Novel sugar coating method and sugar coated solid forms having irregular shape

Abstract

The present invention relates to novel sugar-coated solid forms having an irregular shape, and to a sugar-coating process, in particular for preparing the same.

Description

[0001] This application is a divisional application of the invention patent application filed on June 18, 2018, with application number 201880048034.4 and entitled "Novel Sugar Coating Method and Sugar Coated Solid Form with Irregular Shape". Technical Field

[0002] The subject of this invention is a novel sugar-coated solid form having an irregular shape, and a sugar-coating method specifically for preparing the same. Background Technology

[0003] Sugar coating is an operation specifically used for confectionery or pharmaceuticals, which involves forming a more or less hard crystalline coating (“hard” or “soft” coating) on ​​the surface of solid or powdered products to protect them or to make them visually or taste appealing for various reasons.

[0004] The coating (core) in solid form is carried out in a tank (called a coating roller) rotating about its axis, within which are multiple moving cores of forming mass, on whose surfaces the constituent material of the future coating (“sugar coating solution or syrup”) is distributed in a liquid state. By applying this liquid and evaporating the water introduced by the liquid, a hard and crystalline coating can be obtained.

[0005] Sugar-coated syrups are mainly composed of one or more crystallizable materials and usually also contain binders (such as gum arabic or gelatin), dyes, opacifiers (such as TiO2), inorganic fillers (such as talc, silica, calcium carbonate), strong sweeteners, flavorings, vitamins, and surfactants.

[0006] Sugar coating is a relatively laborious process that involves a number of consecutive steps. Each of these steps (also known as a “sugar coating cycle”) typically includes an application stage, usually by spraying sugar coating syrup onto the core; a rotation stage (also known as a pause time) to distribute the syrup onto the core; and a stage to dry each new layer of syrup by blowing in hot and dry air.

[0007] Sugar coating makes it possible to obtain solid forms with a particularly attractive appearance, but its implementation and the resulting visual effects lack flexibility. In particular, and this is the subject of the invention, it is impossible to obtain solid forms with complex, irregular shapes, such as embossed indentations or ridges, in sugar coating. This is because when sugar-coating solid forms with such irregular shapes, the latter are shielded after sugar coating: the sugar coating liquid fills the grooves and cavities formed by the embossed indentations (“fill marks”) and amplifies the subsequently rounded ridges. Maintaining the asymmetry that the core optionally exhibits is also impossible, for example, when these cores are granular. Therefore, solid forms obtained by sugar coating typically have a coarse and rounded overall shape that is not very faithful to the shape of the initial core.

[0008] Therefore, for example in pharmaceuticals, film coating of tablets is generally preferred. In this method, a film-forming composition is applied, typically based on cellulose derivatives (such as hydroxypropyl methylcellulose (HPMC)) or, more recently, modified starch, rather than a syrup. This film-forming composition forms a thin film on the tablet surface and advantageously allows embossed indentations present on the tablet surface, such as markings, active molecule names, or dosages of active molecules, to be retained.

[0009] Although this method can maintain precise shape, it still results in tablets with a much less appealing appearance than sugar-coated forms. Furthermore, film coating produces amorphous coatings, which are far less stable than the crystalline coatings obtained from sugar coating.

[0010] Therefore, there is currently no method for producing sugar-coated solid forms with their original shape. Thus, when a manufacturer wishes to display a logo or other pattern on the surface of a sugar-coated solid form, it is achieved by applying a colored composition to the surface of the sugar-coated form.

[0011] One approach to solving this problem is described in document US 2008 / 0026131 A1. This document discloses a sugar coating method that can preserve the irregular shape of chocolate. However, this method can only preserve a rough and round overall shape, not complex irregular shapes. The teachings of document US 2008 / 0026131 A1 cannot produce sugar-coated solid forms with complex irregular shapes (such as bumps or embossed indentations). This method is particularly lengthy and laborious, involving multiple sugar coating cycles (applying syrup / distributing / drying).

[0012] Purpose of the invention

[0013] Therefore, the object of the present invention is to provide a sugar-coated solid form with a complex, irregular shape, and to provide a method for achieving this object.

[0014] Another object of the present invention is to provide a particularly simple and flexible method for sugar coating in solid form.

[0015] Invention Introduction

[0016] The applicant has been able to produce sugar-coated solid forms in which irregular shapes (such as embossed indentations or ridges) and asymmetrical shapes are retained after sugar coating.

[0017] The applicant achieved this goal by implementing at least one novel sugar coating method, characterized in that:

[0018] Step (a) involves spraying a sugar coating solution containing a crystallizable material composition onto a moving core bed, placing the core in a chamber equipped with a perforated roller, and the spraying being performed through at least one compressed air nozzle.

[0019] At least one accompanying step (b) of step (a) is used to dry the sprayed sugar coating solution;

[0020] Step (c) collect the resulting sugar-coated solid form.

[0021] The method of the present invention is applicable to various solid forms (tablets, chewing gum, etc.) and provides manufacturers with a variety of possibilities, especially now enabling consumers to have a new look in the form of solid sugar coatings.

