CN121511078A

CN121511078A - Film-forming compositions comprising budding short-stalk polysaccharides and dextran

Info

Publication number: CN121511078A
Application number: CN202480011288.4A
Authority: CN
Inventors: Y·布伦; L·豪; S·克拉利; S·罗巴特; J·赵
Original assignee: Danisco US Inc
Current assignee: Danisco US Inc
Priority date: 2023-02-14
Filing date: 2024-02-14
Publication date: 2026-02-10
Also published as: WO2024173525A1; EP4665311A1

Abstract

本发明涉及适用于胶囊膜、胶囊壳的水性成膜组合物，以及用于生产这样的胶囊膜、胶囊壳的方法及其用途。This invention relates to aqueous film-forming compositions suitable for capsule films and capsule shells, as well as methods for producing such capsule films and capsule shells and their uses.

Description

Film-forming composition comprising pullulan and dextran

Technical Field

The present invention relates to aqueous film-forming compositions suitable for use in capsule films, capsule shells, and methods for producing such capsule films, capsule shells and uses thereof.

Background

Capsules are widely used for administering pharmaceuticals and nutrients to humans and animals. Capsules also have different uses, such as serving as a reservoir for plant fertilizers for ease of application, a reservoir for colorants, a reservoir for food materials or food supplements, and a reservoir for cosmetic ingredients. Pullulan is a convenient material for the membrane portion of capsules, because a pullulan membrane can be formed on the needles of capsules during the preparation of capsules by means of a gelling agent.

Pullulan capsules are natural, label-clear, have organic authentication potential and have extremely low oxygen permeation. Pullulan capsules are ideal substitutes for gelatin capsules and HPMC capsules under the current consumer demand. Carrageenan is considered an unsafe material as a commonly used gelling agent for pullulan capsules, and consumers demand carrageenan-free products. In addition, pullulan capsules containing carrageenan as a clotting system tend to exhibit different solubilities when the pH, salt concentration, and protein concentration vary in the digestive tract. Another common gelling agent is gellan gum, which is generally more pH dependent than the capsules made with carrageenan.

There is a continuing need for alternative capsule membranes and capsule shells that provide different materials with improved properties.

Drawings

FIG. 1. Synthesis of beta-1, 3 glucan using a three enzyme system using sucrose phosphorylase, laminaria disaccharide phosphorylase and laminaria oligosaccharyl phosphorylase.

FIG. 2 SEC chromatograms of SK-018 (red) and SK-019 (black).

FIG. 3 comparison of normalized puncture force statistic analysis of pullulan films with films made with blends of pullulan and beta-1, 3 glucan (Exp 806 as shown in Table 4).

FIG. 4 comparison of normalized puncture strength statistical analysis of pullulan films with films made with blends of pullulan and beta-1, 3 glucan (Exp 0122 as shown in Table 1).

Disclosure of Invention

It is an object of embodiments of the present invention to provide an aqueous film forming composition suitable for improved capsule coating, film or capsule shell.

The present invention relates in a broad aspect to aqueous film-forming compositions suitable for use in improved or alternative capsule materials.

Accordingly, in a first aspect, the present invention relates to an aqueous film-forming composition comprising a) one or more water-soluble film-forming polysaccharides having a MW of higher than about 15 kDA, the one or more polysaccharides comprising units selected from the group consisting of glucose units, fructose units and galactose units, which units are bound together by glycosidic bonds, and b) beta-1, 3-glucan having a MW in the range of about 1 to about 15 kDa.

In a second aspect, the present invention relates to a capsule shell comprising an aqueous film-forming composition comprising a) one or more water-soluble film-forming polysaccharides having a MW of greater than about 15 kDA, the one or more polysaccharides comprising units selected from the group consisting of glucose units, fructose units and galactose units, the units being bound together by glycosidic linkages, and b) beta-1, 3-glucan having a MW in the range of about 1 to about 15 kDa.

In a third aspect, the present invention relates to a capsule comprising a capsule shell prepared from the composition of the present invention or a capsule shell according to the present invention.

In a further aspect the invention relates to a method for producing a capsule film or capsule shell comprising the steps of providing an aqueous composition according to the invention, preheating moulding needles to a temperature of + -5 ℃ above the highest viscosity point of the aqueous composition at a temperature below the gelation temperature, impregnating the preheated moulding needles into the aqueous composition, forming a film on said needles by removing said moulding needles from said composition, and drying the film on the moulding needles at a temperature above the gelation temperature.

