Patent Description:
Allulose is a hexoketose monosaccharide sweetener, which is a C-<NUM> epimer of D-fructose and is rarely found in nature. It has <NUM> % relative sweetness but <NUM> % energy of sucrose, and is suggested as an ideal sucrose substitute for food products. It shows important physiological functions, such as blood glucose suppressive effect, reactive oxygen species scavenging activity, and neuroprotective effect. It also improves the gelling behavior and produces good flavor during food process.

A non-cariogenic sweetener with a major component of allulose has been reported in literature to offer health benefits relevant to weight management and obesity related illnesses (i.e. type II diabetes, metabolic disorders).

Allulose has already been used as a sweetener in food and drink formulations, (see for instance patent applications <CIT>, <CIT> and <CIT>), but could not be found in the form of tablets in the prior art.

However there would be a great advantage to have tablets based on allulose, i.e., tablets comprising great amount of allulose, for use as a sweetener with health related benefits in confectionary products as well as nutritional and dietary supplement. Human or vetenary pharmaceutical solid dosage form (tablets) could also take advantages of such excipient.

The direct compression techniques enable the manufacture of tablets containing a precise amount of (active) ingredients, at high speed and at relatively low cost.

Direct compression consists in strongly compressing a powder into a die using a punch, so as to impart thereto the form of a tablet. The high pressure applied allows aggregation of the molecules of the powder which produces a solid tablet.

These powders include various ingredients, usually:.

Commonly used direct compression excipients are anhydrous lactose, cellulose and microcrystalline cellulose (MCC). Direct compression excipients are the major ingredients in these compositions, as their role and their quantities are of importance in these compositions. They must be in large amounts to allow the obtaining of a solid dosage form.

As a result, only a little amount of other material can usually be introduced in tablets. This is why tablets comprising great amounts of allulose could not be found in the prior art.

However, the inventors succeeded in obtaining tablets which can comprise more than <NUM> % by weight of allulose.

To do so, the inventors prepared allulose capable of acting as a direct compression excipient, and as a result, that can be introduced in significant amounts in tablets. The allulose according to the invention can advantageously fill both roles of sweetener and direct compression excipient.

Indeed, allulose is not naturally compressible; meaning that allulose obtained by natural crystallization in water is not compressible. It lacks flow, cohesion or lubricating properties necessary for the production of tablets by direct compression.

The allulose developed by the inventors is in the form of granules, is compressible, and allows the preparation of tablets having hardness greater than <NUM> N.

<CIT> relates to a probiotic compressed tablet comprising probiotics and a stabilizing agent of these probiotics. The bulking agent may be carbohydrates, which include allulose.

<CIT> relates to rare saccharides having physiological activity such as psicose as active ingredients of a composition that can inter alia take the form of tablets.

<CIT> relates to a composition for treating neuropathic pain which contains one or more substance selected from the group consisting of D-allose, D-allose derivatives, D-psicose. The composition can inter alia take the form of tablets.

<CIT> relates to a composition for improving taste of a high-intensity sweetener, wherein the rare sugar is at least D-psicose and/or D-allose. The composition can take any form including solids inter alia of a granule or a solid such as a tablet.

<CIT> relates to an agent for treating and/or preventing accelerated energy expenditure and/or diminished energy expenditure functionality comprising D-psicose as an active ingredient. The agent can take any form including solids inter alia of a granule or a solid such as a tablet.

<CIT> discloses a fructose-based granulated product and a process for making the same.

<CIT> relates to crystals of L-psicose and methods for producing the same.

, <NUM> relates to the use of D-psicose as a food ingredient (<NPL>).

There was no hint in the prior art suggesting allulose acting as a direct compression excipient. A fortiori, there was no hint in the prior art suggesting that this allulose needed to be in the form of granules.

It was thus an object of the present disclosure to provide directly compressible compositions comprising significant amounts of allulose.

It was another object of the disclosure to provide tablets based on allulose, i.e. tablets exhibiting high amounts of allulose, and at the same time, satisfying hardness.

The present invention is as defined in the appended set of claims.

The present invention first relates to a method for the manufacture of granules of D-allulose which are compressible in the sole presence of a lubricant by direct compression, to form a tablet having a diameter of <NUM>, a thickness of <NUM>, an apparent density of <NUM>/ml ± <NUM>/ml, a cylindrical shape with convex faces with a radius of curvature of <NUM>, whose hardness is greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, even more preferably greater than <NUM> N , comprising:.

