New sugar coating method
The novel sugar coating method achieves complex and irregular shapes by simultaneous spraying and drying with low-solids content, addressing the limitations of conventional methods in maintaining core shape and preventing spoilage.
Patent Information
- Application Number
- JP2023071417
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2017-06-19
- Filing Date
- 2023-04-25
- Publication Date
- 2025-07-30
- Estimated Expiration
- 2038-06-18
AI Technical Summary
Existing sugar coating methods fail to produce solids with complex and irregular shapes, as the coating process fills grooves and cavities, obscuring relief impressions and asymmetries, and require high temperatures and solids content, leading to spoilage and sticking of cores.
A novel sugar coating method involving simultaneous spraying and drying of a low-solids content crystalline material solution onto a moving core bed in a rotating drum with holes, using compressed air nozzles, which maintains the irregular shape and allows for the use of heat-labile components.
The method successfully produces sugar-coated solids with retained relief impressions and asymmetries, using low temperatures and reduced binder content, while preventing core sticking and maintaining the core's shape and integrity.
Smart Images

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Abstract
Description
Technical Field
[0001] The subject of the present invention is a novel sugar-coated solid having an irregular shape and a sugar coating method particularly useful for its production.
Background Art
[0002] Sugar coating is an operation particularly used in the confectionery and pharmaceutical industries. For protection for various reasons, or to make it attractive visually or from the taste point of view, it consists of forming a crystallized coating (a "hard" or "soft coating") having some hardness on the surface of a solid or powder product.
[0003] The coating of the solid (core) is carried out in a tank known as a coating drum that rotates around its axis, in which there are a plurality of cores forming a moving population, on the surface of which the constituent material of the later outer skin ("sugar coating liquid or syrup") is distributed in a liquid state. By applying this liquid and evaporating the water introduced by the liquid, a hard crystalline coating is obtained.
[0004] The sugar coating syrup is mainly composed of one or more crystalline materials and usually contains binders such as gum arabic and gelatin, dyes, opacifiers such as TiO2, inorganic fillers such as talc, silica, calcium carbonate, high-intensity sweeteners, flavors, vitamins, and activators.
[0005] Sugar coating is a relatively labor-intensive process, which includes a number of consecutive steps. Each of these steps, also called a "sugar coating cycle", typically includes an application stage by spraying the sugar coating syrup onto the core usually, a rotation stage for distributing the syrup on the core, also called a rest time, and a drying stage for each new layer of the syrup by blowing hot dry air.
[0006] Sugar coating allows obtaining solids with a particularly attractive appearance, but it lacks flexibility in terms of its implementation and the appearance obtained. In particular, and this is the subject of the present invention, sugar coating makes it impossible to obtain solids with complex and irregular shapes, such as relief impressions or bumps. This is because, when solids with such irregularities are sugar coated, the latter are hidden after sugar coating. The sugar coating liquid fills the grooves and cavities formed by the relief impressions ("logo filling") and also expands and subsequently rounds the bumps. It is also unable to preserve any asymmetries that the cores may optionally exhibit, for example, when these cores are granular. Therefore, the solids obtained by sugar coating usually have a rough and rounded overall shape that is not very faithful to the shape of the starting cores.
[0007] For this reason, for example, in pharmaceuticals, film coating of tablets is usually preferred. In this process, rather than syrup, a film-forming composition is applied, typically based on a cellulose derivative such as hydroxypropylmethylcellulose (HPMC), or more recently on modified starch. This film-forming composition forms a thin film on the surface of the tablet, which advantageously allows the retention of relief markings present on the surface of the tablet, such as a logo, the name of the active molecule, or the dosage of the active molecule.
[0008] While this process allows the tablet to retain its correct shape, it still results in a tablet with a much less attractive appearance than the sugar-coated form. Furthermore, film coating produces an amorphous coating, which is not obtained with sugar coating. It is much less stable than the crystallized coatings that are produced.
[0009] Therefore, currently, there is no method for producing sugar-coated solids that retain their original shape, so if a manufacturer wants to display a logo or other pattern on the surface of a sugar-coated solid, they can do so by applying a coloring composition to the surface of the sugar-coated form.
[0010] One approach to this problem is described in US Patent Application Publication No. 2008 / 0026131A1. This document discloses a sugar coating method that allows the chocolate to retain its irregular shape. However, this method only allows the chocolate to retain its rough, round overall shape, not its complex, irregular shape. The teachings of US Patent Application Publication No. 2008 / 0026131A1 do not allow the creation of sugar-coated solids with complex, irregular shapes, such as raised or relief impressions. This particularly lengthy and laborious method involves multiple sugar coating cycles (syrup application / dispensing / drying). Summary of the Invention [Problem to be solved by the invention]
[0011] Object of the invention It is therefore an object of the present invention to provide sugar-coated solids having complex and irregular shapes, and a method that makes it possible to obtain them.