In a further aspect, the present invention relates to the use of a composition according to the invention for manufacturing capsules in an infusion moulding process, such as a hot dip needle process.

Detailed Description

These inventors have found that a natural polymer, beta-1, 3 glucan, which can act as a clotting system to promote gelation of one or more film-forming polysaccharides having a MW above about 15 kDA, comprising units of glucose units, fructose units and galactose units (e.g., pullulan), can be used in capsules. The same concept will apply to dextran-based capsules that may use alpha-1, 6 dextran or enzymatically prepared pullulan-like material (branched alpha-1, 6-alpha-1, 4 dextran based on alpha-1, 6 or alpha-1, 4) and beta-1, 3 dextran that will impart gelling properties that promote hard capsule manufacture.

Commercial high MW beta-1, 3 glucan (curdlan, about 2000 kDa) is insoluble in cold water due to the presence of a large number of intramolecular/intermolecular hydrogen bonds. However, beta-1, 3 glucan suitable for use in the compositions of the present invention is typically about 2 kDa, having about 15 glucose units. The inventors have identified three major components in beta-1, 3 glucan. It was found that component 2 should preferably be > 70%, with component 3 preferably being < 30% to give the best film properties.

As detailed above, the present invention relates to an aqueous film-forming composition comprising a) one or more water-soluble film-forming polysaccharides having a MW above about 15 kDA, the one or more polysaccharides comprising units selected from the group consisting of glucose units, fructose units and galactose units, the units being bound together by glycosidic linkages, and b) beta-1, 3-glucan having a MW in the range of about 1 to about 15 kDa.

In some embodiments, the beta-1, 3-glucan is thermally reversible in water.

In some embodiments, the beta-1, 3-glucan has a MW in the range of about 1 to about 14 kDa, such as about 1 to about 12 kDa, preferably in the range of about 1 to about 10 kDa, and more preferably in the range of about 1 to about 5 kDa, and most preferably in the range of about 2 to about 4 kDa.

In some embodiments, the beta-1, 3-glucan comprises glucose units in the range of about 5 to about 1000 glucose units, such as in the range of about 5 to about 300 glucose units, preferably in the range of about 7 to about 100 glucose units, more preferably in the range of about 9 to about 50 glucose units, and most preferably in the range of about 12 to about 20 glucose units.

In some embodiments, the beta-1, 3-glucan is unbranched.

In some embodiments, the beta-1, 3-glucan is prepared by an enzymatic reaction using a beta-1, 3-glucan phosphorylase or a beta-1, 3-glucan synthase.

In some embodiments, the beta-1, 3-glucan is derived from algae, fungi, plants, or bacteria.

In some embodiments, the beta-1, 3-glucan is selected from the group consisting of callose, laminarin, and paramylon.

In some embodiments > 70 wt% of the total beta-1, 3-glucan has a Degree of Polymerization (DP) above 9, more preferably > 80 wt% of the total beta-1, 3-glucan has a DP above 11, and most preferably > 90 wt% of the total beta-1, 3-glucan has a DP above 12.

In some embodiments, the water-soluble film-forming polysaccharide is selected from the group consisting of starch, pullulan, and dextran, such as alpha-dextran.

In some embodiments, the water-soluble film-forming polysaccharide is an enzymatically produced polysaccharide.

In some embodiments, the water-soluble film-forming polysaccharide is derived from algae, fungi, plants, or bacteria.

In some embodiments, the water-soluble film-forming polysaccharide is pullulan. In some embodiments, the pullulan is enzymatically produced.

In some embodiments, the water-soluble film-forming polysaccharide is an alpha-glucan, preferably an alpha-1, 6-glucan having an alpha-1, 2 branch, an alpha-1, 6-glucan having an alpha-1, 3 branch, or an alpha-1, 4 glucan having an alpha-1, 6 branch.

In some embodiments, the water-soluble film-forming polysaccharide has a solution viscosity in the range of about 500 cps to about 5000 cps at a temperature in the range of about 5 ℃ to about 80 ℃, wherein the solution concentration is in the range of about 10 wt% to about 40 wt%.

In some embodiments, the compositions according to the present invention are substantially free of cations, such as monovalent or divalent cations.

In some embodiments, the final film composition comprises less than 5wt%, preferably less than 3 wt%, most preferably less than 1 wt% sugar molecules (such as glucose, fructose, sucrose, and glucose-1-phosphate) based on the dry film.