[0022] In this method, drying and spraying are carried out simultaneously. Surprisingly, despite the core being constantly moistened, it did not erode and retained its irregular shape.

[0023] This is particularly surprising because until now it has been accepted that the spraying must be stopped for a short period of time during this method: otherwise, the cores will be permanently wetted, preventing the material used for sugar coating from crystallizing, causing the solid form to erode and degrade, and the cores to stick together (the phenomenon of clumping). However, this phenomenon has not been observed even on highly hygroscopic cores (i.e., water-loving cores) in the method of this invention.

[0024] Therefore, unlike conventional sugar coatings, the method of the present invention does not require the sugar coating solution to have a high solids content (at least 70% for conventional sugar coatings containing maltitol). This also contradicts common sense in the art for the same reasons described above (significant core wetting).

[0025] The ability to use low-solids content offers several advantages. First, it allows for the use of sugar coating solutions at low temperatures, thus enabling the introduction of heat-sensitive components into these liquids or the composition of the core to be sugar-coated.

[0026] In practice, if high temperatures are conventionally used in sugar coating, the sugar coating solution will have a high content of crystallizable material in the solution. Since such a high solid content is not required in the method of the present invention, the temperature of the sugar coating solution can be reduced.

[0027] Secondly, this also allows for the use of crystallizable materials with low solubility in water for sugar coating. This advantage is well demonstrated in point 1 of the embodiment (test “Man-IN1 to –IN5”), where mannitol is used for sugar coating. Unlike prior art methods, this sugar coating does not require the addition of large amounts of binder. In other words, strictly speaking, sugar coating can be performed here because crystallizable materials can constitute the majority.

[0028] Therefore, the method of this invention enables, for the first time, the acquisition of a sugar-coated solid form, wherein the sugar coating layer has a high mannitol content, without the need to add excessive amounts of binders, such as gum arabic or polyvinyl alcohol. Man-IN5 testing even indicates that the binder can be omitted.

[0029] The method developed by the applicant also has other advantages, making it applicable to sugar coating in solid forms that do not have particularly complex, irregular shapes. In particular, the method of the present invention is far more flexible than conventional sugar coating methods and can be implemented particularly easily.

[0030] Furthermore, this method is applicable to a variety of crystallizable materials, as shown in point 1 of the examples below. Sucrose, xylitol, erythritol, and mannitol are particularly effective in providing very satisfactory results.

[0031] Finally, the method of the present invention does not necessarily require major modifications to its parameters (drying temperature, sugar coating solution formulation) during its implementation, and can be carried out in relatively simple and compact equipment.

[0032] No existing technical literature discloses or suggests this method. For example, the aforementioned document US 2008 / 0026131A1 never describes the simultaneous drying and spraying. Summary of the Invention

[0033] The first subject of the invention is a sugar-coated solid form having at least one embossed indentation and / or at least one ridge, and / or being asymmetrical, wherein the sugar coating layer of the asymmetrical sugar-coated solid form faithfully matches the shape of the core from which the asymmetrical sugar-coated solid form is derived.

[0034] The subject of this invention also lies in a method, particularly for preparing a sugar-coated solid form having a complex, irregular shape, comprising:

[0035] Step (a) involves spraying a sugar coating solution containing a crystallizable material composition onto a moving core bed, placing the core in a chamber equipped with a perforated roller, and the spraying being performed through at least one compressed air nozzle.

[0036] At least one accompanying step (b) of step (a) is used to dry the sprayed sugar coating solution;

[0037] Step (c) collect the resulting sugar-coated solid form.

[0038] The subject of this invention also lies in a sugar-coated solid form comprising at least one sugar coating layer, said sugar coating layer comprising:

[0039] - A crystallizable material consisting of at least 50% dry weight mannitol; and

[0040] - Optional adhesive, wherein the dry weight ratio of the crystallizable material to the adhesive is greater than 15. Attached Figure Description

[0041] Figure 1.a This is a graph showing the results of the Xyl-IN1 test; Figure 1.b This is a graph showing the results of the Xyl-IN2 test; Figure 1.c This is a graph showing the results of the Xyl-IN3 test; Figure 1.d This is a graph showing the results of the Xyl-IN4 test; Figure 1.e The image shown is a result of testing Xyl-IN5.

[0042] Figure 2.a This is a graph showing the results of the Man-IN1 test; Figure 2.b This is a graph showing the results of the Man-IN2 test; Figure 2.c This is a display of the results of the Man-IN3 test; Figure 2.d This is a graph showing the results of the Man-IN4 test; Figure 2.e The image shown is a result of the Man-IN5 test.

[0043] Figure 3.a The image shown is a result of testing Sac-IN1.

[0044] Figure 4.a The image shown is a result of testing Ery-IN1.

[0045] Figure 5.a This is a graph showing the results of the Sac-CP2 test; Figure 5.b The image shown is a result of testing Sac-CP3.

[0046] Figure 6 It is a function of solubility (g / 100g solution) with respect to solution temperature. Invention Details

[0048] Therefore, the first subject of the invention is a sugar-coated solid form having at least one embossed indentation and / or at least one ridge, and / or being asymmetrical, wherein the sugar coating layer of the asymmetrical sugar-coated solid form faithfully matches the shape of the core from which the asymmetrical sugar-coated solid form is derived.

