Oral composition for oral intake initiation in a patient after an anesthetic procedure

Abstract

The present invention relates to an oral composition designed for the postoperative hydration of patient, which is an excellent solution for supporting postsurgical recovery. This type of product is very important given that, following surgery, patients need rapid and effective hydration, because during and after the procedure many of them experience fluid loss owing to previous fasting, blood loss and the administration of anaesthesia. A beverage specifically formulated for these purposes helps restore essential electrolytes, minerals and liquids more quickly and efficiently than water alone.

Description

ORAL COMPOSITION FOR INITIATION OF ORAL INDUCTION IN A PATIENT FOLLOWING AN ANESTHETIC PROCEDURE FIELD OF INVENTION

[0001] The present invention relates to an oral composition containing balanced electrolytes and additionally contains antiemetic, analgesic, and stimulant products that allow for oral resumption after surgery in a patient; the oral composition produces better recovery and well-being in the patient. BACKGROUND OF THE INVENTION

[0002] Currently, there is a pressing need in the field of oral compositions designed exclusively for oral initiation after surgery because there is no product specifically intended for this purpose; that is, there are many oral rehydration solutions that were designed to hydrate patients after a dehydration process associated with specific pathologies such as diarrhea, hydroelectrolytic alterations associated with extreme exercise, or chronic nutritional alterations associated with alterations of the gastrointestinal tract.

[0003] These solutions were designed for specific purposes and are not intended to safely and efficiently initiate oral feeding in a patient following surgery. Furthermore, aromatic beverages used for this purpose only serve to verify oral tolerance; they do not provide the necessary electrolytes, trace elements, or other medical components that could improve postoperative well-being.

[0004] Typical oral rehydration solutions (ORS) not designed for post-surgical oral initiation are widely used to prevent and treat dehydration. These conventional formulations rely on replacing electrolytes (primarily sodium and potassium) and carbohydrates (usually glucose) lost during dehydration. World Health Organization (WHO) guidelines recommend ORS with specific concentrations of these components for optimal absorption and efficacy. However, conventional ORS focus on fluid and electrolyte replacement without addressing other symptoms that often accompany dehydration, such as swelling and nausea. Swelling can result from fluid and electrolyte loss, especially in cases of severe dehydration or during strenuous exercise.Nausea and vomiting, meanwhile, are common causes of dehydration and can make it difficult to drink fluids, creating a vicious cycle.

[0005] Patents exist covering various oral rehydration solution (ORS) formulations with variations in electrolyte concentrations, carbohydrate types, and the addition of other ingredients such as prebiotics, vitamins, or minerals. However, to our knowledge, no ORS formulations exist that are specifically designed for safe and efficient post-surgical oral initiation and that also effectively incorporate anti-inflammatory and antiemetic agents within the same composition, thus offering a more comprehensive approach to dehydration management.

[0006] In the state of the art, oral rehydration solutions (ORS) are known, as is the case of the United States patent application US2007259054, which provides an oral rehydration mixture, including 47 to 75% by weight of a saccharide containing glucose, 6 to 13% by weight of sodium chloride, 6.5 to 19% by weight of potassium chloride, 2 to 5% by weight of sodium citrate, 10 to 16% by weight of citric acid, and 0.3 to 0.5% by weight of a chlorinated sucrose isomer. An oral rehydration solution is also indicated or provided, which includes water, 1.2 to 1.8% by weight of a glucose-containing saccharide, 35 to 50 mEq / L of sodium, 15 to 56 mEq / L of potassium, 35 to 90 mEq / L of chloride, 10 to 30 mEq / L of citrate, and 0.01 to 0.5 g / L of a sweetener. The solution has an osmolarity of 200 to 311 mEq / L.

