Saturated fatty acids, their preparation system and use

Abstract

The present invention relates to a process for preparing a mixture of acetylated fatty acids and a system for carrying out said process. Furthermore, the present invention relates to a composition comprising, or alternatively comprising, said mixture of acetylated fatty acids. Finally, the present invention relates to the said composition for use in the treatment and prevention of (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular diseases or heart diseases; (iv) all osteoarticular injuries after injury including sports injuries; (v) all degenerative joint injuries (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory and traumatic tendons and muscles. Furthermore, it is envisaged that the composition of the present invention will also be used in the treatment and / or prevention of diseases and disorders Nos. 1 to 6 above, in connection with rehabilitation therapy. This composition includes the aforementioned mixture in a pharmaceutical form for oral use (foodstuff, supplement or novel medical device), for example in the form of a tablet, lozenge, capsule, pill, granule, dispersible powder, syrup, solution, spray solution, for topical use (composition for a medical device), i.e. as a cream, powder, ointment, gel or spray, for use on the skin, or formulated as an adhesive for transdermal use.

Description

801 362 Description of an invention entitled: Saturated fatty acids, their preparation system and use The present invention relates to a process for preparing a mixture of cetyl fatty acids and a system for carrying out said process. Furthermore, the present invention relates to a composition comprising a mixture of said fatty acids or comprising alternative fatty acids. Finally, the present invention relates to the use of said composition in the treatment and / or prevention of: (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular diseases or heart diseases; (iv) all post-traumatic osteoarticular injuries including sports injuries; (v) all degenerative joint injuries (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory and traumatic tendons and muscles. Furthermore, it is envisaged that the composition of the invention will be used in the treatment and / or prevention of the above-mentioned diseases and disorders in connection with rehabilitation therapy.This composition includes the aforementioned mixture in a pharmaceutical form for oral use (foodstuff, supplement or novel medical device), for example in the form of a tablet, lozenge, capsule, pill, granule, dispersible powder, syrup, solution, spray solution, in a topical use form (composition for a medical device), i.e. formulated as a cream, powder, ointment, gel or spray for use on the skin, or even for transdermal use in the form of a patch. It is well known that an esterification reaction between a fatty acid and a long chain alcohol (longer than C12) or a high molecular weight alcohol (MW greater than 200) can be carried out in the presence of a chemical solvent such as toluene which acts as an azeotropic solvent to remove the water of esterification. An acidic catalyst such as sulfuric acid is also used in the reaction and the process is carried out in a reactor equipped with a Marcusson apparatus. When such a process is used, the final ester product, which contains waxy compounds, appears black due to the presence of sulfuric acid which causes partial carbonization of the final ester product. The black color can be removed by washing with dilute alkali, which neutralizes the catalyst and sodium chloride which helps in phase separation. Using this type of process, it is also necessary to completely remove the solvent used from the final ester product. Complete solvent removal is not always easy and in any case represents significant cost and technological complexity.As a result of the mandatory steps at the end of the esterification reaction, this known process is very expensive and requires very complex technologies. Furthermore, the use of solvents in the esterification reaction does not always guarantee complete removal of the solvent from the final product and there is always the risk of having residual solvent content in the final product that could exceed the limits imposed by law for medical or cosmetic applications. This is why the use of the final product obtained by using solvents, even if it suffers from a large reduction in the amount of solvent, can face regulatory obstacles if used for oral or dermal applications. G. Bartoli et al. (Adv. Synth. Catal. 2005, 1, 33-38) described a method for the esterification of carboxylic acids with alcohols in the presence of zinc perchlorate hexahydrate as catalyst and manganese sulfate as water-absorbing agent. The presence of a solid water-absorbing agent requires additional filtration and purification steps, which is undesirable for large-scale reactions. Furthermore, it is important to emphasize that the perchlorate ion is a strong oxidizing agent that, even at relatively low temperatures, causes the destruction of alkyl compounds such as reactants and reaction products to which this invention relates. This is particularly true for structures containing unsaturated systems. Furthermore, the presence of perchlorates can also be a hazard, since perchloric acid and its salts may cause explosions in the reaction environment. Another important factor is that perchloric acid, such as sulfuric acid and paratoluene sulfonic acid, catalyzes a parasitic reaction that leads to the formation of unsaturated fatty acid esters, i.e., esters of long-chain acids from hydroxy acids by esterification of two acids of similar structure or different formulas, which are undesirable by-products, for example through the formation of an epoxide on the double bond of the unsaturated fatty acid. Therefore, the need remains for a process (and an associated system) that is easy to carry out, economical and can be prepared, with high efficiency, an ester that can be used as a raw material for the formulation of a final product for oral and topical use. It is desirable to have a process (and an associated system) that does not require the removal of solvent at the end of the esterification reaction, but is nevertheless able to remove both the water produced in the esterification reaction during the progress of the reaction and the unreacted compounds at the end of the reaction.Furthermore, it is desirable to have a process (and associated system) that does not generate secondary reactions or by-products such as osteolides. However, the use of vacuum during the esterification reaction not only affects the simple removal of water produced from the reaction vessel but also the removal of the initial reactants (i.e. fatty acid and cetyl alcohol) that have not yet reacted. As a result, not only does the reaction efficiency decrease, but a blockage occurs in the refrigerant placed before the vacuum pump and after the reactor or reaction vessel even in the early phases of the reaction. Therefore, from a plant engineering perspective, there is a need to introduce changes / modifications to the existing systems to overcome their limitations and shortcomings. After a long and extensive research activity, the applicant surprisingly found that the above-mentioned disadvantages could be overcome thanks to the process (and its associated system) described below: Thanks to the process (and the system associated therewith) described and claimed herein, the applicant is able to prepare a mixture of cetyl fatty acids easily and at a reasonable cost with a high reaction rate and high yield