[0049] The solid form of the present invention has a particular irregular shape, namely, embossed indentations, ridges, or asymmetries. Examples of embossed indentations include patterns (such as logos) or inscriptions (brand names, molecule names, dosages, etc.). Embossed indentations exist on the surface of the solid form, while ridges, on the contrary, help to define the overall shape of the sugar-coated solid form. In particular, these sugar-coated solid forms are characterized in that the core from which these sugar-coated solid forms are derived has itself a regular shape. Specifically, this means that these irregular shapes of the initial core are retained after sugar coating. Specifically, this means that the inscriptions are legible and the patterns are identifiable. These irregular shapes also cover asymmetrical shapes, i.e., shapes without an axis of symmetry. Here, it refers to the sugar coating layer of an asymmetrical sugar-coated solid form faithfully matching the shape of the core from which the asymmetrical sugar-coated solid form is derived.

[0050] Preferably, this solid form of the invention has at least one embossed indentation and / or at least one raised area, more preferably, it has at least one embossed indentation.

[0051] The subject of this invention also lies in a sugar-coated solid form having an irregular shape, optionally as described above, characterized in that it comprises at least one sugar coating layer, said sugar coating layer comprising:

[0052] - A crystallizable material consisting of at least 50% dry weight mannitol; and

[0053] - Optional adhesive, wherein the dry weight ratio of the crystallizable material to the adhesive is greater than 15.

[0054] Preferably, the crystallizable material of the sugar coating layer in the form of a sugar coating solid is composed of at least 60% dry weight, preferably at least 70% dry weight, preferably at least 80% dry weight, preferably at least 90% dry weight of mannitol, or even composed of mannitol alone.

[0055] More preferably, in these sugar coating layers in solid form, the ratio of crystallizable material to binder, on a dry weight basis, is greater than 20, or even greater than 30, or even greater than 40. The sugar coating layer may also advantageously be binder-free.

[0056] In sugar coating, the term "solid form" generally refers to any solid presentation of the sugar-coated material ("sugar-coated solid form") or a solid presentation capable of sugar coating ("core"). Typical examples are tablets, hard gel capsules, soft capsules, pills, microspheres, granules, seeds, biscuits, breakfast cereals, confectionery (such as chewing gum), boiled candy, chewing paste, jelly candy, chocolate, fruits and vegetables, or other products in powder and / or crystalline form. For example, these solid forms can have food, pharmaceutical, veterinary, or cosmetic purposes. They can be for human consumption by adults or children or for animal consumption. They can also be products for chemical or agrochemical purposes, although in the context of this invention, solid forms intended for ingestion are preferred. Preferably, these solid forms are selected from tablets and chewing gum.

[0057] Preferably, the sugar-coated solid form of the present invention comprises at least one sugar-coating layer, the composition of which is the same as that of the sugar-coating liquid used in the sugar-coating method of the present invention; it should be understood that only the composition of the solid constituting the sugar-coating liquid is considered here.

[0058] Preferably, the percentage of the sugar coating in solid form according to the present invention is greater than 1%. This percentage of sugar coating, i.e., "weight increase," is typically determined by the following method:

[0059] (Weight of sugar coating in solid form – weight of core) / weight of core x 100.

[0060] Preferably, the sugar coating percentage is greater than 3%, more preferably greater than 5%, more preferably greater than 7%, more preferably greater than 10%, for example, at least 15%, or even at least 20%.

[0061] The subject of this invention also lies in a sugar coating method, which is particularly suitable for preparing a sugar-coated solid form according to the invention, the method comprising:

[0062] Step (a) involves spraying a sugar coating solution containing a crystallizable material composition onto a moving core bed, placing the core in a chamber equipped with a perforated roller, and the spraying being performed through at least one compressed air nozzle.

[0063] At least one accompanying step (b) of step (a) is used to dry the sprayed sugar coating solution;

[0064] Step (c) collect the resulting sugar-coated solid form.

[0065] An apparatus for carrying out the method of the present invention typically includes a unit for storing the sugar coating liquid, the unit comprising at least one outlet for conveying the sugar coating liquid to an outlet of a device for spraying the sugar coating liquid. The sugar coating liquid is applied by means of a device for spraying onto a core bed housed in a chamber, the chamber being equipped with a rotating drum for actuating the core bed. More specifically, the drum is a perforated rotating drum, and the selected spraying device includes at least one compressed air nozzle. The apparatus also includes an air inlet at the level of the drum chamber for drying the sugar coating liquid. In particular, the drying air is discharged through perforations in the rotating drum, especially by drawing air from the chamber.

[0066] The components that can be used in the device of the present invention are commercially available, and their arrangement is not particularly difficult for those skilled in the art.

[0067] The sugar coating solution used in this invention comprises a crystallizable material composition.

[0068] The term "crystallizable material composition" generally refers to a composition of substances that can crystallize by evaporating the solvent that dissolves them.

[0069] Preferably, the crystallizable material composition for use in the sugar coating solution of the present invention comprises at least one substance selected from sugars and polyols, preferably selected from monomers and dimers.

