JP2524602B2 - Soft capsule - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application] The present invention is intended to prevent mutual adhesion of soft capsules by coating the surface of the soft capsule with a sucrose fatty acid ester. .

Soft capsules consist of gelatin, glycerin as a plasticizer,
A film formed by adding D-sorbitol or the like, which can be filled with an oily liquid, suspension, powder or tablet. Especially when the content is an oily liquid or suspension, the content is excellent in uniformity. In addition, it is one of the dosage forms that is beautiful in appearance and is rapidly growing in recent years.

(Problems to be solved by the prior art and the present invention) The film moisture of the soft capsule is usually about 5 to 13% w / w, but when the film moisture content is high as a general property of the soft capsule, Or it easily softens when stored in a hot place (for example, 40 ℃ or higher). Therefore, for example, when the soft capsule is stored in a hard container such as a bottle, the soft capsule adheres to the wall of the bottle, the soft capsules adhere to each other, and it becomes difficult to take them out. Has the drawback of.

Conventionally, there has been surface treatment of soft capsules as a method for preventing mutual adhesion of soft capsules. For example, a method using carnauba wax (Japanese Patent Application No. 56-156212) is known. However, although this method can prevent mutual adhesion of soft capsules to some extent, it is not always sufficient.

[Structure of the Invention] (Means for Solving the Problem) This time, the present inventors can significantly prevent mutual adhesion of soft capsules by coating the surface of the soft capsule with sucrose fatty acid ester. The inventors have found out what can be done and have completed the present invention.

As the sucrose fatty acid ester used in the present invention,
The fatty acid forming the ester is not particularly limited,
Examples thereof include palmitic acid, stearic acid, lauric acid, acetic acid, oleic acid, caprylic acid, capric acid, linoleic acid and linolenic acid. Further, as the composition ratio of mono-, di- and triesters, the ratio of mono-esters to di- and triesters (mono-ester /
The di- and triesters) are preferably 0.3 to 1.3. The form of sucrose fatty acid ester is not particularly limited, but 20
Powder particles of 0 mesh or less are desirable.

As a method of coating the surface of the soft capsule, for example, sucrose fatty acid ester is sieved to classify 200 mesh or less, and then an appropriate amount of the soft capsule is put into a coating pan, and the powdery powder is shaken while rotating. Spray sugar fatty acid ester. However, the method is not particularly limited as long as it is a method capable of being sprayed on the surface of the soft capsule and uniformly coated, and any method may be used. Increasing the coverage reduces the tendency for mutual adhesion, but also reduces the luster of the soft capsule surface. The optimum concentration for maintaining the beauty of appearance and effectively preventing mutual adhesion is about 0.03% w / w with respect to the coating amount (coating) of the soft capsule.

Next, the present invention will be described in more detail with reference to Examples, Reference Examples and Test Examples.

Example 1. Soft capsule A (major axis 12.60 m / m, minor axis 7.05 m / m, film moisture 8.4%, disintegration time 8 minutes, hardness 15 kg or more, weight 350 mg)
After taking 1000 capsules and placing in a polyethylene bag, 0.015, 0.030, 0.060 and 0.150% w / w sucrose fatty acid ester (trade name DK Ester F10, manufactured by Daiichi Kogyo Seiyaku Co., Ltd., 200 mesh or less based on the coating weight Particle size) was added, and the mixture was shaken up and down, left and right for 5 minutes, mixed, and coated. The obtained soft capsule was designated as Sample III.

Example 2. Soft capsule B (major axis 7.4 m / m, minor axis 6.5 m / m, film moisture 6.
4%, disintegration time 12 minutes, hardness 15kg or more, weight 200mg) 1000
Capsules were taken, and sucrose fatty acid ester (DK ester F10) was used in the same manner as in Example 1 to obtain 0.030% w / w based on the coating weight.
Added and coated. Here, the soft capsule coated with DK ester F10 was designated as Sample VII.

Reference Example 1. Soft capsule A was coated with carnauba wax (trade name carnauba wax, manufactured by Noda Wax Co., Ltd., particle size of 200 mesh or less) in the same manner as in Example 1. The obtained soft capsule was designated as Sample IV.

Reference Example 2. The soft capsule B was coated with carnauba wax (trade name carnauba wax, Noda Wax Co., Ltd., particle size of 200 mesh or less) in the same manner as in Example 2. The obtained soft capsule was designated as Sample VIII.

[Effects of the Invention] Test Example 1. The coating concentration is 0.015 to 0.150 with respect to the weight of the soft capsule skin.
The mutual adhesion-preventing effect of Samples III and IV with% w / w added is shown in Tables I and II.

As is clear from Tables I and II, the effect of preventing mutual adhesion was observed in any of the coating agents, and the result increased with increasing amount, but the effect was particularly remarkable when sucrose fatty acid ester was used, as compared with carnauba wax. Was excellent.

Test Example 2. Table III shows the results of the experiment conducted using the soft capsule B.

The soft capsule B is slightly smaller than the soft capsule A and is a harder soft capsule with less film moisture. Therefore, even if it is an untreated product, the degree of mutual adhesion is different.
It was mild compared to. As is clear from Table III, sucrose fatty acid ester also acted effectively on such soft capsules, and the degree of the effect was even better than that of carnauba wax.

Claims (1)

(57) [Claims] 1. A soft capsule having a soft capsule surface coated with sucrose fatty acid ester.