JPS63264519A - Gelatin film coating for soft capsule - Google Patents

Abstract

PURPOSE:To obtain the titled gelatin film having reduced moisture absorption, without damaging excellent properties such as jelly strength, bond strength, viscosity and luster, containing a polyphosphate. CONSTITUTION:A gelatin film containing 0.2-40wt.%, preferably 5-40wt.$% based o gelatin of a salt (preferably sodium salt) of pyrophosphoric acid, tripolyphosphoric acid, tetrapolyphosphoric acid, pentapolyphosphoric acid or hexapolyphosphoric acid. The gelatin film is further mixed with 10-50wt.% xylitol, sorbitol or polyethylene glycol. Occurrence difficulty (slipping, adhesion and sticking) in application to automatic dispensing machine or unit-dose- packaging can be prevented by reduction in moisture absorption.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a gelatin film for soft capsules, and more particularly to a gelatin film with low hygroscopicity used as an outer shell of soft capsules.

The soft capsules mentioned here are capsules formed from softened gelatin, which is usually obtained by blending gelatin with a plasticizer such as glycerin or sorbitol. It can be obtained by pouring the filling into a bag-like softened gelatin sheet and molding it into an appropriate shape.

[Conventional technology and its problems]

The gelatin film used as the outer shell of conventional soft capsules is composed of gelatin as a base and a plasticizer such as glycerin, D-sorbitol, or polyethylene glycol added thereto. In particular, gelatin films prepared by adding glycerin have very excellent properties such as jelly strength, adhesive strength, and viscosity. Almost all contain glycerin.

In recent years, various automatic dispensing machines have been developed and are being used to improve the efficiency of dispensing operations. In addition, unit-dose-packages are used because of the ease of drug administration, especially to the elderly.
ng is used. However, when ordinary soft capsules are used for these purposes, they tend to be slippery for automatic dispensing machines, and the unit-dose-pack
For ing, adhesion is an obstacle to usability.

FIG. 1 shows moisture absorption equilibrium diagrams for hard capsule shells and soft capsule shells. As is clear from FIG. 1, the soft capsule shell has clearly higher hygroscopicity than the hard capsule shell, and the various problems described above are thought to be due to this property.

However, most of the conventional patents related to the outer shell of soft capsules are related to the solubility of the outer shell, and only a few are related to prevention of moisture absorption, so that sufficient effects have not yet been obtained.

As mentioned above, the soft capsule shell has greater hygroscopicity than the hard capsule shell, and for this reason, it is difficult to use in automatic dispensing machines or unit-do
When applied to se-packaging, problems such as slippage, adhesion, and adhesion occur, making it difficult to use soft capsules for these applications.

[Means for Solving the Problems] The present inventors have completed the present invention as a result of intensive research to solve the above-mentioned problems with the soft capsule shell.

That is, the present invention provides a gelatin film for soft capsules, which is characterized by containing a polyphosphate.

Examples of the polyphosphate used in the present invention include salts such as pyrophosphoric acid, tripolyphosphoric acid, tetrapolyphosphoric acid, pentapolyphosphoric acid, hexapolyphosphoric acid, etc. alone or in mixtures, and sodium salts are preferred. The content of polyphosphate is preferably 0.2 to 40% by weight, and 5 to 40% by weight based on gelatin.
40% by weight is more preferred.

In addition to gelatin and polyphosphate, xylitol, sorbitol, mannitol, polyethylene glycol, etc. can be added to the gelatin film of the present invention. The blending amount of these ingredients is preferably 10 to 50% by weight based on gelatin.

〔Effect of the invention〕

The gelatin film for soft capsules of the present invention has low hygroscopicity,
Furthermore, it is a useful gelatin film that does not impair the excellent properties of a normal soft capsule shell, such as jelly strength, adhesive strength, viscosity, and gloss.

〔Example〕

The present invention will be explained in more detail with reference to Examples below, but the present invention is not limited to these Examples.

Example 1 20 g of gelatin was placed in a beaker containing 40 mZ water in advance and allowed to absorb water and swell. After the gelatin had sufficiently absorbed water and swelled, it was heated to 60° C. and stirred to uniformly dissolve the gelatin. Furthermore, an aqueous solution of sodium polyphosphate prepared by adding 4-4ml of water to 1 g of commercially available sodium polyphosphate was added to the gelatin solution and stirred to make it homogeneous. The gelatin composition thus prepared was uniformly poured onto a glass plate and dried at room temperature for 48 hours to obtain a gelatin film.

Example 2 A gelatin film was obtained according to Example 1 except that 1 g of sodium polyphosphate and 4 g of sorbitol were used instead of 1 g of sodium polyphosphate.

Example 3 A gelatin film was obtained according to Example 1, except that Ig sodium polyphosphate and 4 g xylitol were used instead of 1 g sodium polyphosphate.

Example 4 A gelatin membrane was obtained according to Example 1 except that 1 g of sodium polyphosphate, 2 g of sorbitol, and 2 g of xylitol were used instead of 1 g of sodium polyphosphate.

Example 5 20 g of gelatin was placed in a beaker containing 40 m7 of 1% sodium chloride solution in advance and allowed to absorb water and swell. Thereafter, 4 g of sorbitol and 1 g of commercially available sodium polyphosphate were added and dissolved in a hot bath (60° C.), poured uniformly onto a glass plate, and then dried at room temperature for 48 hours to obtain a gelatin film.

