A new natural system with technical lubrication properties

Abstract

The present invention relates to systems with emergent properties, in particular systems suitable for use as lubricants, for example for the manufacture of tablets and capsules and as technical adjuvants for operating processing machines for the preparation of said substances, providing novel natural systems with lubricating activity (suitable for use as lubricants) of 100% natural origin, compositions containing them, their use and methods for their preparation. In particular, the present invention provides novel natural systems with lubricating activity (suitable for use as lubricants) consisting of 100% products of natural origin (not chemically synthesized), consisting of flours of fruits or seeds, including seeds, characterized by the presence of fatty acids, optionally in combination with natural gums, to replace the common powder lubricants of chemical origin.

Description

[Technical field]

[0001] The present invention relates to systems with emergent properties, in particular systems suitable for use as lubricants, for example for the manufacture of tablets and capsules, and as technical adjuvants for operating processing machines for the preparation of said substances, providing novel natural systems with lubricating activity (suitable for use as lubricants) of 100% natural origin, compositions containing them, uses and methods for the preparation of said lubricants. In particular, the present invention provides novel natural systems with lubricating activity (suitable for use as lubricants) composed of 100% products of natural origin (not chemically synthesized) consisting of flour of fruits or seeds, including seeds, said fruits or seeds being characterized by the presence of fatty acids, optionally in combination with natural gum, to replace commonly used powder lubricants of chemical origin. [Background technology]

[0002] Lubricants are substances that make it possible to prevent the adhesion of the powder to be compressed to the surface of the die-cutting matrix, to reduce friction and to facilitate the expulsion of the tablets from the matrix. These materials can be used directly in the mixture and / or externally (technical adjuvants) in the formulation to obtain compatible tablets or capsules.

[0003] The lubricating effect of an agent and its effectiveness (whether used as an additive or technical adjuvant, or both) can be evaluated, for example, by monitoring the tablet ejection force detected throughout the compression process.

[0004] Furthermore, the fundamental properties of the powder (particle size and distribution, or particle size distribution and specific surface area) and the derived properties (bulk density and flowability) play an important role in obtaining a compatible solid pharmaceutical form.

[0005] In the conventional production process schemes used for the manufacture of tablets and capsules of products of vegetable origin, the addition of stearates of chemical origin is expected to make the mixture slippery. Alternatively, the use of stearates is expected as a technical adjuvant for the operation of processing machines, where the stearates are added externally and leave traces of the adjuvant on the surface of the product.

[0006] Magnesium stearate is one of the most used lubricants worldwide and is derived from the reaction between magnesium chloride or oxide and stearic acid at high temperature in an aqueous environment. Increasing the mixing time leads to the formation of a lamellar layer that can coat the active ingredients, effectively sequestering them and delaying their bioavailability. Summary of the Invention [Problem to be solved by the invention]

[0007] There is therefore a need to provide mixtures that make it possible to avoid the use of stearates of chemical origin, both as components of formulations and as technical adjuvants in the conventional production processes used to manufacture capsules and tablets of products of natural origin, thus making it possible to obtain 100% natural products.

[0008] Document JP2007320856 describes lubricants that use the properties of fats and oils present in vegetable raw materials, in particular soybeans, document US2020 / 170936 describes rice husk-based lubricants, and document KR2020 / 0009128 describes cocoa powder-based lubricants. The type and amount of vegetable fat that must be present in said lubricants to achieve a technical action equivalent to that of magnesium stearate is not reported in the above documents. Some lubricants for tablets, consisting of natural substances such as derivatives of seeds and / or fats of some plants, are beginning to be described in the state of the art, but lubricants consisting of 100% natural ingredients technically equivalent to magnesium stearate do not appear to be available. [Brief description of the drawings]

[0009] [Figure 1] 1 is a graph showing a target curve of the ejection force [N] (item of the example of experiment 4) for defining a range of values ​​that contribute to the ejection force ensuring the release of the tablet from the die cutter. A standard powder mixture (also called standard mixture) consisting of microcrystalline cellulose and calcium carbonate or limestone powder in a weight ratio of 4:1 was obtained and performance tests were carried out with said mixture and a composition containing 1% magnesium stearate (w / w of the composition) with different mixing times to evaluate the tablet ejection force. The mixing time was related to the ejection force obtained to construct the target curve. The measurements carried out in FIG. 1 make it possible to establish a range of the extrusion force exerted by magnesium stearate to be used as a basis for the comparative tests. In particular, two parameters were identified: the mixing time at which the lowest ejection force value of the mixture is obtained equal to 5', and the mixing time at which the highest ejection force value of the mixture is obtained equal to 30'. The range of ejection forces considered effective based on the quality of the tablets obtained is between 0.05 and 0.50 N. [Diagram 2]Figure 1 shows a comparison of the ejection force of various fruit powders containing seeds (example of item 5 of experiment). Compression tests were carried out using a composition consisting of a standard mixture according to the present invention with the addition of fruit powders containing seeds of caraway, fennel and cumin, taken individually in weight percentages relative to the total weight of the composition. This composition contained in the same formulation an amount of fatty acid approximately equivalent to that present in 1% magnesium stearate, calculated according to the desired ratio of fatty acid based on table 1 herein. In particular, the ejection force of a composition containing fruit powders consisting of seeds of fennel, caraway and cumin (achene) and the standard mixture (microcrystalline cellulose and calcium carbonate in a weight ratio of 4:1) was evaluated. Results obtained with compositions (standard mixture and powder of fruit with seeds) with a weight percentage of 4.21% of powder of fruit with fennel seeds relative to the total weight of the composition, a weight percentage of 3.75% of powder of fruit with caraway seeds relative to the total weight of the composition, and a weight percentage of 3.91% of powder of fruit with caraway seeds relative to the total weight of the composition, using the same optimal mixing time (equal to 5 minutes) as found for magnesium stearate. The values ​​of the ejection force of the tablets were then analyzed and compared with the parameters obtained from the compression of a standard mixture (microcrystalline cellulose and calcium carbonate or limestone powder in a weight ratio of 4:1) which additionally contains 1% by weight of magnesium stearate relative to the total weight of the formulation (standard mixture + stearate), and with the values ​​of the maximum experimental ejection force for other products (whose generally accepted value corresponds to 0.5 N). The control is represented by the composition with mixing times of 5 and 30 minutes described with reference to FIG. 1. All compression tests were carried out with the same operating parameters. In all tests, the measured ejection forces are less than 0.5 N, but the values ​​obtained tend to be towards the upper limit (i.e. 0.5 N) set in the study based on the values ​​measured for magnesium stearate in Figure 1. [Diagram 3]1 shows the ejection force of a mixture containing a mixture of powdered seeds and / or fruits and gum arabic (also known as gum acacia) (example of item 6 of experiment). A system consisting of powdered gum arabic and powdered fruits with seeds or powdered fennel, caraway, cumin or mixtures of said powders of fruits with seeds in a ratio of 7:1 was premixed and the mixture obtained was placed in the standard mixture described above at a concentration of 32.34% (4.21% powdered fruits with seeds of fennel, caraway and cumin and 28.13% gum arabic in a ratio of 1:1:1) by weight relative to the total weight of the composition obtained (standard mix + mixture of powdered fruits with seeds and gum arabic). The ejection force values ​​obtained in comparison with the control (standard mix and 1% magnesium stearate by weight) and with the composition described above containing single fruits with powdered seeds (4.21% fennel, 3.75% caraway, 3.91% cumin) are reported below. Under the same operating conditions, a composition consisting of the standard mixture, gum arabic and powders of several fruits containing seeds (fennel, caraway and cumin) contributes to the generation of lower ejection force values ​​compared to a composition consisting of the standard mixture and powders of a single type of fruit containing seeds (fennel, caraway or cumin) and similarly compared to a composition consisting of the standard mixture and magnesium stearate. The exact values ​​obtained in the experiment illustrated in Figure 3 are shown in Table 4 of Experiment 6. [Figure 4] Figure 4 is a graph showing the distribution curve obtained by sieving using the sieving method (Example item of experiment 7). A mixture of gum arabic and powder of fruits including fennel seeds in a ratio of 5:1 was granulated with water and sieved by vibrating sieve. The obtained granules were subjected to particle size analysis, the results of which are shown in Figure 4. The physical properties of the granules are shown in Table 8. [Diagram 5]Graph showing comparative ejection force (item of the example of experiment 7). The ejection force values ​​obtained are reported in comparison with those obtained for the control defined above. The "Gum-Fennel" pregranulation system shows a different ratio with respect to that of the composition of FIG. 3, the pregranulated granules consisting of 2% by weight of powder of fruits containing fennel seeds and 10% by weight of gum arabic, compared to a total of 12% by weight in the composition containing the granules and the standard mixture. This figure demonstrates that with this system it is possible to obtain tablets without adding magnesium stearate either in the formulation or externally. Moreover, the amount of processed system added to this blend is much lower than that used in the composition of FIG. 3, thus demonstrating that even lower amounts of gum arabic and powder of fruits containing seeds than those tested in FIG. 3 are sufficient. The ejection force of the pregranulated granules described in FIG. 4 was also compared with respect to the same amount of its 355 μm particle size fraction. The pregranulated granules and their fractions have comparable lubrication properties. [Figure 6] 1. Full graph of ejection force (Example section of experiment 6, Table 5). All ejection force values ​​of the compositions listed in Table 5 are reported. This figure shows a completely unexpected synergistic effect both in a composition in which the natural lubricant system consists of a mixture of flours of different fruits containing seeds and, even more effectively, in a composition in which the natural lubricant system consists of gum arabic and flours of one or more fruits containing seeds. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Terminology As used herein, the term "IC Carr Index" refers to a dimensionless physical quantity that characterizes the compressibility of a powder or granular material.