[0012] The invention also aims to provide a particularly simple and flexible method for sugar-coating solid products. [Means for solving the problem]
[0013] Presentation of the invention Applicants have been able to produce sugar-coated solids in which irregular and asymmetric shapes, such as relief impressions and ridges, are retained after sugar-coating.
[0014] The applicant: a step (a) of spraying a coating liquid containing a composition of crystalline material onto a moving bed of cores, the cores being placed in a chamber comprising a rotating drum with holes, the spraying being carried out by means of at least one compressed air nozzle; at least one step (b) carried out simultaneously with step (a) of drying the sprayed sugar coating liquid; a step (c) of recovering the sugar-coated solid material thus obtained; This has been achieved by implementing at least one novel sugar coating method, characterized in that it comprises:
[0015] The method of the present invention can be applied to a variety of solid products (tablets, chewing gum, etc.), offering numerous possibilities for manufacturers and consumers to create new appearances, especially for solid sugar-coated forms. In this method, drying and spraying are carried out simultaneously. In fact, surprisingly, the latter remains intact and retains its irregular shape, despite the core being continuously wet.
[0016] This is particularly surprising since it was previously accepted that spraying had to be stopped for significant periods during the process (otherwise the cores would be constantly wet, preventing the substances used in the sugar coating from crystallizing, leading to spoilage and deterioration of the solids, and causing the cores to stick together (the phenomenon of sticking together and forming clumps). However, this phenomenon is not observed with the method of the present invention, even with highly hygroscopic cores, i.e. cores that seek water.
[0017] Therefore, in contrast to conventional sugar coating, the method of the present invention does not require the sugar coating liquid to have a high solids content (at least 70% for conventional sugar coating with maltitol), which is also contrary to general knowledge in the art for the same reasons as stated in the previous paragraph (significant wetting of the core).
[0018] The ability to use a low solids content has several advantages. First, this gives the possibility of using the sugar coating solution at a low temperature, and as a result, the possibility of incorporating heat - labile components into these liquids or into the composition of the core to be sugar - coated. In fact, when high temperatures have conventionally been used for sugar coating, the sugar coating solution should be made to have a high content of crystalline material in solution. Since this high solids content is not required in the method of the present invention, the temperature of the sugar coating solution can be lowered.
[0019] Second, this also makes it possible to perform a sugar coating operation using a crystalline material with low solubility in water. A good example of this advantage is shown as point 1 (tests "Man - IN1 to IN5") in Example 1. Here, mannitol was used for the sugar coating. This sugar coating, in contrast to prior - art processes, does not require the addition of a large amount of binder to it. That is, since the crystalline material can occupy most of the proportion, the sugar coating is strictly speaking carried out here.
[0020] Therefore, the method of the present invention makes it possible for the first time to obtain a sugar - coated solid in which the sugar - coated layer has a high content of mannitol without the need to add an excessive amount of binder such as gum arabic or polyvinyl alcohol. Test Man - IN5 even shows that it is possible not to use a binder.
[0021] The method developed by the applicant also has other advantages that are useful especially for sugar - coating solids that do not have particularly complex and irregular shapes. In particular, the method of the present invention is much more flexible than conventional sugar - coating processes and may be particularly easy to implement.
[0022] Furthermore, this method is applicable to various crystalline materials, as shown in point 1 of the following examples. Particularly satisfactory results are obtained with sucrose, xylitol, erythritol, and mannitol.
[0023] Finally, the method of the present invention does not necessarily require major modifications of its parameters (drying temperature, formulation of the coating liquid, etc.) during its implementation and can be carried out with relatively simple and compact equipment.
[0024] None of the prior art documents disclose or suggest such a method, for example in the above-mentioned document US Patent Application Publication No. 2008 / 0026131 A1, drying and spraying are not performed simultaneously.
[0025] A first subject of the present invention is a sugar-coated solid that has at least one relief impression and / or at least one protuberance and / or is asymmetrical, the sugar coating layer of said asymmetric sugar-coated solid faithfully conforming to the shape of the core from which it originates.
[0026] The subject of the present invention is spraying a coating liquid containing a composition of crystalline material onto a moving core bed, (a) the core is placed in a chamber comprising a rotating drum having holes therein, and the spraying is performed by at least one compressed air nozzle; at least one step (b) carried out simultaneously with step (a) of drying the sprayed sugar coating liquid; a step (c) of recovering the sugar-coated solid material thus obtained; This method is also particularly useful for making sugar-coated solids having complex and irregular shapes, including
[0027] The subject of the present invention is - a crystalline material consisting of at least 50% mannitol by dry weight; and - optional binder, the binder having a crystalline material / binder ratio by dry weight greater than 15 The present invention also relates to a sugar-coated solid product comprising at least one sugar-coating layer containing [Brief explanation of the drawings]
[0028]
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Mode for Carrying Out the Invention
[0029] Therefore, a first subject of the present invention is a sugar-coated solid having at least one relief imprint and / or at least one protrusion and / or being asymmetric, wherein the sugar coating layer of the asymmetric sugar-coated solid faithfully conforms to the shape of the core from which it is derived.
