Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/282—Organic compounds, e.g. fats
  • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
  • A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
  • A23P20/10—Coating with edible coatings, e.g. with oils or fats
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
  • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
  • A23G3/0002—Processes of manufacture not relating to composition and compounding ingredients
  • A23G3/0063—Coating or filling sweetmeats or confectionery
  • A23G3/0089—Coating with atomised liquid, droplet bed, liquid spray
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
  • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
  • A23G3/0002—Processes of manufacture not relating to composition and compounding ingredients
  • A23G3/0095—Coating by tumbling with a liquid or powder, spraying device-associated, drum, rotating pan
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
  • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
  • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
  • A23G3/343—Products for covering, coating, finishing, decorating
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
  • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
  • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
  • A23G3/50—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by shape, structure or physical form, e.g. products with supported structure
  • A23G3/54—Composite products, e.g. layered, coated, filled
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
  • A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
  • A23L29/37—Sugar alcohols
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
  • A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
  • A23P20/10—Coating with edible coatings, e.g. with oils or fats
  • A23P20/15—Apparatus or processes for coating with liquid or semi-liquid products
  • A23P20/18—Apparatus or processes for coating with liquid or semi-liquid products by spray-coating, fluidised-bed coating or coating by casting
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2004—Excipients; Inactive ingredients
  • A61K9/2013—Organic compounds, e.g. phospholipids, fats
  • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
  • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

• the present invention relates to new sugar-coated solid forms having irregular shapes, as well as a coating process particularly useful for their preparation.
• Sugar coating is an operation used in particular in confectionery or in pharmacy, which consists in creating a more or less hard crystallized coating ("hard” or “soft coating”) on the surface of products. solid or powdery, to protect them for various reasons or to make them attractive visually or tastefully.
• the coating of the solid form (core) is carried out in a vat rotating about its axis and called a dredger, inside which there is a plurality of nuclei forming a mass in motion, on the surface of which is distributed to the liquid state the constitutive material of the future envelope (“liquid or syrup coating”).
• the hard and crystalline coating is obtained by applying this liquid and evaporation of the water brought by it.
• the coating syrup is mainly composed of one or more crystallizable materials, and also conventionally contains binding agents such as gum arabic or gelatin, dyes, opacifiers such as TiO 2 , mineral fillers such as talc, silica, calcium carbonate, intense sweeteners, flavors, vitamins, active ingredients.
• binding agents such as gum arabic or gelatin, dyes, opacifiers such as TiO 2 , mineral fillers such as talc, silica, calcium carbonate, intense sweeteners, flavors, vitamins, active ingredients.
• the coating is a relatively laborious process, including a large number of successive steps.
• Each of these steps also called “coating cycles”, typically includes an application phase, generally by spraying a coating syrup on the cores, a rotary phase of distribution of said syrup on the cores also called pause time, and a drying phase of each new layer of syrup made by blowing hot and dry air.
• the drageification makes it possible to obtain solid forms having a particularly attractive appearance, but lacks flexibility as to its implementation and as to the visuals that can be obtained. In particular, and this is the subject of the present invention, it is not possible in drageification to obtain solid shapes having complex irregular shapes, for example relief impressions or ridges. sugar-coated
• FIRE I LLE OF REM PLACEM ENT (RULE 26) solid forms having such irregularities, the latter are masked after coating: the coating liquid fills the grooves and cavities formed by the printing in relief ("logo in-filling"), and enlarges the edges which then round off. It is also not possible to maintain the asymmetry that the nuclei eventually present, as for example when these nuclei are seeds.
• the solid forms obtained by coating thus conventionally have a generally coarse and rounded shape, not very faithful to that of the starting nuclei.
• film lamination of tablets (“film coati ng").
• a film-forming composition generally based on cellulose derivatives such as hydroxypropylmethylcellulose (HPMC), or more recently, modified starches.
• HPMC hydroxypropylmethylcellulose
• This film-forming composition forms a thin film on the surface of the tablets and advantageously makes it possible to preserve the impressions in relief present on the surface of the tablets, such as logos, active molecule names or active dosages.
• the film coating produces an amorphous coating, which is much less stable than the crystallized coating resulting from the coating.
• the object of the present invention is thus to provide solid, sugar-coated shapes having complex irregular shapes, as well as a process making it possible to achieve this.
• the invention also aims to provide a particularly simple and flexible method for the coating of solid forms.