In some embodiments, the concentration of the water-soluble film-forming polysaccharide, such as pullulan, is at least about 80% by weight, such as at least about 82% by weight, such as at least about 85% by weight, such as at least about 87% by weight, such as at least about 90% by weight, based on the dry film.

In some embodiments, the concentration of the water-soluble film-forming polysaccharide, such as pullulan, is at least about 80 wt% to 95 wt%, such as in the range of 82 wt% to 95 wt%, such as 85 wt% to 90 wt%, such as 87 wt% to 90 wt%, based on the dry film.

In some embodiments, the concentration of beta-1, 3-glucan is at least about 0.1 wt%, such as at least about 0.2 wt%, 0.4 wt%, 0.6 wt%, 0.8 wt%, 1.0 wt%, 1.2 wt%, 1.4 wt%, 1.6 wt%, 1.8 wt%, 2.0 wt%, 2.5 wt%, 3.0 wt%, 3.5 wt%, 4.0 wt%, 4.5 wt%, 5.0 wt%, 5.5 wt%, 6.0 wt%, 6.5 wt%, 7.0 wt%, 7.5 wt%, 8.0 wt%, 8.5 wt%, or 9.0 wt%, based on the dry film.

In some embodiments, the concentration of beta-1, 3-glucan is in a range of no more than about 9.0 wt%, such as no more than about 8.5 wt%, 8.0 wt%, 7.5 wt%, 7.0 wt%, 6.5 wt%, 6.0 wt%, 5.5 wt%, 5.0 wt%, 4.5 wt%, 4.0 wt%, 3.5 wt%, 3.0 wt%, 2.5 wt%, 2.0 wt%, 1.8 wt%, 1.6 wt%, 1.4 wt%, 1.2 wt%, 1.0 wt%, 0.8 wt%, 0.6 wt%, such as in a range of 0.1 wt% to 10.0 wt%, such as 0.2 wt% to 8.0 wt%, such as 0.4 wt% to 6.0 wt%, such as 0.6 wt% to 4.0 wt%, such as 0.8 wt% to 4.0 wt%, such as 1.0 wt% to 4.0 wt%, based on the dry film.

In some embodiments, the composition according to the present invention further comprises a plasticizer, wherein the plasticizer is a polyol, such as a sugar alcohol, e.g., sorbitol, mannitol, erythritol, xylitol, or glycerol (propane-1, 2, 3-triol), or a glycerol acetate selected from the group consisting of glycerol monoacetate, glycerol diacetate, and glycerol triacetate, TEC (triethyl citrate), dibutyl sebacate, and dibutyl phthalate, or mixtures thereof.

In some embodiments, the compositions according to the present invention further comprise at least one ingredient selected from the group consisting of surfactants such as dimethicone, sodium lauryl sulfate, lecithin, sorbitan esters, colorants, flavors, or mixtures thereof.

Beta-1, 3-glucan consists of glucose polymers with variable Molecular Weights (MW). The present invention relates to aqueous compositions comprising beta-1, 3-glucan having a MW in the range of about 1 to about 15 kDa. Beta-1, 3-glucan has a Degree of Polymerization (DP), and it is understood that when the beta-1, 3-glucan is enzymatically prepared, the distribution of components having different degrees of polymerization can be "manipulated" such as by enzyme dosage, temperature, etc. The inventors have identified three major components in beta-1, 3 glucan, which differ in DP and in MW. In the aqueous film-forming composition according to the invention, the ratio of the maximum MW component of beta-1, 3-glucan having a Degree of Polymerization (DP) of higher than 9 is preferably higher than 70%.

One or more film-forming polysaccharides

Any suitable film-forming polysaccharide or polysaccharides having a MW of greater than about 15 kDa comprising units selected from the group consisting of glucose units, fructose units, and galactose units, which are joined together by glycosidic bonds, may be used in the films of the present invention. Those skilled in the art will know these suitable polymers.

Suitable film-forming polymers for use in accordance with the present invention include starch, pullulan and dextran (e.g., alpha-dextran, such as alpha-1, 6-dextran having alpha-1, 2 branches, alpha-1, 6-dextran having alpha-1, 3 branches, or alpha-1, 4-dextran having alpha-1, 6 branches).

Suitable film-forming polymers for use in accordance with the present invention may be naturally derived (without chemical modification via chemical methods involving additional chemicals that are not naturally derived, i.e., non-microbial or non-enzymatic methods) or enzymatically synthesized. Suitable film-forming polymers for use in accordance with the present invention may be naturally derived and purified from suitable species, including algae, fungi, plants or bacteria.