[0030] The solid of the present invention has a specific irregular shape, namely a relief imprint, a protrusion, or an asymmetry. Examples of relief imprints can include patterns (such as logos) or engraved characters (brand names, molecular names, dosages, etc.). While the relief imprint is present on the surface of the solid, the protrusion instead contributes to characterizing the overall shape of the sugar-coated solid. These sugar-coated solids are characterized in particular by the fact that the cores to be sugar-coated themselves have an irregular shape. This means in particular that these irregular shapes of the original core are maintained even after sugar coating. This means in particular that the engraved characters are readable and the patterns are distinguishable. These irregular shapes include asymmetric shapes, i.e., shapes without an axis of symmetry. This means here that the sugar coating layer of the asymmetric sugar-coated solid faithfully conforms to the shape of the core from which they are derived.
[0031] Preferably, this solid of the present invention has at least one relief imprint and / or at least one bulge, more preferably at least one relief imprint.
[0032] The subject of the present invention is - a crystalline material consisting of at least 50% mannitol by dry weight; and - an optional binder, wherein the crystalline material / binder ratio by dry weight is greater than 15 It is also an optionally sugar-coated solid having an irregular shape as described above, characterized by comprising at least one sugar coating layer containing the above.
[0033] Preferably, the crystalline material of the sugar coating layer of this sugar-coated solid consists of at least 60%, preferably at least 70%, preferably at least 80%, preferably at least 90% mannitol by dry weight, or even consists only of mannitol.
[0034] More preferably, in the sugar coating layer of these sugar-coated solids, the crystalline material / binder ratio by dry weight is greater than 20, further greater than 30, and further greater than 40. The sugar coating layer may advantageously not contain a binder.
[0035] In sugar coating, the term "solid matter" generally means any solid form of the substance to be sugar-coated ("sugar-coated solid matter") or a solid form that can undergo the sugar coating operation ("core"). Typical examples are tablets, hard gel capsules, soft capsules, pellets, microspheres, granules, seeds, cookies, breakfast cereals, confectionery (such as chewing gum, candies, chewing candies, gummies, chocolates, etc.), fruits, vegetables, or other products in powder and / or crystalline form. These solid matters can have, for example, food, pharmaceutical, veterinary, or cosmetic purposes. They may be intended for human consumption by adults or children, or for animals. They may be products for chemical or agricultural purposes, but from the perspective of the present invention, solid matters intended to be ingested are preferred. Preferably, these solid matters are selected from tablets and chewing gum.
[0036] Preferably, the sugar-coated solid matter of the present invention comprises at least one sugar coating layer, and its composition is the same as the composition of the sugar coating solution used in the sugar coating method of the present invention; it is understood here that only those constituting the solids of the sugar coating solution are considered.
[0037] Preferably, the sugar-coated solid matter of the present invention has a sugar coating ratio greater than 1%. This "sugar coating ratio" is also known as the "mass increase rate" and is usually determined by the following method: (Weight of sugar-coated solid matter - Weight of core) / Weight of core × 100.
[0038] Preferably, this sugar coating ratio is greater than 3%, preferably greater than 5%, preferably greater than 7%, preferably greater than 10%, for example at least 15%, and further at least 20%.
[0039] The subject matter of the present invention is · A step of spraying a sugar coating solution containing a composition of a crystalline material onto a moving core bed, wherein the core is disposed in a chamber equipped with a rotating drum having holes, and the spraying is performed by at least one compressed air nozzle (step (a)); · At least one step (b) performed simultaneously with step (a) of drying the sprayed sugar coating solution; · A step (c) of recovering the solid thus obtained and coated with a sugar coating It is also a sugar coating method particularly useful for producing a sugar-coated solid of the present invention, including the above.
[0040] The apparatus used to carry out the method of the present invention typically includes a sugar coating solution storage unit including at least one outlet for transferring the sugar coating solution to a sugar coating solution spraying device. The sugar coating solution is applied by a device for spraying it onto the core bed in the chamber, and the chamber is equipped with a rotating drum for moving the core bed. More specifically, the drum is a rotating drum with holes, and the selected spraying device includes at least one compressed air nozzle. The apparatus also includes an air inlet for drying the sugar coating solution at the height of the drum chamber The drying air is discharged particularly through the holes of the rotating drum and particularly by the suction of air from the chamber.
[0041] The elements of the apparatus useful in the present invention are commercially available, and their configuration is not particularly difficult for those skilled in the art.
[0042] The sugar coating solution useful in the present invention includes a composition of a crystalline material.
[0043] The term "composition of a crystalline material" generally means a composition composed of substances that can be crystallized by evaporation of the solvent in which they are dissolved.
