A composition for improving eating safety in patients with dysphagia, a method of preparing the same, and use thereof

Abstract

This invention relates to a composition for improving the safety of feeding in patients with dysphagia. The composition comprises 30-85% (w / w) maltodextrin or starch, 10-60% (w / w) edible gum, 1-15% (w / w) erythritol, and a pharmaceutically acceptable carrier. The composition of this invention has a high viscosity per unit mass, which facilitates the uniform dispersion of drugs or nutrients, accurately providing the necessary drugs or nutrients to patients with dysphagia, and significantly reducing the incidence of aspiration, choking, or related infections caused by swallowing difficulties.

Description

Technical Field

[0001] This invention relates to the field of biomedicine, specifically to a composition for improving the safety of eating in patients with dysphagia, its preparation method, and its application. Background Technology

[0002] Dysphagia, caused by various factors and occurring in different locations, severely affects patients' food intake, nutrient absorption, and oral medication administration. It can even lead to aspiration pneumonia or infection, and in severe cases, endanger life. The 2017 "Epidemiological Survey Report on Dysphagia in Specific Populations in China" showed that the prevalence of dysphagia in China was 38.7%.

[0003] The causes of dysphagia include physiological reasons, surgical procedures, genetic factors, and disease-related causes. These include age-related decline in swallowing ability, muscle weakness caused by radiotherapy and chemotherapy, neurodegeneration related to physiological processes and the nerve innervation of the swallowing reflex, and diseases associated with neurological disorders, infectious diseases, autoimmune diseases, metabolic diseases, myopathic diseases, iatrogenic diseases, post-surgical muscle or neurological disorders, radiation therapy, corrosive and structural diseases, etc.

[0004] For patients with dysphagia who can eat orally, adjusting the texture and consistency of food is a prerequisite for ensuring safe and effective eating. The texture of food affects the swallowing process; by adjusting the texture, some patients can eat safely and effectively. Studies have shown that adding thickening agents to liquid foods increases their viscosity and reduces their flowability, giving patients sufficient time to react and control the epiglottis from covering the trachea. This is an important method for prolonging the swallowing time of liquid foods, reducing swallowing safety risks, and is also one of the effective measures to address eating difficulties in patients with dysphagia.

[0005] CN105831711B discloses an instant thickener that provides a comfortable viscosity and its preparation method, wherein the thickener is composed of 20.00% xanthan gum and 80.00% maltodextrin.

[0006] CN 110326792 A discloses a non-complete nutritional liquid diet based on tamarind polysaccharide, containing 0.2% to 0.35% tamarind polysaccharide, 0.15% to 0.3% xanthan gum, 2% to 12% erythritol, 2% to 10% resistant dextrin and 1% to 15% nutrients, with the balance being water.

[0007] CN110522011A discloses a thickening component for improving swallowing disorders, containing 30%–45% hydrophilic gum, 10%–30% starch, and 40%–60% maltodextrin, wherein the hydrophilic gum includes xanthan gum, guar gum, locust bean gum, and locust bean gum.

[0008] The aforementioned products are prone to clumping or forming lumps during formulation, have a slow hydration rate, are inconvenient to use, and increase the risk of residue remaining in the pharynx after swallowing. Therefore, there is an urgent clinical need to develop viscosity compositions with moderate viscosity, good dispersibility, and uniformity. Summary of the Invention

[0009] The purpose of this invention is to provide a composition that improves the safety of eating for patients with dysphagia, wherein the composition contains 30-85% (w / w) maltodextrin or starch, 10-60% (w / w) edible gum, 1-15% (w / w) erythritol, and optionally a pharmaceutically acceptable carrier.

[0010] In a preferred embodiment of the present invention, the content of maltodextrin or starch in the composition is 35-80% (w / w), preferably 40-78% (w / w).

[0011] In a preferred embodiment of the present invention, the starch is selected from any one or a combination of modified corn starch, tapioca starch, hydroxypropyl distarch phosphate, potato starch, and resistant dextrin.

[0012] In a preferred embodiment of the present invention, the content of edible gum in the composition is 15-55% (w / w), preferably 20-50% (w / w).

[0013] In a preferred embodiment of the present invention, the edible gum is selected from any one or a combination of xanthan gum, guar gum, sodium alginate, locust bean gum, sodium carboxymethyl cellulose, black bean gum, flaxseed gum, okra gum, konjac mannan, carrageenan, cowpea gum, fenugreek gum, tamarind gum, cinnamon gum, gum arabic, Indian gum, pectin, cellulose, tragacanth gum, and ebony gum.