[0007] In another aspect, the invention provides an oral rehydration solution comprising water, 1.2 to 3.0% by weight of a glucose-containing saccharide, 35 to 90 mEq / L of sodium, 30 to 56 mEq / L of potassium, 35 to 90 mEq / L of chloride, and 10 to 30 mEq / L of citrate. The solution has an osmolarity of 200 to 311 mEq / L. In another aspect, the invention provides an oral rehydration solution comprising water, 1.2 to 3.0% by weight of a glucose-containing saccharide, 35 to 55 mEq / L of sodium, 15 to 56 mEq / L of potassium, 35 to 90 mEq / L of chloride, and 10 to 25 mEq / L of citrate. The solution has an osmolarity of 200 to 270 meq / L. In another aspect, the invention provides an oral rehydration solution, comprising water, 1.3 to 1.9% by weight of a glucose-containing saccharide, 36 to 54 meq / L of sodium, 24 to 56 meq / L of potassium, 52 to 79 meq / L of chloride, 16 to 25 meq / L of citrate, and 0.08 to 0.12 g / L of a chlorinated sucrose isomer.The solution has an osmolarity of 200 to 311 meq / L.

[0008] US patent 10463067 refers to oral rehydration products for the treatment of mammals suffering from gastrointestinal disorders that may arise from nutritional, parasitic, prion, bacterial, viral, or protozoal causes and lead to fluid depletion, acidosis, and imbalances or loss of essential electrolytes.The patent proposes an oral rehydration composition comprising the following: l-glutamic acid in a range of approximately 0.01% to approximately 0.40% w / w; monosodium glutamate in a range of approximately 0.05% to approximately 0.80% w / w; approximately 1.50% w / w glucose monohydrate; approximately 0.20% w / w sodium chloride; approximately 0.15% w / w potassium chloride; approximately 0.35% w / w glycine; approximately 0.30% w / w trisodium citrate; approximately 0.15% w / w sodium dihydrogen phosphate; approximately 0.10% w / w xanthan gum; 85% steviol glycoside extract in a range of approximately 0.01% to approximately 0.03% w / w; approximately 0.20% w / w citric acid monohydrate; hydrolyzed whey in a range of approximately 0.15% to approximately 1.00% w / w; approximately 1.00% w / w of hydrolyzed wheat; comprises cereals as a protein source; comprises enzyme cofactors and comprises a monosaccharide.

[0009] The United States of America patent application US2016219916 proposes an oral rehydration formula for those who have suffered dehydration resulting from fever, diarrhea, vomiting or combinations thereof.An oral rehydration composition based on galacto-oligosaccharides is proposed, comprising a carbohydrate source present in a sufficient amount to provide from approximately 10 mmol / L to approximately 285 mmol / L of carbohydrates per liter of oral rehydration formula, a sodium source present in a sufficient amount to provide from approximately 10 mEq / L to approximately 95 mEq / L of sodium per liter of oral rehydration formula, a galacto-oligosaccharide (GOS) source present in a sufficient amount to provide from approximately 1 g / L to approximately 10 g / L of galacto-oligosaccharide; and between 50 and 100% of the GOS in the oral rehydration formula is beta-GOS, and the GOS has a degree of polymerization of between 2 and 60.The formula is aqueous with a pH of approximately 2 to approximately 6.5, and GOS are present in an amount of approximately 2.5 g / L to approximately 3.5 g / L. The GOS source comprises less than approximately 20% lactose. The carbohydrate is dextrose and is present in an amount of approximately 30 mmol / L to approximately 200 mmol / L of the oral rehydration formula. The dextrose-to-sodium molar ratio is approximately 0.5: to approximately 4:1. The sodium source is at least one of sodium chloride, sodium phosphate, sodium citrate, sodium carbonate, sodium bicarbonate, sodium hydroxide, or combinations thereof.