[0011] As used herein, the term "IH Hausner Index" refers to the ratio between the compressed density of a powder and its initial density. This parameter is useful for assessing the flowability of a powder or a mixture of powders.

[0012] As used herein, the term "bulk density" refers to the density of a powder, taking into account interparticle and intraparticle spaces.

[0013] The term "tap density" as used herein refers to the value of density after packing. The terms "Dv10", "Dv50" and "Dv90" and "Span" refer to the following: - Dv10: 10% of the volume of distribution of particle size values ​​is less than the indicated value. - Dv50: Fifty percent of the volume of distribution of the particle size value is less than the indicated value. Mean volume of distribution value - Dv90: 90 percent of the volume of distribution of the particle size value is less than the stated value. - The span is calculated using the following formula:

number

[0014] A value corresponding to 1 corresponds to a Gaussian distribution.

[0015] The term "granulation" refers to the technical conversion of a substance or material into granules for the purpose of end use or further processing.

[0016] The term "compression" refers to a production process aimed at obtaining a tablet by mechanical means.

[0017] The term "ejection force" refers to an experimental parameter that makes it possible to measure the phenomenon of adhesion of the tablet to the die cutter, measured in "N". For the purposes of this specification, the maximum value of the ejection force considered acceptable is equal to 0.5 N, above which technical problems related to friction, adhesion and descaling, such as the adhesion of the tablet to the die cutter of the machine, are observed. The value of the ejection force is an index of the effectiveness of the lubrication system used, in particular a good lubricant is capable of reducing the value of the ejection force to values ​​below 0.1 N. The term "system with emergent properties" refers in this specification to a mixture or composition that exhibits an emergent behavior, i.e. a system in which the agents that make up the mixture acting in a given environment are present in the form of a system, thus giving rise to a more complex behavior. This property itself is not easily predictable and represents a subsequent level of development of the system. A complex emergent behavior is not a property of a single entity, but is in fact necessary to execute the entire system in order to obtain the observed emergent behavior.

[0018] In the present invention, 100% natural means that what is defined as 100% natural does not contain any components obtained from chemical synthesis, but only components of natural origin, in particular products derived from plants. The term "active ingredient" as used herein refers to a substance endowed with a specific biological activity, such as a therapeutic or prophylactic effect, including all of the substances in the formulation that exert a specific activity.

[0019] The standard mixture of powders, also referred to herein as the standard mixture, is a mixture of 4:1 microcrystalline cellulose and calcium carbonate or limestone powders, and a system with various concentrations depending on the type of lubricant or lubricant.

[0020] As used herein, the expression "physiologically active system" refers to a physiologically active system whose constituents interact with each other both structurally and functionally to determine emergent properties. The system described is physiologically active because it is capable of interacting with a living body by acting on a multi-level mechanism without artificially modifying a single and specific function. As used herein, the term "powdered natural raw material" refers to natural raw materials (seeds, fruits containing seeds, fruits, etc.) that have been dried and ground by a grinding process.

[0021] As used herein, the term "relative humidity" refers to the ratio of the density of the vapor contained in a substance to the density of saturated vapor at the temperature of the substance. Relative humidity is a measure of the amount of water vapor contained in a substance.

[0022] As used herein, the term "formulated preparation" refers to a mixture of active ingredients and, optionally, excipients, colorants, flavorings, and carriers for the preparation of a product in the form of a capsule or tablet. Formulated preparations are readily identifiable by those skilled in the art and are any formulation in which magnesium stearate can normally be used as a lubricant.

[0023] Thus, by seed-containing fruit it is intended the entire fruit including the seeds contained therein.

