Novel low temperature compositions

JP2025510411A5Pending Publication Date: 2026-03-19LESAGE +1
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
LESAGE
Filing Date
2023-03-21
Publication Date
2026-03-19

AI Technical Summary

Technical Problem

Existing cryotherapy devices suffer from instability and flexibility issues during freeze/thaw cycles, leading to rapid deterioration and reduced effectiveness over time.

Method used

A cryogenic composition containing a high amount of superabsorbent polymer granules, combined with a hydrophobic compound and moisturizer, forms a stable and flexible thermal treatment device that maintains surface temperature stability and flexibility over multiple cycles.

Benefits of technology

The device achieves a stable surface temperature between 7-10°C for up to 120 minutes and remains flexible after freezing, withstanding over 60 freeze/thaw cycles without deterioration, and significantly reduces preparation time.

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Abstract

The present invention relates to a novel cryogenic composition and its preparation method intended for use in heat treatment equipment. The present invention also relates to heat treatment equipment, more particularly to medical equipment used to cool parts of the human or animal body, especially after trauma, inflammation or surgery. The present invention finds application in the therapeutic and / or medical field, but also in other fields, for example for cooling or maintaining food or beverages at low temperatures.
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Description

[Technical field]

[0001] The present invention relates to novel cryogenic compositions and methods for their preparation, intended for use in heat treatment devices. The present invention also relates to heat treatment devices, more particularly medical devices used to cool parts of the human or animal body, in particular after trauma, inflammation or surgery. The present invention therefore finds application in the therapeutic and / or medical field, but also in other fields, for example for cooling or maintaining food or beverages at low temperatures. [Background technology]

[0002] Cryotherapy, or cold therapy, emerged in the 1970s and is now widely used in the medical field to heal damaged tissues, promote healing, and relieve physical pain from sprains, tendonitis, strains, etc. Its principle consists in exposing a part of the human or animal body to low temperature, which causes the secretion of endorphins, which have an analgesic effect and thus a lowering of the pain threshold. Therefore, cryotherapy is used after trauma or surgery, taking advantage of its hemolytic and anti-edema effects.

[0003] Cryotherapy uses different sources of cold: Nitrogen-based devices using flash vaporization of liquid nitrogen. This technique is cumbersome as it involves the use of heavy and bulky equipment. Water-based heat treatment devices. Water is one of the best materials to restore low temperatures. However, at temperatures below 0°C, water turns into ice, which has the disadvantage that due to its solid structure it is difficult to adapt to anatomical structures and at very low temperatures can cause tissue damage. Devices based on antifreeze compositions that do not exhibit a phase change upon freezing at -25°C. These compositions exist in the form of beads or gels, but cannot be effectively used in cryotherapy because the low temperatures restored are highly unstable. Devices using these compositions have surface temperatures that, upon thawing, can be as low as approximately -5°C for gels and beads. Phase change devices, such as those described in patent EP1011558. This patent describes a composition comprising water, an absorbent product of acrylic polymer type, and a moisturizing agent. During freezing, part of the water contained in the network of the absorbent product is released and undergoes a phase change to ice crystals. Upon heating, the water returns to the absorbent network. These compositions remain flexible and conformable. However, they do not tolerate repeated freeze / thaw cycles well and tend to become less flexible as the cycles progress, making them uncomfortable and less effective in use. These compositions also have the disadvantage of requiring a container that includes a semi-permeable, waterproof, breathable area, making the device complicated. The latter also reduces the use time of the device further, since the surface temperature during thawing is below 0°C for a long time, since it is necessary to wait for the temperature to stabilize above 0°C or to insert an insulating layer between the device and the skin before use.