Plasticizer(s)

Examples of the plasticizer include surfactants such as sucrose fatty acid esters, glycerin fatty acid esters, monoglyceride fatty acid esters, polyoxyethylene sorbitan fatty acid esters and the like, esters of citric acid such as triethyl citrate (TEC), polyols such as glycerin, propylene glycol, polyethylene glycol and the like, glucose such as fructose and glucose liquid sugar, sugar such as sucrose, sugar alcohols such as sorbitol, maltitol, mannitol, erythritol, xylitol, dodecanol, tridecanol, tetradecanol, pentadecanol, hexadecanol, heptadecanol, octadecanol, higher alcohols such as hexadecanol, isostearyl alcohol, 2-octyldodecanol and the like (preferably having 6 to 22 carbon atoms), and oils and fats such as medium chain fatty acid esters (preferably having 6 to 12 carbon atoms). Which is found below. These plasticizers may be used alone or in combination of two or more.

Experimental part

Example 1

The synthesis of beta-1, 3 glucan used in the following examples is shown in figure 1.

Two large batches of beta-1, 3 glucan (SK 018 and SK019; table 1) were prepared using a three enzyme system (FIG. 1). The reaction was performed in a pot in which three enzymes were combined together, sucrose phosphorylase (LEI 2183-WO 2020023278) from Lactobacillus amylophilus (Lactobacillus amylovorus) GRL1118, laminaria disaccharide phosphorylase [ CRC12031] (M. Kitaoka, T. Sasaki and H. Tamiguchi), arch. Biochem. Biophys. [ Biochemical and biophysical archives ] (1993) DOI 10.1006/abbi.1993.1383 DOI: 10.1006/abbi.1993.1383) and laminaria oligosaccharase [ CRC12027-WO 2019209559A1] from Clostridium griseum (Clostridium grantti) DSM 8605. The enzyme was expressed recombinantly in a Bacillus host (CBS 12-1). The enzyme reaction was performed at 37 ℃.

TABLE 1 composition of beta-1, 3 glucan batches produced in a one pot reaction using LEI 2183, CRC 12031 and CRC 12027.

SEC analysis of two beta-1, 3 glucans is shown below.

Samples (SK-018 and SK-019) were dissolved in distilled water at 50℃in a heater shaker for 2 hours. Each sample was prepared at two concentration levels (1.5 and 1.8 mg/mL, respectively). Samples were filtered through a 0.45 μm nylon syringe filter prior to analysis.

Samples were analyzed by a chromatograph consisting of Agilent (Agilent) G7111B pump, G7129A autosampler, G7116A column oven, and G7162A fold detector (RI). The sample was injected into a column (Tosoh) TSKgel G2500 PW) maintained at 35 ℃. The RI detector is also set at 35 ℃. The eluent was water containing 0.05 wt% NaN ₃. The flow rate was 0.5 mL/min. The injection volume was 0.1 mL. The chromatogram in fig. 2 is obtained by subtracting a blank (distilled water) chromatogram from the sample chromatogram.

The three components are identified in the chromatogram as components 1, 2 and 3. For SK-018 and SK-019, the total peak area of the three components divided by the concentration of the injected sample is similar. The concentration of each component is calculated by dividing the peak area of the component by the total peak area. The results are listed in table 2. The concentration of the major component (component 2) in SK-018 was higher than SK-019.

TABLE 2 concentration of Components 1, 2 and 3

The SEC elution times for component 2 for the two samples are compared in table 3. The elution time for component 2 in SK-018 was slightly lower than that of component 2 in SK-019, indicating that the MW of this component in SK-018 was slightly higher.

TABLE 3 elution time of component 2

Comparative example:

An example formulation with beta-1, 3 glucan (SK-019) is shown in Table 4.

Table 4. Formulations of pullulan with beta-1, 3 glucan (SK-019).

As seen in fig. 3, the puncture strength of the film made from the blend of pullulan and beta-1, 3 glucan (Exp 806 as shown in table 4) was lower than that of pullulan itself. The puncture distance of the membranes made from blends of pullulan and beta-1, 3 glucan (Exp 806 as shown in table 3) was also lower than that of pullulan itself.

Example 2

An example formulation with beta-1, 3 glucan (SK-018) is shown in Table 5.