[0010] However, none of the prior art examples have a specific development for subsequent oral initiation in a patient who has undergone surgery safely and efficiently. Therefore, it is desirable to develop a product designed to improve postoperative recovery in patients, which could represent benefits in the patient's sense of well-being and, in real terms, in the recovery of the hydroelectrolytic balance associated with the prolonged fasting that many of these patients experience. Additionally, administering analgesic, antiemetic, and anti-inflammatory medications achieves a greater sense of well-being compared to simply offering hydration solutions, which sometimes do not meet the needs of patients, because the requirements are not the same if it is abdominal, orthopedic, neurosurgical, thoracic, or other types of surgery. OBJECT OF THE INVENTION

[0011] It relates to an oral composition that contains balanced electrolytes and additionally contains antiemetic, analgesic and stimulant products that allow oral resumption after surgery in a patient that once ingested produces better recovery and well-being in the patient. DETAILED DESCRIPTION OF THE INVENTION

[0012] An object of this invention is to provide an oral composition designed for the hydration of post-surgical patients, which is an excellent solution to support recovery after surgery. This type of product is very important because a patient after surgery requires rapid and effective rehydration since, during and after surgery, many patients experience fluid loss due to prior fasting, blood loss, and the administration of anesthesia. A beverage specifically formulated for such purposes helps to replenish essential electrolytes, minerals, and fluids more quickly and efficiently than water alone.

[0013] Regarding metabolic recovery after surgery, the body needs energy to initiate repair processes and fight potential infections. A beverage containing simple carbohydrates, essential amino acids, and vitamins improves the metabolic response and promotes healing. It can also help prevent complications, as post-surgical dehydration can lead to issues such as hypotension, weakness, dizziness, and even delayed recovery; a suitable beverage can minimize these risks and help maintain fluid and electrolyte balance.

[0014] However, patients who have recently undergone surgery may have difficulty swallowing solid foods or even large quantities of liquids. A beverage designed with a pleasant texture and flavor, and which is also easy to digest, could encourage adequate intake.

[0015] Speaking specifically about the texture and flavor possibilities of the beverage of the present invention, it is important to note that the beverage's texture must be carefully designed, taking into account the needs and limitations of post-surgical patients. The consistency or texture should be liquid enough to be easy to swallow but not so watery that it goes unnoticed or is perceived as unsatisfactory. The texture of an oral rehydration beverage plays a fundamental role in the consumption experience because a slightly thick beverage, with a consistency similar to that of a thick or semi-liquid liquid, can facilitate the swallowing process by providing greater perception and control as it passes through the throat.This feature is particularly useful for avoiding the "fast-passing" sensation typical of very thin liquids, which can often cause discomfort or risk of aspiration, especially in vulnerable patients; the controlled viscosity also improves the contact of the liquid with the oral cavity and pharynx, allowing for better tissue hydration and a more comfortable experience.

[0016] A slightly thick consistency not only makes swallowing easier but also enhances the product's sensory perception, giving an impression of greater substance and quality. This can be achieved through the use of stabilizers that do not alter the flavor but provide a uniform texture; in this way, the beverage not only fulfills its functional purpose of rehydration but also optimizes convenience and safety for a wider audience.

[0017] A slightly viscous texture can be pleasant and provide a feeling of satiety without being heavy. Natural thickening agents such as xanthan gum or modified starches can be used to adjust the viscosity, ensuring they don't interfere with the flavor or nutritional benefits. Creating hydrogels (with a soft, gelatinous consistency) or emulsions can also offer a more appealing texture for the consumer. In addition to encapsulating essential nutrients, it's crucial to ensure the beverage has a uniform texture, free of lumps or particles that might be unpleasant or difficult to swallow. Microencapsulation can also be used, where tiny droplets of nutrients, minerals, or flavorings are integrated into the beverage to gradually release components as it's consumed.Another option to consider is hydrating foams, which qualify as drinks with a foam or mousse-like texture. This could be a novel option for patients who have an aversion to conventional liquids, or a texture between a gel and a drink that dissolves easily in the mouth could be useful for patients with moderate dysphagia.

[0018] In summary, a light and fluid texture may be ideal for patients without swallowing problems, facilitating quick and effective consumption; a slightly viscous texture with an intermediate consistency (like that of a nectar) may be useful for patients who require a more substantial but easy-to-drink product; this also helps to keep the active components in homogeneous suspension; and a thick or gelled texture may be suitable for patients with dysphagia (difficulty swallowing), where a thicker or even gel-like beverage may be safer, reducing the risk of aspiration.

