 8.0, more advantageous at a maximum of 7.5, even more advantageous at a maximum of 7.2, even more advantageous at a maximum of 7.0, even more advantageous at a maximum of 6.8, even more advantageous at 6.4, even more advantageous at 6.2, and even more advantageous at a maximum of 6.0. The lower limit for the water content (in wt.%) of the powdered starch is ideally 4.0, more advantageous at 4.5, even more advantageous at 5.0, and even more advantageous at 5.5. If the water content of the powdered starch is too low, the resulting powder form will be too unstable; if the water content is too high, the powdered starch can stick to the products, forming a so-called powder crust. Depending on the severity of this powder crust, the products are then of inferior quality to unusable.

[0270] In an advantageous embodiment, the water content in wt.% of the powdered starch for sugar-free products is a maximum of 7.4, more advantageously a maximum of 7.2, even more advantageously a maximum of 7.0, even more advantageously a maximum of 6.8, even more advantageously a maximum of 6.6, even more advantageously a maximum of 6.4, even more advantageously a maximum of 6.0, and even more advantageously a maximum of 5.8.

[0271] The temperature of the powder starch in °C is advantageously in the range of 20–65 °C, more advantageously in the range of 20–60 °C, even more advantageously in the range of 25–55 °C, still more advantageously in the range of 25–50 °C, and still more advantageously in the range of 25–45 °C. Under these conditions, advantageous surface finishes of the products are obtained.

[0272] Advantageously, the temperature of the powdered starch is also at a temperature corresponding to the drying temperature, as specified below. This has the advantage that the temperature of the starch powder coming from the drying process does not need to be changed, which would involve effort and costs.

[0273] The drying of the products cast in powder molds is advantageously carried out at a temperature in °C in the range of 35 - 65, more advantageously in the range of 40 - 60, even more advantageously in the range of 45 - 57 and still more advantageously in the range of 45 - 55.

[0274] The relative humidity in % during the drying of the products is advantageously in the range of 10 - 50, more advantageously in the range of 15 - 45, even more advantageously in the range of 15 - 40 and still more advantageously in the range of 17 - 35.

[0275] The areas mentioned are advantageous in terms of drying time and for good product quality.

[0276] After drying, the boxes containing the products are dusted with powder, meaning the products are separated from the powdered starch. Then the products are oiled, inspected, defective products are removed, and finally, the products are packaged.

[0277] The unit weight of the ready-to-package products in grams is advantageously between 0.5 and 5 grams, even more advantageous between 1.5 and 4.0 grams, and still more advantageous between 1.6 and 3.9 grams. This meets market demands while also achieving favorable textures in this range. The subjective perception of the product's hardness or softness depends not only on the material but also on its size. A significantly larger product requires more force to chew or bite through.

[0278] Casting compounds produced using the inventive method

[0279] In an advantageous embodiment, the inventive method is used to produce and process casting compounds comprising pourable particles, syrup, water, acid and optionally an active ingredient.

[0280] In an advantageous embodiment, the proportion of particles suitable for application is in the range of 5 - 25 wt.%.

[0281] In an advantageous embodiment, casting compounds are produced and processed using the inventive method, wherein the casting compound comprises a pourable component in the form of pourable particles, as well as syrup, water, acid and active ingredient, and: a) the proportion of particles is in the range of 5 - 25 wt.%; b) the water content of the casting compound is in the range of 15 - 27 wt.%; c) the proportion of active ingredients is in the range of 0.01 - 30 wt.%;

[0282] With further advantageous embodiments of the inventive method, casting compounds are produced and processed, wherein the advantageous compositions of the casting compounds and their temperature ranges correspond to those mentioned in the chapter Casting compounds based on various pourable components.

[0283] In an advantageous embodiment of the inventive process, casting compounds are produced and processed, wherein the swellable component is selected from the group consisting of gelatin, pectin, carrageenan, alginates, agar-agar, and gum arabic, or combinations thereof. In an advantageous embodiment of the inventive process, casting compounds are produced and processed, wherein the swellable component is gelatinized starch.

[0284] In an advantageous embodiment, casting compounds are produced and processed using the inventive method, wherein the casting compound comprises gelatinized starch, syrup, water, acid and active ingredient, and: a) the proportion of starch is in the range of 8 - 25 wt.%; b) the water content is in the range of 15 - 27 wt.%; c) the ratio of starch to syrup is in the range of 0.13 - 0.29; d) the proportion of active ingredient is in the range of 0.01 - 30 wt.%.

[0285] With further advantageous embodiments of the inventive method, casting compounds are produced and processed, wherein the advantageous compositions of the casting compounds and their temperature ranges correspond to those mentioned in the chapter on starch-based casting compounds.