[0014] In a preferred embodiment of the present invention, the content of erythritol in the composition is 1.5-12% (w / w), preferably 2-10% (w / w).

[0015] In a preferred embodiment of the present invention, the pharmaceutically acceptable carrier is selected from any one or a combination of acid-base regulators, preservatives, stabilizers, flavoring agents, or fragrance agents.

[0016] In a preferred embodiment of the present invention, the formulation is selected from any one of granules, powders, mixtures, elixirs, pastes, and emulsions. The compositions of the present invention employ various dosage forms well-known in the art.

[0017] In a preferred embodiment of the present invention, the flavoring agent is selected from any one or a combination of sorbitol, xylitol, mannitol, lactitol, maltitol, and erythritol.

[0018] In a preferred embodiment of the present invention, the composition contains 40-78% maltodextrin, 20-50% edible gum, and 2-10% erythritol, with the remainder being water.

[0019] In a preferred embodiment of the present invention, the composition contains 20-76% maltodextrin, 20-50% xanthan gum, 1-15% guar gum, 1-10% sodium alginate and 2-10% erythritol, with the balance being water.

[0020] In a preferred embodiment of the present invention, the composition contains 40-78% maltodextrin, 10-15% xanthan gum, 10-15% guar gum, 10-15% sodium alginate, and 2-10% erythritol, with the balance being water.

[0021] In a preferred embodiment of the present invention, the viscosity of the aqueous solution of the composition with a content of 2% is not less than 2500 CP, preferably not less than 3000 CP, and more preferably not less than 3500 CP.

[0022] Another object of the present invention is to provide a method for preparing a composition that improves the safety of eating in patients with dysphagia. The composition contains 30-85% (w / w) maltodextrin or starch, 10-60% (w / w) edible gum, 1-15% (w / w) erythritol, and optionally a pharmaceutically acceptable carrier. The preparation of the composition includes the following steps: weighing the required amounts of maltodextrin or starch, edible gum, and optionally a pharmaceutically acceptable carrier, mixing them evenly, granulating, and drying to obtain the final product.

[0023] In a preferred embodiment of the present invention, the drying process is selected from any one of fluidized bed drying, reduced pressure drying, vacuum drying, spray drying, and atmospheric pressure drying.

[0024] Another object of the present invention is to provide the use of the composition of the present invention in the preparation of articles that improve the safety of eating for patients with dysphagia.

[0025] The compositions of the present invention help reduce the risk of aspiration or choking during swallowing in patients with dysphagia.

[0026] In a preferred embodiment of the present invention, the composition is used to promote safe swallowing in patients with dysphagia.

[0027] In a preferred embodiment of the present invention, the patients with swallowing disorders are selected from any of the following categories: patients undergoing swallowing training during tube feeding, patients receiving dietary care after gastric tube removal, patients receiving dietary care after mechanical ventilation extubation, patients receiving dietary care in neurological settings, patients with central nervous system diseases, patients with traumatic brain injury, patients with cranial nerve lesions, patients with neuromuscular junction diseases, patients with muscle diseases, patients with organic lesions of the oropharynx, patients with organic lesions of the esophagus, patients with extrinsic mediastinal diseases, patients with degenerative changes, patients with tumors, patients with sarcopenia, patients with digestive system diseases, patients with respiratory system diseases, patients with long-term intubation, patients with malocclusion or missing teeth, patients with oral ulcers or incisions, patients who have undergone tracheal intubation or incision surgery, and patients receiving dietary care in the elderly.

[0028] In a preferred embodiment of the present invention, the patient with dysphagia is selected from any of the following: stroke patients, traumatic brain injury patients, Parkinson's disease patients, cerebral palsy patients, radiation encephalopathy patients, dementia patients, locked-in syndrome patients, brainstem or cerebellar lesion patients, fourth ventricle tumor patients, brainstem encephalitis patients after hand-foot-mouth disease, poliomyelitis patients involving the bulbar part of the brain, orofacial or cervical dystonia patients, myasthenia gravis patients, multiple cranial neuritis patients, oculopharyngeal muscular dystrophy patients, congenital cleft palate patients, patients after cervical spine, oral and pharyngeal surgery, patients after oral, nasopharyngeal and head and neck radiotherapy or chemotherapy, gastroesophageal reflux disease patients, achalasia patients, esophageal tumor patients, and patients after esophageal surgery.

[0029] In a preferred embodiment of the present invention, the product is selected from any one or a combination of pharmaceutical preparations, nutritional preparations, dietary supplements, functional foods, and beverage products.

[0030] Unless otherwise stated, when this invention relates to percentages between liquids, the percentage is volume / volume percentage; when this invention relates to percentages between liquids and solids, the percentage is volume / weight percentage; when this invention relates to percentages between solids and liquids, the percentage is weight / volume percentage; the remainder is weight / weight percentage.