[0024] SUMMARY OF THE PRESENT APPLICATION The authors of the present invention have attempted to identify natural systems with lubricating technical activity suitable for use as lubricants in the manufacturing process of tablets and capsules and in machines for such manufacturing, which exhibit a different technical action, for example in terms of effectiveness, than that exerted by the single components of such systems, in order to make it possible to produce products made entirely from natural substances and therefore not made from chemical synthesis. In order to obtain a lubricant made of 100% natural substances and with an effectiveness comparable to that of magnesium stearate, the inventors have examined the lubricating properties of powders of various fruits containing seeds or powders of seeds containing fatty acids with similar chain lengths to those present in magnesium stearate in the manufacture of tablets or capsules, and have evaluated the lubricating activity of these powders in comparison with magnesium stearate. Grinding of fruits containing seeds or seeds converts these materials into powders that can be effectively blended into 100% natural product formulations. Furthermore, the milling process allows exposure of the lipid components, which can effectively interact with the active powder or granules of the product, thereby allowing for effective lubrication.

[0025] This effective contact makes it possible to convert the mixture obtained into capsules and / or tablets, guaranteeing the functionality of the technology used for these conversions, thereby avoiding the use of stearates of chemical origin, both as formulation components and technical adjuvants, in the conventional production processes used to manufacture capsules and tablets of products of natural origin, thus making it possible to obtain 100% natural products.

[0026] Furthermore, the authors of the present invention have surprisingly discovered that natural gums such as gum arabic have a lubricating effect in the preparation of tablets and capsules, even when used as the sole lubricant or as a component of a lubricant.

[0027] As shown in Figure 2, the control at the optimal mixing time derived from the curve in Figure 1 shows an ejection force value below 0.1 N due to the effectiveness of magnesium stearate in lubrication, while for the purposes of the present invention, the fruit powder with seeds shows an ejection force value close to what is considered to be the maximum acceptable limit of the ejection force value at the same mixing time considered optimal for the control at t minutes. While all the individual fruit or seed powders with seeds tested achieve an "acceptable" lubrication activity, it is not possible to obtain the excellent ejection force values ​​observed with magnesium stearate.

[0028] Surprisingly, the present authors have found that a suitable blend of seed-containing fruit powders or seed powders provides a system with the emergent property of a synergistic effect, with a lubricating activity that is unexpectedly significantly superior to that of a single powder, and that this effectiveness is further enhanced after mixing one or more seed-containing fruit powders with a vegetable gum / powder, thereby achieving a 100% natural system with a lubricating action that is even superior to that of magnesium stearate (suitable for use as a lubricant).Furthermore, the present authors have surprisingly found that the same vegetable gum is capable of achieving an effective lubricating activity by itself in the manufacture of capsules and tablets. In other words, the authors of the present invention have surprisingly discovered that the association of a vegetable gum with a powder of a particular seed-containing fruit or seed, or with a different powder of a seed-containing fruit or different powder of a seed, optionally in combination with a vegetable gum (also referred to herein as a natural gum), results in a system with emergent properties that have excellent lubricating properties that are comparable, if not better, than those exhibited by one of the most common and effective synthetic chemical lubricants for the manufacture of tablets and capsules, namely magnesium stearate, at its optimum use conditions, i.e. a mixing time of 5 minutes (see FIG. 6).

[0029] The inventive system presented here is in the form of a mixture or composition, thus resulting in an excellent lubricant suitable for the manufacture of 100% natural formulations.

[0030] Therefore, the object of the present invention is to: - from one or more fruits or seed genus including seeds in powder form and natural gum powder, or a mixture consisting of a mixture of seeds of at least three different species in powder form, in which the fruits or seeds including seeds from each of said species in powder form have a proportion of C, relative to the total fatty acids, of more than 45% w / w. 16 ~C 18 a mixture of fatty acids and of seeds-containing fruits containing at least 21% w / w of fatty acids, said species being cumin, caraway and fennel;

[0031] - compositions comprising a mixture according to the invention as the only lubricant; - use of the subject mixture of the present invention as a lubricant in the preparation of tablets, capsules and solid compositions; - Use of natural gums as lubricants in the preparation of tablets, capsules and solid compositions;

[0032] - a process for producing a capsule or tablet or a solid composition, comprising the step of mixing the mixture of the present invention with a suitable compounding preparation, said mixture being the only lubricant used in said process;

[0033] - a method for producing a capsule or tablet or solid composition comprising the steps of: i) providing one or more fruits or seeds including seeds and / or natural gums in powder form, wherein the fruits or seeds including the powdered seeds from each of said species have a percentage of C with respect to total fatty acids of greater than 45% w / w. 16 ~C 18 providing a seed which contains fatty acids and a proportion of fatty acids of at least 21% w / w, said seeds being cumin and / or caraway and / or fennel; ii) mixing said one or more seeds of fruit or seeds including seeds and / or said natural gums in powder form with a suitable blend preparation for a period of time ranging from 2 to 30 minutes, preferably from 5 to 15 minutes, even more preferably for 5 minutes; iii) subjecting the product obtained in step ii) to compression or encapsulation, the components used in steps i) and ii) constituting (being the only lubricants used in the process); A method comprising: - A capsule, tablet or solid composition obtainable by said process.

[0034] Further advantages and / or embodiments of the present invention will be apparent from the detailed description that follows.

[0035] Detailed Description The authors of the present invention have surprisingly discovered that the association of a vegetable gum with a powder of a fruit containing seeds or a powder of a seed, or with a different powder of a fruit containing seeds or a different powder of a seed, results in a system with emergent properties having excellent lubricating properties comparable to those exhibited by one of the most common synthetic chemical lubricants for the manufacture of tablets and capsules, namely magnesium stearate, at optimal use conditions.

[0036] The object of the present invention is therefore represented by a mixture consisting of one or more seeds of fruit or seeds containing seeds in powder form and a powdered natural gum, or by a mixture of at least three different species of fruit or seeds containing seeds in powder form, wherein the fruit or powdered seeds containing seeds of each of said species have a proportion of C 2 O 3 , 4 O 4 , 5 O 5 , 6 O 6 , 7 O 7 , 8 O 8 , 9 O 9 , 10 O 10 , 11 O 12 O 13 O 14 O 15 O 16 O 17 O 18 O 19 O 20 O 25 O 26 O 27 O 28 O 29 O 30 O 31 O 32 O 33 O 34 O 35 O 36 O 37 O 38 O 39 O 40 O 45 O 46 O 37 O 38 O 47 O 39 O 48 O 39 O 49 O 34 O 35 O 36 O 37 O 38 O 49 O 39 O 48 O 39 O 49 O 34 O 35 O 36 O 37 O 3 ... 16 ~C 18 The seeds of fruits or powdered seeds containing fatty acids and containing seeds in a proportion of at least 21% w / w of fatty acids are cumin, caraway and fennel. As can be seen from Table 1 in the Examples section of this specification, the C 16 ~C 18The fatty acids are mainly oleic and linoleic. According to the invention, said species is preferably characterized in that its dried fruits contain traditional seeds, i.e. seeds that remain viable and can withstand long periods of time without germination (several years).