without solvents and in a suitable preparation method for a pharmaceutical composition or a composition for a medical device or a supplement for oral use in the form of tablets, lozenges, capsules, pills, granules, dispersible powders, syrups, solutions, spray solutions, in a form for topical use, i.e. as a cream, powder, ointment, gel or spray for application to the skin, or even for transdermal use in the form of a patch. The present invention relates to a process for preparing a mixture of cetyl fatty acids as set forth in the appended claims. The present invention relates to a system for preparing a mixture of cetyl fatty acids according to the process of the present invention as set forth in the appended claims. The present invention relates to a composition comprising the aforementioned mixture of cetyl fatty acids as set forth in the appended claims. The present invention relates to a composition comprising the aforementioned mixture of cetyl fatty acids for use in the treatment and / or prevention of: (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular diseases or heart diseases; (iv) all post-traumatic osteoarticular injuries including sports injuries; (v) all degenerative joint injuries (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory-traumatic tendons and muscles, as claimed in the claims of the patent. The present invention relates to a composition for use in the treatment and / or prevention of the diseases and disorders listed in numbers 1 to 5 above in connection with rehabilitation therapy. A mixture of the aforementioned cetyl fatty acids and the aforementioned compound can rapidly and effectively promote the reduction of inflammatory mechanisms, thus providing very potent anti-inflammatory activity. Preferred configurations of the present invention are described below in detail without limiting the scope of the invention. The process of the present invention comprises the step of contacting at least one fatty acid of vegetable or animal origin (reacting agent) with a cetyl alcohol (reacting agent) [1-hexadecanoyl, CAS 36653-82-4, EINECS 253-149-0] and a catalyst in the absence of a solvent (such as, for example, in the absence of water or in the absence of any organic or inorganic solvent). The two reactants are contacted at an initial pressure of about 1 atmosphere (1 atmosphere = 1.01 bar). During the entire esterification reaction period, the pressure can be kept constant at about 1 atmosphere, or it can be reduced, as described below, by adjusting the vacuum program for the entire reaction period. The fatty acids are of plant or animal origin and are selected from the group consisting of or alternatively consisting of myristic acid, e.g. myristic acid of the type [tetradecanoic acid, CAS 544-63-8, EINECS 208-875-2], oleic acid, e.g. oleic acid of the type [CAS 112-80-1, EINECS 204-007-1] and mixtures thereof. The myristic acid may be a myristic acid having a purity of from 90 to 99%, preferably from 94 to 98%. The oleic acid may be an oleic acid having a purity of from 70 to 95%, preferably from 75 to 90%, even more preferably from 80 to 85%. In preferred embodiments, the initial mixture of fatty acids can consist of 50 to 99% by weight of myristic acid, including myristic acid of the type [tetradecanoic acid, CAS 544-63-8, EINECS 208-875-2] and from 1 to 50% by weight of oleic acid, for example oleic acid of the type [CAS 112-80-1, EINECS 204-007-1]. In another preferred configuration, the initial mixture of fatty acids can comprise from 60 to 90% by weight of myristic acid, e.g. myristic acid of the type [tetradecanoic acid, CAS 544-63-8, EINECS 208-875-2] and from 40% to 10% by weight of oleic acid, e.g. oleic acid of the type [CAS 112-80-1, EINECS 204-007-1]. For example, the initial fatty acid composition contains 65% by weight of myristic acid, e.g., myristic acid type [tetradecanoic acid, CAS 544-63-8, EINECS 208-875-2] and about 35% by weight of oleic acid, e.g., oleic acid type [CAS 112-80-1, EINECS 204-007-1]. The catalyst is a metal catalyst and can preferably be zinc powder. In one case, the catalyst used is zinc metal powder. The amount of catalyst added is from 0.05 to 0.3% by weight relative to the total weight of the reaction reactants (i.e. fatty acid or mixture of fatty acids + cetyl alcohol). Desirably, the amount of catalyst added is from 0.1% to 0.25% by weight; even more preferably, it is from 0.15% to 0.20% by weight. It has been found that the use of a metal powder catalyst such as zinc metal powder is particularly advantageous because, in addition to ensuring excellent yield and high purity of the reaction product, it can be easily separated from the final mixture by filtration. For example, the zinc content in the final product obtained from the inventive process is equal to or less than 20 ppm. This value is fully compatible with the use of the reaction product for pharmaceutical or cosmetic purposes, it being also noted that zinc has a much higher tolerance than other metals, such as tin and titanium, which can be used as catalysts in esterification reactions in the form of salts, e.g. chlorides or oxides. The reaction is carried out at a temperature of from 150 to 200°C, preferably at a temperature of from 160 to 190°C, even more preferably at about 180°C. The reaction time is from 1 hour to 10 hours, preferably from 1 hour to 8 hours, more preferably from 4 hours to 7 hours. A person skilled in the art is aware of the fact that the reaction time depends on the reaction conditions used (temperature, pressure, type of catalyst and concentration of reactant). The removal of water of reaction formed during the esterification reaction is an essential step to achieve the desired conversion / reaction efficiency. The removal of water from the reaction medium can be accomplished by distillation under vacuum carried out throughout the esterification reaction in the reactor, using a vacuum program that applies a nonlinear reduction in the reaction pressure (see Method II and Apparatus II described below). In this case, the vacuum program is applied to the entire system and the entire process. Alternatively, the removal of water from the reaction medium can be achieved at a constant pressure of about 1 atmosphere by using an inert gas flow introduced into the reaction medium during the esterification reaction. The inert gas flow is used to transport / remove water of reaction from the reaction medium (see Method I and Apparatus I described below). It has been found that the use of an inert gas such as nitrogen, argon or their mixtures also has a protective effect against oxidation of the materials, especially in relation to unsaturated systems, such as myristoleic acids or other unsaturated fatty acids that may be present (such as palmitoleic, oleic, linoleic and linolenic acids). It is advantageously understood that the final product according to the present invention (shown as MI in Figure 1-4) has a high purity, for example more than 95%. In fact, using appropriate analytical methods such as gas chromatography with a flame ionization detector (GC-FID), no impurities such as oxidation by-products or osteolides, which were generally obtained in significant amounts under esterification conditions according to previous methods, were detected. Typically, the reaction yield is greater than 95% and the mixture at the end of the reaction contains no more than 3% of cetyl alcohol and no more than 1.4% of the initial fatty acid mixture (weight / total weight of the MI mixture). After filtering the catalyst and optionally a deodorant treatment to produce MF (Figure 1-4), for example at 180°C