[0070] Advantageously, sugar and polyol constitute at least 50% dry weight of the crystallizable material composition of the sugar coating solution, preferably at least 70% dry weight, and even more preferably at least 90% dry weight. Most preferably, the crystallizable material composition of the sugar coating solution consists entirely of substances selected from sugar and polyol.

[0071] In this invention, it should be understood that when referring to the dry matter of a compound, the matter may contain impurities.

[0072] Preferably, the sugars and polyols are selected from xylitol, sucrose, erythritol, mannitol, dextrose, isomaltitol, maltitol, or optionally combinations thereof. Most preferably, the sugars and polyols are selected from sucrose, mannitol, xylitol, erythritol, or optionally combinations thereof, and more preferably from sucrose, mannitol, xylitol, or optionally combinations thereof.

[0073] Preferably, the crystallizable material composition of the sugar-coated liquid consists entirely of a single substance. Therefore, for example and advantageously, the crystallizable material composition that can be used in the present invention is xylitol or sucrose or erythritol or mannitol or dextrose or isomaltitol or maltitol.

[0074] The concentration of crystallizable substances in the sugar coating solution is selected in such a way that the crystallizable material is dissolved in the sugar coating solution.

[0075] Typically, particularly when the sugar coating solution is an aqueous liquid, the concentration of the crystallizable material in the sugar coating solution of the present invention is less than 90%, which corresponds to the dry weight of the crystallizable material in the sugar coating solution relative to the total weight of the sugar coating solution. Preferably, this concentration is less than or equal to 70%, more preferably less than or equal to 60%, more preferably less than 60%, or even less than or equal to 55%, or even less than or equal to 50%, or even less than or equal to 45%, or even less than or equal to 40%, or even less than or equal to 35%, or even less than or equal to 30%, or even less than or equal to 25%, or even equal to 20%. This concentration is generally greater than 10%, or even at least equal to 15%, or even at least equal to 20%.

[0076] The maximum concentration of crystallizable materials naturally depends on the properties of these materials, and also on the temperature of the sugar coating solution. For example, for xylitol, sucrose, erythritol, mannitol, dextrose, isomaltitol, and maltitol, refer to [reference needed]. Figure 6 This indicates the maximum concentration of these crystallizable materials in water as a function of liquid temperature. Therefore, for example, when the crystallizable material composition consists of sucrose, the concentration of the crystallizable material in the sugar-coating solution is preferably less than or equal to 67% at 20°C; less than or equal to 15% when mannitol is involved; less than or equal to 61% when maltitol is involved; less than or equal to 63% when xylitol is involved; less than or equal to 25% when isomaltitol is involved; less than or equal to 27% when erythritol is involved; and less than or equal to 48% when dextrose is involved.

[0077] Typically, the sugar coating solution of this invention contains substances other than crystallizable materials, provided that they do not conflict with the properties required by this invention, and in particular with the quality of the obtained sugar-coated solid form and / or the operability of the method. For example, such other compounds are:

[0078] - Adhesives, such as gum arabic and polyvinyl alcohol;

[0079] - Coloring substances, such as pigments and opacifiers, such as titanium dioxide;

[0080] - Flavoring agents, sweeteners;

[0081] -Active agents, such as active agents for pharmaceuticals, nutrition, health care or phytosanitary purposes.

[0082] Preferably, the solid content of the sugar coating solution of the present invention is less than 90% by weight, preferably less than 85% by weight, preferably less than 80% by weight, preferably less than 75% by weight, preferably less than or equal to 70% by weight, preferably less than or equal to 60% by weight, preferably less than 60% by weight, or even less than or equal to 55% by weight, or even less than or equal to 50% by weight, or even less than or equal to 45% by weight, or even less than or equal to 40% by weight, or even less than or equal to 35% by weight, or even less than or equal to 30% by weight, or even less than or equal to 25% by weight, or even equal to 20% by weight. This solid content is typically greater than 10%, preferably at least 15%, and more preferably at least 20%.

[0083] Therefore, preferably, the solid components of the sugar coating solution of the present invention consist of the following:

[0084] Crystallizable materials of -50.0% to -100.0% dry weight, especially those as defined above;

[0085] Other components, particularly those as defined above, ranging from -0.0% to 50.0% of dry weight;

[0086] The sum of these percentages equals 100.0%.

[0087] Preferably, the sugar coating solution of the present invention contains at least 60.0% dry weight, preferably at least 70.0% dry weight, preferably at least 80.0% dry weight, preferably at least 90.0% dry weight, or even at least 94.0% dry weight, or even at least 95.0% dry weight, or even at least 96.0% dry weight of crystallizable material.

[0088] Typically, the solid content of the sugar coating solution of the present invention comprises less than 5.0% dry weight, preferably less than 4.0% dry weight, and more preferably less than 3.0% dry weight of pigment and / or dye.

[0089] Typically, the solid content of the sugar coating solution of the present invention comprises less than 5.0% dry weight, preferably less than 4.0% dry weight, preferably less than 3.0% dry weight, preferably less than 3.0% dry weight, preferably less than 2.0% dry weight of an opaque agent.