• the Applicant has been able to produce solid, sugar-coated shapes in which irregular shapes such as relief impressions, ridges, and asymmetrical shapes are preserved after coating.
• the Applicant has achieved this through the implementation of at least one new coating process, characterized in that it comprises:
• the process of the invention applies to various solid forms (tablets, chewing gums, etc.) and offers a multitude of possibilities for manufacturers, and in particular that of being able to now offer the consumer new visuals of solid, sugar-coated forms. .
• the method of the invention does not require that the coating liquid has a high content of dry materials (at least 70% for a conventional coating with maltitol). This also goes against the general knowledge of the trade, for the same reasons as those mentioned in the previous paragraph (significant humidification of the cores).
• low levels of solids can be used has a number of advantages. Firstly, it gives the possibility of using coating liquids at low temperatures, and thus introducing thermolabile ingredients in these liquids or in the cores compositions to be coated. Indeed, if high temperatures are conventionally used in coating, it is to allow the coating solution to have a high content of crystallizable materials in solution. This high dry matter is not necessary in the process of the invention, the temperature of the coating liquid can be lowered.
• the process developed by the Applicant has further advantages that make it also useful for the coating of solid forms that do not have particularly complex irregular shapes.
• the method of the invention is much more flexible than conventional methods of coating, and can be particularly simple in its implementation.
• the subject of the present invention is a solid coated form having at least one raised impression, and / or at least one edge, and / or in that it is asymmetrical, the coating layer of said asymmetrical sugar-coated solid form. faithfully marrying the shape of the nucleus from which it comes.
• the present invention also relates to a process which is particularly useful for the preparation of sugar-coated solid forms having complex irregular shapes, comprising:
• step (b) at least one step (b) concurrent with step (a), drying said sprayed coating liquid;
• the present invention also relates to a coated solid form comprising at least one coating layer comprising:
• crystallizable materials consisting of at least 50% by dry weight of mannitol; and, optionally, binders, the ratio by dry weight crystallizable materials / binders being greater than 15.
• the present invention thus has for its first object solid forms coated with at least one embossed impression, and / or at least one edge, and / or in that it is asymmetrical, the coating layer of said asymmetrical sugar-coated solid form marrying faithfully the shape of the nucleus from which it comes.
• the solid forms of the invention have particular irregular shapes, i.e., relief prints, edges, or asymmetries.
• relief printing include patterns (such as logos) or inscriptions (brand names, molecule names, assays, etc.). Relief impressions are present on the surface of solid forms, while edges are more involved in defining the general shape of the sugar-coated solid shape.
• These solid forms coated with sugar are particularly characterized in that the nuclei to be coated from which they are derived themselves have these irregular shapes. It is understood that these irregular shapes of the initial nuclei are preserved after coating. This means in particular that the inscriptions are legible, and the reasons identifiable.
• These irregular shapes also cover asymmetrical shapes, that is to say not having an axis of symmetry. It is understood here that the coating layer of asymmetrical sugar-coated solid forms closely follows the shape of the cores from which they are derived.
• this solid form of the invention has at least one raised impression and / or at least one edge, more preferably at least one raised impression.
• the subject of the present invention is also a solid coated form, having the irregular shapes as described above or not, characterized in that it comprises at least one coating layer comprising:
• crystallizable materials consisting of at least 50% by dry weight of mannitol; and, optionally, binders, the ratio by dry weight crystallizable materials / binders being greater than 15.
• the crystallizable materials of the coating layer of this coated solid form consist of at least 60% by dry weight of mannitol, preferably at least 70%, preferably at least 80%, preferably at least 90%, or even only mannitol.
• the ratio by dry weight crystallizable materials / binders is greater than 20, or even greater than 30, or even greater than 40.
• the coating layer may also advantageously be free of binders .
• solid form conventionally means any solid presentation of sugar-coated substances ("solid coated form") or capable of undergoing a coating operation ("core”).
• Typical examples are tablets, hard capsules, soft capsules, pellets, microspheres, granules, seeds, biscuits, breakfast cereals, confectionery such as chewing gums, cooked sugars. , chewables, jelly candies, chocolates, fruits and vegetables, or products in the form of powders and / or crystals.
• These solid forms can be for example food, pharmaceutical, veterinary, cosmetic. They can be intended for the human, adult or child, or the animal. They may also be products with a chemical or agrochemical purpose, although solid forms intended to be ingested in the context of the present invention are preferred.
• these solid forms are chosen from tablets and chewing gums.