[0004] WO2017 / 125687 describes low-temperature compositions that contain a liquid hydrophobic compound with a freezing point below 0°C, in which superabsorbent polymer granules with added water and a moisturizing agent are immersed. The liquid phase of these compositions is not an emulsion. These low-temperature compositions have good low-temperature kinetics, but perform poorly in terms of flexibility (aggregation / disintegration of the superabsorbent polymer granules) beyond a certain number of freeze / thaw cycles. Summary of the Invention [Problem to be solved by the invention]

[0005] In this context, the present invention aims to overcome the drawbacks of the prior art devices by proposing a thermal treatment device comprising a novel cryogenic composition that does not deteriorate during freeze / thaw cycles (no aggregation / decomposition of the cryogenic composition over time). The device of the present invention has the advantage of excellent durability and can therefore be reused several times (more than 60 times without deterioration). Within a few minutes after thawing, the device of the present invention has a surface temperature that is ideally between 7 and 10°C and remains stable for at least 70 minutes and up to 120 minutes. The thermal treatment device also remains completely flexible after freezing. [Means for solving the problem]

[0006] The inventors have discovered that these properties can be achieved by using a cryogenic composition containing a high amount of superabsorbent polymer. The cryogenic composition of the present invention has been found to be more stable (survives a greater number of freeze / thaw cycles) and more malleable and flexible after freezing. The cryogenic composition of the present invention, unlike the prior art compositions, provides a more uniform absorbency of the superabsorbent polymer granules, thus improving the stability and flexibility of the heat treatment device of the present invention.

[0007] Another advantage of the present invention is that the preparation time of the low temperature composition is significantly reduced compared to the prior art methods, and the hydration time of the superabsorbent polymer granules is significantly reduced (halved) in the method of the present invention, thus resulting in significant time savings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Thus, according to a first aspect, the present invention provides a method for producing a method for treating a cancer cell comprising: (a) Superabsorbent polymer granules impregnated with a liquid phase The liquid phase of the low temperature composition comprises: (b) at least one hydrophobic compound selected from neopentylene glycol diheptanoate, isopropyl sebacate, isodecyl neopentanoate, isostearyl isostearate, and mixtures thereof; (c) at least one moisturizer; (d) optionally at least one preservative; and (e) water wherein the superabsorbent polymer granules (a) are greater than 6% by weight based on the total weight of the low temperature composition.

[0009] In the sense of the present invention, "superabsorbent polymer" means a polymer that can spontaneously impregnate / absorb at least 20 times its own weight in an aqueous fluid, especially water, in a dry state. This polymer has a high capacity to absorb and retain water and aqueous fluids. After absorbing the aqueous liquid, the polymer granules thus immersed in the aqueous fluid remain insoluble in the aqueous fluid and therefore remain separate. Examples of superabsorbent polymers are described in the work "Absorbent polymer technology, Studies in polymer science 8" by L. BRANNON-PAPPAS and R. HARLAND (Elsevier edition, 1990).

[0010] Among the superabsorbent polymers (a) that can be used in the context of the present invention, mention may be made of cross-linked sodium or potassium polyacrylates, polyacrylamides, copolymers based on ethylene and maleic anhydride, vinyl alcohol copolymers, cross-linked polyethylene oxides, polymers based on starch, gums, and cellulose derivatives, pectins, alginates, agar (or agarose), polyethyleneamines, polyvinylamines, and mixtures thereof. The superabsorbent polymer (a) is preferably a cross-linked acrylic homopolymer or copolymer, more preferably a cross-linked sodium or potassium acrylic homopolymer or copolymer.

[0011] The superabsorbent polymer granules (a) are advantageously present in the low temperature composition of the invention in an amount ranging from 7 to 25%, preferably from 7 to 20%, more preferably from 8 to 15%, even more preferably from 9 to 15%, even more preferably from 10 to 15%, relative to the total weight of the low temperature composition.

[0012] The superabsorbent polymer granules (a) of the invention are advantageously in the form of spherical beads having a diameter of 1 to 6 mm when dehydrated. According to a further preferred embodiment, the spherical beads of superabsorbent polymer (a) are beads of sodium or potassium polyacrylate, more preferably potassium polyacrylate, preferably having a diameter of 1 to 3 mm when dehydrated. The spherical beads are capable of absorbing at least 40 times their mass, a property defined for water under normal conditions of temperature (20° C.) and pressure (100,000 Pa). When hydrated, the spherical beads of superabsorbent polymer (a) swell and form soft beads.

[0013] In the low temperature composition of the present invention, the superabsorbent polymer granules (a) preferably constitute at least 7% by weight, more preferably at least 8% by weight, based on the total weight of the low temperature composition. In a particularly preferred embodiment, the superabsorbent polymer granules (a) constitute at least 9% by weight, more preferably at least 10% by weight, based on the total weight of the low temperature composition.