Table 5. Formulations of pullulan with beta-1, 3 glucan (SK-018).

Comparison of the rheology curves shows that the solution of pullulan and beta-1, 3 glucan shows a synergistic effect during heating at temperatures above 45 ℃, with a gel strength similar to that of HPMC F5 solution. This indicates that by adjusting the solution bath process and the needle temperature, a cold/hot needle process can be used to gel the solution on the capsule needle. The puncture strength of films made from blends of pullulan and beta-1, 3 glucan (Exp 0122 as shown in table 5) was surprisingly better than that of pullulan itself. The puncture distance of a membrane made from a blend of pullulan and beta-1, 3 glucan (Exp 0122 as shown in table 5) was comparable to that of pullulan itself.

Claims

1. An aqueous film-forming composition comprising

a) One or more water-soluble film-forming polysaccharides having a microwave MW greater than about 15 kDa, said polysaccharides comprising units selected from the group consisting of glucose units, fructose units, and galactose units linked together by glycosidic bonds; and

b) β-1,3-glucan having a molecular weight (MW) in the range of about 1 to about 15 kDa.

2. The composition according to claim 1, wherein the β-1,3-glucan is thermally reversible in water.

3. The composition according to any one of claims 1-2, wherein the β-1,3-glucan has a molecular weight (MW) in the range of about 1 to about 14 kDa, such as about 1 to about 12 kDa, preferably in the range of about 1 to about 10 kDa, more preferably in the range of about 1 to about 5 kDa, and most preferably in the range of about 2 to about 4 kDa.

4. The composition according to any one of claims 1-3, wherein the β-1,3-glucan comprises glucose units in the range of about 5 to about 1000 glucose units, such as glucose units in the range of about 5 to about 300 glucose units, preferably glucose units in the range of about 7 to about 100 glucose units, more preferably glucose units in the range of about 9 to about 50 glucose units, and most preferably glucose units in the range of about 12 to about 20 glucose units.

5. The composition according to any one of claims 1-4, wherein the β-1,3-glucan is unbranched.

6. The composition according to any one of claims 1-5, wherein the β-1,3-glucan is prepared by an enzymatic reaction using β-1,3-glucan phosphorylase or β-1,3-glucan synthase.

7. The composition according to any one of claims 1-6, wherein the β-1,3-glucan is derived from algae, fungi, plants or bacteria.

8. The composition according to any one of claims 1-7, wherein the β-1,3-glucan is selected from the group consisting of callose, laminarin, and parastarch.

9. The composition according to any one of claims 1-8, wherein >70% by weight of the total β-1,3-glucan has a degree of polymerization (DP) greater than 9, more preferably >80% by weight of the total β-1,3-glucan has a DP greater than 11, and most preferably >90% by weight of the total β-1,3-glucan has a DP greater than 12.

10. The composition according to any one of claims 1-9, wherein the water-soluble film-forming polysaccharide is selected from the group consisting of starch, budding short-stem polysaccharide and dextran such as α-glucan.

11. The composition according to any one of claims 1-10, wherein the water-soluble film-forming polysaccharide is an enzymatically produced polysaccharide.

12. The composition according to any one of claims 1-11, wherein the water-soluble film-forming polysaccharide is derived from algae, fungi, plants or bacteria.

13. The composition according to any one of claims 1-12, wherein the water-soluble film-forming polysaccharide is budding short-stem polysaccharide.

14. The composition according to claim 13, wherein the budding short-stem polysaccharide is enzymatically produced.

15. The composition according to any one of claims 1-14, wherein the water-soluble film-forming polysaccharide is α-glucan, preferably α-1,6-glucan having α-1,2 branches, α-1,6-glucan having α-1,3 branches, or α-1,4-glucan having α-1,6 branches.

16. The composition according to any one of claims 1-15, wherein the water-soluble film-forming polysaccharide has a solution viscosity in the range of about 500 cps to about 5000 cps at a temperature in the range of about 5°C to about 80°C, wherein the solution concentration is in the range of about 10 wt% to about 40 wt%.

17. The composition according to any one of claims 1-16, wherein it is substantially free of cations, such as monovalent or divalent cations.

18. The composition according to any one of claims 1-17, wherein the final membrane composition comprises less than 5% by weight, preferably less than 3% by weight, and most preferably less than 1% by weight of sugar molecules (such as glucose, fructose, sucrose, and glucose-1-phosphate) based on the dry membrane.

