Compressed solid compositions for parenteral use

Abstract

To provide a compressed solid composition for non-oral use that has a novel binder and / or disintegrant, and methods of use and manufacture thereof.SOLUTION: A compressed solid composition in accordance with the invention comprises fermented molasses as a binder and / or disintegrant. The fermented molasses is obtained by fermentation of beet molasses, sugarcane molasses or a mixture of beet molasses and sugarcane molasses, and the solid content of the fermented molasses is 50%-80%. The fermented molasses according to the invention advantageously makes it possible to replace the synthetic binders conventionally used in compressed solid compositions while at the same time also making it possible to act as a disintegrant on contact with a liquid, in particular water. The present invention thus proposes a new route of exploitation of a product which thus far has only been used in the agricultural and livestock farming field.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to novel binders and / or disintegrants for obtaining compressed solid compositions for parenteral use, and also to a process for preparing said compressed solid compositions. [Background technology]

[0002] The compressed solid composition may be in many forms, generally determined by the intended use, to obtain certain properties and to ensure optimal handling.Indeed, for some applications, it is important that the compressed solid composition has good integrity before use, while also having the ability to disintegrate rapidly during use, especially when contacting with liquid.These properties are generally provided by binders and / or disintegrants.

[0003] The use of binder allows the compressed solid composition, also called agglomerate, to be given a sufficient level of mechanical strength to avoid the problem of particulate formation during its handling or use.The advantage of using binder is generally observed for all known techniques of compaction or agglomeration, such as pressure compaction, pelleting, granulation, nodulation, extrusion or else spray drying.Disintegrants allow the compressed solid composition containing them to disintegrate by contact with liquid, and in particular with water.

[0004] Finally, some agents are called binders and disintegrants because they make it possible to obtain a sufficient level of mechanical strength in dry media while also offering the possibility of disintegration upon contact with liquids.

[0005] Generally speaking, a large number of binders are known to the person skilled in the art: polyvinyl alcohol and its derivatives, cellulose and its derivatives, lignosulfonates, starch and its derivatives, alkali metal silicates, cements, clays and finally molasses, the latter in combination with lime, may be mentioned as examples.

[0006] Polyvinyl alcohol and its derivatives, cellulose and its derivatives, starch and physically and / or chemically modified starches have good binding properties and make it possible to obtain agglomerates which meet the requirements of the agglomeration technique but not necessarily the economic requirements, since the dosages required do not generally make it possible to obtain agglomerates or compacted solid compositions under economically satisfactory conditions.

[0007] Lignosulfonates have the drawback of being aggressive due to their pH and their composition with respect to the flocculation means used. Moreover, during combustion or during the heating operations required in the course of the compaction process, lignosulfonates can lead to the emission of harmful vapors rich in sulfuric acid. The consequence of this is that lignosulfonates represent a not insignificant cause of air pollution and corrosion. Therefore, in the development of more environmentally friendly products with reduced environmental load, lignosulfonates should be avoided.

[0008] Clays are low-cost products that have binding properties, but their field of application is limited. Moreover, it is very often necessary to combine them with other binders. Examples include starchy products and their derivatives.

[0009] Alkali metal silicates require delicate handling and their long term use involves frequent cleaning of the facilities in which they are used.

[0010] The type of binder used in the composition varies depending on the end use. For example, in the field of tablets and solid compositions for detergent use, the binders used are generally synthetic binders.

[0011] For example, the document US Pat. No. 5,999,633 describes a laundry detergent composition in the form of a tablet, which contains, inter alia, clay and a surfactant. The tablet is in the form of a compressed mass of particles held together by a binder that has less dispersing effect on the clay than polyethylene glycol 6000 (PEG 6000). Specifically, the binder is a chemical binder selected from polyethylene glycols having a molecular weight of less than 1500, amine oxides and polyvinylpyrrolidone.

[0012] The document US Pat. No. 5,999,366 describes tablets with improved breaking strength and also a method for their manufacture. The method comprises the steps of providing a binder having a rigidity value G between 10 and 100 GPa, a phase angle value δ of at least 7 degrees, and a boiling point of at least 45° C. at atmospheric pressure. The method then comprises the steps of heating the binder above its boiling point, followed by applying said heated binder to a powder containing a premix of detergent compounds to form a detergent composition. The final step of the process consists of converting the detergent composition into tablets. The binder used is selected from the group consisting of anionic surfactants, non-anionic surfactants, polymeric materials, polyols, sugar acids, sugar alcohols, sugar esters, fatty acids, fatty acid esters, fatty acid amides and mixtures thereof.