[0090] Typically, the solid content of the sugar coating solution of the present invention comprises an amount of binder of less than 15.0% dry weight, preferably less than 10.0% dry weight, or even less than 8.0% dry weight, or even less than 5.0% dry weight.

[0091] Typically, the sugar coating solution used according to the invention is polar and preferably contains water as the main solvent, and most preferably water as the sole solvent.

[0092] In one advantageous embodiment, for the sake of simplicity and because of its possibility, the sugar coating method according to the invention uses a single sugar coating solution, that is, the sugar coating solution has a constant formulation throughout the sugar coating process.

[0093] Typically, the temperature of the sugar coating solution is chosen to ensure good dissolution of the crystallizable material in the sugar coating solution to be sprayed. Therefore, this temperature also depends on the amount of crystallizable material present in the liquid. In the method of the present invention, this temperature is typically selected from 20-90°C. Preferably, the temperature is less than 85°C, more preferably less than 80°C, more preferably less than 75°C, more preferably less than 70°C, or even less than 65°C, or even less than 60°C, or even less than 55°C, or even less than 50°C, or even less than 45°C, or even less than 40°C, or even less than 35°C, or even less than 30°C. This temperature is generally at least 15°C, or even at least 20°C. For example, it corresponds to ambient temperature, typically ranging from 20-25°C.

[0094] In one advantageous embodiment, the sugar coating solution is stored in a closed, single storage unit, and / or the equipment used in the method of the present invention does not include equipment for heating the sugar coating solution. This is because, since the method of the present invention does not necessarily require the use of high sugar coating solution temperatures, such equipment is not essential in the method of the present invention.

[0095] For spraying the sugar coating solution, the number of compressed air nozzles used is typically selected based on the size of the sugar coating chamber, according to the manufacturer's recommendations. Typically, this involves 1-2 nozzles per section, specifically a sugar coating chamber with a diameter of 40 cm. For example, the number of nozzles could be 1-10, or even 1-6.

[0096] Preferably, for spraying, the method of the present invention uses only compressed air nozzles.

[0097] Preferably, the nozzle used according to the invention has an orifice with a diameter selected from 0.1-2.8 mm, preferably 0.1-2.5 mm, more preferably 0.1-2.2 mm, for example 0.3-2.0 mm, or 0.5-1.8 mm, or 0.5-1.5 mm, or 0.5-1.2 mm, or 0.5-1.0 mm.

[0098] Preferably, the spray velocity is selected from 0.5-20.0, more preferably 1.0-20.0, more preferably 2.0-20.0, for example 2.0-15.0, or even 2.0-10.0 g / min / kg core.

[0099] In one advantageous embodiment, the flow rate selected for spraying is increased during sugar coating. In particular, the inventors have noted that, for certain crystallizable materials, using a low flow rate at the start of sugar coating allows for the promotion of a first crystallization stage occurring at the core surface. The flow rate can then be increased to accelerate sugar coating.

[0100] For spraying, the atomization and compression pressures are adjusted according to the flow rate and nozzle orifice, and as recommended by the manufacturer. Typically, these atomization and compression pressures are selected from 0.5-4.0 bar, preferably 0.5-3.5 bar, for example, 0.7-2.5 bar for atomization pressure, and / or 0.7-3.5 bar for compression pressure.

[0101] In this invention, the sugar coating solution is sprayed onto a core bed that moves via a rotating drum.

[0102] For solid forms, the properties of these cores are preferably as defined above; for example, they are tablets or chewing gum. These cores may be completely exposed or coated with one or more layers, such as an adhesive layer, a film coating layer, or even a sugar coating layer, preferably obtained in the same equipment as the sugar coating method used in this invention.

[0103] To move the core bed, the roller speed is selected based on the size of the chamber and the size of the core to be coated. This speed is typically selected from 3-30 rpm, for example, from 10-20 rpm.

[0104] In an advantageous embodiment, particularly for reasons of simplicity and / or space-saving, and because the method of the invention allows for this, the method of moving the core bed excludes the transfer of the cores in the longitudinal direction. Specifically, this means that sugar-coated cores are not transferred from one chamber to another; that is, they are sugar-coated in a single chamber, and / or the core bed is not sugar-coated in the longitudinal chambers along which the cores are transferred.

[0105] For drying, the temperature selected for the drying air is preferably less than 100°C, preferably less than or equal to 80°C, preferably less than or equal to 75°C, preferably less than or equal to 70°C, or even less than or equal to 65°C, or even less than or equal to 60°C, or even less than or equal to 55°C, or even less than or equal to 50°C, or even less than or equal to 45°C, or even less than or equal to 40°C, or even less than or equal to 35°C, or even less than or equal to 30°C, or even less than or equal to 25°C. This drying temperature is typically at least 15°C, preferably at least 20°C.

[0106] For drying, the flow rate can be selected from 50-8000 m / s. 3 / h, for example 100-7000m 3 / h, for example 100-1000m 3 / h.

[0107] Advantageously, the dry air is discharged by suction through the perforations of the perforated rotating drum.