The present invention also relates to the use of granules of D-allulose obtainable according to the above method as a direct compression excipient in a directly compressible composition, the composition consisting in a powdery composition suitable for the manufacture of tablets by direct compression.

The present invention further relates to a method for the manufacture of a tablet, comprising the steps of: providing a directly compressible composition which consists in a powdery composition suitable for the manufacture of tablets by direct compression, the directly compressible composition comprising the granules of D-allulose obtainable by the above method for the manufacture of granules of D-allulose, wherein granules of D-allulose represent at least <NUM>% of the directly compressible composition; followed by directly compressing said composition to form the tablet.

The inventors succeeded in obtaining compositions based on allulose, suitable for direct compression, as evidenced in Example <NUM>. These directly compressible compositions allowed the preparation of tablets having hardness greater than <NUM> N. They comprised <NUM> % by weight of allulose, and no other direct compression excipient was required to obtain these results.

This allulose was obtained through a process of granulation that can be advantageously carried out by solely using water and allulose.

Granulation refers to the act or process in which primary powder particles are made to bind each other to form multiparticulate agglomerates called granules. It is the process of collecting particles together by creating bonds between them. The two principal types of granulation technologies are wet granulation and dry granulation.

In wet granulation, granules are formed by the addition of a granulation liquid onto a powder bed which is under the influence of an impeller (in a High or Low shear granulator), screws (in a twin screw granulator), a rotating device (for instance a rotating pan or a rotating drum), or even preferably, air (in a fluidized bed granulator or in a spray-drier). The agitation and the wetting of the primary powder along the system results in the aggregation of the particles composing said primary powder to produce wet granules. The granulation liquid is removed by drying. The granulation liquid can be water-based or solvent-based. Typical solvents include water, ethanol and isopropanol either alone or in combination.

The granulation liquid mixed into the powders can form bonds between powder particles that are strong enough to lock them together. However, once the liquid dries, the powders usually fall apart.

Granulation process thus can be very complex depending on the characteristics of the powders, and the final objective.

In general the liquid is not strong enough to create and hold a bond. In such instances, one or more binders are required.

To this end co-processing has been the most widely explored and commercially utilized method for the preparation of granules. It consists in combining through an appropriate process, the material to be granulated with one or more established other excipient, in particular binders.

The one or more binders to be selected will strongly depend on the material to be made compressible, and to the granulation process used. Depending on the method, the one or more binders will be introduced at different time during the process. It can be introduced dissolved in suitable solvent or in the form of a powder that will dissolve in the granulation liquid during the process.

Examples of binders are povidone, microcrystalline cellulose (MCC), carboxymethyl cellulose (CMC), hydroxypropyl cellulose (HPMC), starch derivatives like maltodextrins, acacia gum, tragacanth gum, gelatin.

Povidone, which is a polyvinyl pyrrolidone (PVP), is one of the most commonly used pharmaceutical binders in wet granulation processes. When PVP and a solvent are mixed with powders, PVP forms a bond with the powders during the process, and the solvent evaporates.

Sometimes, the use of a binder is not sufficient, and the powder needs to be pre-treated before to be granulated, typically by undergoing a step of spray-drying.

Surprisingly, and as evidenced in Example <NUM>, the inventors found that the compressible granules of allulose obtainable according to the method of invention could be obtained through particular process of wet granulation, by using allulose itself as a binder.

That is to say, that allulose was turn into granules without the need of being co-processed.

Even more surprisingly, and advantageously, no pre-treatment of the powdery allulose was required to obtain such granules of allulose.

This means that not only the inventors were able for the first time to obtain a directly compressible allulose, but also in doing so, found that this was possible thanks to a particularly easy to carry out process. To be implemented, this process does not require excessive number of materials and of steps.

Moreover the granulation liquid is advantageously water-based, so has the advantage of being safe to deal with.

Thanks to the inventors, it is now possible to obtain tablets, comprising significant amounts of allulose, which can be greater than <NUM> % by weight relative to the total weight of the tablet, typically of between <NUM> and <NUM> %. Allulose can advantageously play both role of direct compression excipient and sweetener in the compositions of the present application.