[0044] Preferably, the composition of the crystalline material of the sugar coating solution useful in the present invention contains at least one substance selected from sugars and polyols, preferably selected from monomers and dimers.
[0045] Advantageously, the sugar and the polyol account for at least 50%, preferably at least 70%, more preferably at least 90% of the dry weight of the composition of the crystalline material of the sugar coating solution. Most preferably, the composition of the crystalline material of the sugar coating solution consists entirely of substances selected from sugars and polyols.
[0046] In the present invention, when referring to the dry mass of a compound, it is understood that this mass includes impurities that may be present.
[0047] Preferably, these sugars and polyols are selected from xylitol, sucrose, erythritol, mannitol, dextrose, isomalt, maltitol, or combinations thereof as required. Most preferably, these sugars and polyols are selected from sucrose, mannitol, xylitol, erythritol, or combinations thereof as required, more preferably from sucrose, mannitol, xylitol, or combinations thereof as required.
[0048] Preferably, the composition of the crystalline material of the sugar coating solution consists entirely of a single substance. Thus, for example, and advantageously, the composition of the crystalline material useful in the present invention is xylitol or sucrose or erythritol or mannitol or dextrose or isomalt or maltitol.
[0049] The concentration of the crystalline material of the sugar coating solution is selected such that the crystalline material dissolves in the sugar coating solution.
[0050] Typically, especially when the sugar coating solution is an aqueous liquid, the sugar coating solution of the present invention has a concentration of less than 90% of the crystalline material, and this ratio corresponds to the dry weight of the crystalline material of the sugar coating solution with respect to the total weight of the sugar coating solution. Preferably, this concentration is 70% or less, preferably 60% or less, preferably less than 60%, further 55% or less, further 50% or less, further 45% or less, or 40% or less, further 35% or less, further 30% or less, further 25% or less, further 20%. This concentration is usually greater than 10%, further at least 15%, further at least 20%.
[0051] The maximum concentration of the crystalline material naturally also depends on the nature of these crystalline materials and the temperature of the sugar coating solution. For xylitol, sucrose, erythritol, mannitol, dextrose, isomalt, and maltitol, for example, reference can be made to FIG. 6 showing the maximum concentration of these crystalline materials in water as a function of the temperature of the liquid. Thus, for example, the concentration of the crystalline material in the sugar coating solution at 20 ° C. is preferably when the composition of the crystalline material is sucrose is 67% or less, 15% or less in the case of mannitol, 61% or less in the case of maltitol, 63% or less in the case of xylitol, 25% or less in the case of isomalt, 27% or less in the case of erythritol, and 48% or less in the case of dextrose.
[0052] Generally, the sugar coating solution of the present invention contains substances other than the crystalline material, as long as it does not conflict with the properties desired in the present invention, particularly with respect to the quality of the resulting sugar-coated solid and / or the operability of the process. Such other compounds are, for example, - Binders such as gum arabic and polyvinyl alcohol; - Coloring substances such as pigments and opacifiers (e.g., titanium dioxide); - Flavors and sweeteners; - Active agents such as, for example, pharmaceuticals, nutritional foods, dietary supplements, or those subject to phytosanitary control.
[0053] Preferably, the coating liquid of the present invention has a solids content of less than 90% by weight, preferably less than 85% by weight, preferably less than 80% by weight, preferably less than 75% by weight, preferably not more than 70% by weight, preferably not more than 60% by weight, preferably not more than 60% by weight, even not more than 55% by weight, even not more than 50% by weight, even not more than 45% by weight, even not more than 40% by weight, even not more than 35% by weight, even not more than 30% by weight, even not more than 25% by weight, even not more than 20% by weight, which solids content is usually greater than 10%, preferably at least 15%, more preferably at least 20%.
[0054] Therefore, preferably, the solid content of the coating liquid of the present invention is: - 50.0% to 100.0% by dry weight of crystalline material, specifically as defined above; - 0.0% to 50.0% by dry weight of other ingredients specifically defined above The total of these percentages is 100.0%.
[0055] Preferably, the solids content of the coating liquid of the present invention comprises crystalline material in an amount of at least 60.0%, preferably at least 70.0%, preferably at least 80.0%, preferably at least 90.0%, even at least 94.0%, even at least 95.0%, even at least 96.0% by dry weight.
[0056] Typically, the solids content of the coating liquid of the present invention comprises pigments and / or dyes in an amount of less than 5.0%, preferably less than 4.0%, preferably less than 3.0% by dry weight.
[0057] Typically, the solids content of the coating liquid of the present invention comprises opacifiers in an amount of less than 5.0% by dry weight, preferably less than 4.0%, preferably less than 3.0%, preferably less than 3.0%, preferably less than 2.0%.
[0058] Typically, the solids content of the coating liquid of the present invention includes binder in an amount of less than 15.0% by dry weight, preferably less than 10.0%, even less than 8.0%, and even less than 5.0%.