[0013] Apart from the fact that they are of synthetic origin, another drawback of the available binders arises from their main advantage, since these agents make it possible to obtain aggregates by providing agglomeration such that it is generally not possible to disintegrate them by contact with a liquid such as water. [Prior art documents] [Patent documents]

[0014] [Patent Document 1] European Patent No. 1 048 716 [Patent Document 2] International Publication No. 2005 / 068603 Summary of the Invention [Problem to be solved by the invention]

[0015] There is therefore a need for new binders for the preparation of compressed solid compositions for parenteral use, which can replace the synthetic binders conventionally used and which can also act as disintegrants upon contact with liquids, particularly water. [Means for solving the problem]

[0016] It is therefore to the applicant's credit that he has found that this objective can surprisingly, and contrary to all expectations, be met by fermented molasses, while the latter has hitherto been considered to be a residue from fermentation, with the sole advantage of being utilized in the fields of agriculture and animal husbandry, as a fertilizer for spreading or as animal feed.

[0017] A first subject of the invention relates to compressed solid compositions for parenteral use comprising fermented molasses as binder and / or disintegrant.

[0018] Generally speaking, molasses is a substance known to those skilled in the art. It is a co-product of the production of sugar from beets and sugar cane in sugar refining or brown sugar in refining. The process of producing sugar, whether from sugar cane or from beets, leads to obtaining, after a crystallization step, sugar on the one hand and molasses on the other. Generally speaking, it is widely recognized that the sugar refining process produces about 35-40 kilos of molasses per ton of beets, and 30-35 kilos of molasses per ton of sugar cane. Even at the French national level, the annual production reaches tens of thousands of tons.

[0019] In terms of composition, the solids content of molasses does not vary much and is generally between 70% and 76%. Molasses has a very low or even no content of crude cellulose and fatty substances.

[0020] As a co-product of sugar production, molasses contains a large amount of sugar. The total sugar content is virtually the same regardless of the origin of the molasses, generally between 58% and 70% of the dry weight (DW), although there are some variations depending on the industrial processes applied to beet molasses.

[0021] On the other hand, depending on the origin of molasses, beet or sugar cane, their total sugar composition, while the sugar content is close, is quite different. Thus, in beet molasses, practically all the sugar is in the form of sucrose, while in sugar cane molasses, sucrose alone represents about 2 / 3 of the total sugar, i.e. 30%-40% of the crude product.

[0022] Molasses is a highly viscous substance, which represents a drawback in its transport and storage. However, this high viscosity constitutes an advantage in animal feed, and they are commonly used for ruminants and horses in a mixture with straw or other cellulose-based feeds, such as bran, or as a binder in complete feeds, or to promote the consumption of even less appetizing feeds. In fact, due to the presence of sugars, amino acids and salts, molasses constitutes a feed, whose flavor and odor stimulate the appetite of the animals and facilitate digestion.

[0023] As an alternative to animal feed, molasses is also used by manufacturers to produce what are called "valuable" products through a fermentation process. In fact, using the fermentation mechanisms of several microorganisms, molasses makes it possible to obtain baker's yeast, ethyl alcohol, citric and glutamic acids, lysine or other antibiotics, and also produces a liquid fermentation residue corresponding to fermented molasses.

[0024] Fermented molasses has been considered as a residue of fermentation and its only benefit has been its use in the agricultural and animal husbandry sectors as a spreading fertilizer or in animal feed. In fact, the chemical composition of fermented molasses, despite the depletion of compounds by fermentation, still makes it attractive in feed for ruminants, both with regard to the energy it provides and its nitrogen value.

[0025] Thus, by proposing a compressed solid composition for parenteral use comprising fermented molasses as binder and / or disintegrant, the Applicant believes that it has pioneered a novel way to use fermented molasses by going against the conventional practice for using fermented molasses.

[0026] For the purposes of the present invention, a compressed solid composition is intended to mean any composition that can be obtained by processes of compaction known to those skilled in the art, such as, for example, pressing, pelleting, granulation, granulation, extrusion or else spray drying. A compressed solid composition according to the invention can therefore also be considered to be an agglomerate.

[0027] The compressed solid composition according to the present invention may be in a number of compressed forms, said forms being routinely adapted by those skilled in the art according to the desired application.Accordingly, the compressed solid composition may be in the form of a single-layer or multi-layer tablet, cake, compressed tablet, granule, pellet or other lozenge.Preferably, the compressed solid composition is in the form of a single-layer or multi-layer tablet.

[0028] For the purposes of the present invention, parenteral use is intended to mean that the compressed solid composition is not intended to be ingested by animals or humans and therefore cannot provide food for animals or humans in particular.

[0029] For purposes of clarity, the terms "compressed", "compacted" or otherwise "condensed" are indeed considered synonymous for the purposes of the present invention and may be used interchangeably.

[0030] Fermented molasses is a co-product of molasses obtained after its fermentation by bacteria, yeasts or fungi, said fermentation making it possible to obtain products called "valuable", such as baker's yeast, ethyl alcohol or else citric acid and glutamic acid. Preferably, fermented molasses is obtained by fermentation of molasses by yeasts.

[0031] According to the invention, the fermented molasses can be equally obtained from beet molasses, sugar cane molasses or a mixture of beet molasses and sugar cane molasses. For example, the mixture may contain up to 60% fermented beet molasses, up to 70% fermented beet molasses, up to 80% fermented beet molasses, up to 90% fermented beet molasses or even up to 95% fermented beet molasses. Advantageously, when the fermented molasses is a mixture of fermented beet and sugar cane molasses, said mixture contains 90% fermented beet molasses.