[0031] Unless otherwise stated, the viscosity of this invention is measured using an NDJ rotational viscometer. The technical parameters of the viscometer are controlled as follows: #3 rotor, rotation speed 12rpm-60rpm. The torque is selected between 30% and 90%.

[0032] Compared with the prior art, the beneficial technical effects of the present invention include:

[0033] 1. The composition of this invention scientifically selects edible gum and maltodextrin, making comprehensive use of the thickening effect of edible gum and the excellent dispersibility of maltodextrin. It has the advantages of being easy to mix, dispersing and dissolving quickly, hydrating rapidly, being tasteless, having good stability, being convenient and flexible to take orally, and having no side effects.

[0034] 2. The composition of the present invention can be applied to medical food, general food, health food and other fields. It can be added to beverages (such as water, milk, juice, nutrient solution, coffee, etc.) to increase viscosity, improve the patient's swallowing safety, improve the patient's swallowing function and facilitate the patient's intake of sufficient nutrition and necessary substances.

[0035] 3. The preparation of the composition of the present invention is simple and has the advantages of high safety, low cost, green environmental protection, and suitability for large-scale industrial production. Attached Figure Description

[0036] Figure 1 Thickening effect of the aqueous solution of the composition;

[0037] Figure 2 Stability test of the composition in aqueous solution;

[0038] Figure 3 The thickening effect of the composition when used with different temperatures and different liquids;

[0039] Figure 4 Viscosity fitting results of the composition in aqueous solutions at different temperatures;

[0040] Figure 5 Observations on the dispersibility of the composition when mixed with water (left) and beer (right);

[0041] Figure 6 Combination swallowing contrast imaging. Detailed Implementation

[0042] The present invention will be described below with reference to the embodiments. However, the present invention is not limited to the embodiments.

[0043] Example 1: Preparation of the composition of the present invention

[0044] The composition is as follows: 41g maltodextrin, 5g erythritol, 40g xanthan gum, 4g sodium alginate, and 10g guar gum.

[0045] Mix the raw materials evenly and load them into the raw material container of the spray dryer granulator. Set the inlet air temperature control range on the temperature controller (80℃±15℃) to heat the air in the heat exchange chamber, causing the materials to boil and mix, and then heat up to dry. Weigh 30% of the total dry matter amount of purified water as a binder, set the peristaltic pump speed to 150 rpm and the spray pressure to 0.40 MPa, and granulate for 20 minutes to obtain the final product.

[0046] Example 2: Preparation of the composition of the present invention

[0047] The composition consists of: 70g maltodextrin, 5g erythritol, 10g xanthan gum, 10g sodium alginate, and 10g guar gum.

[0048] Mix the raw materials evenly and load them into the raw material container of the spray dryer granulator. Set the inlet air temperature control range on the temperature controller (80℃±15℃) to heat the air in the heat exchange chamber, causing the materials to boil and mix, and then heat up to dry. Weigh 30% of the total dry matter amount of purified water as a binder, set the peristaltic pump speed to 150 rpm and the spray pressure to 0.40 MPa, and granulate for 20 minutes to obtain the final product.

[0049] Example 3: Preparation of the composition of the present invention

[0050] The composition is as follows: 50g maltodextrin, 5g erythritol, 20g xanthan gum, 15g sodium alginate, and 10g guar gum.

[0051] Mix the raw materials evenly and load them into the raw material container of the spray dryer granulator. Set the inlet air temperature control range on the temperature controller (80℃±15℃) to heat the air in the heat exchange chamber, causing the materials to boil and mix, and then heat up to dry. Weigh 30% of the total dry matter amount of purified water as a binder, set the peristaltic pump speed to 150 rpm and the spray pressure to 0.40 MPa, and granulate for 20 minutes to obtain the final product.

[0052] Example 4: Preparation of the composition of the present invention

[0053] The composition is as follows: 50g maltodextrin, 5g erythritol, 20g xanthan gum, 15g sodium alginate, and 10g guar gum.

[0054] Mix the raw materials evenly and load them into the raw material container of the spray dryer granulator. Set the inlet air temperature control range on the temperature controller (80℃±15℃) to heat the air in the heat exchange chamber, causing the materials to boil and mix, and then heat up to dry. Weigh 30% of the total dry matter amount of purified water as a binder, set the peristaltic pump speed to 150 rpm and the spray pressure to 0.40 MPa, and granulate for 20 minutes to obtain the final product.

[0055] Comparative Example 1

[0056] The composition consists of 80g of maltodextrin and 20g of xanthan gum.