[0019] Regarding the palatability of oral rehydration solutions (ORS), it is known that the presence of minerals such as sodium, potassium, and magnesium can impart a salty or metallic taste which, if not properly balanced, can be unpleasant. This is what is known as improving the palatability of the beverage, which for this purpose is based on counteracting the salty taste with natural acids (such as citric acid) or small amounts of sweeteners. The palatability of the beverage is essential to ensure that patients consume the recommended amount of ORS; therefore, the beverage may contain extracts of natural flavors such as lemon, lime, orange, cocoa, berries, apple, vanilla, cinnamon, coconut, or mint, and generally other natural spices that can make the beverage more appealing and refreshing.The use of these flavorings may vary depending on whether the patient is an adult or an infant because people prefer flavors depending on their age. For example, infant patients may be strongly inclined towards sweet or fruity flavors, while adults may be inclined to prefer more natural flavors such as chamomile, spearmint, cinnamon, or even the refreshing taste of aloe vera.

[0020] Instead of sugar, sweeteners such as stevia, erythritol, or sucralose can be used, providing sweetness without adding calories or affecting glucose levels, which is especially important for diabetic patients. In general, the beverage's flavor should be mild, balanced, and non-intrusive, so overly intense or artificial flavors may be rejected by sensitive individuals. Acidic profiles (such as lemon or orange) are often perceived as refreshing and stimulating, while sweet flavors (such as vanilla or red berries) can be comforting.

[0021] The flavor profile of the beverage must take into account another important variable: its aroma. A natural and appealing aroma complements the flavor, so natural extracts of fruits or herbs like mint or chamomile can enhance the olfactory experience. The aroma should be subtle enough not to overwhelm, especially for patients experiencing nausea. Incorporating flavors that stimulate the sense of smell, such as aloe vera, mint, spearmint, and chamomile, adds significant value to oral rehydration beverages. These not only improve the consumer's sensory experience but also influence the overall taste perception and contribute to the patient's well-being during recovery, making the beverage more appealing and enjoyable to consume.The sense of smell is closely linked to taste, and an appealing aroma can transform the impression of a beverage that might otherwise be perceived as too salty or bland due to the concentration of electrolytes.

[0022] Aloe vera, with its fresh, natural aroma, creates a feeling of purity and cleanliness that reinforces the idea of ​​healthy hydration. Meanwhile, chamomile, with its delicate floral scent, evokes a sense of calm and well-being. These properties not only contribute to the beverage's greater appeal but also differentiate it in the market, offering a more complete experience for the consumer.

[0023] Furthermore, these aromatic extracts are compatible with the other components of the rehydration drinks, ensuring they do not interfere with the stability of the oral rehydration formula. Their inclusion not only enhances the sensory experience but also helps mask the salty taste of the electrolytes, a common challenge when developing oral rehydration drinks.

[0024] Regarding electrolytes, sodium (Na⁺) is the main extracellular cation and plays a crucial role in maintaining fluid balance, nerve transmission, and muscle contraction. This means that most of the sodium in our body is found outside the cells, in the fluid that surrounds them (blood plasma, interstitial fluid, lymph, etc.). Its preponderance in the extracellular fluid (ECF) gives it a fundamental role in a large number of physiological processes. Sodium is the main determinant of ECF osmolarity. Osmolarity refers to the concentration of dissolved particles in a fluid; water moves by osmosis from areas of low osmolarity to areas of high osmolarity. Therefore, sodium, being the main ion in the ECF, controls the movement of water between the intracellular space (inside the cells) and the extracellular space.If the concentration of sodium in the ECF increases (hypernatremia), water moves from the cells into the ECF, which can cause cellular dehydration; if the concentration of sodium decreases (hyponatremia), water moves from the ECF into the cells, which can cause cellular swelling (edema).

[0025] By regulating water movement, sodium also directly influences extracellular fluid (ECF) volume. For example, an increase in sodium concentration retains water in the ECF, increasing its volume, while a decrease in sodium concentration causes water loss from the ECF, decreasing its volume. This control of ECF volume is crucial for maintaining blood pressure and the proper functioning of the circulatory system.