[0037] Fennel fruits, also called double achenes, consist of schismatic fruits, more often a single yellow-green to yellow-brown, segmented miniature fruit ("achene"), 3-12 mm long and 2-4 mm wide. The apical fragment is often found at the upper tip of the hypostyle. Each achene has five straight rib-like projections, especially developed at the joints. The achene has a strong spicy odor, a spicy aroma, and a slightly spicy flavor. The mother plant of fennel fruits is fennel (Foeniculum vulgare), which belongs to the Umbrelliferae family. Caraway fruits, also called Carvi fructus, consist of schismatic fruits of the original diachene. The fruits are 3-6 mm long, about 1 mm thick, grey-brown, mostly slightly sickle-curved, pointed at both ends, and glabrous. The slightly convex dorsal surface has three straight, thin, prominent and distinct ribs; the surface has two, with a slightly arched joint at the margin. The style with a rounded hypostyle is often still present at the upper end. The fruits have a fragrant odor and a spicy, aromatic flavor. The mother plant of the caraway fruit is Carum carvi, which belongs to the Apiaceae family.

[0038] Cumin fruits consist of a straight, oval, thread-like achene, 5-6 mm long, yellowish brown, containing one seed. The seed is aromatic, with a characteristic bitter taste and a strong sweet smell. The mother plant of cumin fruits is Cuminum cyminum or Cuminum odorum, which belongs to the Apiaceae (or Umbralliferae) family. In one embodiment, said species of fruit or seeds containing seeds in powder form have a particle size distribution value calculated as Dv50 between 15 μm and 500 μm, preferably between 150 μm and 350 μm. The Dv50 parameter, like the Dv10 and Dv90 parameters, is an index of particle size distribution measured in μm and indicates the average volume diameter of the fine powder particles. Values ​​of 10, 50 and 90 indicate that 10, 50 and 90% of the analyzed particles are respectively below the corresponding μm value and can be obtained using a laser diffractometer. Examples of laser diffractometer experiments are given in the Examples section of this specification.

[0039] In one embodiment, the fruit containing the seeds or the seeds of the powdered seeds have a specific surface area of ​​25 m 2 / Kg~600m 2 / Kg, preferably 25m 2 / Kg~70m 2 / Kg.

[0040] In one embodiment, the fruit pit or seed, including the seed in powder form,

number

[0041] Span is an index that correlates to D90, D10 and D50 according to the formula above. A value corresponding to 1 corresponds to a perfect Gaussian distribution, while higher values ​​indicate a more polydisperse distribution.

[0042] In one embodiment, the seeds of fruit or seeds, including seeds, in powder form, and the natural gums in powder form are present in a weight ratio of 1:1 to 1:8, preferably 1:5 to 1:7, respectively. To provide a non-limiting example of an embodiment of the invention, the seeds of fruit or seeds, including seeds, in powder form, and the natural gum powder are present in a weight ratio of 1:7 in a formulation whose preparation does not require a granulation step, whereas they are present in a weight ratio of 1:5 in a formulation whose preparation requires a granulation step.

[0043] Granulation is a technological process in which particles of powder (understood as particulate matter) are adhered to one another to form particles with a larger diameter called granules. This process is often used in the pharmaceutical field to prepare granules that are to be used directly or subsequently processed for the preparation of other pharmaceutical forms such as capsules or tablets.

[0044] In a preferred embodiment, said natural gum is gum arabic and / or gum karaya. Gum arabic is a natural gum also known as gum acacia, as it is extracted from two sub-Saharan acacia species: Acacia senegal and Acacia seyal. Like almost all gums and resins of vegetable origin, gum arabic is produced by plants following a natural "gumming" process that is spontaneously activated to perfect its surface and heal wounds. From a chemical point of view, gum arabic is a mixture of calcium, magnesium and potassium salts of arabic acid. Hydrolysis releases the constituent monosaccharides, namely L-arabinose, D-galactose, L-rhamnose and D-glucuronic acid. At the molecular level, gum arabic consists of glycoproteins and oligosaccharides. Gum arabic has a wide range of fields of use, since it is edible and sticky, prevents sugar crystallization and emulsifies fats. Its main applications are in the food industry as a natural additive, in the pharmaceutical industry as an excipient and component, in cosmetics for its film-forming and fixing properties, and in adhesives and paints as a binder for tempera. Karaya gum is a sticky secretion that emerges naturally or after incision from the trunks and branches of some species of the genus Sterculia (especially Sterculia urens). These plants are native to the highlands of India and Pakistan, but some species that produce the gum also grow in Africa. Karaya gum, obtained from Sterculia scaphigera (a Vietnamese species), is instead extracted from the fruit by cold maceration.

[0045] From a chemical point of view, karaya gum is a complex polysaccharide with a high molecular weight, composed of the sugars galactose, rhamnose and glucoronic acid. It is poorly soluble in water and, on contact with water, swells rapidly to reach a volume significantly greater than its initial volume. This property explains its various applications in the industrial and health sectors. It is widely used by the food (E416) and cosmetic industries as a thickener / stabilizer, as a binder and as a laxative gum to add bulk in the treatment of constipation. For this purpose, karaya gum can also be combined with sulfates or magnesium oxide. In a further embodiment, the natural gum powder has a Dv50 in the range of 60 μm to 70 μm, a 100m 2 / Kg~150m 2 / Kg range, preferably 137m 2 / Kg and a span value in the range of 1 to 1.8, preferably 1.75.

[0046] In a preferred embodiment, said mixture of at least three seeds of fruit containing seeds in powder form, or different seeds, is constituted by a fruit powder containing cumin seeds, a fruit powder containing caraway seeds and a fruit powder containing fennel seeds, or may consist of the powders of the above mentioned seeds.

[0047] In a further embodiment, the fruit powder comprising cumin seeds, the fruit powder comprising caraway seeds, and the fruit powder comprising fennel seeds are present in a weight ratio between them of 1:1:1 to 1:1:3, preferably 1:1:1.

[0048] The same applies when the above-mentioned seed powder is used. In an embodiment according to any of the embodiments described herein, the subject mixture of the present invention comprises: - powdered caraway fruit and powdered gum arabic, with seeds in a weight ratio ranging from 1:1 to 1:8, preferably from 1:5 to 1:7; and / or - powdered fennel fruit and powdered gum arabic, with seeds in a weight ratio ranging from 1:1 to 1:8, preferably from 1:5 to 1:7, and / or - powdered cumin fruit and powdered gum arabic containing seeds in a weight ratio ranging from 1:1 to 1:8, preferably from 1:5 to 1:7 It consists of:

[0049] In a preferred embodiment, the mixture comprises caraway fruits, fennel fruits and cumin fruits with seeds in a ratio of 1:1:1, respectively, and gum arabic powder in a weight ratio ranging from 1:1 to 1:8, preferably from 1:5 to 1:7.

[0050] The same applies when the abovementioned seed flours are used.The subject of the present invention is therefore also a tableting lubricant consisting of the inventive mixture as defined in the present description and claims.