[0057] Mix the raw materials evenly and load them into the raw material container of the spray dryer granulator. Set the inlet air temperature control range on the temperature controller (80℃±15℃) to heat the air in the heat exchange chamber, causing the materials to boil and mix, and then heat up to dry. Weigh 30% of the total dry matter amount of purified water as a binder, set the peristaltic pump speed to 150 rpm and the spray pressure to 0.40 MPa, and granulate for 20 minutes to obtain the final product.

[0058] Comparative Example 2

[0059] The composition is as follows: xanthan gum 30g, guar gum 15g, starch 10g, maltodextrin 45g.

[0060] Mix the raw materials evenly and load them into the raw material container of the spray dryer granulator. Set the inlet air temperature control range on the temperature controller (80℃±15℃) to heat the air in the heat exchange chamber, causing the materials to boil and mix, and then heat up to dry. Weigh 30% of the total dry matter amount of purified water as a binder, set the peristaltic pump speed to 150 rpm and the spray pressure to 0.40 MPa, and granulate for 20 minutes to obtain the final product.

[0061] Experimental Example 1 Rapid thickening test

[0062] The composition of Example 1 was prepared into solutions of 1.25%, 2.50%, 3.75%, and 5.00% by adding water, and the viscosity was tested at room temperature. The results showed that the product viscosity increased rapidly with increasing sample concentration, exhibiting non-Newtonian fluid characteristics. A significant thickening effect was achieved with only a small amount added. See [link to product details]. Figure 1 .

[0063] Experimental Example 2 Stability test

[0064] When a 2% aqueous solution of the composition from Example 1 was left to stand at room temperature for 4 hours, the viscosity remained essentially unchanged. (See results below.) Figure 2 .

[0065] Experimental Example 3 Experiments on the thickening effect of the composition in different temperatures and liquids

[0066] The composition of Example 1 was mixed with liquid products at different temperatures in a specified ratio (composition concentration 2%). The results showed that the product exhibited good thickening effects under different temperatures and liquid conditions, unaffected by the type or temperature of the liquid, indicating a wide range of applications. The viscosity remained essentially consistent under the same liquid at different temperatures (e.g., low-temperature water 6℃, room-temperature water 20℃, and hot water 60℃), demonstrating good thickening consistency. See the results below. Figures 3-4 .

[0067] Test Example 4 Gelation observation experiment of the composition

[0068] Eight 300 mL beakers were used to prepare aqueous solutions of the composition from Example 1 at concentrations ranging from 0.1% to 6%. The beakers were tilted downwards at a 45° angle for observation. All samples showed good flowability, and no gelation was observed. Dynamic viscoelastic temperature scanning was performed on each sample using a rotational rheometer. Within the dynamic viscoelastic temperature scanning range, the viscous modulus was greater than the elastic modulus, and the two did not intersect, indicating that the solid-state properties of the system were not significant.

[0069] Experimental Example 5 Observation of swallowing contrast imaging

[0070] The composition of Example 1 was prepared into a 2.5% aqueous solution. Ten volunteers of different ages were selected, and observation using a swallowing imaging device revealed that no residue of the sample remained in the pharynx and esophagus during swallowing. The results are shown in the figure below. Figure 6 .

[0071] Experimental Example 6 Sensory evaluation test

[0072] Volunteers aged 40-70 years with different levels of the Kubota water swallowing test were selected, and aqueous solutions of the composition of Example 1 at different concentrations were prepared according to their swallowing disorder levels. Subjects rated the sensory and overall acceptability of the samples after administration. The results are shown in Table 1.

[0073] Table 1 Sensory Analysis of Subjects

[0074]

[0075] The above description of specific embodiments of the present invention does not limit the present invention. Those skilled in the art can make various changes or modifications based on the present invention, and as long as they do not depart from the spirit of the present invention, they should all fall within the scope of protection of the claims of the present invention.

Claims

1. A composition for improving the safety of eating in patients with dysphagia, the composition comprising 41% maltodextrin, 40% xanthan gum, 10% guar gum, 4% sodium alginate and 5% erythritol.

2. The use of the composition of claim 1 in the preparation of articles that improve the safety of eating for patients with dysphagia, wherein the patients with dysphagia are selected from any one of patients undergoing swallowing training during feeding tube, patients receiving dietary care after gastric tube removal, patients receiving dietary care after mechanical ventilation extubation, neurological patients receiving dietary care, and elderly patients receiving dietary care.

3. The application according to claim 2, wherein the article is selected from any one of pharmaceutical preparations, nutritional preparations, functional foods, and beverage products.

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