EP-4740746-A1 - COMPOSITION FOR PRODUCING CAPSULE FILM, METHOD FOR PRODUCING MATERIAL FOR PRODUCING CAPSULE FILM, AND CAPSULE FILM

Abstract

An object of the present invention is to enhance the formability of a capsule film material containing plant-based protein (for example, a soft capsule film material) to impart novel functions to capsule formulations. Examples of the novel functions include that the capsule film itself exhibits various biological effects, that a system that delivers the active substance of a capsule formulation to intestines, in particular, the large intestine (DDS: Drug Delivery System) is realized, and that a highly active drug is used as the content, etc. As a solving means, there is provided a composition for producing a capsule film, the composition containing at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids, and a plant-derived protein. The composition for producing a capsule film is subjected to pressurized heat treatment to prepare a material for producing a capsule film, and the material for producing a capsule film can be formed into a capsule of a capsule formulation (preferably, a soft capsule formulation).

Inventors

• TSUNODA, YAMATO
• YANAGIHARA, Aoi
• HIRASAWA, WATARU

Assignees

• Sunsho Pharmaceutical Co., Ltd.

Dates

Publication Date

20260513

Application Date

20240612

Claims (19)

1. A composition for producing a capsule film, the composition comprising at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids, and a plant-derived protein.
2. The composition according to Claim 1, wherein a content mass ratio of the at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids to the plant-derived protein is 25:75 to 80:20.
3. The composition according to Claim 1 or 2, wherein a content ratio of water is less than 20 mass%.
4. The composition according to Claim 1 or 2, wherein the plant-derived protein includes at least one type selected from the group consisting of soybean-derived proteins, adzuki bean-derived proteins, kidney bean-derived proteins, cacao bean-derived proteins, wheat-derived proteins, buckwheat-derived proteins, and rice-derived proteins.
5. The composition according to Claim 1 or 2, wherein the at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids includes glycerin.
6. A method for producing a material for producing a capsule film, the method comprising a step of pressurizing and heating a composition containing at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids, and a plant-derived protein.
7. The method for producing according to Claim 6, wherein a content mass ratio of the at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids to the plant-derived protein is 25:75 to 80:20.
8. The method for producing according to Claim 6 or 7, wherein a content ratio of water in the composition is less than 20 mass%.
9. The method for producing according to Claim 6 or 7, wherein the plant-derived protein includes at least one type selected from the group consisting of soybean-derived proteins, adzuki bean-derived proteins, kidney bean-derived proteins, cacao bean-derived proteins, wheat-derived proteins, buckwheat-derived proteins, and rice-derived proteins.
10. The method for producing according to Claim 6 or 7, wherein the at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids includes glycerin.
11. The method for producing according to Claim 6 or 7, wherein the heating temperature is 50 to 200°C.
12. A capsule film comprising at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids, and a plant-derived protein.
13. The capsule film according to Claim 12, wherein a content mass ratio of the at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids to the plant-derived protein is 25:75 to 80:20.
14. The capsule film according to Claim 12 or 13, wherein the plant-derived protein includes at least one type selected from the group consisting of soybean-derived proteins, adzuki bean-derived proteins, kidney bean-derived proteins, cacao bean-derived proteins, wheat-derived proteins, buckwheat-derived proteins, and rice-derived proteins.
15. The capsule film according to Claim 12 or 13, wherein the at least one type selected from the group consisting of polyols, triesters, and trialkylamino acids includes glycerin.
16. The capsule film according to Claim 12 or 13, wherein the plant-derived protein has been subjected to pressurized heat treatment.
17. A capsule formulation comprising the capsule film according to Claim 12 or 13, and a content encapsulated in the capsule film.
18. A method for reducing digestibility of a protein, the method comprising a step of pressurizing and heating a composition containing the protein.
19. The method according to Claim 18, wherein the composition further contains a polyol.