[0051] The characterization of the basic properties of the powders used in the present invention shows significantly different values ​​between the fruit powders containing seeds and magnesium stearate, both in terms of specific surface area and Dv50, but at the same time the characterization of the indirect properties such as the flowability index (IC) and the compressibility index (IH) shows values ​​comparable, if not lower, to those obtained with magnesium stearate.

[0052] A further object of the present invention is represented by a composition comprising the mixture defined according to the previously described embodiments, said composition being a tablet, capsule or solid composition, said mixture being the only lubricant contained in said composition. A non-limiting example of a tablet according to any of the embodiments of the present invention is as follows: Plain or coated tablets (sugar-coated pills): swallowed whole Tablets: Not swallowed whole, but dissolves in the mouth Chewable tablets: Chewed before swallowing Sublingual tablet: absorbed through the mucous membrane of the tongue (e.g., nitroglycerin) Soluble tablets: Dissolved in water; these tablets are often effervescent to facilitate dissolution or improve flavor Sterile tablets for preparing an injection solution Sterile compress for subcutaneous implantation A tablet used as a vaginal pessary, most often replacing gelatin pessaries Tablets for preparing solutions for external or diagnostic use (pregnancy tests, denture adhesives, etc.) Furthermore, the tablet according to the present invention may be a coated tablet, said coating also being a coating for its controlled release.

[0053] In one embodiment, the mixture of powdered fruit or powdered seeds including seeds is present in the composition at a concentration of from 1% to 35% w / w, preferably from 3% to 4.5% in the mixture without natural gums and preferably from 12 to 33% in the mixture containing natural gums.

[0054] In one embodiment, the composition is a pharmaceutical product, a cosmetic product, a nutraceutical composition, a medical device, a dietary supplement, a food. In an embodiment, the composition is a pharmaceutical composition, the composition comprises at least one natural active complex system (such as, for example, one or more plant extracts or fractions thereof) or one or more pharmacologically or physiologically active ingredients, and one or more pharmacologic acceptable excipients and / or carriers (such as, for example, plant extracts or derivatives) of pharmaceutical grade or other powdered natural raw materials, preferably of natural origin. The excipients and / or pharmacologic acceptable carriers are known to those skilled in the art. The medical device corresponds in the present invention to a medical device according to any of the classes described in the Medical Device Regulation 745 / 2017, in the EEC Directive 93 / 42 on medical devices (which also includes materials, not just "devices" in the mechanical sense of the term).

[0055] The composition may also be in the form of a food, such as a food for special medical purposes, a dietary supplement, or any form that complies with the regulatory provisions of the country in which the composition is produced.

[0056] In one embodiment, the composition is in the form of a capsule, tablet, powder, granule, capsule, solid composition (e.g., solid toothpaste).The use of the mixture defined by the embodiment herein is also an object of the present invention as a lubricant in the preparation of tablets, capsules, powders, granules, capsules, solid compositions (e.g., solid toothpaste).

[0057] A further object of the present invention is the use of a natural gum, preferably gum arabic or karaya, as a lubricant in the preparation of tablets, capsules and solid compositions.

[0058] In one embodiment the natural gum is present in the range of 1% to 35% by weight of the tablet, capsule or solid composition.

[0059] In a further embodiment, the natural rubber powder has a Dv50 value in the range of 60 μm to 70 μm and a 100 m 2 / Kg~150m 2 / Kg range, preferably 137m 2 / Kg and a span value in the range of 1 to 1.8, preferably 1.75. In summary, the present invention also relates to a drug, cosmetic, dietary supplement, medical device, dietary supplement, food, consisting of a capsule, tablet or solid composition comprising the lubricating system of the present invention according to any of the embodiments described herein as the only lubricant.

[0060] In one embodiment, said mixture is contained within a product in the form of a tablet, capsule, solid composition, such as, for example, a solid toothpaste, and is therefore used only as an internal lubricant. However, said mixture may also be used only as the sole lubricant for the lubrication of a machine suitable for the preparation of said product form, and therefore as an external lubricant. The use of the subject mixture of the present invention for lubricating a machine may be carried out by spraying through a nozzle. Thus, for the purposes of the present invention, in the case of the above-mentioned uses, a suitable micronization of the powder may be carried out so as to obtain a particle size distribution suitable for the required use. Thus, the object of the present invention is also a method for producing a capsule or tablet or solid composition, comprising a step of mixing the mixture as defined in the present specification and claims with a suitable formulation preparation (i.e. including other substances or ingredients that must be present in said capsule, tablet or composition), and the sole lubricant being said mixture. The present invention also relates to a method for producing a capsule or tablet or solid composition, comprising the following steps: i) providing one or more fruits or seeds including seeds and / or natural gums in powder form, wherein the fruits or seeds including the powdered seeds from each of said species have a percentage of C with respect to total fatty acids of greater than 45% w / w. 16 ~C 18 and a fatty acid content of at least 21% w / w. ii) mixing said one or more seeds of fruit or seeds including seeds and / or said natural gums in powder form with a suitable blend preparation for a period of time comprised between 2 and 30 minutes, preferably between 5 and 15 minutes, even more preferably for 5 minutes; iii) subjecting the product obtained in step ii) to compression or encapsulation; wherein the components used in steps i) and ii) constitute the only lubricant used in the process.

[0061] Optionally, the above process may comprise a further step between steps i) and ii) above of granulating said fruit or seeds, including seeds, in powder form, and / or said natural gums.

[0062] The present invention also relates to a method for producing the above capsule or tablet or solid composition, wherein step ii) comprises the following steps: iia) granulating the blend preparation with natural gums; iib) is replaced by a step of mixing the granulate obtained in step ii) with the one or more fruits or seeds, including seeds, in powder form prepared in step i) for a period of time ranging from 2 to 30 minutes, preferably from 5 to 15 minutes, even more preferably 5 minutes, until a homogeneous mixture is obtained. In one embodiment, the granulate obtained in step iia) is dried until a relative humidity between 23% and 26% is reached, before mixing at point iib). The steps of granulation, compression or encapsulation and mixing for the purposes of the method of the present invention are carried out in accordance with techniques known in the prior art.

[0063] A compounded preparation according to this specification is any preparation for preparing a tablet, capsule or solid composition described elsewhere in this specification, and no lubricant is added to this preparation.In other words, compounded preparation corresponds to a preparation that undergoes the manufacturing process of a capsule or tablet or solid product, to which a person skilled in the art adds magnesium stearate as lubricant or other lubricants commonly used in pharmaceuticals, nutraceuticals, cosmetics, food, for the preparation of products that must be compressed or encapsulated by industrial machines commonly used for this purpose.Therefore, it is possible to understand the general definition of compounded preparation / preparation, since a person skilled in the art knows which preparations are suitable for being converted into a tablet, capsule or solid product after appropriate addition of lubricant.