[0032] Initially, fermented molasses contains more than 90% water, but it is advantageously concentrated to reduce the amount of water and obtain a higher solids content.

[0033] Thus, the solids content of the fermented molasses or the mixture of beet and cane molasses according to the invention may be between 50% and 80%. Preferably, the solids content of the fermented molasses is between 55% and 75%, most particularly between 55% and 65%, for example about 60%.

[0034] As they are traditionally intended or used as fertilizer or animal feed, fermented molasses are also defined by the distribution of nitrogen-based materials therein and by their aminogram. Fermented molasses according to the invention may therefore have a distribution of nitrogen-based materials as follows: - Nitrogen from total amino acids: 25%-50% of total nitrogen - Nitrogen from betaine: 0%-40% of total nitrogen - Ammoniacal nitrogen: 2%-3% of total nitrogen.

[0035] With regard to the aminograms of protein of the fermented molasses according to the invention, the average content of amino acids may be as presented below, the range of values ​​being given in g / kg of solids: - Aspartic acid: 6~8 - Threonine: 0.5~3 - Serine and glutamic acid: 115-130 - Proline: 3~4 - Glycine: 4~5 - Alanine: 2.5~3.5 - Valine: 2.5~3.5 - Methionine and cysteine: 0.5-3 - Isoleucine: 1.5~2.5 - Tyrosine: 2~3.5 - Leucine: 3~4.5 - Phenylalanine: 1~2 - Lysine: 0.5~2.5 - Histidine: 0.5~2 - Arginine: 0.2~1

[0036] As a co-product resulting from fermentation, fermented molasses has a low sugar content. "Low sugar content" is intended to mean fermented molasses that contains less than 5% by weight, less than 4% by weight, less than 3% by weight, less than 2% by weight, most particularly less than 1% by weight of sugar relative to the total weight of the dry extract. Preferentially, the fermented molasses according to the invention does not contain sugar.

[0037] The fermented molasses according to the invention, also called raw fermented molasses, may be subjected to one or more chemical or physicochemical treatments. For example, the fermented molasses may be subjected to potassium removal or demineralization. Such treatments may modify the composition of the fermented molasses in terms of its nitrogen-based material. The potassium removal treatment may, for example, consist of acidification of the raw fermented molasses with a solution of H2SO4, followed by neutralization with aqueous ammonia.

[0038] Treatments that may be applied to fermented molasses qualitatively and quantitatively alter the mineral content. Thus, crude fermented molasses may have a crude ash content of 14% to 22% by weight of the crude product and a potassium content of 5% to 18% by weight of the crude product. On the other hand, in the case of depotashed or demineralized fermented molasses, the crude ash content ranges from 5% to 14% by weight of the crude product and the potassium content is generally less than 4% by weight of the crude product.

[0039] Due to the high ash content, raw fermented molasses has a density which may range from 1.10 to 1.50. Preferably, the density of fermented molasses is from 1.20 to 1.40, most particularly from 1.25 to 1.35.

[0040] The fermented molasses according to the invention has a viscosity of 500 mPa.s to 5000 mPa.s, preferably 1000 mPa.s to 4000 mPa.s, and a slightly acidic pH of 5 to 6.

[0041] Thus, the compressed solid composition according to the invention comprises crude or desalted fermented molasses as a binder and / or disintegrant.

[0042] Said fermented molasses is present in the compressed solid composition in an effective proportion, where effective proportion is intended to mean sufficient to obtain the desired effect, i.e., in particular to obtain a compressed solid composition that can be transported, handled and / or stored without substantial damage and that can disintegrate upon contact with a liquid, such as water.

[0043] Advantageously, the amount of raw or desalted fermented molasses used in the pressed solid composition according to the invention may be between 0.1% and 15% by weight, preferentially between 0.5% and 5% by weight and even more preferentially between 0.5% and 1.5% by weight relative to the total weight of the pressed solid composition.

[0044] The binding properties thus revealed in fermented molasses make it possible to obtain a compressed solid composition having sufficient mechanical strength to avoid the problem of the formation of fine particles during its handling. Advantageously, fermented molasses also acts as a disintegrant, making it possible for the compressed solid composition to disintegrate when in contact with liquids, in particular when in contact with water.

[0045] With the compressed solid compositions according to the invention, the inventors have therefore identified a new route for utilizing fermented molasses as well as an alternative for using synthetic binders or binders not previously used to obtain solid compositions, examples being, inter alia, polyethylene glycol, polyvinylpyrrolidone, ethoxylated fatty alcohols, starch, hydroxyethylcellulose, gelatin or else microcrystalline cellulose.

[0046] Thus, the compressed solid composition comprising fermented molasses according to the invention may be free of polyethylene glycol and / or polyvinylpyrrolidone and / or ethoxylated fatty alcohols and / or starch and / or hydroxyethylcellulose and / or gelatin and / or microcrystalline cellulose.