[0059] The sugar coating solution used according to the present invention is typically polar, preferably contains water as the main solvent, and most preferably contains water as the only solvent.
[0060] In an advantageous embodiment, for simplicity and where possible, the sugar coating method according to the present invention uses a single sugar coating solution. That is, the sugar coating solution has a constant formulation throughout the period during which the sugar coating is being continued.
[0061] The temperature of the sugar coating solution is typically selected such that the crystalline material dissolves well in the sugar coating solution before being sprayed. Therefore, this temperature also depends on the amount of crystalline material present in the liquid. In the method of the present invention, this temperature is typically selected from the range of 20 to 90 °C. Preferably, this temperature is less than 85 °C, preferably less than 80 °C, preferably less than 75 °C, preferably less than 70 °C, further less than 65 °C, further less than 60 °C, further less than 55 °C, further less than 50 °C, further less than 45 °C, further less than 40 °C, further less than 35 °C, further less than 30 °C. This temperature is usually at least 15 °C, further at least 20 °C. This corresponds to the ambient temperature which is typically in the range of 20 to 25 °C, for example.
[0062] In an advantageous embodiment, the sugar coating solution is stored in a simple storage unit that is enclosed and / or the equipment useful in the method of the present invention does not have a device for heating the sugar coating solution. This is because the method of the present invention does not necessarily require the use of a high sugar coating solution temperature and these devices are not essential for the method of the present invention.
[0063] For the spraying of the sugar coating solution, the number of compressed air nozzles used is usually selected according to the manufacturer's recommendations and depending on the dimensions of the sugar coating chamber. This number of nozzles is typically 1 to 2 nozzles per area of the sugar coating chamber with a diameter of 40 cm. This number of nozzles is, for example, in the range of 1 to 10, for example 1 to 6. <##
[0064] Preferably, the method of the present invention uses only compressed air nozzles for atomization.
[0065] Preferably, the nozzle used according to the invention has an orifice with a diameter selected from the range of 0.1 to 2.8 mm, preferably 0.1 to 2.5 mm, preferably 0.1 to 2.2 mm, for example 0.3 to 2.0 mm, or 0.5 to 1.8 mm, or 0.5 to 1.5 mm, or 0.5 to 1.2 mm, or 0.5 to 1.0 mm.
[0066] Preferably, the spray flow rate is selected in the range of 0.5 to 20.0, preferably 1.0 to 20.0, preferably 2.0 to 20.0, for example 2.0 to 15.0, or even 2.0 to 10.0 g / min / kg of cores.
[0067] In one advantageous embodiment, the flow rate selected for spraying is increased during sugar coating. In particular, the inventors have noticed that for certain crystalline materials, using a low flow rate at the beginning of sugar coating can promote the initial crystallization phase that occurs on the surface of the core. The flow rate can then be increased to accelerate sugar coating.
[0068] For spraying, the atomization and compression pressures are adjusted depending on the flow rate and nozzle orifice and in accordance with the manufacturer's recommendations, and are typically selected in the range of 0.5 to 4.0 bar, preferably 0.5 to 3.5 bar, for example 0.7 to 2.5 bar for the atomization pressure, and / or 0.7 to 3.5 bar for the compression pressure.
[0069] In the present invention, the coating liquid is sprayed onto a bed of cores that is moved by a rotating drum.
[0070] The properties of these cores are preferably as defined above for the solid matter. These are, for example, tablets or chewing gums. These cores may be completely exposed or may be coated with one or more layers, such as a gum layer, a film coating layer, or even a sugar coating layer, and said layers are preferably obtained with the same apparatus as those used in the sugar coating method of the present invention.
[0071] To move the core bed, the rotational speed of the drum is selected according to the dimensions of the chamber and the size of the cores to be sugar-coated. This is usually in the range of 3 to 30 rpm, for example selected in the range of 10 to 20 rpm.
[0072] In one advantageous embodiment, for reasons of particular simplicity and / or the amount of space occupied, and because the method of the present invention allows it, the process of moving the core bed excludes the transfer of the cores in the longitudinal axis direction. This means, in particular, that the cores to be sugar-coated are not transferred from one chamber to another, i.e., they are sugar-coated in a single chamber, and / or are not sugar-coated in the longitudinal chamber in which the core bed is transferred.
[0073] For drying, the temperature selected for the drying air is preferably less than 100°C, preferably 80°C or less, preferably 75°C or less, preferably 70°C or less, more preferably 65°C or less, more preferably 60°C or less, more preferably 55°C or less, more preferably 50°C or less, more preferably 45°C or less, more preferably 40°C or less, more preferably 35°C or less, more preferably 30°C or less, or 25°C or less. This drying temperature is usually at least 15°C, preferably at least 20°C.
[0074] For drying, the flow rate can be selected in the range of 50 to 8000 m3 / h, for example in the range of 100 to 7000 m3 / h, for example in the range of 100 to 1000 m3 / h.