The granules of D-allulose obtainable according to the method of the invention are particularly advantageous for both manufacture of suckable and chewable sweet tablets. Indeed, the tablets obtained out of the granules of D-allulose obtainable according to the method of the invention exhibit excellent taste and texture, as compared to the sweet tablets of prior art, in particular as compared to the tablets made out of directly compressible sweet sugar or sugar alcohol of prior art. These tablets exhibit smooth sensation in the mouth when sucking, with no sticking and no gritty sensation, as well as pleasant chewable texture.

This was not possible before the present invention, because compressible allulose could not be found. If high amounts of allulose would have been used, the compositions obtained thereof would have been impossible to compress.

Granules of D-allulose obtainable according to the method of invention are compressible in the sole presence of a lubricant by direct compression, to form a tablet having a diameter of <NUM>, a thickness of <NUM>, an apparent density of <NUM>/ml ± <NUM>/ml, a cylindrical shape with convex faces with a radius of curvature of <NUM>, whose hardness is greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, even more preferably greater than <NUM> N.

In order to evaluate if a material is compressible and can allow forming tablets having the hardness complying with the invention, the person skilled in the art can adapt the nature and the amount of lubricant used. The material to be compressed can be for instance composed of <NUM> % by weight of said material and <NUM> % of lubricant, usually magnesium stearate.

The tablet can be formed by means of a single punch press, for instance like the one disclosed in "Procedure <NUM>" hereinafter in the Examples.

The hardness can be evaluated by the person skilled in the art on a hardness tester. An example of such hardness tester is disclosed in "Procedure <NUM>" described hereinafter in the Examples. The value given in newtons usually corresponds to a mean value from <NUM> measurements.

In general, the hardness is lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N.

The granules of D-allulose obtainable according to the method of the invention preferably has mean volume diameter D <NUM>,<NUM> between <NUM> and <NUM>, preferably between <NUM> and <NUM> and more preferably between <NUM> and <NUM>.

The mean volume diameter D <NUM>,<NUM> can be determined by the person skilled in the art on a LASER diffraction granulometer type LS <NUM> from the company BECKMAN-COULTER, equipped with its powder dispersion module (dry method), following the manufacturer's technical manual and specifications. The measurement range of the LASER diffraction granulometer type LS <NUM> is from <NUM> to <NUM>. The operating conditions of hopper screw speed and intensity of vibration of the dispersion channel are determined in such a way that the optical concentration is between <NUM>% and <NUM>%, ideally <NUM>%. The results are calculated in percentage by volume, and expressed in µm.

Allulose used according to the invention is in the D- configuration.

In the present invention, D-allulose is used because easier to obtain.

The granules of D-allulose obtainable according to the method of the invention can be used as a direct compression excipient in a directly compressible composition, the composition consisting in a powdery composition suitable for the manufacture of tablets by direct compression.

In the present invention, "directly compressible composition" means a powdery composition suitable, per se, for the manufacture of tablets by direct compression. This composition always comprises a direct compression excipient or a mixture of direct compression excipients. Such composition allows the manufacture of tablets of sufficient hardness, and of satisfying appearance.

Preferably, the granules of D-allulose obtainable according to the method of the invention are further used as a sweetener, preferably as a low-calorie sweetener, i.e. for the manufacture of tablets having calorific value lower than <NUM> kcal/g, preferably lower than <NUM> kcal/g, preferably lower than <NUM> kcal/g, preferably lower than <NUM> kcal/g, even more preferably lower than <NUM> kcal/g.

It is preferably used as a sweetener having a relative sweetness, as compared to sucrose, of between <NUM> and <NUM>, preferably of between <NUM> and <NUM>, typically of <NUM>.

Preferably, the granules of D-allulose obtainable according to the method of the invention are further used as a health ingredient having physiological functions, such as blood glucose suppressive effect, reactive oxygen species scavenging activity, and/or neuroprotective effect.

A directly compressible composition comprising the granules of D-allulose obtainable according to the method of invention is described herein.

Thanks to the granules of D-allulose obtainable according to the method of invention, the directly compressible composition described herein can comprise significant amounts of allulose, notably without requiring the adding of other direct compression excipients.