• the solid coated forms of the invention comprise at least one coating layer whose composition is identical to that of the coating liquid used in the coating process of the invention; it being understood that only what constitutes the dry matter of the coating liquid is considered here.
• the solid coated forms of the invention have a percentage of coating greater than 1%.
• This percentage of coating otherwise known as “mass gain”, is conventionally determined as follows:
• This percentage of coating is preferably greater than 3%, preferably greater than 5%, preferably greater than 7%, preferably greater than 10%, for example at least 15%, and even at least 20%. %.
• the subject of the invention is also a coating method which is particularly useful for the preparation of coated solid forms according to the invention, comprising:
• the equipment used to implement the process of the invention typically comprises a storage unit for the coating liquid, comprising at least one outlet for transporting the coating liquid to a device for spraying the coating liquid.
• the coating liquid is applied through the spraying device on a bed of cores contained in the chamber, said chamber being provided with a rotating drum for moving said bed of cores.
• the drum is a perforated rotary drum, and the selected spray device comprises at least one compressed air nozzle.
• the equipment further comprises an air inlet at the drum chamber for drying the coating liquid. The exit of the drying air is effected in particular through the perforations of the rotary drum, in particular by suction of the air from the chamber.
• the elements of the equipment useful to the invention are commercially available, and their arrangement does not represent any particular difficulties for a person skilled in the art.
• the coating liquid useful in the invention comprises a composition of crystallizable materials.
• composition of crystallizable materials conventionally means a composition consisting of substances capable of crystallizing by evaporation of the solvent in which they are dissolved.
• the composition of crystallizable materials of the coating liquid useful in the invention comprises at least one substance chosen from sugars and polyols, preferably chosen from monomers and dimers.
• the sugars and polyols represent at least 50%, preferably at least 70%, and even more preferably at least 90% by dry weight of the composition of crystallizable materials of the coating liquid.
• the composition of crystallizable materials of the coating liquid consists entirely of substances selected from sugars and polyols.
• this mass includes any impurities.
• these sugars and polyols are selected from xylitol, sucrose, erythritol, mannitol, dextrose, isomalt, maltitol or possibly a combination thereof.
• these sugars and polyols are selected from sucrose, mannitol, xylitol, erythritol, or possibly a combination thereof, more preferably from sucrose, mannitol, xylitol, or possibly a combination of them.
• the composition of crystallizable materials of the coating liquid consists entirely of a single substance.
• the crystallizable material composition useful for the invention is xylitol, or sucrose, or erythritol, or mannitol, or dextrose, or isomalt, or maltitol.
• the concentration of crystallizable materials of the coating liquid is chosen so that the crystallizable materials are solubilized in said coating liquid.
• the coating liquid of the invention has a concentration of crystallizable materials of less than 90%, this percentage corresponding to the dry weight of crystallizable materials of the coating liquid relative to the weight total of said coating liquid.
• this concentration is less than or equal to 70%, preferably less than or equal to 60%, preferably less than 60%, even less than or equal to 55%, even less than or equal to 50%, or even less than or equal to 45%, even less than or equal to 40%, even less than or equal to 35%, even less than or equal to 30%, even less than or equal to 25%, or even equal to 20%.
• This concentration is generally greater than 10%, or even at least 15%, or even at least 20%.
• the maximum concentration of crystallizable material naturally depends on the nature of these crystallizable materials, as well as the temperature of the coating liquid.
• sucrose, erythritol, mannitol, dextrose, isomalt and maltitol reference may be made, for example, to FIG. 6 which shows the maximum concentrations of these crystallizable materials in water according to the temperature of the liquid.
• the concentration of crystallizable materials of a 20 * ⁇ coating liquid is preferably less than or equal to 67% when the composition of crystallizable materials is sucrose, less than or equal to 15% when mannitol, less than or equal to 61% in the case of maltitol, less than or equal to 63% in the case of xylitol, less than or equal to 25% in the case of isomalt, less than or equal to 27% in the case of erythritol, less than or equal to 48% in the case of dextrose.
• the coating liquid of the invention comprises other substances than crystallizable materials, as long as it does not contravene the properties sought in the present invention, in particular as regards the quality of the obtained sugar-coated solid forms and / or the workability of the process .
• Such other compounds are for example:
• binders such as gum arabic, polyvinyl alcohol
• coloring substances such as pigments, opacifying agents such as, for example, titanium dioxide;
• assets for example pharmaceutical, nutritive, nutraceutical, or phytosanitary.