[0108] Preferably, the perforated wall region of the rotating roller used in this invention preferably occupies at least 50% of the surface area of ​​the roller wall, more preferably at least 60%, more preferably at least 70%, more preferably at least 80%, and more preferably at least 90%. Most preferably, the roller wall is perforated over its entire surface.

[0109] Preferably, the temperature of the core bed for sugar coating is a maximum of 70°C, more preferably a maximum of 60°C, more preferably a maximum of 55°C, more preferably a maximum of 50°C, more preferably a maximum of 45°C, or even a maximum of 40°C, or even a maximum of 35°C, or even a maximum of 30°C, or even a maximum of 25°C. The temperature of the core bed for sugar coating is typically at least 10°C, or even at least 15°C.

[0110] Preferably, before sugar coating begins, that is, before spraying begins, the method of the present invention includes the step of heating the core bed to be sugar coated. In particular, this step is intended to bring the core bed to a target temperature.

[0111] The sugar coating method of the present invention simultaneously performs spraying and drying of the spray liquid.

[0112] However, it is conceivable to introduce a distribution step (“pause time”) and to spray without drying, provided that this does not conflict with the properties required in the present invention, and in particular with the quality of the obtained sugar-coated solid form and / or the operability of the method.

[0113] Preferably, the sugar coating process stage in which spraying is not optionally accompanied by drying accounts for less than 50% of the total sugar coating process time, more preferably less than 40%, more preferably less than 30%, more preferably less than 20%, more preferably less than 10%, and more preferably less than 5%. Most preferably, in the absence of drying, the sugar coating process does not include a spraying stage.

[0114] Preferably, the optional pause time (the time between two spraying stages during which neither spraying nor drying occurs) accounts for less than 50% of the total time of the sugar coating method, more preferably less than 40%, more preferably less than 30%, more preferably less than 20%, more preferably less than 10%, and more preferably less than 5%. Most preferably, the sugar coating process does not include a pause time.

[0115] Preferably, the percentage of sugar coating in solid form obtained by the method of the present invention is greater than 1%, preferably greater than 3%, preferably greater than 5%, preferably greater than 7%, preferably greater than 10%, for example at least 15%, or even at least 20%.

[0116] Preferably, the sugar coating percentage is at least 0.05% / minute, preferably at least 0.10% / minute, more preferably at least 0.13% / minute, or even at least 0.15% / minute, or even at least 0.20% / minute, or even at least 0.30% / minute.

[0117] The method of the present invention may also include conventional steps other than those aimed at achieving a sugar-coated solid form, provided that this does not conflict with the properties desired in the invention, particularly with the quality of the obtained sugar-coated solid form and / or the operability of the method. Examples of other steps include, for instance, sizing, smoothing, polishing, and coloring. Advantageously, if these steps are performed, they are carried out in the same equipment used in the sugar-coating method of the present invention. It is understood that if the composition used contains a certain amount of such crystallizable material, thereby effectively forming a layer of crystalline substance, particularly crystalline substances of sugars and / or polyols, some of these steps (such as sizing or coloring) may sometimes be incorporated into the sugar-coating step.

[0118] Regarding these other general steps, it is interesting to note that the sugar coating performed according to the method of the invention has resulted in a good level of smoothness in solid form. Furthermore, coloring can be achieved directly by adding a colorant to the sugar coating solution.

[0119] The method of the present invention may further include an initiation step. This initiation step involves applying the powdered composition once or multiple times to a core bed that is to be sugar-coated, or is undergoing sugar-coating, preferably to a core bed undergoing sugar-coating. Typically, the powdered composition contains crystalline materials. Typically, these crystalline materials have the same properties as the crystallizable materials of the sugar-coating solution, but may also be different. Typically, the amount of powdered composition applied relative to the weight of the tablet is less than 10% by weight, preferably less than 5%.

[0120] Preferably, when using dextrose, isomaltitol, maltitol, or combinations thereof, the method includes an additional initiation step. Preferably, when using sucrose, xylitol, mannitol, erythritol, or combinations thereof, the method excludes this initiation step.

[0121] The apparatus that can be used in this invention may include other elements conventionally used in sugar coating, provided that this does not conflict with the properties required in this invention, and in particular with the quality of the obtained solid form of sugar coating and / or the operability of the method.

[0122] Interestingly, in this respect, the prior art sometimes mentions the use of a clumping crusher for the purpose of preventing clumping during sugar coating. Such a clumping crusher is not required in the method of the present invention. Therefore, preferably and advantageously, because it is possible in the method of the present invention, the chamber of the drum used according to the invention does not contain a clumping crusher.

[0123] The invention will be more clearly understood through the following examples, which are exemplary and non-limiting. Detailed Implementation

[0124] 1. The sugar coating test according to the present invention

[0125] 1.1 Equipment used

[0126] Use equipment with the following characteristics:

[0127] - Perforated rotating drum: 30.48cm in diameter, 2L capacity;

[0128] - Anti-slip strips x6;

[0129] - One compressed air atomizing nozzle (Schlick 970 / 7-1S75); orifice diameter 0.8mm;

[0130] - Peristaltic pump (Watson Marlow 323); Three-roller pump (313DW);

[0131] - Pipe: Inner diameter 2mm: Outer diameter 6mm.