In the directly compressible composition described herein, granules of D-allulose preferably represent at least <NUM> % of the directly compressible composition, preferably at least <NUM> %, preferably at least <NUM> %, preferably at least <NUM> %, preferably at least <NUM> %, preferably at least <NUM> %, preferably at least <NUM> %, typically between <NUM> and <NUM> %, even between <NUM> and <NUM> %, said percentage being expressed in dry weight, with respect to the total dry weight of said directly compressible composition.

Preferably, the directly compressible compositions described herein comprise no more than <NUM> % of direct compression excipients other than the granules of D-allulose obtainable according to the method of the invention, preferably no more than <NUM> %, preferably no more than <NUM> %, preferably no more than <NUM> %, preferably no more than <NUM> %, preferably no more than <NUM> %, preferably no more than <NUM> %, more preferably no more than <NUM> %, and most preferably <NUM> %, said percentage being expressed in dry weight, with respect to the total dry weight of said directly compressible composition.

It is an object of the present invention to provide a method for the manufacture of granules of D-allulose which are compressible in the sole presence of a lubricant by direct compression, to form a tablet having a diameter of <NUM>, a thickness of <NUM>, an apparent density of <NUM>/ml ± <NUM>/ml, a cylindrical shape with convex faces with a radius of curvature of <NUM>, whose hardness is greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, even more preferably greater than <NUM> N , comprising:.

In general, step (a) simply consists in dissolving powdery D-allulose into water, to obtain an aqueous solution of D-allulose.

Powdery allulose can be, for instance, individual crystals, classically obtained by crystallization from a solvent such as water or a mixture of water and ethanol, preferably water alone.

Powdery D-allulose can also be composed of, or can also comprise, the granules obtained in step (c) or (c'), which are preferably grinded before undergoing step (b).

Step (a) is preferably performed at a temperature which allows good dissolving of D-allulose into water. It is preferably performed at ambient temperature as allulose is very soluble in water (about <NUM> per <NUM> water at <NUM>). For the preparation of a granulation liquid comprising higher concentrations of D-allulose, a heating will be required. Typically the D-allulose will be dissolved in water heated from <NUM> to <NUM>. Preferably, the granulation liquid is applied by means of a spraying system, for instance by using one or more spraying nozzle(s). It is preferably applied in the form of fine droplets.

The quality of the contact between the granulation liquid and the powdery D-allulose during step (b) notably depends on the mean used to move the powdery D-allulose. This can be performed by subjecting the powder to the influence of an impeller (in a High or Low shear granulator), screws (in a twin screw granulator), a rotating device (for instance a rotating pan or a rotating drum), or even preferably, air (in a fluidized bed granulator or in a spray-drier).

The drying performed in step (c) is preferably performed concomitantly to the granulation step (b), by way of a granulator using air for granulation and for drying like spray-driers or fluidized bed granulators and dryers.

The method for the manufacture of granules of D-allulose according to the invention is preferably a continuous process using in particular a mixer-granulator, a continuous fluid bed granulator, or a spray-dryer.

The continuous process preferably includes the recycling of the granules obtained in step (c) or (c'). In this case, the granules are preferably grinded before undergoing step (b). The amount of recycled granules can be adapted so as to optimize the crystallization of D-allulose, to prevent the excessive formation of amorphous allulose. The ratio by weight of granulation liquid to the recycled granules is thus preferably of between <NUM>:<NUM> and <NUM>:<NUM>, preferably of between <NUM>:<NUM> and <NUM>:<NUM>.

The continuous process can be performed in an spray-dryer preferably equipped with a high pressure spray-drying nozzle, for instance of MSD-type, which preferably comprises the recycling of particles in the drying chamber.

Granulation may be carried out using, for example, a mixer-granulator operating batchwise, semi-continuously or continuously such as the vertical FLEXOMIX marketed by SCHUGI, a device of the DRIAM or DUMOULIN type, or the horizontal CB marketed by LODIGE into which is introduced, by way of a weight feeder, the starting powdery allulose to be granulated continuously and the granulation liquid by way of a volumetric feeder.

When using a SCHUGI vertical FLEXOMIX type, the starting powdery allulose and the granulation solution are very intimately mixed in the mixer-granulator fitted with a shaft with knives arranged in the form of blades, and a system of spraying liquids by way of injection nozzles.

According to a preferred embodiment of the invention, satisfactory dispersion of the constituents and agglomeration of the particles of the starting powdery D-allulose are carried out by high speed stirring, i.e. at a value at least equal to <NUM> rpm, preferably at least equal to <NUM> rpm. At the outlet of the mixer-granulator, the granules formed are discharged continuously into a dryer-ageing device.