[0014] In the low-temperature composition of the present invention, the hydrophobic compound (b) advantageously has a freezing point of less than -7°C, preferably less than -10°C, more preferably less than -15°C, even more preferably less than -20°C. It advantageously has a high molecular weight in the range of 200 to 700 g / mol. The hydrophobic compound (b) is in liquid form. It is preferably selected from neopentylene glycol diheptanoate, isopropyl sebacate, isodecyl neopentanoate, isostearyl isostearate, and mixtures thereof, more preferably neopentylene glycol diheptanoate. These hydrophobic compounds (b) are commercially available, for example, from the company STEARINERIE DUBOIS under the references DUB DNPG (neopentylene glycol diheptanoate, freezing point: -55°C), DUB DIS (isopropyl sebacate, freezing point: -20°C), DUB VCI10 (isodecyl neopentanoate, freezing point: -35°C), DUB ISIS (isostearyl isostearate) or from the company INTERCHIMIE.

[0015] The amount of the hydrophobic compound (b) is preferably 0.1 to 8%, more preferably 0.1 to 6%, and even more preferably 0.1 to 4%, based on the total weight of the low-temperature composition.

[0016] In the low temperature composition of the present invention, the humectant (c) may be selected from glycerol, sorbitol, polyethylene glycol, (di)propylene glycol, polypropylene glycol, 1,5-pentanediol, propylene glycol, butylene glycol, diethylene glycol, paraffin oil, and mixtures thereof, preferably from glycerol, (di)propylene glycol, polypropylene glycol, and mixtures thereof, more preferably from (di)propylene glycol, polypropylene glycol, and mixtures thereof. Dipropylene glycol is the most preferred humectant (d).

[0017] The content of the moisturizer (c) is preferably 1 to 20%, more preferably 5 to 20%, and even more preferably 5 to 15%, based on the total weight of the low-temperature composition.

[0018] If preservative (d) is present, it is advantageously selected from isothiazolinones, such as 2-methyl-2H-isothiazol-3-one, 5-chloro-2-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazolin-3-one, and mixtures thereof. Preservative (d) is preferably 2-methyl-2H-isothiazol-3-one, for example sold under the name Microcare®MT (manufacturer THOR). Advantageously, preservative (d) is free of formaldehyde compounds.

[0019] If preservative (d) is present, it is preferably present in an amount of 0.05 to 5%, more preferably 0.05 to 4%, and even more preferably 0.1 to 3%, based on the total weight of the low temperature composition.

[0020] The liquid phase of the low temperature composition of the invention is advantageously in the form of an oil-in-water emulsion in which the fatty phase preferably consists of a hydrophobic compound (b) and the aqueous phase consists of a humectant (c), optionally a preservative (d) and water (e).

[0021] According to a preferred embodiment, the low temperature composition of the present invention comprises: (a) 7 to 25% by weight, preferably 7 to 20% by weight, more preferably 8 to 15% by weight, of superabsorbent polymer granules; (b) 0.1 to 8% by weight, preferably 0.1 to 6% by weight, more preferably 0.1 to 4% by weight, of at least one hydrophobic compound selected from neopentylene glycol diheptanoate, isopropyl sebacate, isodecyl neopentanoate, isostearyl isostearate, and mixtures thereof; (c) 1 to 20% by weight, preferably 5 to 20% by weight, more preferably 5 to 15% by weight, of at least one moisturizing agent; (d) 0.05 to 5% by weight, preferably 0.05 to 4% by weight, more preferably 0.1 to 3% by weight, of at least one preservative; (e) Water: 60 to 90% by weight, preferably 65 to 85% by weight, more preferably 70 to 85% by weight wherein the percentages are expressed as weight percentages based on the total weight of the cryogenic composition, the total weight of the cryogenic composition being 100%.