[0132] 1.2 Sugar coating liquid

[0133] The tested sugar coating solution had the following formulation (dry basis %):

[0134] serial number GA PVA PVA2 BF N Crystallizable materials tested 96.5％ 96.5％ 94.5％ 98.5％ 95.5％ Gum Arabic* 2.0％ - - - 2.0％ PVA (Polyvinyl alcohol) - 2.0％ 4.0％ - - Titanium dioxide 1.0％ 1.0％ 1.0％ 1.0％ - Blue pigment (Blue n. Lake) 0.5％ 0.5％ 0.5％ 0.5％ - Natural blue pigment (GNT) - - - - 2.5％

[0135] *Introduced as a solution of 40% by weight solids

[0136] All of these sugar-coated solutions were contained in single-shell tanks at ambient temperature (20-25°C).

[0137] 1.3 core

[0138] The following batches of core were used as the sugar coating matrix:

[0139] serial number Comp-SORB 900g of (hygroscopic) sorbitol tablets have a 330mg embossed indentation. Comp-MANN 900g of (non-hygroscopic) mannitol tablets with 330mg embossed indentation. CG Chewing gum contains gum base, sorbitol, mint flavoring, etc.

[0140] 1.4 Methods and Results

[0141] The common conditions for all tests are as follows: operating pressure 4 bar; atomization and compression pressure 1.0 or 1.3 bar (selected according to the manufacturer's recommendation and the viscosity of the solution); pressure differential -0.25 mbar; drum speed 18 rpm; drying air flow rate 100 m³ / min. 3 / h.

[0142] Before spraying begins, heat the tablet bed for 2 minutes to reach the required core bed temperature. Then, spraying and drying are performed simultaneously throughout the process (without pauses). At the end of the sugar coating, stop spraying and allow the solid form to dry for an additional 2 minutes.

[0143] The table below lists the results obtained and the method characteristics specific to each test.

[0144]

[0145]

[0146]

[0147] *These cores do not include embossed indentations.

[0148]

[0149]

[0150]

[0151]

[0152] *These cores do not include embossed indentations.

[0153] 1.5 discuss

[0154] The method of the present invention advantageously allows sugar coating of all types of solid forms in a very simple manner, and makes it possible to successfully preserve complex irregular shapes, such as embossed indentations, ridges, and asymmetrical shapes.

[0155] Therefore, the inventors have successfully achieved this in, for example, sugar-coated tablets and chewing gum, whether they are hygroscopic (“Comp-SORB” and “CG”) or non-hygroscopic (“Comp-MANN”), while retaining embossed indentations on their surfaces.

[0156] Surprisingly, despite the core being constantly moistened, the core did not erode and retained its irregular shape (without "mark filling," i.e., filling the grooves and cavities formed by the embossed indentation). For example, in the test "Man-IN1 to -IN5," a sugar coating solution containing only 20% solids was used. In fact, the resulting sugar-coated tablets had a clearly visible irregular shape ( Figure 2.a ), especially the fully identifiable embossed indentations ( Figures 2.b) to 2.e) ).

[0157] The method of the present invention also has other, but not insignificant, advantages that make it equally applicable to sugar-coated solid forms with conventional shapes.

[0158] The sugar coating solution used can contain all types of crystallizable materials, and the formulation can be very simple. For example, tests “Xyl-IN3” and “Man-IN5” show that a binder-free (“BF”) sugar coating solution is also suitable for the method of the present invention. The method of the present invention also enables the successful sugar coating of solid forms with a “natural” sugar coating solution, which in particular is free of titanium dioxide (test “Xyl-IN4”, using sugar coating solution “N”).

[0159] Furthermore, the method of the present invention allows for the use of very low solid content, which is unheard of in sugar coating. All tests presented herein used sugar coating solutions with a solid content not exceeding 60%. Therefore, the method of the present invention allows for the use of carbohydrates (e.g., mannitol) with low solubility in water for sugar coating.

[0160] The method of this invention also allows for the use of lower drying temperatures. The main purpose of testing “Man-IN1” is to illustrate this effect, and the test shows that sugar coating with mannitol is possible at a temperature of 25°C. The obtained sugar-coated solid form has a very clear shape, faithfully resembling the shape of the initial core. Figure 2.a In particular, the use of exceptionally low drying temperatures allows for lower core bed temperatures, making sugar coating of core compositions containing heat-labile components possible, especially in the case of certain active agents (particularly pharmaceutical active agents). Therefore, in the testing of “Man-IN1”, the tablet bed temperature did not exceed 26°C.

[0161] Since the method of this invention does not necessarily require the sugar coating solution to contain a large amount of crystallizable material, the temperature of the sugar coating solution can also be very low. In these tests, the sugar coating solution used was actually at ambient temperature (20-25°C). In addition to facilitating the implementation of the method, this also allows for the use of heat-sensitive components in these liquids.

[0162] Finally, the solid form obtained by the method of the present invention is also satisfactory in terms of its color and surface feel.

[0163] 2. Comparison of sugar coating test

[0164] In this section, the inventors attempted to sugar-coat 1 kg of Comp-SORB tablets with embossed indentations according to the aforementioned document US 2008 / 0026131 A1.