Discharge takes place preferably by gravity in the case of said vertical granulator, and by thrust by way of the shaft of rotating knives if the horizontal granulator is used.

This second drying-ageing step at the outlet of the mixer-granulator makes it possible to remove, if necessary, all or part of the water originating from the binder such that crystallization and stabilization take place after the prior granulation step.

The dryer-ageing device may be, for example, a fluidized bed dryer-ageing device or a rotary ageing drum. The granules of D-allulose are obtained after cooling and optionally sieving.

In this case, the fine particles may be recycled directly to the start of granulation, and the coarse particles may be ground and recycled to the start of sieving.

Granulation can be performed in a high shear granulator, using a high speed propeller and a chopper to avoid too big lumps to be created. Such high shear granulators are very common in the pharmaceutical industry and manufactured by well-known suppliers (GLATT, DIOSNA, IMA and the like). Using such equipment the drying step © has to be done after the granulation step (b).

On the opposite, fluidized bed granulators (GLATT, GEA and the like) enable to do granulation step (b) and drying step (c) concomitantly. This process used to be a batch one but modern fluid bed granulators have been designed to run continuously. Such continuous equipment is preferred.

For step (a), and because this is more convenient, the starting allulose is in general the same as the one used in the moving powdery allulose.

Optional step (c') can be performed to allow granules to further crystallization and stabilization at a controlled temperature. This step (c') is preferably performed in a fluid bed or in a rotary drum.

The granules of D-allulose obtainable according to the method of the invention may comprise other ingredients, as long as it does not negatively affect the desired properties of the granules.

When present, the other ingredients are generally introduced in the process of the method for the manufacture of granules of D-allulose according to the invention, via the granulation liquid or via the moving powdery D-allulose.

Such 'other ingredients' can be without limitation:.

However, to limit the number of materials used, and because it is not required to obtain a satisfactory direct compression excipient, the granules preferably contain substantially no binders, other than allulose.

In general, the total amount of 'other ingredients', will be lower than <NUM> %, preferably lower than <NUM> %, preferably lower than <NUM> %, preferably lower than <NUM> %, most preferably equal to <NUM> %, said percentage being expressed in dry weight, with respect to the total dry weight of said granules.

By 'other ingredients' the inventors do not mean to include impurities, like those resulting from the synthesis of allulose, typically residual fructose.

In particular, the D-allulose such as defined in the present invention generally has purity between <NUM> and <NUM> %, said percentage being expressed in dry weight of allulose with respect to the total dry weight of said D-allulose.

The purity can in particular be determined by the person skilled in the art by using HPLC method with calcium column.

It is another object of the present invention to provide a method for the manufacture of a tablet, comprising the steps of: providing a directly compressible composition which consists in a powdery composition suitable for the manufacture of tablets by direct compression, the directly compressible composition comprising the granules of D-allulose obtainable by the method of the invention for the manufacture of granules of D-allulose, wherein granules of D-allulose represent at least <NUM>% of the directly compressible composition; followed by directly compressing the composition to form the tablet.

In the present invention, "tablet" means any solid edible preparation, which is obtained by direct compression. These tablets can be in the form of suckable tablets like mints, or in the form of soft or hard chewable tablets. They can be normal or multi layers tablets. They can be used as a nutritional or dietary supplement, or as a pharmaceutical, and can be intended for humans, adults or children, or to animals. Preferably the tablet is a sweet tablet, having calorific value lower than <NUM> kcal/g, preferably lower than <NUM> kcal/g, preferably lower than <NUM> kcal/g, preferably lower than <NUM> kcal/g, even more preferably lower than <NUM> kcal/g.

It preferably has a relative sweetness, as compared to sucrose, of between <NUM> and <NUM>, preferably of between <NUM> and <NUM>, for example of <NUM>.

Preferably, the tablet has hardness greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N.

In general, the hardness of the tablet is lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N, even lower than <NUM> N.

The tablets can be coated, notably by regular spray-drying of a film-forming composition onto a moving bed of tablets. The coating layer in general, will not exceed <NUM> % in weight of the coated tablet. The tablets may also be coated with sugars or polyols, using a "sugar-coating" process to form a frosting or a soft or hard coating, depending on the amount of powders or the coating process used.