[0075] The drying air is preferably discharged by suction of air through the holes of a rotating drum with holes.
[0076] Preferably, the zone of the perforated wall of the rotary drum useful in the present invention preferably occupies at least 50%, preferably at least 60%, preferably at least 70%, preferably at least 80%, preferably at least 90% of the surface area of said drum wall. Most preferably, the drum wall has holes over its entire surface area.
[0077] Preferably, the temperature of the core bed receiving the sugar coating is at most 70°C, preferably at most 60°C, preferably at most 55°C, preferably at most 50°C, preferably at most 45°C, more preferably at most 40°C, more preferably at most 35°C, more preferably at most 30°C, more preferably at most 25°C. This temperature of the core bed receiving the sugar coating is usually at least 10°C, more preferably at least 15°C.
[0078] Preferably, before the start of the sugar coating, i.e., before the start of spraying, the method of the present invention includes a step of heating the core bed to be sugar-coated. This step is particularly aimed at bringing the core bed to the target temperature.
[0079] The sugar coating method of the present invention performs the spraying and drying of the spraying liquid simultaneously.
[0080] However, as long as this does not conflict with the desired properties in the present invention, particularly with respect to the quality of the obtained sugar-coated solid and / or the operability of the process, it is possible to envisage the introduction of a distribution step ("rest time") and a spraying step in the absence of drying.
[0081] Preferably, the sugar coating process stage during which spraying is not optionally carried out simultaneously with drying preferably occupies less than 50%, preferably less than 40%, preferably less than 30%, preferably less than 20%, preferably less than 10%, preferably less than 5% of the sugar coating process time. Most preferably, the sugar coating does not include a spraying stage without drying.
[0082] Preferably, the optional rest time (the time between two spraying stages during which neither spraying nor drying is performed) accounts for less than 50% of the sugar coating process time, preferably less than 40%, preferably less than 30%, preferably less than 20%, preferably less than 10%, preferably less than 5%. Most preferably, the sugar coating does not include a rest time.
[0083] Preferably, the sugar-coated solid obtained by the method of the present invention has a sugar coating ratio greater than 1%, preferably greater than 3%, preferably greater than 5%, preferably greater than 7%, preferably greater than 10%, for example at least 15%, further at least 20%.
[0084] Preferably, this sugar coating ratio is at least 0.05% per minute, preferably at least 0.10% per minute, preferably at least 0.13% per minute, further at least 0.15% per minute, further at least 0.20% per minute, further at least 0.30% per minute per unit time.
[0085] The method of the present invention may include normal steps other than those aimed at sugar coating the solid, as long as they do not conflict with the properties desired in the present invention, particularly the quality of the obtained sugar-coated solid and / or the operability of the process. Examples of other steps can include, for example, gumming, smoothing, polishing, coloring. Advantageously, when such steps are performed, they are performed in the same apparatus as that used in the sugar coating process of the present invention. It is understood that some of these steps, such as gumming or coloring, may be assimilated into the sugar coating step when the composition used contains an amount of crystalline material effective to form a layer of crystalline substance, particularly a crystalline substance of sugar and / or polyol.
[0086] Regarding these other normal steps, it is interesting to note that the sugar coating carried out according to the method of the present invention can already smooth the solid matter at an excellent level. Furthermore, by adding a colorant to the sugar coating solution, coloring can be directly carried out.
[0087] The method of the present invention may also include a starting step. This starting step consists of applying the powder composition to the core bed to be sugar-coated one or more times, or performing sugar coating, preferably performing sugar coating. This powder composition typically contains a crystalline material. These crystalline materials typically have the same properties as the crystalline materials in the sugar coating solution, but may also be different. The amount of the powder composition to be applied is typically less than 10% by weight, preferably less than 5% by weight, based on the weight of the tablet.
[0088] Preferably, when dextrose, isomalt, maltitol, or a combination thereof is used, the method includes an additional starting step. Preferably, when sucrose, xylitol, mannitol, erythritol, or a combination thereof is used, the method excludes this starting step.
[0089] The apparatus useful in the present invention may also include other elements commonly used in sugar coating, as long as they do not conflict with the characteristics desired in the present invention, particularly the quality of the sugar-coated solid matter obtained and / or the operability of the process.
[0090] In this regard, it is interesting to note that the prior art has sometimes mentioned the use of a lump breaker, the purpose of which is to prevent the appearance of lumps during sugar coating. Such a lump breaker is not required in the method of the present invention. Therefore, preferably, and also because it is advantageously possible in the context of the method of the present invention, the chamber of the drum used according to the present invention does not have a lump breaker.
[0091] The present invention will be more clearly understood by the following exemplary and non-limiting examples.