[0165] 2.1 Equipment used

[0166] Use equipment with the following characteristics:

[0167] - Rotating drum: 30cm in diameter;

[0168] - Anti-slip strips x8;

[0169] - One compressed air atomizing nozzle (BINKS 460); orifice diameter 0.8mm;

[0170] - Peristaltic pump (Watson Marlow 323); Three-roller pump (313DW);

[0171] - Pipe: Inner diameter 2mm: Outer diameter 6mm.

[0172] 2.2 Sugar Coating Solution

[0173] According to document US 2008 / 0026131 A1, Example 1, the sugar coating solution used is as follows:

[0174] - "Gum Syrup": Formula (dry basis %): 96.0% sucrose; 4.0% gum arabic (introduced as a solution of 40% by weight solids); solid content: 72%.

[0175] - "Smooth Syrup": Formula (dry basis %): 97.0% sucrose; 2.0% glucose syrup; 1.0% titanium dioxide; solids content: 70%.

[0176] - "Color paste": Formula (dry weight %): 98.0% sucrose; 2.0% blue pigment (Blue n. Lake); solid content: 69%.

[0177] If necessary, the temperature of these liquids can be adjusted to ensure complete dissolution of the compound.

[0178] 2.3 Methods and Results

[0179] In subsequent tests, the conditions of Example 1 in document US 2008 / 0026131 A1 (drying temperature, solids, etc.) were followed. Parameters such as spray flow rate or drum speed were adjusted to the size of the sugar coating chamber available to the inventors.

[0180] Testing Sac-CP1:

[0181] The first test was conducted by performing several cycles according to the table below. Each cycle consists of a spraying phase, a pause time (distribution), and then a drying step:

[0182]

[0183] Although the drying capacity of the equipment is higher than that described in document US 2008 / 0026131 A1 (50m), 3 / hVS 15.3m 3 / h), but the test could not be completed and had to be stopped due to excessive adhesion forming clumps.

[0184] Therefore, a second test was conducted to avoid the phenomenon of sticking together into clumps and to fully reproduce Example 1 of document US2008 / 0026131 A1.

[0185] Testing Sac-CP2:

[0186] Following the failure of the Sac-CP1 test, the first cycle of the first phase was modified: operator intervention was performed to allow core stacking, and the operating conditions were modified. The test was conducted according to the following table:

[0187]

[0188] The results are shown in Figure 5.a Such sugar-coated tablets are very coarse and have a rough, round overall shape. Markings and embossing on the core are covered and no longer identifiable. The inventors noted that the surface of the tablets began to deteriorate from the first cycle of sugar coating. Despite the high solids content of the sugar coating solution used, the tablets dissolved within the first two minutes, and crystallization was very difficult.

[0189] Testing Sac-CP3: A third test was conducted, which only included the "smooth" sugar coating stage of the Sac-CP2 test. Similar results were obtained as with the Sac-CP2 test. Figure 5.b ): The sugar-coated slices are roughly round and covered with embossed marks.

Claims

1. Sugar coating process for the preparation of a sugar coated solid form, said sugar coating process comprising: - a step (a) of spraying a sugar coating liquid comprising a composition of crystallizable material onto a moving bed, said bed being placed in a chamber provided with a perforated drum and said spraying being performed through at least one compressed air nozzle; - at least one step (b) accompanying step (a) of drying said sprayed sugar coating liquid; - a step (c) of collecting the sugar coated solid form thus obtained, wherein the solids content of said sugar coating liquid comprises an amount of at least 70.0 dry weight % of crystallizable material, wherein said composition of crystallizable material comprises at least one substance selected from the group consisting of sugars and polyols, wherein said sugars and polyols are monomers.

2. The sugar coating process according to claim 1, characterized in that said composition of crystallizable material comprises at least one substance selected from the group consisting of polyols.

3. The sugar coating process of claim 1 wherein said composition of crystallizable material comprises at least one substance selected from the group consisting of sugars.

4. The sugar coating process of claim 1 wherein said sugars and polyols represent at least 50 dry weight % of the composition of crystallizable material of said sugar coating liquid.

5. The sugar coating process of claim 1 wherein said sugars and polyols represent at least 70 dry weight % of the composition of crystallizable material of said sugar coating liquid.

6. The sugar coating process of claim 1 wherein said sugars and polyols represent at least 90 dry weight % of the composition of crystallizable material of said sugar coating liquid.

7. The sugar coating process according to claim 1, wherein said sugars and polyols are selected from the group consisting of xylitol, erythritol, mannitol, dextrose or combinations thereof.

8. The sugar coating process according to claim 1, wherein said sugars and polyols are selected from the group consisting of xylitol, erythritol, mannitol or combinations thereof.

9. The sugar coating process according to claim 1, wherein the concentration of crystallizable material of said sugar coating liquid is less than 90 %, this percentage corresponding to the weight of crystallizable material of the sugar coating liquid relative to the total weight of said sugar coating liquid.

10. The sugar coating process according to any one of claims 1 to 9, characterized in that said compressed air nozzle has an orifice with a diameter comprised between 0.1 and 2.8 mm.

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