and at a residual pressure of 10 mbar, the cetyl alcohol content is less than 1.5% and the fatty acid mixture content is less than 0.9%. Purities greater than 97.5% are obtained. The Applicant has surprisingly shown that by applying a carefully selected vacuum program according to the degree of progress of the reaction, it is possible to proceed the reaction optimally with only water being evacuated without distilling off the reactants, most notably in the initial phases of the reaction, for example in the first two / three hours (see Method II, Apparatus II). In one configuration, the reaction is carried out by applying a vacuum program (reducing the pressure inside the reactor and the entire system in a non-linear manner - see Method II, Apparatus II) in which the applied pressure is for example equal to 600 mbar and is reduced non-linearly to 5 mbar, for example after 7 hours. Preferably, the initial reaction pressure is about 1 atmosphere and then a reduction in pressure is applied, which is for example equal to 600 mbar in the first hour and then reduced for example to 500 mbar 2 hours after start, 300 mbar 3 hours after start, 200 mbar 5 hours after start and 5 mbar 7 hours after start (total reaction time 7 hours). Other vacuum programs can also be used. The applicant has found it useful to equip the reactor of the system of the present invention with a vertical condenser and a horizontal condenser, arranged in series and at controlled temperatures (Method II, Apparatus II), or alternatively, with a single horizontal condenser (see Method I, Apparatus I). The vertical condenser is maintained at a temperature of 70 to 90°C, preferably at a temperature of about 80°C, while the horizontal condenser is maintained in both cases at a temperature of 10 to 40°C, preferably at a temperature of about 25°C. The vertical condenser helps to evaporate the water and at the same time to condense the reactants, which are thus recycled to the reaction vessel. Furthermore, it has proven particularly advantageous in both cases to pass an inert gas through the reactor during the reaction. Preferably, said inert gas is a nitrogen gas. In the first mentioned configuration (Method I, Apparatus I), the inert gas is introduced into the reaction medium, preferably as a continuous flow, not in the middle of the reaction mass, but in the upper volume (at the reactor head), of the said reaction mass present in the reactor. In the second configuration mentioned (Method II, Apparatus II), the inert gas is introduced into the reaction medium, preferably as a continuous flow, into the reaction mass in the reactor (added to the mass) using a channel inserted into the middle of the reaction mass. This invention relates to a system for carrying out a process for producing a mixture of cetyl fatty acids containing or substituted with cetyl myristate and / or cetyl oleate. In the first configuration illustrated in Figure 1 (Method I), the system 1 comprises a reactor 2 represented by a tank 3 equipped with a stirring means 4 such as a mechanical stirrer, for example, a heating means 5, such as a jacket, located on the outer surface of the tank 3 through which a hot liquid is placed to pass, a means 6 for controlling the temperature inside the tank, a means 7 for blowing an inert gas into the tank, an inlet port 8 located in the upper part of the tank 3a so as to allow the entry of solids or reactants, an outlet port 9 located in the lower part of the tank 3 so as to allow the collection of reaction samples, and a valve 10 allowing the discharge of the mixture at the end of the process. The reactor 2 is connected to a horizontal condenser 11 via a vessel 3, having a first inlet end 11a and a second outlet end 11b by means of a channel 12. The main axis of the horizontal condenser 11 is arranged in a manner parallel to the remaining surface of the reactor 2. The channel 12 is located between the upper part of the vessel 3a and the first inlet end of the horizontal condenser 11a. The horizontal condenser 11 is connected to a vessel 13 for collecting the reaction water by means of a channel 14. The channel 14 is located between the second outlet end 11b and the upper part of the vessel 13a. In a first configuration, process (I) is used to prepare a mixture of cetyl fatty acids comprising or substituted with cetyl myristate and / or cetyl oleate using the system of Figure 1. This process includes a step in which oleic and / or myristic acid are contacted with cetyl alcohol for reaction in the presence of a catalyst such as zinc metal, so as to produce reaction mixture 15. In order to carry out this step, the aforementioned fatty acids, cetyl alcohol and, at a later time, when the mass of reactants is in a molten state, the catalyst (in the absence of a solvent) are introduced into reactor 2 by introducing them through port 8. The reaction mixture reaches a reaction temperature equal to or less than 100°C and a pressure of about 1 atm. For heating purposes, a hot liquid, for example a heated oil or pressurized steam, is used, at such a temperature that the desired temperature for the reaction is achieved in the jacket 5 of the vessel 3. During the heating step of the reaction mixture 15 located inside the reactor 2, the stirring means 4 and the temperature control means 6 are activated and an inert gas, for example nitrogen, is blown into the vessel 3 with the aid of the suction means 7. The inert gas, nitrogen, is not blown into the reaction mixture 15, but is introduced into the tank 3 almost, in fact in the volume present above the reaction mixture 15. The said fatty acids, cetyl alcohol and catalyst (preferably in the absence of solvents, a pressure equivalent to about 1 atmosphere and a temperature of from 150 to 200 degrees Celsius) cause an esterification reaction in the reaction mixture 15 to produce cetyl esters and water. The esterification reaction is carried out without the use of a vacuum, at a pressure of about 1 atm.The water resulting from the esterification present in the reaction mixture 15, under the reaction temperature and pressure conditions, is converted into vapor which is removed from the tank 3. The water vapor is removed from the tank 3 thanks to the nitrogen flow introduced / blown into a part of the upper volume of the reaction mixture 15 (the upper volume of the reaction mixture). The water vapor and nitrogen reach the horizontal condenser 11 through the channel 12. The inert gas outlet from the tank 3 passes through the channels 12 and 14 and is recovered and reintroduced into the tank 3 (using a system of pipes and valves not shown in Figure 1) thanks to the blowing means 7. The purpose of the horizontal condenser 11 is to condense the water of esterification and remove it from the reaction mixture 15 in a manner that drives the esterification reaction to the highest possible efficiency. The water of esterification is converted into a liquid state and collected in the tank 13 using the channel 14. To achieve condensation of the water of esterification, the condenser 11 is maintained at a temperature below 100 ° C, for example at a temperature of 10 to 40 ° C, preferably 20 to 30 ° C, and a pressure of about 1 atm. At the end of the esterification reaction (without the use of solvents, at a pressure of about 1 atmosphere and without vacuum) the mixture of cetyl fatty acids is cooled and discharged through the valve 10. In a second configuration, illustrated in Figure 2 (second method), the system 1 comprises a reactor 2 represented by a tank 3 equipped with a stirring means 4 such as a mechanical stirrer for example, a heating means 5, such as a