[0026] Regarding the transmission of nerve impulses, it should be noted that sodium plays an essential role in their generation, along with potassium, participating in the sodium-potassium pump mechanism. This membrane protein pumps sodium out of the cell and potassium into the cell, creating an electrochemical gradient that is fundamental for the excitability of nerve cells. Sodium also participates in muscle contraction, including cardiac muscle contraction, so changes in sodium concentrations can affect the strength and coordination of muscle contractions. Sodium, along with other ions such as bicarbonate and chloride, helps maintain the body's acid-base balance, which is crucial for the proper functioning of enzymes and other proteins.

[0027] Potassium (K⁺) is another preferred electrolyte in the present invention because it is the principal intracellular cation and is essential for cell function, muscle contraction, and acid-base balance. Potassium is the most abundant positively charged ion within cells; approximately 98% of the body's total potassium is found inside cells, primarily in muscle tissue. This high intracellular concentration of potassium, in contrast to the low extracellular concentration, is crucial for a number of vital physiological functions. For example, potassium plays a fundamental role in maintaining the cell membrane potential, which is the difference in electrical charge between the inside and outside of the cell. This charge difference is essential for the excitability of nerve and muscle cells, enabling the transmission of nerve impulses and muscle contraction.The sodium-potassium pump, a membrane protein that pumps sodium out of the cell and potassium in, is primarily responsible for maintaining this electrochemical gradient.

[0028] Potassium, being the main intracellular ion, influences the movement of water into and out of cells. Water moves by osmosis from areas of low solute concentration to areas of high solute concentration; therefore, a high concentration of potassium inside the cell attracts water inward, helping to maintain proper cell volume. Furthermore, this ion is a cofactor for numerous enzymes, meaning it is necessary for these enzymes to function correctly, participating in important metabolic processes such as protein synthesis, carbohydrate metabolism, and energy production. Along with sodium and calcium, this ion participates in muscle contraction, including the contraction of the heart muscle. Thus, an imbalance in potassium levels can affect the strength and coordination of muscle contractions and even lead to cardiac arrhythmias.

[0029] Another electrolyte present in the invention is the chloride ion (Cl⁻), which is the main anion (negatively charged ion) in the extracellular fluid (ECF). This means that most of the chloride in our body is found outside the cells, playing a crucial role in a variety of physiological functions. For example, chloride contributes significantly to the osmolarity of the ECF, which influences the movement of water between cells and the extracellular space, maintaining proper fluid balance in the body. Chloride participates in regulating the body's acid-base balance by exchanging with other ions, such as bicarbonate (HCO₃⁻), helping to maintain blood pH within a narrow, healthy range.This ion is an essential component of hydrochloric acid (HCl), the main acid in gastric juice. HCl is crucial for the digestion of food, especially proteins, and also helps control bacterial growth in the stomach. Chloride also participates in the transmission of nerve impulses, although its role is less direct than that of sodium and potassium. It contributes to neuronal inhibition, which helps regulate the excitability of the nervous system. Chloride is involved in the transport of carbon dioxide (CO₂) from the tissues to the lungs for elimination; this process is known as the "chloride exchange" or "Hamburger effect."

[0030] Another electrolyte present in the invention is the Magnesium ion (Mg²⁺), which is the fourth most abundant cation in the human body and the second most abundant intracellular cation (after potassium). Although only a small fraction of the body's total magnesium is found in the extracellular fluid (ECF), its role in numerous physiological processes is crucial. For example, approximately 60% of the body's magnesium is stored in the bones, where it contributes to their structure and strength; 39% of magnesium is found inside cells, mainly in muscle and soft tissues; and about 1% of magnesium is found in the ECF (blood plasma and interstitial fluid).

[0031] Magnesium participates in over 300 enzymatic reactions in the body, making it an essential mineral for a wide range of biological functions. It is crucial for energy production, as this ion is an essential cofactor for the enzymes that produce adenosine triphosphate (ATP), the primary source of cellular energy. Magnesium regulates muscle contraction, nerve impulse transmission, and neurotransmitter release; it acts as a natural calcium channel blocker, helping to relax muscles and prevent neuronal overexcitation. Furthermore, magnesium is necessary for protein synthesis from amino acids and participates in the synthesis and repair of DNA and RNA, the carriers of genetic information. Additionally, magnesium helps relax blood vessels, contributing to healthy blood pressure, and plays a role in glucose metabolism and insulin sensitivity.