Description

Technical Field The present invention relates to a composition for producing a capsule film, a method for producing a material for producing a capsule film, and a capsule film. Background Art The underlying pathological conditions of age-associated diseases, such as malignant neoplasms and COPD, and non-communicable diseases (NCD) have been reported to be associated with chronic inflammation, such as increased levels of blood inflammatory markers such as inflammatory cytokines, etc. From the viewpoints of extending healthy life expectancy and preventing care, the importance of preventing and alleviating chronic inflammation is increasing, and nutritional intake focusing on the anti-inflammatory effects while being based on the intake of sufficient energy, high-quality proteins, vitamins, and minerals has become necessary. Under such circumstances, NPL 1 reported that an anti-inflammatory effect by the TNF-α lowering effect was confirmed among elderly people aged 70 or over living in low-cost nursing homes as a result of taking soybean protein, which is a plant-based protein, for a certain period of time. In addition, plant-based proteins have been confirmed to have various physiological activities. Furthermore, it is known that hydrolysis of a protein makes the protein indigestible. Hydrolysis of a protein is done by heat treatment (including pressurized heat treatment), enzyme treatment, acid treatment, or the like. Techniques for making proteins indigestible have also been reported, and, for example, PTL 1 describes that a protein-containing plant-derived material is subjected to proteolytic enzyme treatment to produce an indigestible-component-rich raw material. Indigestible proteins are also referred to as resistant proteins or the like, and are sometimes categorized as one of Luminacoids (fermentable dietary fibers). Indigestible proteins are rarely hydrolyzed by digestive enzymes in the stomach and the small intestine and can be delivered to the large intestine. Thus, indigestible proteins are known to exhibit dietary fiber-like physiological functions, and are reported to have a cholesterol lowering effect, a bowel movement improvement effect, etc. (PTL 2). Citation List Patent Literature PTL 1: Japanese Unexamined Patent Application Publication No. 2008-189625PTL 2: Japanese Unexamined Patent Application Publication No. 2019-129737 Non Patent Literature NPL 1: Japan Plant Protein Foods Association Research Report "Nutritional effects of intake of plant-based protein on extending healthy life expectancy of elderly people" [online], November 2020 [retrieved: June 2, 2023], Internet <URL: https://www.protein.or.jp/wp-content/themes/protein.or.jp/pdf/study3.pdf> Summary of Invention Technical Problem Under such situations, plant-based proteins are expected to be adopted to various applications as food, beverages, and pharmaceuticals that have health promoting effects. However, compositions that contain plant-based proteins have low formability in general, and preparing the formulation thereof has been difficult in some cases. Thus, an object of the present invention is to enhance the formability of a capsule film material containing a plant-based protein (for example, a soft capsule film material) to impart novel functions to capsule formulations. For example, by allowing a capsule film of a capsule formulation to contain a plant-based protein, the capsule film itself is expected to exhibit various biological effects. In addition, it is anticipated that, by making the plant-based protein contained in the capsule film material indigestible, a system (DDS: Drug Delivery System) that delivers the active substance of the capsule formulation to intestines, in particular, the large intestine, would be realized. Furthermore, it is anticipated that, by making the plant-based protein contained in the capsule film material indigestible, a capsule formulation that encapsulates highly reactive content (highly active substance) in a capsule film would be provided. Solution to Problem The present invention relates to, for example, a composition for producing a capsule film. [1] A composition for producing a capsule film, the composition containing at least one type (these may also generically be referred to as the "formability imparting component") selected from the group consisting of polyols, triesters, and trialkylamino acids, and a plant-derived protein.[2] The composition described in [1] above, in which the content mass ratio of the formability imparting component to the plant-derived protein is 25:75 to 80:20.[3] The composition described in [1] or [2] above, in which a content ratio of water is less than 20 mass%.[4] The composition described in any one of [1] to [3] above, in which the plant-derived protein includes at least one type selected from the group consisting of soybean-derived proteins, adzuki bean-derived proteins, kidney bean-derived proteins, cacao bean-derived proteins, wheat-derived proteins,