[0047] According to certain embodiments, the fermented molasses may have substances added to it, in particular to exhibit certain physical properties. Thus, molasses may contain cellulose-based derivatives, such as carboxymethylcellulose, hemicellulose, lignin, ethylcellulose, methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, derivatives from starch production, such as wheat, corn, cassava, tapioca, potato or rice starch, dextrins and other modified starches, dextrans, sugar derivatives, such as glucose, fructose, lactose, sucrose, sorbitol, glycerol, natural gum of diutan, gellan, xanthan, caramel, sorbitol, glycerol, sorbitol, glycerol, natural gum of diutan, gellan, xanthan, caramel, sorbitol, sorbitol, glycerol ... It may have compounds added thereto, selected from the group including geenan type, pectins, alginates, chitosan, gum arabic, gum tragacanth, carob gum, gum acacia, agar, guar gum, production derivatives such as beet pulp, chicory pulp, dried or not dried apple pomace, sugar cane bagasse, citrus pulp, fruit juice waste, waste from gum manufacture, waste from starch manufacture, mineral derivatives, smectites, bentonite and other clays derived from silica, lime, magnesium and others of the same family, and also mixtures of some of these compounds. Preferably, the fermented molasses has carboxymethylcellulose added thereto. The amount of compound added to the fermented molasses may be between 0.1% and 2%, preferentially between 0.1% and 1%, more preferably still between 0.1% and 0.5%, the percentages being expressed as dry weight relative to the total dry weight of the fermented molasses including the substances added thereto.

[0048] The compressed solid composition may also contain one or more additives, which may be selected from additives known to those skilled in the art, such as foaming agents, detergents, sequestering agents, pelleting additives, brighteners, polymers, surfactants, flow agents, stabilizers, defoamers, dyes, or other lubricants.

[0049] Examples of stabilizers include esters of parahydroxybenzoic acid, such as methylparaben and propylparaben, alcohols, such as chlorobutanol, benzyl alcohol and phenylethyl alcohol, phenols, such as phenol and cresol, sulfites, such as sodium bisulfite and sodium sulfite, edetates, such as sodium edetate and tetrasodium edetate, as well as hydrogenated oils, sesame oil, sodium chondroitin sulfate, dibutylhydroxytoluene, adipic acid, ascorbic acid, esters of stearyl-L-ascorbic acid, sodium L-ascorbate, L-aspartic acid, sodium L-aspartate, sodium acetyltryptophan, acetanilide, aprotinin solution, aminoethylsulfonic acid, aminoacetic acid, DL-alanine, L-alanine, benzalkonium chloride, and sorbic acid.

[0050] Examples of lubricants include stearic acids such as stearic acid, calcium stearate and magnesium stearate, waxes such as white beeswax and carnauba wax, sulfates such as sodium sulfate, silicate compounds such as magnesium silicate and light anhydrous silicic acid, lauryl sulfates such as sodium lauryl sulfate, cocoa butter, carmellose calcium, carmellose sodium, caropeptides, hydrated silicon dioxide, hydrated amorphous silicon oxide, dried aluminum hydroxide gel, glycerol, light liquid paraffin, hydrogenated oil, synthetic aluminum silicate, sesame oil, wheat starch, talc, macrogol, and phosphoric acid.

[0051] Examples of detergents include polyacrylates, acrylic / maleic copolymers, monomeric polycarbonates such as citrates, gluconates, oxydisuccinates, glyceryl mono-, di- and trisuccinates, carboxymethyloxysuccinates, carboxymethyloxymalonates, dipicolinates and hydroxyethyliminodiacetates.

[0052] According to a particular embodiment, the pressed solid composition may also comprise at least one active substance, at least one filler, and optionally at least one additive, which may be selected from foaming agents, detergents, sequestering agents, pelleting additives, brighteners, polymers, surfactants, flow agents, stabilizers, defoamers, dyes or other lubricants.According to this particular embodiment, the pressed solid composition may be in tablet form and has applications in the fields of household, agricultural and industrial cleaning and / or cleaning.An example of household cleaning and / or cleaning may be machine cleaning, especially cleaning in a dishwasher.

[0053] According to a particular embodiment, the compressed solid composition for parenteral use according to the invention has a friability of between 5% and 15%, preferably between 5% and 11%, most particularly between 6% and 8%.

[0054] According to a particular embodiment, the compressed solid composition for parenteral use according to the invention has a hardness of between 50N and 90N, preferably between 60N and 80N and most particularly between 70N and 75N.

[0055] According to a particular embodiment, the compressed solid composition for parenteral use according to the invention has a dust content (dust area) of less than 3, preferably less than 2.5 and most particularly less than 2.

[0056] According to another particular embodiment, the compressed solid composition for parenteral use according to the invention may be packaged in a bag to protect it from moisture and provide additional protection for handling and / or transportation and / or storage. Advantageously, the bag is a biodegradable and / or water-soluble bag.