[0032] The electrolyte concentrations of the present invention may vary depending on the individual patient's circumstances, and especially the type of surgery they have undergone. For example, sodium concentrations below 5 mEq / L are justified in specific situations where sodium loss is not the primary concern, such as in mild hypertonic dehydration (where there is a greater loss of water than electrolytes). In these cases, a high sodium concentration could exacerbate the imbalance. The use of concentrations above 100 mEq / L is justified in cases of significant sodium loss; however, higher concentrations require strict medical supervision due to the risk of hypernatremia.

[0033] Regarding potassium, ranges less than 5 mEq / L will be indicated when potassium loss is not the main concern, while ranges greater than 50 mEq / L are justified to replace significant potassium losses.

[0034] The chloride concentration will be adjusted to maintain electrolyte balance with sodium and potassium, following the principles of electroneutrality and cation concentrations.

[0035] For magnesium, ranges greater than or equal to 50 mEq / L are based on the search for a more pronounced effect on muscle and nerve recovery during the post-surgical patient's recovery.

[0036] Turning now to the details of the carbohydrates used in the present invention, it is important to note that carbohydrates, also known as saccharides or carbs, are one of the body's main sources of energy. Their primary function is to provide energy to cells, tissues, and organs, including the brain and muscles. When we consume foods containing carbohydrates, the digestive system breaks them down into simpler sugars, primarily glucose, which is absorbed into the bloodstream, raising blood sugar levels (glycemia). The body uses glucose in various ways, the main one being for immediate energy, where this carbohydrate serves as immediate fuel for cells, providing the energy necessary for daily activities.It is also possible that this carbohydrate is stored in the liver and muscles as glycogen, which acts as an energy reserve that the body can use when blood glucose levels drop. Furthermore, if glycogen stores are full and there is still excess glucose, the body converts it into fat for long-term storage.

[0037] The presence of carbohydrates in oral rehydration solutions (ORS), mainly glucose, has two main purposes: the first is to provide energy to the body, especially during recovery from dehydration, and the second is to improve the absorption of sodium and water because glucose facilitates the active transport of sodium and water through the walls of the small intestine, which improves the effectiveness of rehydration; this process is known as sodium-glucose cotransport.

[0038] The carbohydrates used in the present invention may be selected from glucose, sucrose, fructose, or mixtures thereof.

[0039] The concentration of carbohydrates in the present invention may vary depending on the circumstances of each patient and especially the type of surgery they have undergone. For example, a range of less than 10 g / L is justified for situations where rehydration with minimal caloric intake is sought, such as in people with insulin resistance, type 2 diabetes, or those following low-carbohydrate diets, while ranges greater than 60 g / L are justified for people with high energy demands due to the type of surgery they underwent.

[0040] It is important to note that fructose has a lower glycemic index than glucose, meaning it produces a slower and smaller increase in blood sugar levels. This could be beneficial for people with glycemic control problems; however, it should be considered that fructose absorption may be slower in some people and that high concentrations can cause gastrointestinal discomfort.

[0041] Turning now to other components of the oral rehydration solution of the present invention, such as antiemetics, these are substances used to prevent and treat nausea and vomiting. These symptoms can be caused by a variety of factors, including gastrointestinal illnesses such as infections, food poisoning, etc.; side effects of chemotherapy drugs, anesthesia, opioids, etc.; motion sickness; pregnancy-related symptoms; or dizziness due to stress or anxiety.

[0042] Antiemetics act on different receptors and neural pathways involved in the vomiting reflex. The main mechanisms of action include blocking the action of serotonin, a neurotransmitter that plays an important role in stimulating vomiting, especially in cases of chemotherapy and postoperative nausea. They can also block the action of dopamine, another neurotransmitter involved in the vomiting reflex. Other antiemetics can block histamine receptors, which can also be involved in vomiting, particularly in motion sickness, or further block the action of acetylcholine, a neurotransmitter that can stimulate vomiting.