Examples
[0092] 1. Sugar coating test according to the present invention 1.1. Apparatus used An apparatus having the following features was used: - Perforated rotating drum: diameter 30.48 cm, volume 2 L; - 6 anti-slip bars; - 1 compressed air spray nozzle (Schlick 970 / 7-1 S75); orifice diameter 0.8 mm; - Peristaltic pump (Watson Marlow 323 type); 3-roller head (313DW); - Tube: inner diameter 2 mm: outer diameter 6 mm.
[0093] 1.2. Sugar coating solution The sugar coating solutions tested had the following formulations (dry basis %).
[0094]
Table 1
[0095] All of these sugar coating solutions were contained in a single-shell storage tank at ambient temperature (20 - 25 °C).
[0096] 1.3. Core The following batches of cores were used as sugar coating substrates.
[0097]
Table 2
[0098] 1.4. Process and results The conditions common to all tests were as follows: operating pressure 4 bar; atomization and compression pressure 1.0 or 1.3 bar (selected according to the viscosity of the solution as recommended by the manufacturer); differential pressure -0.25 mbar; drum rotation speed 18 rpm; drying air volume 100 m3 / h.
[0099] Before the start of spraying, the tablet bed was heated for 2 minutes to bring the core bed to the desired temperature. Subsequently, spraying and drying were carried out simultaneously throughout the process (without downtime). Spraying was stopped at the end of the sugar coating, and the solids were dried for an additional 2 minutes.
[0100] The following table shows the results obtained and the process characteristics specific to each test.
[0101] [Table 3]
[0102] [Table 4]
[0103] [Table 5]
[0104] [Table 6]
[0105] 1.5. Discussion The method of the present invention advantageously enables sugar coating of all kinds of solids according to a very simple process and enables successful retention of complex and irregular shapes such as relief imprints, ridges, and asymmetric shapes.
[0106] Therefore, the inventors have successfully sugar-coated, for example, tablets and chewing gums while maintaining the relief imprints present on their surfaces simultaneously, regardless of whether they are hygroscopic ("Comp-SORB" and "CG") or non-hygroscopic ("Comp-MANN").
[0107] Surprisingly, despite the continuous wetting of the core, the latter is not impaired and the complex and irregular shape is maintained (there is no "logo filling", i.e., the grooves and cavities formed by the relief imprinting are not filled). For example, in tests "Man-IN1 to IN5", a sugar coating solution containing only 20% solids was used. In fact, the obtained sugar-coated tablets have a clearly visible irregular shape (Figure 2a), especially a completely distinguishable relief imprint (Figure 2.b) to 2.e)).
[0108] The method of the present invention has other advantages that cannot be ignored and is similarly useful for sugar-coating solids having a conventional shape.
[0109] The sugar coating solution used may contain any kind of crystalline material and can be made very simple in terms of formulation. For example, tests "Xyl-IN3" and "Man-IN5" show that a sugar coating solution without a binder ("BF") is also suitable for the method of the present invention. The method of the present invention also makes it possible to successfully sugar-coat solids with a "natural" sugar coating solution that does not contain titanium dioxide (test "Xyl-IN4" using sugar coating solution "N").
[0110] Furthermore, the method of the present invention makes it possible to use a very low solids content, which is also unknown in sugar coating. In all the tests shown herein, a sugar coating solution with a solids content not exceeding 60% was used. Therefore, the method of the present invention makes it possible to use carbohydrates with low solubility in water (e.g., mannitol) for sugar coating.
[0111] The method of the present invention also enables the use of relatively low drying temperatures. The main purpose of the test "Man-IN1" is to illustrate this effect, and the test shows that it is possible to perform sugar coating with mannitol at a temperature of 25°C. The obtained sugar-coated solid has a very distinct shape that is faithful to the shape of the starting core (Figure 2.a). The ability to use particularly low drying temperatures especially enables obtaining a similarly low core bed temperature, and thus enables sugar coating of a core composition having heat-labile components, similar to the case of certain active agents (especially pharmaceutical active agents). Therefore, in the test "Man-IN1", the temperature of the tablet bed does not exceed 26°C.
[0112] Since the method of the present invention does not necessarily require the sugar coating solution to contain a large amount of crystalline material in the solution, the temperature of the latter can also be made very low. In these tests, in fact, the sugar coating solution used was at ambient temperature (20 - 25°C). This, in addition to making the process easy to carry out, enables the use of heat-labile components in these liquids.
[0113] Finally, the solids obtained by the method of the present invention are also satisfactory with regard to their color and the feel of their surface.
[0114] 2. Comparative sugar coating tests In this part, the inventors attempted to sugar coat 1 kg of Comp-SORB tablets having relief imprints according to the above-mentioned US Patent Application Publication No. 2008 / 0026131A1.