19. The composition according to any one of claims 1-18, wherein the concentration of the water-soluble film-forming polysaccharide, such as budding short-stem polysaccharide, is at least about 80% by weight based on the dry film, such as at least about 82% by weight, such as at least about 85% by weight, such as at least about 87% by weight, such as at least about 90% by weight.

20. The composition according to any one of claims 1-19, wherein the concentration of the water-soluble film-forming polysaccharide, such as budding short-stem polysaccharide, is at least about 80%-95% by weight based on the dry film, such as in the range of 82%-95% by weight, such as 85%-90% by weight, such as 87%-90% by weight.

21. The composition according to any one of claims 1-20, wherein the concentration of β-1,3-glucan is at least about 0.1 wt% based on the dry film, such as at least about 0.2 wt%, 0.4 wt%, 0.6 wt%, 0.8 wt%, 1.0 wt%, 1.2 wt%, 1.4 wt%, 1.6 wt%, 1.8 wt%, 2.0 wt%, 2.5 wt%, 3.0 wt%, 3.5 wt%, 4.0 wt%, 4.5 wt%, 5.0 wt%, 5.5 wt%, 6.0 wt%, 6.5 wt%, 7.0 wt%, 7.5 wt%, 8.0 wt%, 8.5 wt%, or 9.0 wt%.

22. The composition according to any one of claims 1-21, wherein the concentration of β-1,3-glucan is in the range of no more than about 9.0 wt% based on the dry film, such as no more than about 8.5 wt%, 8.0 wt%, 7.5 wt%, 7.0 wt%, 6.5 wt%, 6.0 wt%, 5.5 wt%, 5.0 wt%, 4.5 wt%, 4.0 wt%, 3.5 wt%, 3.0 wt%, 2.5 wt%, 2.0 wt%, 1.8 wt%, 1.6 wt%, 1.4 wt%, 1.2 wt%, 1.0 wt%, 0.8 wt%, 0.6 wt%, such as in the range of 0.1 wt%-10.0 wt%, such as 0.2 wt%-8.0 wt%, such as 0.4 wt%-6.0 wt%, such as 0.6 wt%-4.0 wt%, such as 0.8 wt%-4.0 wt%, such as 1.0 wt%-4.0 wt%.

23. The composition according to any one of claims 1-22, further comprising a plasticizer, said plasticizer being a polyol, such as a sugar alcohol like sorbitol, mannitol, erythritol, xylitol, or glycerol (propane-1,2,3-triol), or a glyceroacetate selected from the class consisting of glyceromonoacetate, glycerodiacetate, and glycerotriacetate, TEC (triethyl citrate), dibutyl sebacate, and dibutyl phthalate, or mixtures thereof.

24. The composition according to any one of claims 1-23, further comprising at least one component selected from the group consisting of: surfactants such as dimethyl silicone oil, sodium lauryl sulfate, lecithin, sorbitol ester, colorants, flavoring agents, or mixtures thereof.

25. A capsule shell comprising an aqueous film-forming composition, said composition comprising:

26. The capsule shell according to claim 25, wherein it is a hard capsule shell.

27. The capsule shell according to any one of claims 25-26, which is prepared from the composition according to any one of claims 1-24.

28. A capsule comprising a capsule shell prepared from the composition according to any one of claims 1-23 or a capsule shell according to any one of claims 25-27.

29. The capsule of claim 28, further comprising a filling material, said filling material comprising a pharmaceutically active ingredient, a dietary supplement, a flavoring agent, a food ingredient, an agrochemical, or a fragrance.

30. A method for producing a capsule membrane or capsule shell, the method comprising the steps of: providing an aqueous composition according to any one of claims 1-24; preheating a molding needle to a temperature above 65°C of the aqueous composition; immersing the preheated molding needle in the aqueous composition at a temperature ranging from 53°C to 65°C; forming a film on the needle by removing the molding needle from the composition; and drying the film on the molding needle at a temperature above 65°C.

31. A method for producing a capsule membrane or capsule shell, the method comprising the steps of: providing an aqueous composition according to any one of claims 1-24; precooling a molding needle in the aqueous composition at a temperature ranging from 20°C to 53°C; immersing the precooled molding needle in the aqueous composition at a temperature above 65°C; forming a film on the needle by removing the molding needle from the composition; and drying the film in a drying chamber.

32. Use of the composition according to any one of claims 1-24 for manufacturing capsules in an impregnation molding process such as a hot-dip needle process or a cold-dip needle process.