[0057] According to another particular embodiment, the compressed solid composition comprising fermented molasses as binder and / or disintegrant is in the form of an effervescent cleaning cake for toilets, dishwasher tablets, calcium hypochlorite tablets for swimming pools, or granulated fertilizer.

[0058] As examples of compressed solid compositions which may be in the form of multi-layer tablets, in particular multi-layer dishwasher tablets, we mention the compositions summarized in the table below:

[0059] [Table 1]

[0060] Another subject of the invention relates to the use of fermented molasses as a binder and / or disintegrant for the preparation of compressed solid compositions for parenteral use.

[0061] Fermented molasses is as defined above. The use of fermented molasses as binder and / or disintegrant in compacted solid compositions is twofold advantageous: firstly, the use according to the invention makes it possible to propose a new way of utilizing molasses, which up until now was only intended for spreading or for animal feeding; secondly, the use according to the invention makes it possible to replace the synthetic binders conventionally used, thereby making it possible to obtain compacted solid compositions that are more environmentally friendly.

[0062] The amount of fermented molasses used in the pressed solid composition may be from 0.1% to 15% by weight, preferentially from 0.5% to 5% by weight, and even more preferentially from 0.5% to 1.5% by weight, relative to the total weight of the pressed solid composition.

[0063] The compressed solid composition may be as defined above and may be in the form of a mono- or multi-layer tablet, a cake, a compressed tablet, a granule, a pellet or otherwise a lozenge.Preferably, the compressed solid composition is in the form of a mono- or multi-layer tablet.

[0064] Another subject of the invention relates to a binding and / or disintegrating composition comprising at least fermented molasses as binding agent.

[0065] The fermented molasses according to the invention may also be used as such in a binding and / or disintegrating composition containing one or more other components of any type, including those with binding properties, or those capable of increasing, for example, the mechanical strength of the final product, in particular the agglomerates, or minimizing the phenomenon of disintegration to which said agglomerates may be subject during their handling or storage. Fermented molasses is as defined above.

[0066] According to certain embodiments, the bonding composition according to the invention may also comprise a hardener, ie a hardener that can further improve the bonding strength.

[0067] According to certain embodiments, the fermented molasses may have substances added to it, in particular to exhibit certain physical properties. Thus, molasses may contain cellulose-based derivatives, such as carboxymethylcellulose, lignin, hemicellulose, ethylcellulose, methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, derivatives from starch production, such as wheat, corn, cassava, tapioca, potato or rice starch, dextrins and other modified starches, dextrans, sugar derivatives, such as glucose, fructose, lactose, sucrose, sorbitol, glycerol, natural gum of diutan, gellan, xanthan, caramel, sorbitol, glycerol, sorbitol, glycerol, natural gum of diutan, gellan, xanthan, caramel, sorbitol, sorbitol, glycerol ... It may also have compounds added thereto selected from the group comprising geenan type, pectins, alginates, chitosan, gum arabic, gum tragacanth, carob gum, gum acacia, agar, guar gum, production derivatives such as beet pulp, chicory pulp, dried or non-dried apple pomace, sugar cane bagasse, citrus pulp, fruit juice waste, waste from gum manufacture, waste from starch manufacture, mineral derivatives, smectites, bentonite and other clays derived from silica, lime, magnesium, and others of the same family, and also mixtures of several of these compounds.

[0068] Another subject of the present invention relates to a method for producing a compressed solid composition for parenteral use, comprising the steps of: 1) providing an active substance, a filler, and optionally at least one additive selected from foaming agents, detergents, sequestering agents, pelleting additives, brighteners, polymers, surfactants, flow agents, stabilizers, defoamers, dyes or other lubricants; 2) incorporating fermented molasses into the compounds provided in the previous step to obtain a mixture; 3) compressing the mixture to obtain the compressed solid composition.

[0069] Thus, the first step of the process consists of providing an active substance, a filler, and optionally at least one additive selected from foaming agents, detergents, sequestering agents, pelleting additives, brighteners, polymers, surfactants, flow agents, stabilizers, antifoam agents, dyes or else lubricants. The active substance and the filler are selected by the person skilled in the art depending on the desired application of the compacted solid composition.

[0070] The fermented molasses is then incorporated according to a second step into the compounds provided according to the first step of the process so as to obtain a mixture. The fermented molasses is as described above, i.e. in particular a co-product obtained by fermentation of molasses. The amount of molasses incorporated according to this step can be between 0.1% and 15% by weight, preferentially between 0.5% and 5% by weight, and even more preferentially between 0.5% and 1.5% by weight, relative to the total weight of the mixture.

[0071] The inclusion step can be carried out by techniques known to those skilled in the art and leading to obtaining a mixture. Thus, the inclusion step can be obtained, for example, by spraying.

[0072] Finally, the third step of the method according to the invention consists of a compressing step, which can be carried out according to techniques known to those skilled in the art, resulting in the compaction or agglomeration of the mixture prepared in the previous step.The compressing step can thus be carried out, for example, by compression on a rotary press, by pelleting, by granulation, by nodulation, by extrusion or else by spray drying.As an example, the compressing step by compression can be carried out through a rotary press.The compressing step thus makes it possible to obtain a compacted solid composition, which can be in several forms, such as, for example, a monolayer or multilayer tablet, a cake, a compressed tablet, a granule, a pellet or else a lozenge.

