FILM, CAPSULE AND FILM-FORMING COMPOSITION COMPRISING WATER-SOLUBLE SALT AS OPACIFYING AGENT

Abstract

Problem to be solved: To provide a whitened or opacified capsule and film without using a white pigment such as titanium dioxide. Solution: A film, a capsule and a film-forming composition characterized by containing a film-forming polymer component selected from gelatin and pullulan and an opacifying agent consisting of a water-soluble salt except calcium salt carbonate and bicarbonate, wherein the salt is selected from a sodium salt, potassium salt, an ammonium salt and a magnesium salt.

Claims

1. A film comprising a film-forming polymer component and an opacifying agent comprising a water-soluble salt, except calcium salt, carbonate and bicarbonate, wherein the film-forming polymer component comprises one selected from the group consisting of gelatin and pullulan.

2. A film according to claim 1 wherein the opacifying agent comprises one or more water-soluble salts.

3. The film according to claim 1, wherein the film-forming polymer component comprises gelatin.

4. The film according to claim 1, wherein the water-soluble salt is a sodium salt, a potassium salt, an ammonium salt or a magnesium salt.

5. The film according to claim 1, wherein the water-soluble salt is selected from the group consisting of sodium malate, sodium citrate, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium succinate, sodium polyphosphate, sodium pyrophosphate, dipotassiurn hydrogen phosphate, potassium dihydrogen phosphate, potassium acetate, ammonium chloride, magnesium chloride and magnesium sulfate.

6. The film according to claim 3, wherein one or more water-soluble salts are selected from phosphates including hydrogen phosphate, dihydrogen phosphate, pyrophosphate and polyphosphate.

7. The film according to any one of the claim 1, wherein a degree of opacity is adjusted with a total amount of the salt being in the range 0.5 to 30 parts by weight with respect to a total amount of 100 parts by weight of the film-forming polymer component in terms of dry weight.

8. The film according to claim 7, wherein a degree of opacity is adjusted with a total amount of the salt being in the range of 1 to 15 parts by weight with respect to a total amount of 100 parts by weight of the film-forming polymer component in terms of dry weight.

9. The film according to claim 7, wherein a degree of opacity is adjusted with a total amount of the salt being in the range of 2 to 15 parts by weight with respect to a total amount of 100 parts by weight of the film-forming polymer component in terms of dry weight.

10. The film according to claim 1, colored in a color other than white by adding a dye or a pigment.

11. A capsule suitable for oral delivery which is formed of the film according to claim 1.

12. The capsule according to claim 11, wherein the capsule is free from a white pigment.

13. The capsule according to claim 11, wherein the combination of the film forming polymer component and the water-soluble salt is, gelatin and sodium polyphosphate, gelatin and sodium pyrophosphate, gelatin and sodium citrate, gelatin and disodiurn hydrogen phosphate, gelatin and sodium dihydrogen phosphate, gelatin and dipotassiurn hydrogen phosphate, gelatin and potassium dihydrogen phosphate, gelatin, sodium polyphosphate and sodium pyrophosphate, or gelatin, sodium polyphosphate and disodium hydrogen phosphate.

14. The capsule according to according to claim 11, wherein the combination of the film forming polymer component and the water-soluble salt is, gelatin and sodium polyphosphate, gelatin and sodium pyrophosphate, gelatin and disodium hydrogen phosphate, gelatin and sodium dihydrogen phosphate, gelatin and dipotassiurn hydrogen phosphate, gelatin and potassium dihydrogen phosphate, gelatin, sodium polyphosphate and sodium pyrophosphate, or gelatin, sodium polyphosphate and disodiurn hydrogen phosphate,

15. A film-forming composition to form a film or a capsule according to claim 11, comprising a film-forming polymer component dissolved in water and an opacifying agent comprising a salt.

16. Use of a salt as an opacifying agent in the manufacture of films or capsules according to claims 1, characterized in that said salt is selected from the group consisting of sodium salts, potassium salts, ammonium salts and magnesium salt.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0053] FIG. 1 shows a printed matter obtained by preparing a film-forming aqueous solution, which is obtained by adding, to an about 34% gelatin solution, 7.5 parts by weight of sodium polyphosphate relative to 100 parts by weight of the gelatin, printing patterns on a glass plate heated in an oven at 105° C. by use of a template having pattern cuts and heating the plate at 60° C. for 15 minutes.

EXPERIMENTAL EXAMPLE

[0054] Various types of test samples each containing a film-forming polymer and a salt were prepared and opacity of the films in a film-formation process was examined.

[0055] In the following tables, the contents of salts are represented by parts by weight relative to 100 parts by weight (on a dry basis) of a film base.

[0056] The white ratio and the degree of whiteness were visually evaluated based on the following criteria.

[0057] The “white ratio” represents the area percentage of whitened parts regardless of the “degree of whiteness”; whereas, the “degree of whiteness” represents the (color) density of a white-looking portion.

[0058] White ratio: ⊚ 100 to 90%, o 90 to 80%, Δ 80 to 70%, □ 70% or less

[0059] Degree of whiteness: ⊚ pure white, o white, Δ transparent-like white, □ dull white

[0060] Films were prepared by drying naturally in a room.