[0022] Another object is to provide a method for preparing the low temperature composition according to the invention, comprising the steps of: (i) preparing an oil-in-water emulsion by adding, under stirring, at least one hydrophobic compound (b) to an aqueous mixture based on at least one humectant (c), optionally at least one preservative (d), and water (e); (ii) adding superabsorbent polymer granules (a) to the oil-in-water emulsion obtained at the end of step (i); (iii) impregnating the oil-in-water emulsion obtained at the end of step (ii) with superabsorbent polymer granules (a) and leaving the superabsorbent polymer granules (a) at room temperature until they reach a size preferably between 2 and 4 times their initial size. The present invention relates to a method comprising the steps of:

[0023] Step (i) of preparing the oil-in-water emulsion is carried out with stirring, preferably at a speed of 5000-15000 rpm, more preferably 8000-12000 rpm, for a time preferably in the range of 30 seconds to 5 minutes, more preferably 30 seconds to 3 minutes. Stirring can be carried out using a Dynamic SMX800 turbo mixer.

[0024] Step (iii), impregnation of the oil-in-water emulsion obtained at the end of step (ii) with superabsorbent polymer granules (a), is preferably carried out for a period ranging from 1 to 5 hours, more preferably from 1 to 2 hours.

[0025] Also part of the invention is a heat treatment device comprising a sealed container, in which the cryogenic composition according to the invention is contained. Advantageously, the container is made of a flexible material such as polyvinyl chloride (PVC), polychloroprene (neoprene), polytetrafluoroethylene (PTFE) or polyethylene (PE), preferably polyethylene (PE). According to an advantageous embodiment, the container is a multi-layer material comprising at least one layer of polyethylene (PE). The device is preferably a sealable flexible medical bag that can be applied to parts of the human or animal body for purposes such as absorbing hematomas, edema or for relieving pain.

[0026] The heat treatment device of the present invention can be obtained by simply filling a sealed container, preferably a medical bag, with the low-temperature composition of the present invention. The low-temperature composition of the present invention is preferably manually stirred before being used to fill a sealed container. In practice, the low-temperature composition is usually stored in a drum, and the low-temperature composition can be homogenized before use by rotating it 1-2 times (manual stirring) before use.

[0027] The present invention is therefore primarily directed to a medical device selected from a face mask, a splint for the shoulder, elbow, ankle, knee, hip or wrist, and any support, comprising a sealable flexible medical bag according to the present invention.

[0028] The cryogenic composition of the present invention or the heat treatment device of the present invention can be used to cool a part of the human or animal body, preferably after trauma, inflammation or surgery. The temperature can be visually controlled using a thermochromic pigment that is pre-added to the cryogenic composition of the present invention. It may also be included in the material that constitutes the container. This pigment may be a thermochromic pigment, such as those marketed by the company OliKrom.

[0029] The heat treatment device of the present invention may also be intended for non-medical applications and may be used to reduce or maintain the temperature of, or promote the preservation of, food or beverages (e.g. wine), or to transport heat sensitive items in low temperature environments, where the temperature can be visually controlled using thermochromic pigments as described above.

[0030] The heat treatment device of the present invention can be used in a heat treatment method for reducing the temperature of a part of the human or animal body or for reducing the temperature of a food or beverage, the method comprising: (i') freezing the device according to the invention at a temperature below 0°C, preferably at a temperature between -20°C and -30°C, for a time which may range from 2 to 4 hours, (ii') manually kneading the device obtained at the end of step (i'); (iii') applying the device obtained at the end of step (ii') to a part of the human or animal body, preferably for a period of between 30 and 120 minutes, with or without the use of a medical device according to the invention. Includes.

[0031] In addition to the provisions set forth above, the present invention also includes other provisions that will become apparent from the following additional description of examples that highlight advantageous properties of the low temperature compositions of the present invention. EXAMPLES

[0032] Example 1:

[0033] A low temperature composition according to the present invention was prepared by mixing 11400g of water with 1620g of dipropylene glycol (supplier: INTERCHIMIE) and 30g of 2-methyl-2H-isothiazol-3-one (Microcare®MT, THOR) under manual stirring. 450g of neopentylene glycol diheptanoate (DUB DPNG from STEARINERIE DUBOIS) was added to the mixture of water, dipropylene glycol, and 2-methyl-2H-isothiazol-3-one, and then the mixture was stirred at a speed of 11000 rpm for 1 minute and 30 seconds using a Dynamic SMX800 turbo mixer to form an oil-in-water emulsion. Next, 1500g (i.e., 10% by weight based on the total weight of the composition) of potassium polyacrylate beads with a diameter of 1.5 mm (supplier: Shanghai Chuangshi Medical Technology Group Co., Ltd.) was added to the resulting emulsion. The emulsion was left to stand at room temperature for 1.5 hours until the potassium polyacrylate beads reached an average diameter of 4 mm (step of impregnating the emulsion with polymer beads). 390 g of the resulting mixture was poured into a polyethylene (PE) bag with a diameter of 295 mm. The bag was then sealed and placed in a -20°C freezer for 3 hours. During freezing, some of the water contained in the polymer beads underwent a phase change and turned into tiny ice crystals that look like snow.

[0034] Once out of the freezer, a TESTO175 T2 temperature recorder with a CTN type probe was used to measure 14g / cm 2 The temperature of the sample was measured every minute for 120 minutes under compression of 100 μm. Measurements were taken every minute at the interface of the freezing bag and a 2 cm thick bag of water at 20 °C. The temperature of the bag was maintained at 7-10 °C for 71 minutes. Thus, the bag can be used for a cryotherapy treatment for 71 minutes.

[0035] The aging of the cryogenic composition was also evaluated by measuring the number of freeze / thaw cycles. When the polymer beads start to aggregate, the flexibility of the freezing bag decreases and aging becomes visible. For the cryogenic composition of Example 1, the bag always remained homogeneous (no degradation of the polymer beads) and flexible up to the 60th freeze / thaw cycle. At this stage, the measurement was stopped.

[0036] Counterexample 1:

[0037] A low-temperature composition representative of the prior art WO2017 / 125687A1 was prepared by mixing 14000 g of water and 1190 g of dipropylene glycol (source: INTERCHIMIE) with manual stirring. 350 g (i.e., 2.2% by weight relative to the total weight of the composition) of potassium polyacrylate beads with a diameter of 1.5 mm (source: Shanghai Chuangshi Medical Technology Group Co., Ltd.) were added to the water and dipropylene glycol mixture. The mixture was left to stand at room temperature for 3 hours until the potassium polyacrylate beads reached an average diameter of 5.5 mm (step of impregnating the polymer beads). 56 g of neopentylene glycol diheptanoate (DUB DPNG from STEARINERIE DUBOIS) was poured into a polyethylene (PE) bag with a diameter of 295 mm. A previously prepared mixture of water, dipropylene glycol, and potassium polyacrylate beads was also added to the PE bag. The bag was then sealed and placed in a freezer at -20° C. for 3 hours. During freezing, some of the water contained in the polymer beads underwent a phase change and turned into tiny ice crystals that look like snow.

[0038] As in Example 1, after removal from the freezer, a TESTO175 T2 temperature recorder was used with a CTN type probe to measure 14 g / cm 2 The temperature of the sample was measured every minute for 120 minutes under compression of 100 mm. Measurements were taken every minute at the interface between the freezing bag and a 2 cm thick bag of water at 20 °C. The temperature of the bag was maintained between 7.5 and 10 °C for 70 minutes.

[0039] As in Example 1, the aging of the cryogenic composition of Counter Example 1 was evaluated by measuring the number of freeze / thaw cycles. As the polymer beads start to aggregate, the flexibility of the freezing bag decreases and the aging becomes visible. The bag deteriorates from the 3rd freeze / thaw cycle (aggregation of polymer beads), then loses homogeneity and flexibility, and is no longer usable from the 25th freeze / thaw cycle.

[0040] Counterexample 2:

[0041] A low temperature composition was prepared by mixing 12150g of water with 1620g of dipropylene glycol (supplied by INTERCHIMIE) and 30g of 2-methyl-2H-isothiazol-3-one (Microcare®MT, THOR) under manual stirring. 450g of neopentylene glycol diheptanoate (DUB DPNG from STEARINERIE DUBOIS) was added to the mixture of water, dipropylene glycol, and 2-methyl-2H-isothiazol-3-one, and then the mixture was stirred at a speed of 11000 rpm for 1 minute and 30 seconds using a Dynamic SMX800 mixer to form an oil-in-water emulsion. Next, 750g of potassium polyacrylate beads (supplied by Shanghai Chuangshi Medical Technology Group Co., Ltd.) with a diameter of 1.5 mm (i.e., 5% by weight based on the total weight of the composition) was added to the resulting emulsion. The emulsion was left to stand at room temperature for 2.25 hours until the potassium polyacrylate beads reached an average diameter of 4.7 mm (polymer bead hydration step). 390 g of the resulting mixture was poured into a polyethylene (PE) bag with a diameter of 295 mm. The bag was then sealed and placed in a -20°C freezer for 3 hours. During freezing, some of the water contained in the polymer beads underwent a phase change and turned into tiny ice crystals that looked like snow.

[0042] As in Example 1, when removed from the freezer, a TESTO175 T2 temperature recorder was used with a CTN type probe to measure 14 g / cm 2The temperature of the sample was measured every minute for 120 minutes under compression of 100 μm. Measurements were taken every minute at the interface of the freezing bag and a 2 cm thick bag of water at 20 °C. The temperature of the bag was maintained at 7-10 °C for 70 minutes. Thus, the bag can be used for a 70 minute cryotherapy treatment.

[0043] As in Example 1, the aging of the cryogenic composition of Counter Example 2 was evaluated by measuring the number of freeze / thaw cycles. As the polymer beads start to aggregate, the flexibility of the freezing bag decreases and the aging becomes visible. The bag deteriorates from the 7th freeze / thaw cycle (aggregation of polymer beads), then loses its homogeneity and flexibility, and is no longer usable from the 31st freeze / thaw cycle.

[0044] The above examples show that the cryogenic composition of Example 1 (invention) preserves the integrity of the polymer beads (no aggregation / decomposition of the polymer beads) over more than 60 freeze / thaw cycles while at the same time significantly improving the flexibility of the freezing bag. In addition, the appearance of the cryogenic composition is improved because no degradation of the polymer beads is observed. Another advantage of the cryogenic composition of the invention is that the impregnation time of the polymer beads is reduced to 1.5 hours instead of 3 hours (time saving during the preparation of the cryogenic composition of the invention). Counter example 2 shows that when the cryogenic composition contains less than 6% by weight of superabsorbent polymer granules (a) relative to the total weight of the composition, the aging and decomposition of the cryogenic composition is accelerated compared to the cryogenic composition according to the invention, and the polymer beads decompose rapidly.

Claims

1. (a) Superabsorbent polymer granules impregnated with liquid phase A low-temperature composition comprising the liquid phase, (b) at least one hydrophobic compound selected from neopentylene glycol diheptanoate, isopropyl sebacate, isodecyl neopentanoate, isostearyl isostearate, and mixtures thereof, preferably neopentylene glycol diheptanoate. (c) at least one humectant, (d) at least one preservative, and (e) Water A low-temperature composition comprising the superabsorbent polymer granules (a) in an amount of more than 6% by weight relative to the total weight of the low-temperature composition.

2. The low-temperature composition according to claim 1, characterized in that the superabsorbent polymer granules (a) are present in an amount of at least 7% by weight, preferably at least 8% by weight, preferably at least 9% by weight, and more preferably at least 10% by weight, relative to the total weight of the low-temperature composition.

3. The low-temperature composition according to claim 1 or 2, characterized in that the superabsorbent polymer granules (a) are in an amount of 7 to 25% by weight, preferably 7 to 20% by weight, more preferably 8 to 15% by weight, even more preferably 9 to 15% by weight, and even more preferably 10 to 15% by weight, based on the total weight of the low-temperature composition.

4. (a) Superabsorbent polymer granules in an amount of 7 to 25% by weight, preferably 7 to 20% by weight, more preferably 8 to 15% by weight, even more preferably 9 to 15% by weight, and even more preferably 10 to 15% by weight, (b) 0.1 to 8% by weight, preferably 0.1 to 6% by weight, more preferably 0.1 to 4% by weight, of at least one hydrophobic compound selected from neopentylene glycol diheptanoate, isopropyl sebacate, isodecyl neopentanoate, isostearyl isostearate, and mixtures thereof, preferably neopentylene glycol diheptanoate. (c) At least one humectant in an amount of 1 to 20% by weight, preferably 5 to 20% by weight, more preferably 5 to 15% by weight, (d) At least one preservative in an amount of 0.05 to 5% by weight, preferably 0.05 to 4% by weight, more preferably 0.1 to 3% by weight, (e) Water in an amount of 60-90% by weight, preferably 65-85% by weight, more preferably 70-85% by weight The low-temperature composition according to claim 1 or 2, characterized in that it includes, the percentage is expressed as a weight percentage relative to the total weight of the low-temperature composition, and the total weight of the low-temperature composition is 100%.