The directly compressible compositions and the tablets generally comprise other ingredients. Such 'other ingredients' can be without limitation:.

The following Examples serve to illustrate the invention and should by no means be construed so as to limit the scope of the invention.

In the following examples, granules of allulose were prepared according to the method of the invention and put into the form of tablets whose hardness was determined, according to the Procedure <NUM> described below.

An allulose of prior art, obtained by crystallization in water, was used for comparison.

Compositions composed of <NUM> % by weight of the material to be tested as a direct compression excipient and <NUM> % by weight of magnesium stearate were first prepared.

Tablets were prepared out from these compositions, by means of the single punch laboratory press FROGERAIS AM (SVIAC, Anthony, France).

These tablets had a diameter of <NUM>, a thickness of <NUM>, an apparent density of <NUM>/ml ± <NUM>/ml, and a cylindrical shape with convex faces with a radius of curvature of <NUM>.

The inventors measured the hardness of the tablets thus obtained on an ERWEKA TBH <NUM> GMD hardness tester (ERWEKA, Heusenstamm, Germany). The value given in Newtons corresponds to a mean value from <NUM> measurements.

Granules of allulose were prepared in a fluid bed granulator Strea-<NUM> (Aeromatic_Fielder/ GEA - Bubendorf Switzerland). A solution of allulose is prepared by dissolving <NUM> of allulose in <NUM> of water. This solution is sprayed on <NUM> of powdery allulose fluidized in the fluid bed granulator. The allulose powder used has a mean diameter of <NUM>. The fluidizing air entrance is at <NUM> and the outlet air at <NUM>. This solution is added during <NUM> minutes (spraying speed about <NUM> per minute). The drying (air at <NUM>) is pursued about <NUM> minutes after the end of the spraying so that the powder is sufficiently dried. The granules obtained are sieved between <NUM> and <NUM> to remove the fine and coarse particles, to give granules [i-A].

Allulose granules were prepared using home-made rotating pan granulator. An allulose solution was prepared by dissolving <NUM> of allulose crystal in <NUM> water at a temperature of <NUM> to <NUM>. The solution was sprayed, with compressed air nozzle, on allulose dry powder in a rotating pan with a ratio of liquid to powder at <NUM>:<NUM>. The liquid spray rate was about <NUM> per minute. The liquid temperature was maintained at <NUM> during the process. Granules of allulose of a few millimeters were formed and continuously discharged out of rotating pan while the volume in the pan remains at constant. The granules were dried and maturated at forced-air circulation oven at <NUM> for <NUM> hours and conditioned at ambient temperature for <NUM> hours. The granules were then grinded and sieved at desired particle size of between <NUM> and <NUM> to give granules [i-B].

The granules of allulose [i-A] and [i-B] thus obtained were evaluated in compositions for tableting by direct compression, and compared with allulose of prior art obtained by crystallization in water (allulose [c-C]).

To this end, tablets were prepared out of these materials, the hardness of which was evaluated according to "Procedure <NUM> ". Results are showed in Table <NUM>.

These results show that the inventors succeeded for the first time in obtaining a composition comprising high amounts of allulose, which is compressible.

The inventors succeeded for the first time in obtaining directly compressible allulose, allowing the preparation of tablets having hardness greater than <NUM> N, in the sole presence of a lubricant, in particular in the present case, from compositions composed of <NUM> % by weight of granules of allulose according to the invention and <NUM> % by weight of magnesium stearate.

Claim 1:
A method for the manufacture of granules of D-allulose which are compressible in the sole presence of a lubricant by direct compression, to form a tablet having a diameter of <NUM>, a thickness of <NUM>, an apparent density of <NUM>/ml ± <NUM>/ml, a cylindrical shape with convex faces with a radius of curvature of <NUM>, whose hardness is greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, preferably greater than <NUM> N, even more preferably greater than <NUM> N, comprising:
- a step (a) of preparing a granulation liquid comprising D-allulose;
- a step (b) of granulating powdery D-allulose, by applying the granulation liquid obtained in step (a) onto moving powdery D-allulose;
- a step (c), preferably simultaneous with step (b), of drying the granules obtained in step (b);
- an optional step (c') of maturation of the granules obtained in step (c);
- a step (d) of recovering the granules obtained in step (c) or (c').