TABLE-US-00001 TABLE 1 Examples of opacifying agents used with gelatin Formulation 1 2 3 4 5 6 7 8 9 Gelatin 100 100 100 100 100 100 100 100 100 Sodium polyphosphate 20 10 5 3.5 2 Sodium pyrophosphate 10 5 Potassium carbonate 5 Sodium carbonate 5 Sodium bicarbonate Trisodium citrate Disodium hydrogen phosphate Sodium dihydrogen phosphate Dipotassium hydrogen phosphate Potassium dihydrogen phosphate White ratio ⊚ ⊚ ⊚ ⊚ □ ⊚ ⊚ □ ⊚ Degree of whiteness ◯ Δ Δ Δ □ Δ Δ □ Δ Examples of opacifying agents used with gelatin Formulation 10 11 12 13 14 15 16 17 18 Gelatin 100 100 100 100 100 100 100 100 100 Sodium polyphosphate 2.5 2.5 Sodium pyrophosphate 2.5 Potassium carbonate Sodium carbonate Sodium bicarbonate 5 Trisodium citrate 5 Disodium hydrogen 10 5 2.5 phosphate Sodium dihydrogen 10 phosphate Dipotassium hydrogen 10 phosphate Potassium dihydrogen 10 phosphate White ratio □ □ ⊚ ⊚ ⊚ ⊚ ⊚ ⊚ ⊚ Degree of whiteness □ Δ ◯ Δ □ Δ □ Δ Δ

[0061] Experiments were carried out using formulations 1 to 16 (shown in Table 1) consisting of a film base of gelatin and each of the salts: sodium polyphosphate, sodium pyrophosphate, potassium carbonate, sodium carbonate, sodium bicarbonate, trisodium citrate, disodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate and potassium dihydrogen phosphate. Formulations 8 to 10 using a carbonate or bicarbonate are reference examples. A tendency of forming a film having dull white to transparent-like white and a large white ratio was observed.

[0062] Formulations 17 and 18 subjected to an experiment are formulations using the film base and a salt consisting of a mixture of sodium polyphosphate and sodium pyrophosphate, and the above film base and a salt consisting of a mixture of sodium polyphosphate and disodium hydrogen phosphate, respectively. In these cases, films having a large white ratio and transparent-like whiteness were formed.

EXAMPLES

[0063] Now, the present invention will be more specifically described referring to Examples described below; however, the present invention is not limited to these.

Example 1

[0064] To an about 34% gelatin solution, an aqueous solution containing 5 parts by weight of sodium polyphosphate relative to 100 parts by weight of the gelatin was added to prepare a film-forming aqueous solution. This solution was poured on a glass plate applied with a release agent and heated to about 60° C. and dried at room temperature to form a white film.

Example 2

Colorability of Film

[0065] To an about 34% gelatin solution, an aqueous solution containing 5 parts by weight of sodium polyphosphate and 1 part by weight of gardenia red colorant relative to 100 parts by weight of the gelatin was added to prepare an aqueous film-forming solution. This solution was poured on a glass plate applied with a release agent and heated to about 60° C. and dried at room temperature to obtain a colored film.

[0066] To an about 34% gelatin solution, an aqueous solution containing 5 parts by weight of sodium polyphosphate and 1 part by weight of gardenia blue colorant relative to 100 parts by weight of the gelatin was added to prepare an aqueous film-forming solution. This solution was poured on a glass plate applied with a release agent and heated to about 60° C. and dried at room temperature to obtain a colored film. In both cases, it was confirmed that an opaque colored film is prepared.

[0067] All salts above were used in an amount of 2.5 parts by weight relative to 100 parts by weight of the film base.

Example 3:

Ink Liquid Composed of Film-Forming Composition Containing an Pacifying Agent

[0068] An ink liquid containing gelatin as the film-forming polymer and an opacifying agent, as shown in the following Table 2 was prepared.

TABLE-US-00002 TABLE 2 Formulation of ink liquid Formulation Gelatin 100 Sodium 7.5 polyphosphate White ratio ⊚ Degree of whiteness ⊚ Peeling None

[0069] The white ratio and degree of whiteness were visually evaluated, and the criteria were as follows.

[0070] The “white ratio” represents the area percentage of whitened parts regardless of the “degree of whiteness” and the “degree of whiteness” refers to the density of a white-looking portion.

[0071] White ratio: ⊚ 100 to 90%

[0072] Degree of whiteness: ⊚ pure white

[0073] To an about 34% gelatin solution, an aqueous solution containing 7.5 parts by weight of sodium polyphosphate relative to 100 parts by weight of the gelatin was added to prepare a film-forming aqueous solution. Using a template having pattern cuts, patterns were printed and heat-dried at 60° C. for 15 minutes. As a result, as shown in FIG. 1, printing excellent in white ratio and degree of whiteness emerged. When a peeling test was carried out by cellophane tape, no peeling occurred.

[0074] From the above experiments, it was confirmed that gelatin used as the film-forming polymer in the above formulations can be used for a solution for hard capsules and also applied to ink. Owing to use of an opacifying agent according to the present invention and an ordinary coloring agent in ink or a film-forming polymer for painting, white and colored opaque printed matters, drawings, painted products in accordance with the objects can be obtained.

INDUSTRIAL APPLICABILITY

[0075] The film-forming composition containing a polymer component of gelatin or pullulan dissolved in water and an opacifying agent consisting of a salt can provide a whitened or opacified film having light-shielding property without using titanium oxide, whose carcinogenicity has been reported. The film-forming composition is excellent in solubility and can form a white film stable for a long term. If the composition is used together with a pigment or a colorant, an opaque and colored film can be provided. Accordingly, the film-forming composition is extremely useful particularly as a material for capsules to be charged with a content such as a medicine, an animal medicine, an agricultural chemical, a cosmetic and a healthy food, also, a coating material for tablets and grains, an edible film and edible ink.