5. The low-temperature composition according to claim 1 or 2, characterized in that the superabsorbent polymer of the granules (a) is selected from crosslinked sodium or potassium polyacrylate, polyacrylamide, copolymers based on ethylene and maleic anhydride, vinyl alcohol copolymers, crosslinked polyethylene oxide; polymers based on starch, gum, and cellulose derivatives; pectin, alginate, agar (or agarose), polyethyleneamine, polyvinylamine, and mixtures thereof.

6. The low-temperature composition according to claim 1 or 2, characterized in that the superabsorbent polymer granules (a) are in the form of spherical beads having a diameter of 1 to 6 mm when dehydrated, and the spherical beads can absorb at least 40 times their own mass.

7. The low-temperature composition according to claim 6, characterized in that the superabsorbent polymer granules (a) are beads of sodium polyacrylate or potassium polyacrylate or a mixture thereof, preferably potassium polyacrylate, having a diameter of 1 to 3 mm when dehydrated.

8. The low-temperature composition according to claim 1 or 2, characterized in that the above-mentioned humectant (c) is selected from glycerol, sorbitol, polyethylene glycol, (di)propylene glycol, polypropylene glycol, 1,5-pentanediol, propylene glycol, butylene glycol, diethylene glycol, paraffin oil, and mixtures thereof, preferably selected from glycerol, (di)propylene glycol, polypropylene glycol, and mixtures thereof, more preferably selected from (di)propylene glycol, polypropylene glycol, and mixtures thereof, and even more preferably dipropylene glycol.

9. The low-temperature composition according to claim 1 or 2, characterized in that the preservative (d) is selected from isothiazolinones, for example, 2-methyl-2H-isothiazolinone, 5-chloro-2-methyl-4-isothiazolinone, 2-methyl-4-isothiazolinone, and mixtures thereof, and preferably 2-methyl-2H-isothiazolinone.

10. A method for preparing a low-temperature composition according to claim 1 or claim 2, (i) A step of preparing an oil-in-water emulsion by adding at least one hydrophobic compound (b) to an aqueous mixture based on at least one humectant (c), optionally at least one preservative (d), and water (e) while stirring, (ii) Adding superabsorbent polymer granules (a) to the oil-in-water emulsion obtained at the end of step (i), (iii) Impregnating the oil-in-water emulsion obtained at the end of step (iii) with the superabsorbent polymer granules (a), and allowing the superabsorbent polymer granules (a) to stand at room temperature until they reach a size preferably 2 to 4 times their initial size. A method characterized by including the following.

11. The method according to 10, characterized in that the step (iii) of impregnating the oil-in-water emulsion obtained at the end of step (ii) with the superabsorbent polymer granules (a) is performed for a time in the range of 1 to 5 hours, preferably in the range of 1 to 2 hours.

12. A heat treatment apparatus comprising a sealed container, wherein the sealed container contains the low-temperature composition described in claim 1.

13. The apparatus according to claim 12, characterized in that the container is a sealed, flexible medical bag made of a multilayer material selected from polyvinyl chloride (PVC), polychloroprene (neoprene), polytetrafluoroethylene (PTFE), or polyethylene (PE), preferably containing at least one layer of polyethylene (PE).

14. A medical device comprising a sealed, flexible medical bag as described in claim 13, including a face mask, a splint for the shoulder, elbow, ankle, knee, buttock, or wrist, and any support.

15. Use of the cryogenic composition according to claim 1 or 2, or the heat treatment apparatus according to claim 12, for lowering or maintaining the temperature of food or beverages, or for promoting their preservation, or for transporting heat-sensitive articles in a low-temperature atmosphere.