[0286] The scope of the present invention is not limited to the specific embodiments described herein. Rather, the description and the accompanying figures will reveal to the person skilled in the art various further modifications of the present invention, in addition to the examples disclosed herein, which also fall within the scope of the claims.

[0287] Specifically, where bandwidths for components are specified within the scope of the present invention, these are not to be understood as values ​​that sharply limit the scope of protection. Rather, within a certain tolerance range outside of these ranges, the advantageous effects are achieved, albeit in a less optimal manner.

[0288] The present invention is not limited in scope to the specific embodiments described herein. Rather, the description and accompanying figures will reveal to the person skilled in the art various further modifications of the present invention, in addition to the examples disclosed herein, which also fall within the scope of the claims. Furthermore, the description cites various references, the disclosure content of which is hereby incorporated into the description in its entirety by reference.

[0289] Reference symbol list

[0290] 1 Dosage of swelling component

[0291] 2 Dosage of syrup

[0292] 3. Homogenize the mixture of swelling component and syrup

[0293] 4 Dosage of active ingredient-containing mixture

[0294] 5 Dosage of Aroma

[0295] 6. Combining aroma with active ingredient-containing mixture

[0296] 7. Combine mixture 3 and mixture 6 to form the overall mixture and homogenize the overall mixture.

[0297] 8 Pouring the entire mixture with the pouring machine

[0298] 21 Syrup storage tank

[0299] 22 Orifice eccentric screw pump for syrup

[0300] 23 Motor eccentric screw pump for syrup

[0301] 24 Rotor-Stator Eccentric Screw Pump for Syrup

[0302] 25 Flow meters for mass flow of syrup

[0303] 26 Feed tank for active ingredient-containing mixture

[0304] 27 Throat chamber of the progressive cavity pump for active ingredient-containing mixture

[0305] 28 Motor of the eccentric screw pump for active ingredient-containing mixture

[0306] 29 Rotor-stator of the progressive cavity pump for active ingredient-containing mixture

[0307] 30 flow meters for mass flow of mixture containing active ingredient

[0308] 31 Aroma storage tank

[0309] 32 Aroma pump

[0310] 33 Flow meters for aroma mass flow

[0311] 34 Third vacuum area, throat chamber and mixing area of ​​the progressive cavity pump for swelling component and syrup

[0312] 35 Motor of the progressive cavity pump for swelling component and syrup

[0313] 36 Rotor-stator of the progressive cavity pump for swelling component and syrup

[0314] 37 Flow meter mass flow of swellable component and syrup

[0315] 38 load cells of the progressive cavity pump for swelling component and syrup

[0316] 39 Static mixer for the mass flows, mass distributor, supply of casting compound to the casting machine

[0317] casting machine

[0318] Box into which the products are poured

[0319] Force decoupling from vacuum tower to lower eccentric screw pump

[0320] Force decoupling of syrup line to lower-lying eccentric screw pump

[0321] Force decoupling of the eccentric screw pump from the downstream process area

[0322] Force decoupling of dosing of swelling component to eccentric screw pump with mixing section; first hopper for swelling component, first vacuum zone; second hopper for swelling component, second vacuum zone; first lock; second lock

[0323] Supply of swellable component

[0324] Pumping of swellable component from hopper 47

[0325] Motor-driven swellable component

[0326] Load cells for vacuum tower funnels 47 and 48

[0327] Compensating line

[0328] Connection from the second vacuum area to the third vacuum area

[0329] Pulsation damper

Claims

Patent claims 1. Casting compound for the production of dosage forms using a mogul process, characterized in that the casting compound comprises a swellable component in the form of swellable particles, as well as syrup, water, acid and active ingredient, wherein the swellable particles are in an evacuated state; the proportion of swellable particles is in the range of 5 - 25 wt.%; the water content is in the range of 15 - 27 wt.%; and the proportion of active ingredients is in the range of 0.01 - 30 wt.%.

2. Casting compound according to claim 1, wherein the swelling component is starch and the starch is in the form of gelatinized particles.

3. Casting composition according to claim 1 or 2, wherein the casting composition comprises starch, syrup, water, acid and active ingredient and: the starch in the casting composition is in the form of gelatinized, evacuated particles; the proportion of starch is in the range of 8 - 25 wt.%; the water content is in the range of 15 - 27 wt.%; the weight ratio of starch to syrup is in the range of 0.13 - 0.29; and the proportion of active ingredient is in the range of 0.10 - 30 wt.%.

4. Casting compound according to any of the preceding claims, wherein the syrup is a sugar-free syrup.

5. Casting compound according to claim 4, wherein the weight ratio of starch to syrup is substantially in the range of 0.15 - 0.

31.

6. Casting compound according to claim 1, wherein the swelling component is a hydrocolloid.

7. Casting compound according to one of the preceding claims, wherein, in the particle size distribution of the swellable particles, the proportion of swellable particles below 0.05 mm is less than 40 wt.%.

