KR-102963264-B1 - Liquid Composition for Improving Dysphagia and Method for Manufacturing the Same

Abstract

The present invention relates to a liquid composition for improving dysphagia and a method for manufacturing the same. The composition of the present invention is characterized by having excellent solubility and stability and reduced spiciness, comprising a complex form in which piperine is encapsulated in cyclodextrin. In addition, while providing a viscosity suitable for patients with dysphagia by including xanthan gum, a decrease in viscosity is prevented by applying a process in which high-pressure homogenization is performed first during the manufacturing process to form a nano-dispersion, followed by the hydration of xanthan gum. According to the present invention, it is possible to provide a ready-to-drink dysphagia aid beverage that promotes the swallowing reflex through TRPV1 receptor activation, can be consumed by the patient without aversion, and has stable physical properties.

Inventors

• 조광연
• 주연우
• 최바른

Dates

Publication Date

20260511

Application Date

20251219

Claims (11)

1. Contains piperine, xanthan gum, purified water and an emulsifier, The above piperine is in the form of a complex incorporated in beta-cyclodextrin or gamma-cyclodextrin in a molar ratio of 1:1 to 1:4, and The above emulsifier is one or more selected from the group consisting of lecithin, polyglyceryl-10 oleate, and acacia gum, and The concentration of the piperine is 40 ppm to 200 ppm relative to the total weight of the composition, and The content of the above xanthan gum is 0.1 to 0.5 weight%, and The pH is adjusted to 4.0 to 5.5 by further including citric acid, and It further includes locust bean gum, wherein the weight ratio of the xanthan gum to the locust bean gum is 10:1 to 5:1, and The composition further comprises 1 to 10 weight percent of one or more moisturizers selected from the group consisting of glycerin, propylene glycol, and sorbitol, based on the total weight of the composition. It further comprises 0.5 to 3 weight percent of trehalose based on the total weight of the composition, Further comprising 0.1 to 2 weight percent of sodium hyaluronate or sodium chondroitin sulfate based on the total weight of the composition, It further comprises 0.001 to 0.05 weight% of L-menthol based on the total weight of the composition, Further comprising vitamin C and vitamin E, wherein the weight ratio of vitamin C to vitamin E is 1:1 to 5:1 and the total content of vitamin C and vitamin E is 0.01 to 0.5 weight% relative to the total weight of the composition, Liquid composition for improving dysphagia.
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5. In claim 1, The above L-menthol is dissolved in ethanol or medium-chain triglycerides and then added together with an emulsifier, Liquid composition for improving dysphagia.
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7. (a) a step of mixing piperine with beta-cyclodextrin or gamma-cyclodextrin in a molar ratio of 1:1 to 1:4 and stirring at 50°C to 70°C for 2 to 12 hours to form an inclusion complex; (b) a step of dispersing the above inclusion complex in purified water, adding one or more emulsifiers selected from the group consisting of lecithin, polyglyceryl-10 oleate, and acacia gum, and then homogenizing in the first step; (c) a step of high-pressure homogenization at a pressure of 500 bar to 1,500 bar; and (d) a step of adding xanthan gum and hydrating it; Includes, In step (a) above, when forming the inclusion complex, ultrasound of 20 kHz to 40 kHz is irradiated for 10 to 30 minutes, and After step (a) above, citric acid is added to adjust the pH to 4.0 to 5.5, and The first homogenization of step (b) above is performed at 10,000 rpm to 15,000 rpm for 3 minutes to 10 minutes, and The high-pressure homogenization of step (c) above is repeated 2 to 5 times at a pressure of 700 bar to 1,200 bar, and During the high-pressure homogenization process of step (c) above, the temperature is maintained at 25℃ or lower, and Step (d) above involves adding xanthan gum to the dispersion obtained after high-pressure homogenization in Step (c), hydrating it at 25°C to 30°C for 30 minutes to 2 hours, and then performing a process of mixing locust bean gum with xanthan gum in a weight ratio of 10:1 to 5:1. A method for preparing a liquid composition for improving dysphagia, wherein during the hydration and mixing process of step (d) above, one or more moisturizers selected from the group consisting of glycerin, propylene glycol, and sorbitol, trehalose, sodium hyaluronate or sodium chondroitin sulfate, L-menthol, vitamin C, and vitamin E are additionally added, wherein vitamin C and vitamin E are added in a weight ratio of 1:1 to 5:1.
8. In claim 7, After forming the inclusion complex in step (a) above, the method further includes a step of solidifying the powder by spray drying or freeze drying. The above powder is manufactured with an average particle size of 1 μm to 50 μm, and In step (b) above, the powder is redispersed in purified water, and one or more emulsifiers selected from the group consisting of lecithin, polyglyceryl-10 oleate, and acacia gum are added, followed by primary homogenization. Method for preparing a liquid composition for improving dysphagia.
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Description