[0073] The method according to the invention may also comprise a step of drying after the steps of inclusion and / or compression.

[0074] The present invention will be better understood using the following examples, which are purely illustrative and do not limit the scope of protection in any way. EXAMPLES

[0075] In the examples below, mechanical properties were measured using the following methods: Friability test: This test consists in measuring the loss of mass of a compressed solid composition after 2 minutes of rotation in a drum at 25 revolutions per minute. The test is carried out using an FT2 machine supplied by SOTAX. The friability is determined according to the following formula: F(%) = [(m1-m2) / (m1)] x 100 In the formula, m1 corresponds to the mass of the composition before rotation and m2 corresponds to the mass of the composition after rotation.

[0076] Collapse: This test consists in measuring the disintegration time of a compressed solid composition in a liquid medium. The test is carried out by means of an apparatus that performs back and forth movements while completely submerged in water. For this purpose, the compressed solid composition is placed in a basket and subjected to 60 back and forth movements per minute in a container filled with water heated to 30 ° C ± 1 ° C.

[0077] The first back and forth movement corresponds to TO, and the time elapsed from TO when there is no longer any compressed solid composition residue left in the basket corresponds to the disintegration time. The disintegration time value is given in minutes and corresponds to the average of five measurements.

[0078] hardness: Hardness was calculated using a Synergie 100 tensile tester (MTS) and Test Works 4 software and corresponds to the force required to break a compressed solid composition. Hardness is expressed in Newtons (N) and corresponds to the average of five measurements.

[0079] Dust content: The measurements are carried out using a DustMon L machine and DustMon L software according to the manufacturer's recommendations. The measurements consist of assessing the dust concentration of a mass of compressed solid composition as it falls and passes in front of a laser beam. The numerical value is given in the "dust area".

[0080] Solids: Karl Fischer method.

[0081] Example 1: Preparation of a compressed solid composition for parenteral use containing fermented molasses as a binder and / or disintegrant. For purposes of this example, the compressed solid composition is in the form of a multi-layer tablet comprised of a first layer, an intermediate layer and a third layer.

[0082] A mixture of fermented beet and cane molasses is used. The mixture contains about 90% fermented beet molasses and about 10% fermented cane molasses. The fermented molasses has a solids content of 60%. These fermented molasses then have carboxymethylcellulose added to it in an amount of 0.2% (dry / dry).

[0083] The fermented molasses with added carboxymethylcellulose is mixed in certain amounts (dry / dry) with other compounds to obtain the first and third layers of the tablet. The composition of all layers of the tablet is summarized below:

[0084] [Table 2]

[0085] The compositions are then compressed together using a rotary press to obtain a compressed solid composition in the form of a multi-layer tablet.

[0086] The mechanical properties of the tablets were measured according to the protocol described above and the results are presented in Table 1 below:

[0087] [Table 3]

[0088] The compressed solid composition according to the invention has good mechanical properties and can therefore be easily handled and transported without breaking or generating large amounts of fines. It also has a disintegration time that is compatible with applications in the field of cleaning, where a disintegration time of less than 12 minutes (based on the above protocol) is generally desired.

[0089] Comparative Example 1: Preparation of a compressed solid composition for parenteral use containing polyethylene glycol (PEG) as a binder and / or disintegrant. A second multi-layer tablet was prepared to compare the obtained properties and to demonstrate the advantage of a compressed solid composition containing fermented molasses as a binder and / or disintegrant.

[0090] The polyethylene glycol is mixed in certain amounts (dry / dry) with other compounds to obtain the first and third layers of the tablet. The composition of all layers of the tablet is summarized below:

[0091] [Table 4]

[0092] Each composition is then compressed using a rotary press, following the same protocol as in Example 1, so as to obtain a compressed solid composition in the form of a multi-layer tablet.

[0093] The mechanical properties of the tablets were measured following the same protocol as in Example 1, and the results are presented in Table 2 below:

[0094] [Table 5]

[0095] Thus, the mechanical properties obtained with "conventional" PEG-based compressed solid compositions are comparable to compressed solid compositions according to the invention based on fermented molasses as binder and / or disintegrant.

[0096] Thus, as demonstrated by this comparison, the use of fermented molasses according to the invention as binder and / or disintegrant is also a good alternative to the traditionally used chemical binders, while allowing new ways of utilizing products previously simply intended for spreading or animal feed.

[0097] Example 2: Demonstration of the binding effect of fermented molasses according to the invention. The purpose of this example is to demonstrate the good binding properties of fermented molasses according to the invention.