[0043] In the present invention, natural antiemetics such as curcumin, gingerol, and vitamin B6 can be used. Curcumin is the main bioactive component of turmeric; this substance is a potent natural anti-inflammatory with multiple mechanisms of action, including COX-2 inhibition, inhibition of the NF-κB pathway (a key transcription factor in inflammation), and reduction of pro-inflammatory cytokine production. Gingerol acts as an antiemetic by modulating gastric motility, reducing gastric contractions, and blocking serotonin (5-HT3) receptors in the gastrointestinal tract. The use of ginger to relieve nausea is well documented, especially in cases of morning sickness and postoperative nausea; however, its inclusion in oral rehydration solutions (ORS) for this specific purpose, in combination with its anti-inflammatory properties, represents an innovation.Vitamin B6 or Pyridoxine participates in the synthesis of neurotransmitters involved in the control of vomiting; its antiemetic mechanism of action is not fully understood, but it is believed to modulate the activity of the vomiting centers in the brain.

[0044] The concentration of the antiemetics of the present invention may vary depending on the circumstances of each patient and especially the type of surgery to which he has been subjected, but it has been known by the inventors that the Ginger extract (Gingerol) can range from 50 to 100 mg / L and vitamin B6 (Pyridoxine) from 10 to 25 mg / L, which demonstrates the effectiveness of vitamin B6 in reducing nausea.

[0045] Turning now to the details of the anti-inflammatory compounds used in the oral rehydration solution of the present invention, it is important to note that anti-inflammatories are substances that reduce inflammation, a complex process initiated by the body in response to injury, infection, irritation, or following a surgical procedure. Inflammation is characterized by redness, swelling, heat, pain, and loss of function in a particular organ. In the oral rehydration solution of the present invention, it is beneficial to include natural anti-inflammatory agents such as gingerol, which possesses anti-inflammatory properties by inhibiting the production of pro-inflammatory cytokines such as TNF-α, IL-1β, and IL-6. It also inhibits the activity of cyclooxygenase enzymes (COX-1 and COX-2), although to a lesser extent than traditional NSAIDs, thus reducing the risk of gastric irritation. Furthermore, gingerol has antioxidant effects that contribute to the reduction of inflammation.

[0046] Quercetin is another compound that can be used as an anti-inflammatory. It is a flavonoid found in many fruits, vegetables, and plants; it possesses potent antioxidant and anti-inflammatory properties. Its main mechanisms of action include reducing the release of histamine, leukotrienes, and prostaglandins, substances involved in the inflammatory response; inhibiting the activity of enzymes such as COX-2 and lipoxygenase (LOX), which are involved in the production of inflammatory mediators; and exhibiting an antioxidant effect by neutralizing free radicals that contribute to oxidative stress and inflammation.

[0047] Boswellia serrata is a tree native to India whose resin has been traditionally used in Ayurvedic medicine. Boswellic acids are the main bioactive components of Boswellia serrata and possess potent anti-inflammatory properties. Their mechanisms of action include the inhibition of 5-lipoxygenase (5-LOX), a key enzyme in the synthesis of leukotrienes, inflammatory mediators involved in various inflammatory diseases. Boswellic acids specifically inhibit 5-LOX, which distinguishes them from traditional NSAIDs that primarily inhibit COX. Boswellic acids can also modulate other inflammatory pathways such as complement activation and cytokine release.

[0048] The concentration of the anti-inflammatory agents of the present invention may vary depending on the circumstances of each patient and especially the type of surgery to which they have been subjected, but the inventors have found that, for example, turmeric at a concentration of between 50 and 100 mg / L with a piperine ratio of 10:1; the inclusion of piperine is justified by its ability to significantly increase the bioavailability of curcumin.