• the coating liquid of the invention has a solids content by weight of less than 90%, preferably less than 85%, preferably less than 80%, preferably less than 75%, preferably less than or equal to at 70%, preferably less than or equal to 60%, preferably less than 60%, even less than or equal to 55%, even less than or equal to 50%, even less than or equal to 45%, even less than or equal to 40% %, even less than or equal to 35%, even less than or equal to 30%, even less than or equal to 25%, or even equal to 20%.
• This dry matter is generally greater than 10%, preferably at least 15%, more preferably at least 20%.
• the dry matter of the coating liquid of the invention thus consists of:
• the dry matter of the coating liquid of the invention comprises an amount of at least 60.0% by dry weight of crystallizable materials, preferably at least 70.0%, preferably at least 80% by weight. , 0%, preferably at least 90.0%, or even at least 94.0%, or even at least 95.0%, or even at least 96.0%.
• the dry matter of the coating liquid of the invention comprises less than 5.0% by dry weight of pigments and / or dyes, preferably less than 4.0%, preferably less than 3.0%.
• the dry matter of the coating liquid of the invention comprises an amount of less than 5.0% by dry weight of opacifying agents, preferably less than 4.0%, preferably less than 3.0%, preferably less than 3.0%, preferably less than 2.0%.
• the dry matter of the coating liquid of the invention comprises an amount of less than 15.0% by dry weight of binder, preferably less than 10.0%, or even less than 8.0%, or even less than 5, 0%.
• the coating liquid used in accordance with the invention is typically polar, and preferably comprises water as the majority solvent, most preferably as sole solvent.
• the coating process according to the invention uses a single coating liquid, that is to say that the coating liquid has a formulation constant throughout the duration of the coating.
• the temperature of the coating liquid is typically chosen so that the crystallizable materials are well solubilized in said coating liquid to be sprayed. This temperature is also a function of the amount of crystallizable materials present in the liquid. In the process of the invention, this temperature is typically selected in a range of from 20 to 90 * ⁇ . Preferably, this temperature is less than 85 ° C., preferably less than ⁇ , preferably less than 75 ° C., preferably less than 70 ° C., or even lower than 65 ° C., or even lower than 60 ° C., or even lower.
• This temperature is usually at least 15 * ⁇ , or even at least 20 * ⁇ . It corresponds for example to the ambient temperature, which typically varies from 20 to 25 ⁇ 0 .
• the coating liquid is stored in a single envelope storage unit, and / or the equipment that is useful for the process of the invention is free of a device for heating the coating liquid.
• the method of the invention does not necessarily require the use of high temperatures of coating liquids, these devices are not mandatory in the method of the invention.
• the number of compressed air nozzles used is conventionally chosen according to the dimensions of the chamber of
• FIRE I LLE OF REM PLACEM ENT (RULE 26) sugar coating according to the manufacturer's recommendations.
• This number of nozzles is typically 1 to 2 nozzle (s) for each 40 cm diameter portion of the coating chamber. This number of nozzles varies, for example, from 1 to 10, for example from 1 to 6.
• the method of the invention uses only compressed air nozzles.
• the nozzles used in accordance with the invention have an orifice having a diameter selected in a range from 0.1 to 2.8 mm, preferably from 0.1 to 2.5 mm, preferably from 0.1 to 2.5 mm. at 2.2 mm, for example from 0.3 to 2.0 mm, or from 0.5 to 1.8 mm or from 0.5 to 1.5 mm, or from 0.5 to 1.2 mm, or from 0.5 to 1.0 mm.
• the spray rates are selected in a range of from 0.5 to 20.0, preferably from 1.0 to 20.0, preferably from 2.0 to 20.0, for example 2.0. at 15.0, or even 2.0 at 10.0 g / min / kg of nuclei.
• the flow rate chosen for the spraying is increased during the coating.
• the inventors have found that for certain crystallizable materials, the use of low flow rates at the beginning of coating makes it possible to favor the first phase of crystallization which takes place on the surface of the cores. The flow can then be increased to accelerate the coating.
• the atomizing and crushing pressure is adjusted according to the flow rate and orifice of the nozzle, and according to the manufacturer's recommendations. These atomization and crushing pressures are typically chosen in a range from 0.5 to 4.0 bar, preferably from 0.5 to 3.5 bar, for example from 0.7 to 2.5 bar. for the atomization pressure, and / or 0.7 to 3.5 bar for the crushing pressure.