jacket, located on the outer surface of the tank 3 through which a hot liquid is placed to pass, a means 6 for controlling the temperature inside the tank, a means 7 for blowing inert gas into the tank, an inlet port 8 located in the upper part of the tank 3a so as to allow the entry of solids or reactants, an outlet port 9 located in the lower part of the tank 3 so as to allow the collection of reaction samples, and a valve 10 allowing the discharge of the mixture at the end of the process. The reactor 2 is connected via a vessel 3 to a vertical condenser 16, having a first inlet end 16a and a second outlet end 16b by means of a channel 12. The main axis of the vertical condenser 16 is arranged in a manner parallel to the reactor 2 installation surface. The channel 12 is located between the upper part of the vessel 3a and the first inlet end of the vertical condenser 16a. The vertical condenser 16 is connected to the horizontal vessel 11, having a first inlet end 11a and a second outlet end 11b by means of a channel 17. The main axis of the horizontal vessel 11 is arranged in a manner parallel to the reactor 2 installation surface. The channel 17 is located between the end of the vertical condenser 16b and the said first inlet end of the horizontal vessel 11a. The horizontal condenser 11 is connected to the vessel 13 for collecting the reaction water by means of a channel 14. The channel 14 is located between the end of the second outlet 11b and the upper part of the vessel 13a. The channel 14 includes an outlet 18 to a pump or device (not shown in FIG. 2) capable of creating a vacuum (pressure less than 1 ampere) or, alternatively, a vacuum program with a non-linear pressure reduction. In a second configuration, process (II) is used to prepare a mixture of cetyl fatty acids containing or alternatively comprising cetyl myristate and / or cetyl oleate using the system of Figure 2. The process includes a step in which oleic and / or myristic acid are contacted with cetyl alcohol for reaction in the presence of a catalyst such as zinc metal, so as to produce a reaction mixture 15. In order to carry out this step, the aforementioned fatty acids, cetyl alcohol and catalyst (in the absence of a solvent) are introduced into reactor 2 by introducing them through port 8. The reaction mixture is brought to a reaction temperature equal to or less than 100°C and a pressure of about 1 atm even if the reaction temperature exceeds 100°C, for example a temperature between 150 and 200. For heating purposes, a hot liquid, for example a heated oil or pressurized steam, is used, at such a temperature that the desired temperature for the reaction is achieved in the jacket 5 of the vessel 3. During the heating step of the reaction mixture 15 located inside the reactor 2, the stirring means 4 and the temperature control means 6 are activated and an inert gas, for example nitrogen, is blown into the vessel 3 with the aid of a suction means 7. The inert gas, nitrogen, is blown into the reaction mixture 15. Said fatty acids, cetyl alcohol and catalyst (preferably in the absence of solvents, a pressure equivalent to about 1 atmosphere and a temperature of from 150 to 200 degrees Celsius) cause an esterification reaction in reaction mixture 15 to produce cetyl esters and water. The water resulting from the esterification present in reaction mixture 15, under reaction temperature and pressure conditions, is converted into vapor which must be removed from vessel 3 to increase the efficiency of the reaction.Water vapor is removed from the tank 3 by means of a vacuum program with a nonlinear pressure reduction applied after the condenser 11. Water vapor and nitrogen reach the horizontal condenser 11 by means of channel 12. The inert gas leaving the tank 3 passes through channels 12, 17 and 14 and is recovered and reintroduced by means of a system of pipes and valves not shown in Figure 2, thanks to the suction device 7. The purpose of the vertical condenser 16 (hot) is to evaporate the reaction water and simultaneously condense the reactants, which are thus recovered in the tank 3 by means of channel 12. The evaporated water reaches the condenser 11 by means of channel 17, while the condensation of the reactants and their re-entry into the tank 3 prevents the pipes from clogging and the reactor 2 from shutting down. The purpose of the horizontal condenser 11 (cold) is to condense the water of esterification and remove it from the reaction mixture 15 in such a way as to drive the esterification reaction to the highest possible efficiency. The water of esterification is liquefied and collected in a tank 13 by means of a channel 14 which includes a channel 18 which directs a pump or a device (not shown) to carry out a vacuum program with a non-linear pressure reduction to facilitate the removal of the water of esterification. To condense the water of esterification, the tank 11 is maintained at a temperature below 100°C, for example at a temperature of 10 to 40°C, preferably from 20 to 25°C, and a pressure of about 1 atm. At the end of the esterification reaction (carried out without the use of a solvent), the mixture of cetyl fatty acids is cooled and drained from the 10-liter milk. The myristic acid (tetradecanoic acid) used can be selected, for example, from those having the following percentage composition (GLC) at a concentration of 99% CAS 544-63-8 (EINECS 208-875-2): lauric acid C12: 0 less than or equal to 1, myristic acid C14: 0 greater than or equal to 99%, palmitic acid C16: 0 less than or equal to 1. The oleic acid used can be selected, for example, from those with a concentration of at least 78% oleic acid CAS 112-80-1 (EINECS 204-007-1) with a percentage composition (GLC) of, for example: [lauric acid + myristic acid] C12:0 + C14:0 less than or equal to 0.5, oleic acid C18:1 greater than or equal to 78%; linoleic acid C18:2 less than or equal to 15 and others C18:3 less than or equal to 1. For example, the cetyl alcohol (1-hexadecanol) used can be selected from those identified as CAS 36653-82-4 (EINECS 253-149-0). The MI mixture (Figure 3) of cetyl fatty acids removed from the milk 10 of reactor 2 (Figures 1 and 2) obtained by the process described above (Method I, Apparatus I or Method II, Apparatus II) either comprises or alternatively comprises cetyl myristate and / or cetyl oleate and catalyst. This "initial" MI mixture can be subjected to a purification treatment to (i) reduce the amount of catalyst present therein, (ii) sterilize the mixture and (iii) remove unreacted reactants. For this purpose, the MI mixture is subjected to diatomaceous earth filtration in a filter press so as to result in a filtered Mf mixture in which the catalyst has been removed or significantly reduced. The filtered outlet Mf mixture is introduced into a sterilization apparatus to be treated at a temperature of 150 to 200°C, e.g. 180°C, at a residual pressure of 5 to 15 mbar, e.g. 10 mbar, in the presence of direct steam for a period of time from 1 hour to 5 hours, preferably from 2 hours to 4 hours, e.g. 3 hours, so as to result in the production of a "final" MF mixture. Due to the removal of the catalyst, ICP-IES analysis performed on the “final” MF mixture showed a residual zinc concentration of 19.6 mg / kg in the reaction mixture, with a reduction of about 98% in the initial amount of zinc powder metal introduced, which was equal to 1000 mg / kg of the reaction mixture. Figure 3 shows a purification treatment in which the mixture MI exiting valve 10 of reactor 2 is fed to a mixer 20 in diatomaceous earth by means of a pipe 19. Through channels 21 and 21a, the mixture MI is fed