Liquid Composition for Improving Dysphagia and Method for Manufacturing the Same Liquid Composition for Improving Dysphagia and Method for Manufacturing the Same The present invention relates to a liquid composition for improving dysphagia and a method for preparing the same. Dysphagia is a condition characterized by difficulty swallowing food, and it frequently occurs in patients with geriatric diseases or neurological disorders such as stroke, Parkinson's disease, and dementia. Patients with dysphagia are at a high risk of aspiration, where food enters the airway incorrectly; in severe cases, this can lead to aspiration pneumonia or death by suffocation. To mitigate these risks, the use of thickeners to adjust the viscosity of food has traditionally been employed. Most commercially available thickeners are sold in the form of xanthan gum or starch-based powders, which users mix into water or beverages immediately before consumption. However, these powder products present problems, such as lumps forming during the mixing process or viscosity variations depending on the person mixing, making it difficult to provide patients with consistent physical properties. Additionally, concerns have been raised regarding the instability of amylase (a salivary enzyme), which causes viscosity to change over time. Meanwhile, recent research attempts are being made to physiologically promote the swallowing reflex itself, going beyond physical prescriptions that simply increase viscosity. In particular, there are reports that TRPV1 (Transient Receptor Potential Vanilloid 1) receptor agonists, such as capsaicin in chili peppers or piperine in black pepper, stimulate sensory nerves in the oral cavity and pharynx to shorten the swallowing delay time. However, natural compounds such as piperine have the disadvantage of being poorly soluble in water and unstable to light and heat. Additionally, they pose technical difficulties in developing them into commercially available swallowing aid beverages due to limitations such as causing a strong spicy taste and irritation at effective concentrations, which significantly reduces patient compliance. Therefore, there is an urgent need to develop a liquid formulation that has a uniform viscosity allowing patients to safely consume it immediately upon opening, while also providing an effect that promotes the swallowing reflex without causing aversion. The present invention will be described in detail below. The present invention relates to a liquid composition for improving dysphagia. The composition of the present invention comprises a piperine-cyclodextrin inclusion complex, xanthan gum, and purified water. It may also further comprise an emulsifier, a humectant, a mucoprotective agent, a cooling agent, an antioxidant, etc. Piperine is a natural alkaloid derived from black pepper (Piper nigrum) that acts to promote the swallowing reflex by activating TRPV1 (Transient Receptor Potential Vanilloid 1) receptors. When TRPV1 receptors distributed in the oral and pharyngeal mucosa are activated, sensory nerves are stimulated, and signals are transmitted to the swallowing center in the medulla oblongata, thereby strengthening the swallowing reflex. This shortens the swallowing onset time, accelerates the laryngeal elevation speed, and reduces the pharyngeal transit time, enabling safe and efficient swallowing overall. However, piperine has limitations, such as very low solubility in water (about 40 μg/mL), instability to light and heat, and the potential to cause irritation to the oral mucosa. The present invention solves these problems by forming an inclusion complex with cyclodextrin. Cyclodextrin is a cyclic oligosaccharide having internal hydrophobic cavities, which can be stably maintained in an aqueous solution by encapsulating hydrophobic substances within the cavities. In the present invention, beta-cyclodextrin (β-CD) or gamma-cyclodextrin (γ-CD) may be used. Beta-cyclodextrin consists of 7 glucose units, has a cavity diameter of approximately 6-6.5 Å, and can effectively encapsulate piperine molecules (approx. 5-6 Å). Gamma-cyclodextrin consists of 8 glucose units, has a somewhat larger cavity (approx. 7.5-8.3 Å), but possesses higher water solubility. The inclusion complex of piperine and cyclodextrin can be formed in a molar ratio of 1:1 to 1:4. Preferably, the molar ratio is 1:2 to 1:3. At a molar ratio of 1:1, the inclusion efficiency may be somewhat low, and if it exceeds 1:4, economic efficiency is reduced due to an excess amount of cyclodextrin and the osmotic pressure of the composition may increase excessively. The formation of inclusion complexes can be carried out by heating and stirring in an aqueous solution. A reaction temperature of 50 to 70°C is suitable. Below 50°C, the solubility of piperine is low, which reduces the inclusion efficiency, and above 70°C, piperine may undergo thermal decomposition. A reaction time of 2 to 12 hours is suitable. If the reaction time i