8. Casting compound according to one of the preceding claims, wherein the particles of the swellable component suspended therein have not yet swollen substantially.

9. Casting compound according to one of the preceding claims, wherein the casting compound is substantially free of air bubbles.

10. Dosage form for active ingredient, wherein the dosage form is obtained with a casting compound according to one of claims 1 to 9 and with a mogul process, and wherein the dosage form is cast into powder molds.

11. Dosage form for the active ingredient according to claim 10, wherein the dosage form has a unit weight in the range of 1.0 - 4.5 g.

12. Method for producing a dosage form based on a swellable component using a mogul casting process, wherein the swellable component is continuously dosed from a second vacuum chamber (48) via a connection into a third vacuum chamber (34), where the swellable component is homogeneously mixed under vacuum with continuously dosed syrup in a mixing chamber for the swellable component and the syrup, wherein the second and third vacuum chambers (48, 34) have a pressure of less than 500 mbar.

13. Method according to claim 12, wherein the second vacuum region (48) is supplied batchwise with swellable component from the first vacuum region (47) via a lock (50); and wherein the first vacuum region (47) is filled with swellable component at normal pressure and then evacuated to the vacuum in the second vacuum region (48) before the swellable component from the first vacuum region (47) is transferred to the second vacuum region (48) after opening the lock (50).

14. Method according to one of claims 12 or 13, wherein the swelling component is continuously dosed in a gravimetrically controlled manner over time.

15. Method according to one of claims 12 to 15, wherein the second vacuum region (48) is fluidically connected to a third vacuum region (34) via a force compensator (43) when transitioning to a third vacuum region (34).

16. Method according to any one of claims 12 to 15, wherein syrup is continuously dosed into a mixing area (34) for the swelling component and the syrup.

17. Method according to one of claims 12 to 16, wherein the mixture is continuously discharged from the mixing area (34) for the swelling component and the syrup.

18. Method according to claim 17, wherein the discharge is carried out with an eccentric screw pump (34), and wherein the continuous mass flow from the eccentric screw pump (34-36) is controlled with a Coriolis flow meter (37).

19. Method according to any one of claims 12 to 18, wherein active ingredient in the form of an active ingredient-containing mixture is continuously introduced into the continuous mass stream of swelling component and syrup.

20. Method according to any one of claims 12 to 19, wherein aroma is continuously introduced into the continuous mass stream of the active ingredient-containing mixture.

21. Method according to any one of claims 12 to 20, wherein after combining the mass flow of swelling component and syrup with the mass flow of the active ingredient-containing mixture, which may optionally be flavored, the resulting mass flow is mixed, for example with a static mixer (39).

22. Method according to one of claims 12 to 21, wherein the resulting mixed mass flow, i.e. the resulting casting mass, is continuously fed to a casting machine (41) of a mogul plant, where the casting mass is poured into starch molding powder according to the mogul process.

23. Method according to one of claims 12 to 22, wherein at least one pulsation dampener (57) is provided in the course of the process path after the mixing of swelling component and syrup up to the casting machine (41).

24. Method according to one of claims 12 to 23, wherein the casting compound continuously fed to the casting machine (41) is supplied to the casting machine (41) via a compound distributor (40).

25. Method according to any one of claims 12 to 24, wherein the casting machine is designed according to the first-in, first-out principle.

26. Method according to any one of claims 12 to 25, wherein the casting compound is poured at a temperature in a range of 15 - 55 °C.

27. Method according to any one of claims 12 to 26, wherein the casting compound comprises swellable particles, syrup, water, acid and optionally an active ingredient.

28. Method according to claim 27, wherein the swellable particles are selected from the group consisting of gelatin, pectins, carrageenans, alginates, agar-agar, gum arabic and combinations thereof.

29. The method of claim 27, wherein the swellable particles are gelatinized starch.

30. A method according to any one of claims 12 to 29, wherein a portion of the syrup of the casting compound is dosed into the process together with the active ingredient-containing mixture, wherein the proportion of syrup in wt.% that is dosed into the process with the active ingredient-containing mixture is between A and B and these values ​​are given as follows: A = 0.0029*x + 10; B = 0.0029*x + 20; with x = percentage by weight of the active ingredient-containing mixture in the casting compound.

31. Method according to any one of claims 12 to 30, wherein the throughput of casting material is in the range of 500 kg / h - 5,000 kg / h and the casting machine has a casting rate of 15 - 35 boxes per minute.

32. Method according to any one of claims 12 to 31, wherein the cast products are dried at a temperature in the range of 35 - 65 °C and at a relative humidity of 10 - 50 % and have a unit weight of 1.5 - 4.5 g in the ready-to-package state.

33. Dosage form produced according to a method according to any one of claims 12 to 32.

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