to a vessel 22 by means of a pump 26 located on channel 21 to undergo a series of steps in a filter press 23 by means of a pipe 24 and a pump 25, in order to produce a filtered mixture Mf, in which the catalyst has been removed or greatly reduced. The filtered mixture Mf exiting the filter press 23 is fed to a tank 27 by means of a valve element 27a. The tank 27 is equipped with a heating means 28, a stirring means 29 and a steam blowing means 30. Disinfection and removal of reactants from the Mf mixture is carried out, for example, at a temperature of 180°C and a pressure of 10 mbar. A condenser 32 is placed on the outlet side of the tank 27; it is connected via a pipe 31 to a device for creating a vacuum (not shown in the figure).At the end of the treatment, a final purified mixture of MF is formed or alternatively composed of cetyl myristate and / or cetyl oleate and catalyst in its minimum amount is obtained. The final refined MF mixture, obtained as described above, has a vegetable oil added thereto, such as refined olive oil, in a weight ratio of 3:1 to produce the composition of the invention, optionally said composition may contain pharmaceutical or nutritional additives and additional facilities. The refined olive oil is added to the final refined MF mixture and cooled to about 100°C before being cooled. In preferred embodiments, the composition of the present invention comprises a mixture of cetyl fatty acids and a mixture of fatty acids of plant origin with a high oleic acid content, from olive oil, palm oil and sunflower oil (HOSO), etc. The mixture of said cetyl fatty acids (obtained as described above) and the mixture of fatty acids of plant origin are preferably added in a weight ratio of 5:1, 4:1, 3:1 or 2:1. More preferably, a weight ratio of 3:1. The composition of the present invention may be a mixture of tocophenols and lecithin. The mixture of tocophenols may be present in an amount of from 1 to 5% by weight, preferably from 2 to 3% by weight, based on the total weight of the composition. The lecithin may be present in an amount of from 1 to 10% by weight, preferably from 1 to 5% by weight, based on the total weight of the composition. In a particularly preferred configuration, the composition of the invention comprises 5% by weight of lecithin, 20% by weight of a refined olive oil, 74% by weight of cetyl fatty acid and 1% by weight of mixed tocophenols relative to the total weight of the composition. The applicant has surprisingly found that the composition of the invention is particularly useful in the treatment and prevention of: (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular diseases or heart diseases; (iv) all post-traumatic osteoarticular injuries including sports injuries; (v) all degenerative joint injuries (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory and traumatic tendons and muscles. Furthermore, it is envisaged that the composition of the invention will also be used in the treatment and / or prevention of diseases and disorders Nos. 1 to 6 above, in connection with rehabilitation therapy. The compound of the invention does not have side effects such as kidney or heart disorders compared to known treatments. Arthritis or other inflammatory joint conditions include, but are not limited to, osteoarthritis, ankylosing spondylitis, cervical arthritis, fibromyalgia, osteonecrosis, Paget's disease, bursitis, psoriasis, gout, carpal tunnel syndrome, juvenile rheumatoid arthritis, rheumatoid arthritis Bessackie, psoriatic arthritis, and rheumatoid arthritis. This composition includes the aforementioned mixture in a pharmaceutical form for oral use (foodstuff, supplement or novel medical device), for example in the form of a tablet, lozenge, capsule, pill, granule, dispersible powder, syrup, solution, spray solution, for topical use (composition for a medical device), i.e. as a cream, powder, ointment, gel or spray, for application to the skin, or for transdermal use in the form of an adhesive. The term "adhesive" refers to a textile or synthetic device capable of releasing the cream to the skin area to which it is applied. When administered topically, the amount of the composition administered is from 1 to 15 mg / kg body weight per day. Preferably, the amount of the composition administered is from 3 to 10 mg / kg body weight per day. More preferably, the amount of the composition administered is from 5 to 8 mg / kg body weight per day. The composition of this invention can contain other active ingredients and / or pharmaceutically acceptable additives such as flavorings, stabilizers, and antioxidants. Analysis methods The synthesis reaction of cetyl fatty acids is controlled by the II method of the II apparatus (Figure 2) using a GC-FID (gas chromatography with a flame ionization detector) system, which includes the following: - Zinc-column injector - SE-54 capillary type column (DB-5, HP-5, etc.), length 15 m, internal diameter 0.32 mm, film thickness 0.1 micron; - Flame ionization detector (FID), set at 370°C. - Carrier gas: helium 1 ml / min (constant flow mode); - Oven with temperature programming: starting from 50°C (1 minute) to 180°C (15°C / minute) to 230°C (7°C / minute) to 360°C (10°C / minute) with final isotherm for 15 minutes. A representative sample, taken in an amount of about 5 mg, was initially treated with diazomethane in ether solution to derivatize the free COOH groups, then diluted with heptane (8 mL) and injected. Figure 4 (Example of GC-FID analysis for the synthesis of cetyl myristate) shows a typical GC graph obtained in the case of the synthesis of cetyl myristate of Example 1. When oleic acid is used as a starting material together with myristic acid (Examples 2 and 4), their obtained chromatogram is in Figure 5 (Example of GC-FID analysis for the synthesis of cetyl myristate / oleate). The inhibition times (RT) in minutes are: 8.025 for myristic acid; 9.044 for cetyl alcohol; 10.550 for oleic acid + other C18; 21.167 for cetyl myristate; 22.416 for cetyl palmitate; 23.608 for cetyl oleate + other C18 cetyls. The presence of cetyl palmitate is modified by the combination of oleic acid blends used. Examples of solvent-free configurations were performed in a reactor equipped with a vertical condenser heated to 80 °C and a horizontal condenser heated to 20 °C (Method II and Apparatus II): Example 1 Myristic acid (molecular weight 228) 50.0 g (0.219 mol), cetyl alcohol (molecular weight 242) 53.0 g (0.219 mol), catalyst: 0.1% zinc metal powder (0.1 g), temperature 180 ° C. At the end of the reaction, the sample was filtered. Table 1 Example 2 Myristic acid (molecular weight 228) 65.0 g (0.285 mol). Oleic acid 80% (molecular weight 274) 35.0 g (0.128 mol) [acidity 204.7 NS 200.5 mg KOH / g]. Total moles of acid: 0.413. Cetyl alcohol (molecular weight 242) 100.0 g (0.413 mol). Catalyst: 0.1% zinc metal powder (0.1 g), temperature 180°C. At the end of the reaction the sample was filtered. No blockage of the refrigerant occurred in the early phases of the reaction. Table 2 Example 3 Cetyl alcohol (molecular weight 242) 100.0 g (0.413 mol). Oleic acid 80% (molecular weight 274) 112.0 g (0.409 mol). Catalyst: 0.1% zinc metal powder (0.1 g), temperature 180 ° C. At the end of the reaction the sample was filtered. No refrigerant blockage occurred in the initial phases of the reaction. Table 3 Example 4 Myristic acid (molecular weight 228) 160.0 g (0.701 mol). Oleic acid 80% (molecular weight 274) 88.0 g (0.321 mol) [acidity 204.7 NS 200.5 mg KOH / g]. Total moles of acid: 1.022. Cetyl alcohol (molecular weight 242) 250.0 g (1.033 mol). Zinc metal powder 0.1% (0.2 g), temperature 