Control Example 1 20g of gelatin was placed in a beaker containing 40IIIl of water in advance and allowed to absorb water and swell. After the gelatin had sufficiently absorbed water and swelled, it was heated to 60° C. and stirred to uniformly dissolve the gelatin solution. Then 4g glycerin and 2g
Add sorbitol and stir thoroughly until it becomes transparent. Thereafter, the gelatin composition solution was uniformly poured onto a glass plate and dried at room temperature for 48 hours to obtain a gelatin film.

Comparative Example 2 20 g of gelatin was placed in a beaker containing 20 mZ water in advance and allowed to absorb water and swell. Afterwards, take a warm bath (60℃)
), poured uniformly onto a glass plate, and dried at room temperature for 48 hours to obtain a gelatin film.

Experimental Example 1 (Moisture Absorption Equilibrium) Sections of the gelatin films obtained in Examples 1 to 4 and Control Example 1 were stored at 37° C. under various relative humidity conditions for two weeks, and the desorption of water content was investigated.

The results are shown in FIG.

Compared to the control product obtained in Control Example 1, the products of the present invention obtained in Examples 1 to 4 exhibit slight moisture absorption even at a relative humidity of 70% or higher, and the adhesion of sections to each other is less severe in the control product at a relative humidity of 59% or higher. However, this phenomenon occurs only at relative humidity of 82% or higher in all of the products of the present invention, and the adhesion properties are significantly improved.

Experimental Example 2 (Film Tensile Test) The gelatin films obtained in Examples 1 to 5 and Control Examples 1 to 2 were cut into pieces with a width of 1.5 cm and a length of 5 cm.
Ih 6H20 saturated aqueous solution (25℃ x R, 8,53%
), and a tensile test was conducted with an effective sample length of 1cI11.

The results are shown in FIG.

As is clear from FIG. 3, although the film of Comparative Example 2 has a high Young's modulus, its elongation is low and there is a possibility that cracks may occur. The film of Comparative Example 1 has a low Young's modulus but a high elongation, so it does not crack but is easily deformed. The films obtained in Examples 1 to 5 were hard and tenacious as required for films, and exhibited great elongation. In particular, the films of Examples 3 to 5 are good.

Experimental Example 3 Gelatin films obtained in Examples 1 to 5 and Control Examples 1 to 2 were cut into pieces with a width of 1.5 CIIX and a length of 5 (J) on a saturated sodium chloride aqueous solution (25°C XR, 11° 75%). A tensile test was conducted using an effective sample length of 1 cn+.The results are shown in FIG.

As is clear from FIG. 4, the film of Comparative Example 1 has a small yield stress and is easily deformed. The coatings of Examples 1 to 5 all have a larger yield stress than the coating of Control Example 1 and are less likely to deform.

Experimental Example 4 The gelatin films obtained in Examples 2 to 5 and Control Examples 1 to 2 were cut into 1.5 cm width x 2.5 cm length, and Mg (
NOri z・611□0 on saturated aqueous solution (25℃XR, H
, 53%). After that, the section was placed on a stainless steel plate, various weights were placed on top of the section, and the section was pulled horizontally.
The tensile stress required for movement was determined. The results are shown in Figure 5.

When the degree of slippage is determined from the slope of the graph in FIG. 5, Examples 2 to 5 have better slipperiness than the conventional soft capsule of Comparative Example 1, and have the same slipperiness as the hard capsule of Comparative Example 2. ing.

Prototype example of soft capsule formulation> Prototype example 1 60g of ethylparaben, 20g of methylparaben, 4kg of xylitol, 1kg of sodium polyphosphate, 40g of water
After adding 20 kg of gelatin and dissolving it, 20 kg of gelatin was added to swell and dissolve at 60°C. Then titanium oxide 200
g, and 6 g of food coloring were added and dispersed to prepare a coating liquid. Sesame oil was used as the content liquid, and soft capsules were obtained using a rotary automatic machine.

Prototype Example 2 Soft capsules were obtained according to Prototype Example 1, except that 2 kg of xylitol and 2 kg of sorbitol liquid (70%) were used instead of 4 kg of xylitol.

Prototype control example 1 xylitol 4 kg, glycerin 4 kg instead of sodium polyphosphate 1-, sorbitol solution (70%) 2
Soft capsules were obtained according to Prototype Example 1, except that 1 kg was used.

The capsules obtained in Prototype Example 1.2 had good adhesive strength and good appearance (gloss). Looking at moisture absorption equilibrium, prototype example 1.
Capsules No. 2 had lower hygroscopicity than the capsules of Prototype Control Example 1 (see Figure 6). Also, relative humidity 75% (temperature 4
When stored for one month under conditions (0°C), the capsules of Prototype Control Example 1 suffered from blocking, but the capsules of Prototype Example 1.2 did not cause Pro7 King and showed no problems in the film test.

[Brief explanation of the drawing]

Figure 1 is a moisture absorption equilibrium diagram for hard capsule shells and soft capsule shells, Figure 2 is a diagram showing the results of Experimental Example 1, and Figure 3 is a diagram showing the results of Experimental Example 1.
The figure shows the results of Experimental Example 2, Fig. 4 shows the results of Experimental Example 3, Fig. 5 shows the results of Experimental Example 4, and Fig. 6 shows the results of Experimental Examples 1 and 2 and the prototype control example. 1 is a moisture absorption balance diagram of the soft capsule obtained in 1.

Claims (1)

[Scope of Claims] 1. A gelatin film for soft capsules, characterized by containing a polyphosphate. 2. The content of polyphosphate is 0.2 to gelatin
The gelatin film according to claim 1, which has a content of 40% by weight.