• the coating liquid is sprayed onto a moving bed of cores by means of a rotating drum.
• nuclei is preferably as defined before for solid forms; it is for example tablets or chewing gums.
• These cores can be completely bare, or be coated with one or more layers, for example scrubbing, film-coating or even coating, said layers being preferably obtained in the same equipment as that used for the coating process of the invention.
• the speed of rotation of the drum is chosen according to the dimensions of the chamber and the size of the cores to be coated. It is generally chosen in a range from 3 to 30 rpm, for example in a range from 10 to 20 rpm.
• the movement of the bed of cores excludes the transport of said cores along a longitudinal axis.
• the cores being coated are not transported from one chamber to another, that is to say they are coated in a single chamber, and / or that the bed of cores is not coated in a longitudinal chamber along which they are transported.
• the temperature chosen for the drying air is preferably less than 10 ⁇ , preferably less than or equal to 80%, preferably less than or equal to 75%, preferably less than or equal to 70%, or even less than or equal to 65 * ⁇ , or even less than or equal to 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 ° C, or even less than or equal to 30 ⁇ , or even less than or equal to 25 * ⁇ .
• This drying temperature is generally at least 15%, preferably at least 20%.
• the flow rate can be chosen in a range from 50 to 8000 m 3 / h, for example in a range from 100 to 7000 m 3 / h, for example from 100 to 1000 m 3 / h.
• the exit of the drying air is advantageously effected by suction of air by means of the perforations of the perforated rotary drum.
• the perforated wall area of the rotary drum useful for the invention preferably represents at least 50% of the surface of said drum wall, preferably at least 60%, preferably at least 70%, preferably at least 80% preferably at least 90%. Most preferably the wall of the drum is perforated over its entire surface.
• the temperature of the bed of nuclei being coated is at most 70%, preferably at most 60%, preferably at most 55%, preferably at most 50%, preferably at most more than 45 * ⁇ , not more than 40 * ⁇ , not more than 35 ° C or more than 30 * ⁇ or more than 25 * ⁇ .
• This temperature of the bed of cores being coated is generally at least 10 * ⁇ , or even at least 15 * ⁇ .
• the method of the invention comprises a step of heating the core bed to be coated. This step aims in particular to bring the core bed to a target temperature.
• the coating process of the invention concomitantly performs spraying and drying of the spraying liquid.
• the coating process phases during which the spraying is not carried out concomitantly with the drying process represent less than 50% of the coating process time, preferably less than 40%, preferably less than 30%, preferably less than 20%, preferably less than 10%, preferably less than 5%.
• the coating does not include a spray phase in the absence of drying.
• the possible pause times represent less than 50% of the coating process time, preferably less than 40%, preferably less 30%, preferably less than 20%, preferably less than 10%, preferably less than 5%.
• the coating does not include pause time.
• coated solid forms obtained by the process of the invention preferably have a percentage of coating 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%.
• this percentage of coating is, per unit of time, at least 0.05% per minute, preferably at least 0.10% per minute, preferably at least 0.13% per minute. or at least 0.15% per minute, or even at least 0.20% per minute, or even at least 0.30% per minute.
• the method of the invention may further comprise other usual steps than those aimed at coating the solid forms, as long as it does not contravene the properties sought in the present invention, especially as regards the quality of the sugar-coated solid forms.
• FIRE I LLE OF REM PLACEM ENT obtained and / or the maneuverability of the process.
• steps include, for example, guming, smoothing, polishing, and coloring.
• steps are performed, they are performed in the same equipment as that used in the coating process of the invention. It is understood that some of these steps, such as scrubbing or staining for example, can sometimes be likened to steps of coating, if the composition used comprises such a quantity of crystallizable materials that there is actually forming a layer crystallized substances, in particular sugars and / or polyols.
• the coating made according to the method of the invention already provides a good level of smoothing of solid forms.
• the coloration may also be carried out directly by adding coloring agents in the coating liquid.
• the method of the invention may also comprise a priming step.
• This priming step consists in applying, one or more times, a pulverulent composition to the bed of cores to be coated, or being coated, preferably during coating.
• This powdery composition typically comprises crystalline materials. These crystalline materials are typically of the same nature as the crystallizable materials of the coating liquid, but may be different.
• the amount of powder composition applied is typically less than 10% by weight based on the weight of tablets, preferably less than 5%.
• the method comprises an additional priming step.