180 °C, light flow of nitrogen in the reactor. At the end of the reaction, the sample was filtered. No blockage of the refrigerant occurred in the early stages of the reaction. Determination of the melting point of the resulting compounds according to NGD C27-1976: Due to the very high melting point of fatty substances, the melting point is well defined by measuring the slip and clear points. These temperatures correspond to those at which a fraction of the substance in contact with the wall of the capillary tube begins to melt (slip point) and then slides and enters the capillary tube (clear point). In order to measure them, the substance in question is placed in a special U-shaped tube of fixed dimensions (for thermal insufflation of the melted sample at a temperature of about 10 °C above the melting point) and allowed to cool for a time of at least 16 hours and then immersed in a water bath which is slowly heated. The mixture consisting of cetyl myristate (75% by weight) from Example 1 and refined olive oil (25% by weight) has a slip point of 44.9 °C and a clear point of 47.1 °C. The mixture consisting of cetyl myristate and cetyl oleate (75% by weight) from Example 2 and refined olive oil (25% by weight) has a pour point of 44.4°C and a clear point of 45.1°C.The mixture consisting of cetyl myristate and cetyl oleate (75% by weight) from Example 4 and refined olive oil (25% by weight) has a slip point of 44.2°C and a clear point of 45.2°C. Experimental design In vitro efficacy study – In vitro evaluation of the anti-inflammatory activity of a sample of the cetyl fatty acid mixture obtained by Method I of this invention in a cultured cell. The aim of the present study is to investigate the capacity of the said sample in an in vitro system to modulate the inflammatory mechanisms induced in cultured human synovial cells (fibroblast-like synoviocytes) (ATCC-HTB-93). The anti-inflammatory activity study was performed using ELISA method, using several inflammatory markers, in particular three pro-inflammatory cytokines: TNFalpha, IL1alpha and IL6. Sample preparation and exposure method Before being tested for efficacy, the sample was heated to 50°C in a temperature-controlled bath and stirred to obtain a homogeneous solution. The sample was then emulsified with corn oil (37°C) and a culture medium was added: 0.1 g of the emulsified with 100 μl of corn oil was made up to a volume of 1 ml with culture medium (37°C). Serial dilutions were then made in the culture medium. In order to select the most suitable concentration for the final test, the sample was subjected to a preliminary cytotoxicity test. For this purpose, different concentrations from 10.00% to 0.08% were tested (dilution 1:2). Based on the evaluation of the test results, the 1.00% samples were selected to exert anti-inflammatory activity. To perform the experiment, cultures of synovial cells (fibroblast-like synoviocytes) (ATCC-HTB-93) were treated for 24 h with LPS (lipopolysaccharide from Escherichia coli, 1 μg / ml), a known harmful substance of bacterial nature that induces acute inflammatory stress, and were treated simultaneously with the samples to reach a concentration of 1% based on the initial cytotoxicity test. At the end of the monitored experimental period, the levels of the cytokines of interest in the culture medium were measured using an ELISA test. The results obtained were compared with negative control cultures (no treatment, CTR-) and positive control cultures (treated with LPS only, CTR+). In brief, the experimental protocol was provided to evaluate three proinflammatory markers (TNFalpha, IL1alpha and IL6): Cell culture without treatment (negative control, CTR-), - Cell culture in which an acute inflammation was induced by the test (positive control, CTR+) - Cell culture in which an acute inflammation was induced and simultaneously treated with 1.00% test samples. Evaluation of inflammatory markers (TNFalpha, IL1alpha and IL6) Control culture medium and cells treated with test samples were used to evaluate the inflammatory cytokines TNFalpha, IL1alpha and IL6 using the ELISA method. For this purpose, commercially available kits are used that exploit the competitive binding of the antigen (in this case the cytokine of interest) with the primary antibody. The immune complex (antigen-antibody) is in turn detected by a secondary antibody conjugated to a peroxidase. The addition of peroxidase produces a color reaction with an intensity proportional to the quantities of immune complexes, and therefore proportional to the quantities of bound cytokines. Quantification is based on a calibration curve constructed with standard concentrations of cytokines on an increasing scale. Results and graphs The following table shows the results obtained in this study. The results are reported as the amount of cytokines released into the culture medium during the experimental period (mean ± SD) and as a mean % change compared to control. Anti-inflammatory activity - TNFalpha assessment Table 5: TNFalpha assay in CTR-, CTR+ and cell cultures treated with a sample of the acetylated acid mixture obtained by method I (sample R8P). Results are expressed as mean ± SD (expressed in ng / l) and as mean % changes compared to control. Table 5 TNFalpha ng / l % Variation vs CTR- % Variation vs CTR+ CTR- 145.7 ± 6.4 - CTR+ 185.7 ± 12.3 +27.5% - R8P 1.00% 156.7 ± 6.4 +7.5% -15.6% Anti-inflammatory activity - IL1alpha assessment Table 6: IL1alpha assay performed in CTR-, CTR+ and R8P-treated cell cultures. Results are expressed as mean ± SD (expressed in ng / l) and as mean % change compared to control. Table 6 IL1alpha ng / l % Variation vs CTR- % Variation vs CTR+ CTR- 115.6 ± 8.6 - CTR+ 144.1 ± 5.9 +24.7% - R8P 1.00% 110.1 ± 8.3 -4.7% -23.6% Anti-inflammatory activity - IL6 assessment Table 7: IL6 assay performed in CTR-, CTR+ and R8P-treated cell cultures. Results are expressed as mean ± SD (expressed in ng / l) and as mean % changes compared to control. Table 7 IL6 ng / l % Variation vs CTR- % Variation vs CTR+ CTR- 89.5 ± 9.1 - CTR+ 105.6 ± 5.9 +18.1% - R8P 1.00% 73.7 ± 4.5 -17.6% -30.2% Configurations of the present invention with FRn methods are shown below: FR1. A process for producing a mixture of CI (MI) cetyl fatty acids includes the following steps: - contacting, in a vessel (3) of the reactor (2), at least one fatty acid selected from the group consisting of or, alternatively, of myristic acid, oleic acid or mixtures thereof, with cetyl alcohol and a metal catalyst, in the absence of a solvent, so as to produce a reaction mixture (15); - heating the reaction mixture (15) to a reaction temperature between 150 and 200°C and a reaction pressure of about 1 atmosphere, so as to cause an esterification reaction with the initial formation of cetyl fatty acid esters and ester water. - Allowing the reaction mixture (15) to react for a reaction time of from 1 hour to 8 hours to complete the esterification reaction so that the complete formation of the cetyl fatty acid mixture (MI) is achieved and complete removal of water is achieved by introducing a flow of inert gas into the tank (3) of the reactor (2) for the entire reaction time. FR2. Process according to FR1, in which complete removal of water is achieved by maintaining a constant reaction pressure of about 1 atmosphere and said inert gas flow is introduced into a portion of the upper volume of the reaction mixture (15) via a blowing means (7), thereby allowing water to be drawn from the tank (3). FR3. Process according to FR2, wherein the water drawn from the tank (3) during the esterification reaction is condensed at a constant reaction