[0098] A-Products used: - Carbon black: ENSACO® (Imerys); particle size distribution: Dv10=3.15 μm; Dv50=11.8 μm; Dv90=33.7 μm. - Binder solution 1: Fermented cane molasses with 60% solids. - Binder solution 2: A mixture containing 90% fermented beet molasses and 10% fermented sugar cane molasses with a solids content of 60%. - Binder solution 3 (control): Bretax C (lignosulfonate, Burgo). Bretax C is a known commercially available binder.

[0099] Each binder solution is used to spray onto the carbon black and allow for its granulation.

[0100] B-Dry granulation The carbon black is placed into the (5 liter) vessel of a pilot shear mixer in which the agitating members are set to rotate.

[0101] For each binder solution, an amount of 5% by weight based on the weight of carbon black is sprayed onto the inside of the container using a bi-fluid nozzle to allow granulation of the carbon black.

[0102] The pilot mixer parameters are as follows: - Linear speed: 14.1m / s, - Spray rate: 5g / min, - Pulse pressure: 0.1bar.

[0103] The various tests carried out are summarized in Table 3 below:

[0104] [Table 6]

[0105] C-Particle size analysis: For each test, the resulting carbon black granules were analyzed by laser particle size analysis to analyze the effectiveness of each binder solution.

[0106] Measurement equipment: - Mastersizer 3000 (Malvern) - Aero S accessories. Operating parameters: - Drying route, - Pressure: 0.5bar, - Blank measurement time: 30 seconds, - Measurement time: 60 seconds

[0107] D-Particle size analysis results: [Table 7]

[0108] Compared to the control binder solution, the results demonstrate that the fermented molasses according to the invention makes it possible to obtain a binding effect on carbon black that is just as effective (test 1 vs. test 3) or even more effective (test 2 vs. test 3).

[0109] This example therefore demonstrates the very good binding properties of the fermented molasses according to the invention and the fact that the latter can be advantageously used in compressed solid compositions as a binder.

[0110] Example 3: Demonstration of the binding and disintegration effect of fermented molasses according to the invention. Fermented molasses is used in this example to granulate the fermented cane molasses powder. The products used are summarized below:

[0111] A-Products used: - Fermented cane molasses powder with 97% solids. - Fermented molasses 1: Fermented cane molasses with 60% solids. - Fermented molasses 2: a mixture of fermented beet and cane molasses. The mixture contains about 90% fermented beet molasses and about 10% fermented cane molasses. The fermented molasses has a solids content of 60%. This fermented molasses then has carboxymethylcellulose added to it in an amount of 0.2% (dry / dry).

[0112] Fermented molasses 1 and 2 are used as binding and / or disintegration compositions on fermented cane molasses powder. Fermented molasses is used to granulate the powder and thus obtain a compacted solid composition. The resulting granules were then analyzed.

[0113] B-Particle size analysis: Instrument used for laser particle size measurement: Mastersizer 3000 (Malvern), as mentioned above. The fermented cane molasses powder was analyzed by laser particle size analysis and has the following characteristics: - Dv10=18.1μm, - Dv50=77.5μm, - Dv90=234μm, - Distribution width (distance) = 2.788.

[0114] C-Tests carried out Test 1: For this test, the granulation is carried out in a wet granulator (model VG-25, GLATT) according to the following conditions:

[0115] [Table 8]

[0116] 1501.4 g of fermented cane molasses powder is placed into the granulator.

[0117] Granulation is then carried out with a liquid solution of 10% by weight of molasses 1 relative to the weight of the powder. The amount of sprayed solution is 150 g and the content of sprayed molasses 1 / liquid solution of crude fermented sugarcane molasses powder is 10%.

[0118] Analysis of the obtained granules: The resulting granules, analyzed under the same conditions as fermented cane molasses powder, have the following characteristics: - Dv10=62.4μm, - Dv50=166μm, - Dv90=629μm, - Distribution width (distance) = 3.442.

[0119] Compared to powders, these particle size values ​​show that fermented molasses has a binding effect, making it possible to obtain a compacted solid composition in granular form.

[0120] Test 2: For this test, the granulator is the same as in test 1 and the operating conditions are the same, with the exception of the mixer setting, which is set at 600 rpm.

[0121] 1500g of fermented cane molasses powder is placed in a granulator and granulated with 5% liquid solution of molasses 2. The amount of sprayed solution is 75g, and the content of sprayed solution / raw cane molasses powder is 5%.

[0122] Analysis of the obtained granules: The resulting granules, analyzed under the same conditions as fermented cane molasses powder, have the following characteristics: - Dv10=55.4μm, - Dv50=127μm, - Dv90=305μm, - Distribution width (distance) = 1.965.

[0123] Compared to powders, these particle size values ​​show that fermented molasses has a binding effect, making it possible to obtain a compacted solid composition in the form of granules, where the distribution width is smaller than for powders, reflecting a more concentrated size distribution of the particles of the granules.

[0124] B-Wettability test The wettability of the granules obtained in tests 1 and 2 is compared with that of fermented cane molasses powder according to the following protocol: - Place 100 ml of distilled water at 20°C into a 400 ml beaker. - Take a 10g sample and place it on the surface of the water as the timer starts. - Stop the timer when the specimen is completely wet.