• the method excludes this priming step.
• the equipment useful to the invention may comprise other elements conventionally used in coating, as long as this does not contravene the properties sought in the present invention, in particular as regards the quality of the obtained sugar-coated solid forms and / or the workability of the process.
• the prior art sometimes mentions the use of breakwaters, which are intended to avoid the appearance of collages during coating. Such breakwaters are not necessary in the process of the invention.
• the chamber of the drum used in accordance with the invention is free of breaker clods.
• Tube internal diameter 2 mm: outer diameter 6 mm.
• the coating liquids tested had the following formulations (%:
• the tablet bed was heated for 2 minutes in order to reach the desired temperature for the bed of cores. Spraying and drying were then carried out concomitantly throughout the process (no break time). At the end of coating, the spraying was stopped, and the solid forms dried for another 2 minutes.
• the method of the invention advantageously allows all types of solid forms to be coated in a very simple process, and makes it possible to successfully retain complex irregular shapes, such as relief impressions, ridges, and asymmetrical shapes.
• the inventors have thus succeeded, for example, in coating tablets and chewing gums, whether they are hygroscopic ("Comp-SORB” and "CG”) or not (“Comp-MANN”) while preserving the raised impressions. present on their surface.
• the coating liquids used can contain all kinds of crystallizable materials and can be very simple formulating. Tests “Xyl-IN3” and “Man-IN5", for example, show that a binder-free coating liquid (“BF") is also suitable for the process of the invention.
• BF binder-free coating liquid
• the method of the invention also makes it possible to successfully rubberize solid forms with so-called “natural” coating liquids, which in particular are free of titanium dioxide (Test "Xyl-IN4", using the "N” coating liquid ).
• the method of the invention also allows the use of very low solids, which is also new in coating. All the tests presented here use coating liquids whose dry matter does not exceed 60%. The method of the invention thus makes it possible to use carbohydrates which are poorly soluble in water (for example mannitol) for coating.
• the process of the invention also allows the use of relatively low drying temperatures.
• the main objective of the "Man-IN1" test is to illustrate this effect and shows that a mannitol coating with a temperature of 25 ° C. is possible.
• the resulting sugar-coated solid forms have a very clear shape, faithful to that of the starting nuclei ( Figure 2. a).
• the possible use of particularly low drying temperatures makes it possible in particular to obtain a core bed temperature which is also low, thus making it possible to obtain the coating of core compositions having thermolabile ingredients, as is the case with certain active agents. especially pharmaceutical.
• the temperature of the tablet bed does not exceed 26 ° C.
• the temperature of the coating liquid can also be very low, since the process of the invention does not necessarily require that the latter contain a large amount of crystallizable materials in solution.
• the coating liquids used were indeed at ambient temperature (20-25 ° C.). In addition to facilitating the implementation of the method, this allows the use of thermolabile ingredients in these liquids.
• rotating drum diameter 30 cm;
• Tube internal diameter 2 mm: outer diameter 6 mm.
• Example 1 the coating liquids employed were as follows:
• “Gum syrup” Formulation (% dry): 96.0% sucrose; 4.0% gum arabic (introduced as a 40% solution by weight of solids); Dry matter content: 72%.
• “Smoothing syrup” Formulation (% dry): 97.0% sucrose; 2.0% glucose syrup; 1.0% titanium dioxide; Dry matter content: 70%.
• Color syrup Formulation (% dry): 98.0% sucrose; 2.0% Blue Pigment (Blue No. 1
• Example 1 of US 2008/0026131 A1 drying temperatures, dry materials, etc.
• the parameters such as the spraying rate or the speed of rotation of the drum have been adapted to the size of the coating chamber available to the inventors.
• a first test was carried out according to the following table by carrying out several cycles each consisting of a spraying phase, then a pause time (distribution), then a drying step:
• Test Bag-CP2 A second test was therefore performed in order to avoid this sticking phenomenon and to reproduce Example 1 of US 2008/0026131 A1 in its entirety.
• Test Bag-CP2 A second test was therefore performed in order to avoid this sticking phenomenon and to reproduce Example 1 of US 2008/0026131 A1 in its entirety.
• Test Sac-CP3 A third test was carried out in which only the "Smoothing" Porphyry Phase of the Sac-CP2 Assay was implemented. Results similar to those of the Sac-CP2 Assay were obtained ( Figure 5.b)): the coated tablets had a generally coarse and rounded shape, and the raised prints were covered.

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