pressure in a horizontal condenser (11) and collected in the tank (13); the condenser (11) is preferably maintained at a temperature of 10 to 40°C, and is connected to said tank (3) in its upper part (3a) via a channel (12). FR4. Process according to FR1, in which complete removal of ester water is achieved by using a vacuum program that applies a nonlinear reaction pressure reduction, and a flow of inert gas is blown into the reaction mixture (15) via a blowing means (7), thereby allowing water to be drawn from the tank (3). FR5. Process according to FR4, while the vacuum program preferably applies a reduction in reaction pressure to 600 mbar after the first hour of reaction in a non-linear manner, preferably reaching 5 mbar after 7 hours of reaction. FR6. Process according to FR5, where the water discharged from the tank (3) during the esterification reaction with a vacuum program is condensed in a horizontal condenser (11) and collected in a container (13) after passing through a vertical condenser (16). FR7. The process according to FR6, wherein the refrigerant (11) is maintained at a temperature of above 10°C to 40°C and is connected via a vertical refrigerant (16) to a tank (16) which is maintained at a temperature preferably of from 70 to 90°C. FR8. The process according to any one of FR1 to 7, wherein a mixture of cetyl fatty acids (MI) is subjected to a subsequent purification treatment comprising diatomaceous earth filtration in a filter press (23), so as to produce a filtered mixture Mf in which the metal catalyst is removed or greatly reduced. FR9. The process according to FR8, wherein the filtered mixture Mf is treated in a reactor (27) at a temperature of from 150 to 200°C and a pressure of from 5 to 15 mbar in the presence of water vapor for a period of from 1 hour to 5 hours, so that a final purified mixture (MF) based on cetyl fatty acids is produced. FR10. The composition comprises a final refined mixture (MF) based on cetyl fatty acids obtained based on FR9 and a vegetable oil in a 3:1 weight ratio, said composition being used for the treatment and prevention of (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular diseases or heart diseases; (iv) all post-traumatic osteoarticular injuries including sports injuries; (v) all degenerative joint injuries (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory and traumatic tendons and muscles. Complaint 1- The process of producing a mixture of cetyl fatty acids (MI) includes the following steps: - contacting, in a vessel (3) of the reactor (2), at least one fatty acid selected from the group consisting of or, alternatively, of myristic acid, oleic acid or mixtures thereof, with cetyl alcohol and a metal catalyst, in the absence of a solvent, so as to produce a reaction mixture (15); - heating the reaction mixture (15) to a reaction temperature between 150 and 200°C and a reaction pressure of about 1 atmosphere, so as to cause an esterification reaction with the initial formation of cetyl fatty acid esters and ester water. - Allowing the reaction mixture (15) to react for a reaction time of from 1 hour to 8 hours to complete the esterification reaction so that the complete formation of the cetyl fatty acid mixture (MI) is achieved and complete removal of water is achieved by introducing a flow of inert gas into the tank (3) of the reactor (2) for the entire reaction time. 2- The process according to claim 1, wherein complete removal of water is achieved by maintaining a constant reaction pressure of about 1 atmosphere and a flow of inert gas is blown through a blowing means (7) into a portion of the upper volume of the reaction mixture (15), thereby allowing the ester water to escape from the tank (3). 3- Process according to claim 2, in which the ester water discharged from the tank (3) during the esterification reaction is condensed at a constant reaction pressure in a horizontal condenser (11) and collected in the tank (13); the condenser (11) is maintained at a temperature of 10 to 40°C and is connected to the tank (3) in its upper part (3a) via a channel (12). 4. The process according to claim 1, wherein complete removal of ester water is achieved by using a vacuum program that applies a nonlinear reduction in reaction pressure and a flow of inert gas is blown into the reaction mixture (15) via a blowing means (7), thereby allowing ester water to be drawn from the tank (3). 5. The process according to claim 4, wherein the vacuum program preferably applies a reduction of the reaction pressure to 600 mbar after the first hour of reaction in a non-linear manner, preferably reaching 5 mbar after 7 hours of reaction. 6- The process according to claim 5, wherein the ester water removed from the tank (3) during the esterification reaction with a vacuum program is condensed in a horizontal condenser (11) and collected in the tank (13) after passing through a vertical condenser (16). 7- The process according to claim 6, wherein the refrigerant (11) is maintained at a temperature of from 10°C to 40°C and is connected to the tank (3) via a vertical refrigerant (16) which is maintained at a temperature preferably from 70 to 90°C. 8. The process according to any one of claims 1 to 7, wherein a mixture of cetyl fatty acids (MI) is subjected to a subsequent purification treatment comprising diatomaceous earth filtration in a filter press (23), so as to produce a filtered mixture Mf in which the metal catalyst is removed or greatly reduced. 9. The process according to claim 8, wherein the filtered mixture Mf is treated in a reactor (27) at a temperature of from 150 to 200°C and a pressure of from 5 to 15 mbar in the presence of water vapor for a period of from 1 hour to 5 hours, so that a final purified mixture (MF) based on cetyl fatty acids is produced. 10- A composition comprising the final refined mixture (MF) based on cetyl fatty acids obtained according to claim 9 and a vegetable oil in a 3:1 weight ratio, said composition being used for the treatment and prevention of (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular diseases or heart diseases; (iv) all post-traumatic osteoarticular injuries including sports injuries; (v) all degenerative joint injuries (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory and traumatic tendons and muscles. Abstract The present invention relates to a process for preparing a mixture of cetyl fatty acids and a system for carrying out said process. Furthermore, the present invention relates to a composition comprising, or alternatively comprising, said mixture of cetyl fatty acids. Finally, the present invention relates to said composition for use in the treatment and prevention of (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal disease or cardiovascular or heart disease; (iv) all post-traumatic osteoarticular injuries including sports injuries; (v) all degenerative joint injuries (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory and traumatic tendons and muscles. Furthermore, it is envisaged that the composition of the present invention will also be used in the treatment and / or prevention of diseases and disorders Nos. 1 to 6 above, in connection with rehabilitation therapy.This composition includes the aforementioned mixture in a pharmaceutical form for oral use (foodstuff, supplement or novel medical device), for example in the form of a tablet, lozenge, capsule, pill, granule, dispersible powder, syrup, solution, spray solution, for topical use (composition for a medical device), i.e. as a cream, powder, ointment, gel or spray, for application to the skin, or for transdermal use in the form of an adhesive.