[0125] The results are presented in Table 6 below:

[0126] [Table 9]

[0127] The durations here represent the time required for the various samples to successfully cross the air / water interface.

[0128] The results show that the granules obtained have a significant reduction in wettability. The fermented molasses according to the invention makes it possible to improve this parameter, thereby demonstrating good binding properties.

[0129] C-Disintegration test To highlight the disintegration effect of fermented molasses, disintegration tests are carried out on the granules obtained in the previous tests 1 and 2. The tests are carried out according to the following protocol: - Take 10 g of the sample to be tested and sieve it to collect the sieve fraction between 180 and 125 μm. - Take the sieve containing the 180-125 μm sieved fraction and place it on top of a 2 liter beaker. Add 400 ml of distilled water at -20°C so that the surface of the sieve is submerged. - Stir at approximately 300 rpm.

[0130] The change in weight of the combined mixture is monitored over time, starting immediately after the first ml of distilled water is added, making it possible to reflect the loss of weight of the sample as a function of time.

[0131] The results are presented in Table 7 below:

[0132] [Table 10]

[0133] A positive value at the beginning of the test reflects the absorption of water by the granules. Over time, the results show that under the action of water, the granules obtained from the fermented molasses according to the invention can completely disintegrate, thereby demonstrating the disintegrating effect of said fermented molasses.

[0134] In conclusion, this example therefore demonstrates the binding and disintegration properties of fermented molasses according to the invention, its use in fact making it possible to obtain compacted solid compositions in the form of granules, said granules being capable of subsequently disintegrating under the action of water.

Claims

1. A compressed solid composition for washing and / or cleaning for parenteral use, characterized in that it contains fermented molasses as binder and disintegrant, in the form of a monolayer tablet or a multilayer tablet, said monolayer tablet or said multilayer tablet comprising said fermented molasses in at least one layer, 1. A compressed solid composition for washing and / or cleaning for parenteral use, characterized in that the fermented molasses is selected from fermented beet molasses, fermented sugar cane molasses and a mixture of fermented beet molasses and fermented sugar cane molasses.

2. 2. A compressed solid composition for washing and / or cleaning for parenteral use according to claim 1, characterized in that the solids content of fermented molasses is between 50% and 80%.

3. 2. A compressed solid composition for washing and / or cleaning for parenteral use according to claim 1, characterized in that the fermented molasses contains less than 5% by weight of sugars relative to the total weight of the dry extract.

4. 2. A compressed solid composition for washing and / or cleaning for parenteral use according to claim 1, characterized in that the fermented molasses is supplemented with carboxymethylcellulose.

5. 5. A compressed solid composition for washing and / or cleaning for parenteral use according to claim 4, characterized in that the amount of carboxymethylcellulose (dry / dry) is between 0.1% and 2%.

6. 2. A compressed solid composition for washing and / or cleaning for parenteral use according to claim 1, characterized in that the viscosity of the fermented molasses is between 500 and 5000 mPa.s.

7. 2. A compressed solid composition for washing and / or cleaning for parenteral use according to claim 1, characterized in that it comprises an active substance, a filler and, optionally, at least one additive selected from foaming agents, detergents, sequestering agents, pelleting additives, brighteners, polymers, surfactants, flow agents, stabilizers, antifoam agents, dyes and lubricants.

8. 2. A compressed solid composition for washing and / or cleaning for parenteral use according to claim 1, characterized in that it does not contain polyethylene glycol and / or microcrystalline cellulose and / or polyvinylpyrrolidone and / or starch and / or hydroxyethylcellulose and / or gelatine.

9. Use of the compressed solid washing and / or cleaning composition for parenteral use according to claim 1 for cleaning in a dishwasher.

10. Use of fermented molasses selected from fermented beet molasses, fermented sugar cane molasses and a mixture of fermented beet molasses and fermented sugar cane molasses as a binder and disintegrant for the preparation of a compressed solid composition for washing and / or cleaning for parenteral use as described in claim 1.

11. 11. Use according to claim 10, characterized in that the fermented molasses is present in the compressed solid composition for washing and / or cleaning for parenteral use in an amount ranging from 0.1% to 15% by weight relative to the total weight of the composition.

12. A method for producing a compressed solid composition for washing and / or cleaning for parenteral use according to claim 1, comprising the following steps: - providing a material comprising an active substance, a filler and, optionally, at least one additive selected from foaming agents, detergents, sequestering agents, pelleting additives, brighteners, polymers, surfactants, flow agents, stabilizers, antifoam agents, dyes or lubricants, - incorporating fermented molasses selected from fermented beet molasses, fermented cane molasses and a mixture of fermented beet molasses and fermented cane molasses with the material provided in the previous step to obtain a mixture, - compressing said mixture to obtain said compressed solid composition. The method includes:

13. 13. The method of claim 12, wherein the step of containing is performed by spraying.

14. 14. The method according to claim 12 or 13, characterized in that the compressing step is carried out on a rotary press.

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