[0064] Examples of such preparations are, for example, mixtures of powders and / or granules which, in addition to one or more active ingredients, pharmaceutical substances such as nutraceuticals, foods, cosmetics, etc., also contain one or more of the following: Diluents: increase the mass of the tablet allowing the achievement of the correct volume suitable for processing; Adsorbents: used to agglomerate the granules. In addition, solvents (water or alcohol) that exert a sticky effect when evaporated, or else syrupy solutions or sticky substances (pectin, methylcellulose, carboxymethylcellulose, gelatin, etc.) are used; Glidants: these agents penetrate themselves between the particles of the powder or granules to which they are added and fill the irregular cavities present on their surface; in this way the shape of the powder or granule becomes more regular and friction is reduced; Deflocculation Agent: Deflocculation agent reduces the deflocculation time of tablets may include.

[0065] For example, instead of commonly used lubricants such as Ca stearate, Mg stearate, Al stearate, stearyl alcohol, stearic alcohol, cetyl alcohol, palmitic acid, alcohol, starch, PEG, talc, etc., the method of the present invention uses only the systems or natural gums having the emergent lubricating properties described herein in the form of mixtures.

[0066] Granulation is a technique that involves increasing particle size by agglomeration and is one of the most important single operations in the production of pharmaceutical forms such as tablets and capsules. During the granulation process, small fine or coarse particles are converted into larger agglomerates called granules.

[0067] This technological process can be carried out according to two methods called dry granulation and wet granulation. In both processes, the formation of granules is obtained by establishing bonds between powder particles. Dry granulation involves the use of mechanical compression (slugging) or compaction (roller compaction) to induce cohesion of powder particles, while wet granulation involves the use of liquid granulation (binders / solvents) to induce cohesion by the formation of a wet mass through adhesion.

[0068] To the classical granulation techniques, which include the use of cylinder compressors, or section kneaders with zeta or sigma arms, or even vibratory and rotary granulators, other modern techniques are added, which are listed below: pneumatic granulation, reverse wet granulation, steam granulation, moisture-activated dry granulation, thermally bonded granulation, melt granulation, freeze granulation, foam granulation. Furthermore, in the case of wet granulation, the granulators used play an important role in the granulation during the process and can be classified into three types: low speed, high speed and fluidized bed. Low speed granulators can be kneaders with arms, or vibratory or rotary granulators. On the other hand, high speed granulators essentially consist of a cylindrical vessel, closed by a lid, at the bottom of which there is a rotating blade (impeller). A chopper is inserted into the vessel, consisting of a rotating blade whose function is to break up excessive agglomerates, and a sprayer / nebulizer for adding a binding solution, which can simply be water or an ad hoc solution. Fluidized bed granulation is carried out using an apparatus that mixes, wets and dries in a single process a bed of powder fluidized by air. In this apparatus, an air stream is passed from bottom to top at such a velocity as to keep the powder mass to be granulated in a turbulent suspension (defined as "fluidized"). A binding solution is sprayed in countercurrent directly onto the mass kept in suspension in such a way as to determine the aggregation of the particles and thus the formation of granules. At a certain point in this process, the air is heated to the desired temperature, and therefore this type of apparatus also carries out the drying process of the solid mass in a single step. The drying is in fact carried out at a very low temperature due to the fact that the suspended material has a very large surface to be dried. In a preferred embodiment, the lubricant of the present invention, i.e. the mixture of one or more seeds of fruits or seeds, including seeds, in powder form and / or natural gums as disclosed and defined in the claims, is used in the above method in an amount such that it is present in a total concentration of 1% to 35% by weight relative to the capsule, tablet or solid composition.

[0069] As stated above, according to the present invention, the lubricant is the only lubricant contained in the capsule, tablet or solid composition.

[0070] Capsules, tablets or solid compositions obtainable by the method according to any of the embodiments described herein are also obviously objects of the present invention.From the experimental data reported in the figures and described in the Examples section, it is evident that the presence of the granulation step allows the reduction of the amount of lubricating mixture in the formulation, from the fennel gum system at a concentration of 32.34% in a ratio of 1:7 to the granulated fennel gum system at a concentration of 12% in a ratio of 1:5.

[0071] The term comprising may be replaced by the term "consisting of" anywhere in this specification and claims.

[0072] Some examples are presented below, which have the purpose of better illustrating the methods disclosed herein, and such examples are not to be construed as limiting the scope of the above specification and subsequent claims in any way. EXAMPLES

[0073] The powders used in the examples presented below were physically characterized with respect to nutritional, direct and indirect properties and compared to magnesium stearate.

[0074] Below are the compositions of powders with respect to fat content that are known to have lubricating properties.

[0075] Test 1: Samples of magnesium stearate, fennel, cumin and caraway fruit powders were sent to an external laboratory for complete nutritional composition analysis to examine the presence of fatty acids with lubricating properties. Specifically, GC / FID method was used for fatty acid analysis. Residual moisture % analysis was obtained by gravimetric analysis. Results show that the fatty acids present in the fruit powders with seeds are different from those present in magnesium stearate, but the major fatty acids have the same chain length. [Table 1]

[0076] To evaluate the concentration of fruit powder, including seeds, that will be placed in the mixture for compression testing, 16 ~C 18 The percentage of fatty acids in the chain was compared.

[0077] Considering the amount of fatty acids contained in 1% magnesium stearate, it can be extrapolated to fruit powders containing seeds using various percentages between 1 and 5%.

[0078] Test 2: The fruit powders including seeds were physically characterized in terms of bulk and tapped density and % relative humidity. The density values ​​obtained were used to calculate the relative flowability and compressibility index. [Table 2]

[0079] From the analysis of the data it is clear that the flowability index (IC) and compressibility index (IH) of the neat powder can be characterized as being comparable, if not lower, than those obtained with magnesium stearate.

[0080] Test 3: The particle volume distribution of the powders was determined in solid form using a Mastersizer 3000 laser diffractometer (Malvern, UK). Approximately 5-7 g of powder was analyzed in dry form by employing the following parameters: background measurement time: 10 s, sample measurement time: 19.56 s, lower obscuration limit: 0.10%, upper obscuration limit: 15%, air pressure: 2 bar, hopper gap: 2.50 mm.

[0081] The parameters used were calculated automatically using Mastersizer software v3.81 and were maintained for all analyses in order to compare output values: - Median diameter volume Dv50 is the diameter above which 50% of the distribution exceeds and 50% is below (50% percentile diameter) - The two mean particle size determinations should not differ by more than 5% relative and the curves for the two determinations should be the same. - Dv90, 90% of the volume of distribution is below this value. - Dv10, 10% of the volume of distribution is below this value. - The span is the width of the distribution based on the 10%, 50% and 90% quantiles.