[0115] 2.1. Apparatus used An apparatus having the following characteristics was used: - Rotating drum: diameter 30 cm; - 8 anti-slip bars; - One compressed air spray nozzle (BINKS460); orifice diameter 0.8 mm; - Peristaltic pump (Watson Marlow 323 type); 3-roller head (313DW); - Tube: Inner diameter 2mm: Outer diameter 6mm
[0116] 2.2. Sugar coating liquid The coating liquid used according to Example 1 of US Patent Application Publication No. 2008 / 0026131 A1 was: - "Gum Syrup": Composition (% dry basis): Sucrose 96.0%; Gum Arabic 4% .0% (added in the form of a solution with 40% solids by weight); solids content: 72%. - "Smoothing Syrup": Composition (% dry basis): Sucrose 97.0%; Glucose syrup 2.0%; Titanium dioxide 1.0%; Solids content: 70%. - "Colored Syrup": Composition (dry weight %): sucrose 98.0%; blue pigment (Blue No. 1 Lake) 2.0%; solids content: 69%. If necessary, the temperature of these liquids was adjusted to completely solubilize the compound.
[0117] 2.3. Process and Results In the following tests, the conditions of Example 1 of US Patent Application Publication No. 2008 / 0026131A1 were closely followed (drying temperature, solids, etc.), with parameters such as spray flow rate and drum rotation speed being adjusted to suit the size of the sugar-coating chamber available to the inventors.
[0118] Test Sac-CP1: Initial testing was performed by running multiple cycles, each consisting of a spraying step, followed by a rest period (dispensing), followed by a drying step, according to the table below.
[0119] [Table 7]
[0120] This test stopped because, despite having a higher drying capacity of the device (50 m3 / h compared to 15.3 m3 / h) than that described in US Patent Application Publication No. 2008 / 0026131A1, it became overly stuck together and formed lumps and could not be completed.
[0121] Therefore, in order to avoid this phenomenon of sticking together and forming lumps and to be able to reproduce the entire Example 1 of US Patent Application Publication No. 2008 / 0026131A1, a second test was conducted.
[0122] Test Sac-CP2: Following the failure of Test Sac-CP1, the first cycle of the first stage was modified. An operator intervened to crush the core lumps and changed the operating conditions. This test was conducted according to the following table.
[0123]
Table 8
[0124] The results obtained are shown in Fig. 5.a). The tablets thus sugar-coated are very rough and have a coarse, round overall shape. The logo and imprint present on the core are covered and are no longer distinguishable. The inventors noticed that the surface of the tablets was damaged during the first cycle of the sugar-coating. Despite the sugar-coating solution used having a high solid content, the tablets were solubilized from the first 2 minutes and further crystallization was very difficult.
[0125] Test Sac-CP3: A third test was conducted that only carried out the "smoothing" sugar-coating stage of Test Sac-CP2. Results similar to those of Test Sac-CP2 were obtained (Fig. 5.b)): The sugar-coated tablets had a coarse, round overall shape and the relief imprint was covered.
Claims
1. - A step of spraying a sugar coating solution containing a composition of a crystalline material onto a moving core bed, wherein the core is disposed in a chamber equipped with a rotating drum having holes, and the spraying is performed by at least one compressed air nozzle (step (a)); - At least one step (b) performed simultaneously with step (a) of drying the sprayed sugar coating solution; - A step (c) of recovering the thus obtained sugar-coated solid; comprising the composition of the crystalline material contains at least one substance selected from sugar and polyol, and the sugar and polyol are selected from xylitol, erythritol, mannitol, or a combination thereof, the content of the crystalline material is at least 90.0% by dry weight in the solid content of the sugar coating solution, the compressed air nozzle has an orifice having a diameter selected from the range of 0.1 to 2.8 mm, the temperature of the sugar coating solution is less than 75°C, the step (a) a step of spraying the sugar coating solution at a first spraying flow rate so as to promote the first crystallization phase occurring on the core surface, after the step of spraying at the first spraying flow rate, a step of spraying the sugar coating solution at a second spraying flow rate greater than the first spraying flow rate so as to accelerate the sugar coating; A sugar coating method, characterized by comprising the above.
2. The sugar and polyol occupy at least 50% by dry weight of the composition of the crystalline material of the sugar coating solution, and the sugar coating method according to claim 1 is characterized in this.
3. The sugar coating solution has a crystalline material concentration of less than 90%, and this ratio corresponds to the weight of the crystalline material of the sugar coating solution with respect to the total weight of the sugar coating solution. The sugar coating method according to claim 1 or claim 2 is characterized in this.
4. The compressed air nozzle has an orifice having a diameter selected from the range of 0.5 to 1.5 mm, and the sugar coating method according to any one of claims 1 to 3 is characterized in this.
5. The content of the crystalline material is at least 94.0% by dry weight in the solid content of the sugar coating solution, and the sugar coating method according to any one of claims 1 to 4 is characterized in this.
6. The solid content of the sugar coating solution is 30% by weight or less, and the sugar coating method according to any one of claims 1 to 5 is characterized in this.
7. The sugar coating method according to any one of claims 1 to 6, including the step of heating the core floor performed before the step (a).
Citation Information
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