[0049] Turning now to the details of the minerals contained in the oral rehydration solution (ORS) of the present invention, it should be noted that some minerals can offer additional benefits in ORS, especially in certain dehydration contexts. Zinc is an essential micronutrient that participates in numerous biological functions, including cell growth, immune function, protein synthesis, and wound healing. In the context of rehydration, zinc plays a crucial role in the regeneration of the intestinal epithelium and also strengthens local immune function in the intestine, helping to fight infections.

[0050] The concentration of zinc used in the ORS of the present invention may vary depending on the circumstances of each patient and especially the type of surgery to which they have been subjected, but the inventors have found that a concentration greater than 20 mg / L is justified because a more potent effect is sought in the regeneration of the intestinal epithelium and the strengthening of the immune system.

[0051] Another important aspect is the potential for personalization of the beverage, as different types of surgery place different demands on the body. For example, patients undergoing gastrointestinal surgery might require low-residue formulas, while cardiac patients might need low-sodium formulas. A personalized beverage could make a significant difference.

[0052] Another object of the present invention relates to a method for treating or preventing dehydration in a subject who requires it, comprising the administration of the described composition. The method of administering this composition is based on its application to treat or prevent dehydration in subjects who require it. As already indicated herein, dehydration is a condition that can be caused by multiple factors, including gastrointestinal diseases, prolonged exposure to heat, intense physical activity, or postoperative states. The administration of this composition allows for efficient rehydration by providing essential electrolytes, rapidly absorbed carbohydrates, and compounds with anti-inflammatory and antiemetic effects, improving not only hydration but also gastric tolerance and the consumer experience.

[0053] Although the present invention has been described with the preferred embodiments shown, it is understood that modifications and variations that preserve the spirit and scope of this invention are understood to be within the scope of the attached claims.

Claims

1. An oral rehydration composition enabling oral resumption after surgery in a patient, characterized in that it comprises: sodium at a concentration greater than 100 mEq / L; potassium at a concentration greater than 50 mEq / L; chloride at a concentration that maintains electrolyte balance with sodium and potassium; magnesium at a concentration greater than 50 mEq / L; sodium citrate at a concentration of between 5-20 mEq / L and citric acid at a concentration of between 2-10 mEq / L; carbohydrates, comprising glucose in a proportion greater than 50% by weight of the total carbohydrates present, at a concentration of between 10 and 50 g / L; ginger extract at a concentration of between 50 and 100 mg / L; quercetin at a concentration of between 10-100 mg / L; vitamin B6 at a concentration of between 10 and 25 mg / L; curcumin at a concentration of between 50 and 100 mg / L in combination with piperine in a 10:1 ratio (curcumin: piperine);Boswellia serrata (standardized extract) at a concentration of between 100 and 500 mg / L, zinc at a concentration greater than 20 mg / L, and one or more flavorings.

2. The oral rehydration composition enabling oral resumption after surgery in a patient of claim 1, wherein the electrolytes are dissolved in an aqueous matrix to create a ready-to-drink beverage with a uniform texture and pleasant taste 3. The oral rehydration composition that allows for oral resumption after surgery in a patient of claim 1 wherein said flavorings are selected from the group consisting of flavors of orange, mango, coconut, pineapple, lemon, lime, cocoa, red fruits and their mixtures, aloe vera extracts, mint or spearmint, chamomile, cinnamon.

4. The oral rehydration composition enabling oral restart after surgery in a patient of claim 1 wherein the composition is dissolved in drinking water to create a ready-to-drink beverage with an osmolarity adjusted between 150-300 mOsm / L.

5. The oral rehydration composition that enables oral resumption after surgery in a patient of claim 1, wherein it includes a stabilizer system that ensures texture uniformity, prevents separation, and provides a smooth mouthfeel. These stabilizers include xanthan gum (0.1-0.5% w / w), guar gum (0.05-0.2% w / w), and lecithin (0.1-0.3% w / w), which also contribute to improved flavor retention and a homogeneous appearance.

6. The oral rehydration composition enabling oral resumption after surgery in a patient of claim 1, preventing dehydration in a patient requiring it by administering the composition of any of the preceding claims 7. A method for treating or preventing dehydration in a subject requiring it, comprising the administration of the composition of any of the preceding claims.