[0082] Seed-containing fruits: Comparison of the data shows that the tested powders have values ​​of specific surface area and average particle distribution that differ from those of magnesium stearate. [Table 3]

[0083] Test 4: Definition of a range of values ​​contributing to the ejection force that ensures release of the tablet from the die cutter. A standard powder blend suitable for the purpose (79% microcrystalline cellulose, 20% calcium carbonate, 1% magnesium stearate) was obtained and performance tests at different blending times were carried out.

[0084] The ejection force of the tablets was then evaluated.

[0085] The mixing time was related to the ejection force obtained to construct the target curve (Figure 1). A time longer than 30 minutes was not considered useful as it could result in overmixing of the mixture, which would have a negative effect on the bioavailability of the APS present in the formulation. Furthermore, the maximum ejection force value at which the tablet press begins to have problems with the tablets sticking to the die cutter, resulting in non-conforming tablets, was considered to be equal to 0.50 N for the purposes of this invention.

[0086] Therefore, the range of pushing force considered to be effective is 0.05 to 0.50N.

[0087] Test 5: Development of mixtures containing single seeds as lubricants. A standard mixture was obtained and compression tests were carried out using fruit powders containing caraway, fennel and cumin seeds taken individually at a ratio containing an amount of fatty acid equivalent to that present in 1% magnesium stearate in the same formulation.

[0088] The tablet ejection force values ​​were then analyzed and compared with the parameters obtained by compressing a base blend containing 1% magnesium stearate, and with the maximum experimental ejection force values ​​for the other products. All compression tests were performed using the same operating parameters and are shown in Figure 2.

[0089] Looking at the data available, we can infer the following: -An indirect indicator describing the rheological behavior of the powder itself is related to the compressibility of the mixture containing the single ingredients. Surprisingly, with the raw materials studied, the particle volume distribution value (dv50) and the specific surface area appear to be independent of the success of the compression test.

[0090] In all tests the measured extrusion forces are below 0.5 N, but the values ​​obtained tend to be towards the upper limit set in this study. In conclusion, the fruit powders including seeds used individually seem to exert a lubricating effect, but are not completely effective, and therefore it may be advantageous to investigate systems that allow optimizing this lubricating effect.

[0091] Test 6: Development of blends containing a mix of seeds and gums Gum arabic was tested in a functional synergy study.

[0092] Gum arabic is a 100% natural raw material obtained from the exudate of the acacia tree. While its binding and superdisintegrating properties are known in the literature, its lubricating properties have not been previously investigated.

[0093] The objective of this study was to investigate the possible synergy between gum arabic and fruit seed flour with regard to lubricating properties.

[0094] A mixture of gum arabic and seed powder in a 7:1 ratio was premixed and placed into the standard mixture. Figure 3 shows the ejection force values ​​obtained compared to the blank and to the mixture containing a single seed. [Table 4]

[0095] With the other components present in the mixture and the operating conditions being the same, the system consisting of gum arabic and fruit powder containing seeds in combination produces lower extrusion force values ​​compared to fruit powder containing seeds and magnesium stearate alone tested individually.

[0096] Table 5: Detailed representation of the experiments performed and the data obtained for the various combinations. The table shows the ejection force data obtained with the standard powder mixture itself (microcrystalline cellulose and calcium carbonate in a 4:1 ratio), or with magnesium stearate added, or with different powders of fruits containing seeds (caraway, fennel, cumin), or with gum arabic, or with the system with the emergent properties of the invention in the form of a powder or granule (a mixture of powders of different fruits containing seeds, or a mixture of gum arabic and powders of one or more fruits containing seeds). From the table it is clear how the mixture of at least three different powders of fruits containing seeds or at least one powder of fruits containing seeds and gum arabic has a synergistic effect to achieve a 100% natural lubrication system. In particular, the association of gum arabic with at least one fruit containing seeds.

[0097] Pol.Imp stands for fine powder. The granules in the table are those described in Experiment 7. TQ stands for being itself. [Table 5]

[0098] In the figure, the data shown in rows 3 and 7 above are shown as 5' and 30' controls.

[0099] Test 7: Development of mixtures containing technological processing systems for fruits and gums, including seeds A mix of gum arabic and fennel fruit powder with seeds in the ratio of 5:1 was granulated with water and sieved through a vibrating sieve.

[0100] Granulation, particularly fluidized bed granulation, was carried out by an apparatus that mixes, wets and dries in a single process a bed of powder fluidized by air. In this apparatus, an air stream is passed from bottom to top at such a speed as to keep the powder mass to be granulated in a turbulent suspension (defined as "fluidized"). The binding solution is sprayed in countercurrent directly onto the mass kept in suspension in such a way as to determine the aggregation of the particles and thus the formation of granules. At a certain point in the process, the air is heated to the desired temperature, and therefore this type of apparatus also carries out the drying process of the solid mass in a single step. Drying is in fact carried out at a very low temperature due to the fact that the suspended material has a very large surface to be dried. The granules consisting of gum acacia and fennel seeds in a ratio of 5:1 obtained using the technique described were added to a standard mixture and then compressed.

[0101] The amounts of raw materials and binding solution (water) used are shown in Table 6 and are calculated based on the volume of the container. [Table 6]

[0102] Table 7 below shows the range of experimental parameters used to obtain the granules of interest. [Table 7]

[0103] The resulting granules were subjected to particle size analysis by a Mastersizer 3000 laser diffractometer (see previous experiment), with the results shown in Figure 4. The granules themselves and the majority of the sieved portion (355 μm) were also characterized in terms of specific surface area, span and Dv50 and showed no significant differences. [Table 8]

[0104] Both were evaluated in compression tests.

[0105] The ejection force values ​​obtained are shown in FIG. 5, compared to those obtained for the blank.

[0106] In fact, the same "fruit gum powder with seeds" system with a different ratio than the non-granulated mixture (7:1) in point 3) makes it possible to obtain tablets without adding magnesium stearate either in the formulation or externally. Moreover, the amount of processed system added to this mixture is much lower (from 32% to 12%) than that used in the mixture shown in Figure 3. [ka]

[0107] The powders of fruits including seeds and powdered natural gums may optionally be pre-granulated. [ka] [ka]

[0108] The charcoal and maltodextrin are granulated in a fluid bed granulator which performs both the nucleation and drying steps (as described above).

[0109] The granulated product is mixed with magnesium stearate and then compressed to form a final product containing some residual moisture which is removed by secondary fluid bed drying.

[0110] [ka]

[0111] The charcoal, maltodextrin and gums are mixed and granulated using a granulator at low speed for 15 minutes, then they are dried in an oven.