Claims

CLAIMS 1. A process for preparing a mixture of cetylated fatty acids (MI) comprising the steps of: - placing in contact, in a container (3) of a reactor (2), at least one fatty acid selected from the group comprising or, alternatively, consisting of myristic acid, oleic acid or mixtures thereof, with a cetyl alcohol and a metal catalyst, in the absence of a solvent, so as to yield a reaction mixture (15); - heating said reaction mixture (15) to a reaction temperature comprised from 150°C to 200°C and a reaction pressure of about 1 atmosphere, so as to give rise to an esterification reaction with the initial formation of esters of cetylated fatty acids and esterification water; - allowing said reaction mixture (15) to react for a reaction time comprised from 1 hour to 8 hours until completion of said esterification reaction so as to obtain the complete formation of a mixture of cetylated fatty acids (MI) and the complete removal of said esterification water, the latter being achieved by introducing a flow of inert gas into the container (3) of said reactor (2) for the whole reaction time.

2. The process according to claim 1, wherein said complete removal of esterification water is achieved by maintaining the reaction pressure constant at about 1 atm and introducing said flow of inert gas, via a blowing means (7), into the portion of volume above the reaction mixture (15), thus allowing the esterification water to be drawn out of the container (3).

3. The process according to claim 2, wherein the esterification water drawn out of the container (3) during the esterification reaction at a constant reaction pressure is condensed in a horizontal condenser (11) and collected in a container (13); preferably, said condenser (11) is maintained at a temperature comprised from 10°C to 40°C and is connected to said container (3), in the upper portion (3a) thereof, via the conduit (12).

4. The process according to claim 1, wherein said complete removal of esterification water is achieved by using a vacuum program that applies a reduction in the reaction pressure in a non-linear manner and introducing said flow of inert gas, via the blowing means (7), into the reaction mixture (15), thus allowing the esterification water to be drawn out of the container (3).

5. The process according to claim 4, wherein the vacuum program preferably applies a reduction in the reaction pressure to 600 mbar after the first hour of reaction in a non-linear manner, preferably arriving at 5 mbar after a reaction time of seven hours.

6. The process according to claim 5, wherein the esterification water, drawn out of the container (3) during the esterification reaction with the vacuum program, is condensed in a horizontal condenser (11) and collected in a container (13) after having passed through a vertical condenser (16).

7. The process according to claim 6, wherein said condenser (11) is maintained at a temperature preferably comprised from 10°C to 40°C and is connected to said container (3) via the vertical condenser (16), which is maintained at a temperature preferably comprised from 70°C to 90°C.

8. The process according to any one of claims 1-7, wherein said mixture of cetylated fatty acids (MI) is subjected to a subsequent refinement treatment, which comprises diatomaceous earth filtration in a filter press (23), so as to yield a filtered mixture Mf in which the metal catalyst present therein is removed or greatly reduced in amount.

9. The process according to claim 8, wherein the filtered mixture Mf is treated in a reactor (27), at a temperature comprised from 150°C to 200°C and a pressure comprised from 5 mbar to 15 mbar in the presence of water vapour for a period of time comprised from 1 hour to 5 hours, so as to yield a final refined mixture (MF) based on cetylated fatty acids.

10. A composition comprising a final refined mixture (MF) based on cetylated fatty acids obtained according to claim 9, and a vegetable oil in a 3:1 ratio by weight; said composition being for use in the treatment and prevention of (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular or heart diseases; (iv) all post-traumatic osteoarticular pathologies including sports injuries; (v) all degenerative joint pathologies (arthrosis, gonarthrosis, coxarthrosis, etc.) and (vi) inflammatory-traumatic tendon and muscular conditions. ABSTRACT The present invention relates to a process for preparing a mixture of cetylated fatty acids and a system for carrying out said process. Furthermore, the present invention relates to a composition comprising, or alternatively, consisting of said mixture of cetylated fatty acids. Finally, the present invention relates to said composition for use in the treatment and / or prevention of: (i) rheumatoid arthritis of inflammatory and non-inflammatory origin, in particular osteoarthritis; (ii) other inflammatory joint conditions; (iii) psoriasis, lupus, periodontal diseases or cardiovascular or heart diseases; (iv) all post-traumatic osteoarticular pathologies including sports injuries; (v) all degenerative joint pathologies (arthrosis, gonarthrosis, coxarthrosis, etc.), and (vi) inflammatory-traumatic tendon and muscular conditions. Furthermore, it is envisaged that the composition of the present invention be used in the treatment and / or prevention of the above-mentioned pathologies and disorders (i)-(vi) in association with a rehabilitative therapy. The composition comprising said mixture is formulated in a pharmaceutical form for oral use (novel food, supplement or medical device), i.e. in the form of a pill, pastille, capsule, tablet, granules, dispersible powder, syrup, solution or sprayable solution; for topical use, i.e. in the form of a cream, unguent, ointment, gel or spray to be used as such for application on the skin, or else for transdermal use in the form of a patch.

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