[0112] The resulting granules are mixed with fruit powder containing fennel seeds and then compressed to form a final product containing some residual moisture, which is removed by secondary drying in an oven. Example of preparation of charcoal tablets without the addition of synthetic stearates:- Micronization of fennel seeds - Aqueous granulation of 70% charcoal with 10% gum and 17.6% maltodextrin for 15 minutes - Dry the granules until a relative humidity between 23% and 26% is reached. - Mix the dry granules with fennel seed powder at a concentration of 2.4% for a period of time ranging from 5 to 10 minutes until a homogenous mixture is obtained. - Compression - Final drying of the tablets. [Table 9]

Claims

1. from a mixture of one or more fruits or seed species, including seeds, in powder form, and natural gum powder, or a mixture consisting of a mixture of seeds of at least three different species in powder form, wherein the fruits or seeds, including seeds, from each of said species, in powder form, have a proportion of C of more than 45% w / w relative to the total fatty acids. １６ ~C １８ The mixture as described above, wherein the fruits or seeds containing fatty acids and having a proportion of fatty acids of at least 21% w / w and in powder form are cumin, caraway and fennel.

2. 2. The mixture of claim 1, wherein the fruit or seed powders including cumin, caraway and fennel seeds have a weight ratio of 1:1:1 to 1:1:3, preferably 1:1:

1.

3. caraway fruits or seeds, including the seeds, in the form of a powder, and gum arabic powder, in a weight ratio ranging from 1:1 to 1:8, preferably from 1:5 to 1:7, and / or fennel fruits or seeds, including the seeds, in the form of a powder, and gum arabic powder, in a weight ratio ranging from 1:1 to 1:8, preferably from 1:5 to 1:7, and / or cumin fruits or seeds, including the seeds, in powder form, and gum arabic powder, in a weight ratio ranging from 1:1 to 1:8, preferably from 1:5 to 1:

7.

3. The mixture according to claim 1 or 2, consisting of:

4. 4. A mixture according to any one of claims 1 to 3, consisting of fruit or seed powders including caraway, fennel and cumin seeds in a weight ratio of 1:1:1 to 1:1:3, preferably 1:1:1, and powdered gum arabic in a weight ratio ranging from 1:1 to 1:8, preferably 1:5 to 1:

7.

5. 5. The mixture according to any one of claims 1 to 4, wherein the flour of fruits or seeds including seeds has a particle size distribution value calculated as Dv50 of 15 μm to 500 μm, preferably 150 μm to 350 μm.

6. The powder of the seed-containing fruit or seed has a specific surface area of ​​25 m ２ / kg~600m ２ / kg, preferably 25m ２ / kg~70m ２ 6. The mixture according to claim 1, having a molecular weight of 1.0 kg / kg.

7. The powder of the fruit or seed containing the seed, [0010] The mixture according to any one of claims 1 to 6, having a span value, expressed as:

8. 8. The mixture according to claim 1, wherein the natural gum is gum arabic and / or gum karaya.

9. The natural gum powder has a Dv50 value in the range of 60 μm to 70 μm, ２ / kg~150m ２ / kg range, preferably 137m ２ 9. The mixture according to claim 1, having a specific surface area of ​​0.01g / Kg and a span value in the range of 1 to 1.8, preferably 1.

75.

10. A tableting lubricant comprising a mixture according to any one of claims 1 to 9.

11. 11. A capsule, tablet or solid composition comprising a mixture according to any one of claims 1 to 9 or a lubricant according to claim 10 as the only lubricant.

12. 12. A capsule, tablet or solid composition according to claim 11, wherein the mixture according to any of claims 1 to 9 or the lubricant according to claim 10 is present in a concentration of 1% to 35% w / w, preferably 3% to 4.5%.

13. 13. A capsule, tablet or solid composition according to claim 11 or 12, wherein said capsule, tablet or composition is made up of ingredients having 100% natural origin.

14. A pharmaceutical, cosmetic, nutritional supplement, medical device, dietary supplement, or food, comprising the capsule, tablet, or solid composition according to any one of claims 11 to 13.

15. 10. Use of a mixture according to any one of claims 1 to 9 as a lubricant in the preparation of tablets, capsules and solid compositions.

16. 16. The use according to claim 15, wherein said mixture is the only lubricant contained in a product in the form of a tablet, capsule or solid composition and / or is used for lubricating a machine suitable for the preparation of said product form.

17. Use of a natural gum, preferably gum arabic or gum karaya, as a lubricant in the preparation of tablets, capsules and solid compositions.

18. 18. The use according to claim 17, wherein the natural gum is present in the range of 1% to 35% by weight of the tablet, capsule or solid composition.

19. The natural gum powder has a Dv50 value in the range of 60 μm to 70 μm, ２ / kg~150m ２ / kg range, preferably 137m ２ / Kg and a span value in the range of 1 to 1.8, preferably 1.

75.

20. A method for producing a capsule or tablet or solid composition, comprising the step of mixing a mixture as described in claims 1 to 9 with a suitable compounding preparation, wherein the only lubricant used in the method is said mixture.

21. 1. A method for producing a capsule or tablet or solid composition comprising the steps of: i) providing one or more fruits or seeds including seeds and / or natural gums in powder form, wherein the fruits or seeds including the powdered seeds from each of said species have a percentage of C with respect to total fatty acids of greater than 45% w / w. １６ ~C １８ and a fatty acid content of at least 21% w / w. ii) mixing said one or more seeds of fruit or seeds including seeds and / or said natural gums in powder form with a suitable blend preparation for a time period comprised between 2 and 30 minutes, preferably between 5 and 15 minutes, even more preferably for 5 minutes; iii) subjecting the product obtained in step ii) to compression or encapsulation; wherein the components used in steps i) and ii) constitute the only lubricant used in the process.

22. 22. The method according to claim 20 or 21, comprising a further step between steps i) and ii) of granulating the one or more fruits or seed species, including seeds, in powder form, and / or the natural gums.

23. Step ii) comprises the steps of: iia) granulating the blend preparation with natural gums; iib) mixing the granulate obtained in step ii) with the one or more fruits or seeds including seeds in powder form prepared in step i) for a period of time ranging from 2 to 30 minutes, preferably from 5 to 15 minutes, even more preferably for 5 minutes, until a homogenous mixture is obtained.

23. A method for producing a capsule or tablet or solid composition according to claim 21 or 22, wherein

24. 24. The method according to claim 23, wherein the granulate obtained in step iia) is dried until a relative humidity between 23% and 26% is reached before mixing in point iib).

25. 25. The method according to any one of claims 22 to 24, wherein the granulation is dry granulation, wet granulation, dry air compression granulation, reverse wet granulation, steam granulation, moisture activated dry granulation, thermoadhesive granulation, melt granulation, freeze granulation or foam granulation.

26. 26. The method according to any one of claims 20 to 25, wherein the one or more fruits or seeds including seeds and / or natural gums in powder form are present in a total concentration of from 1% to 35% by weight with respect to the capsule, tablet or solid composition.

27. 27. The method according to any one of claims 20 to 26, wherein the natural gum is gum arabic and / or gum karaya.

28. 28. A capsule, tablet or solid composition obtainable by the method according to any one of claims 2 to 27.

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