JPS61221117A - Enteric hard capsule - Google Patents

Abstract

PURPOSE:An enteric hard capsule that is produced by forming enteric films on the whole surface of the cap of the capsule, on the part which is overlapped with the cap and the body surface exposed without overlapping with the cap. CONSTITUTION:An enteric hard capsule is composed of the cap 1 and the body 2 and is produced by forming enteric films 3 such as hydroxypropylmethylcellulose phthalate film on the whole surface of the cap 1 and the surface of the body parts which is overlapped with the cap 1 and exposed from the cap 1. In other words, prelocked capsules are coated with an enteric agent, filled with drugs 4 in a usual manner and locked to give capsules which can prevent gastric juice from coming through the overlapping part, because the part is coated with the enteric films.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Field of Application] The present invention relates to enteric-coated hard capsules, which are used, for example, in the medical field.

[Prior art] Enteric-coated hard capsules include those in which the entire surface of the capsule is coated with an enteric agent after the pharmaceutical is filled in the capsule, and those in which the pharmaceutical is filled in a capsule formed with an enteric agent, locked, and then capped. It is known that the outer peripheral surface of the lower end is sealed with an enteric agent.

[Problems to be Solved by the Invention] Among conventional enteric-coated hard capsules, those in which the entire surface of the capsule filled with pharmaceuticals is coated with an enteric agent,
Loss due to defective products that occur during the coating process is not limited to capsules, but also leads to the loss of expensive pharmaceuticals.
Unfavorable from an economic point of view. Furthermore, depending on the type of medicine, there is a risk that the medicine completely filled in the capsule may deteriorate due to heat or solvent during the coating process.

Furthermore, hard capsules made of enteric-coated agents are more expensive than conventional gelatin hard capsules, and have not yet been put to practical use.

The inventors of this invention conducted research to resolve the above-mentioned drawbacks of conventional enteric-coated hard capsules, and after coating pre-locked capsules with an enteric agent,
Simply fill the medicine with the usual method and lock it. Surprisingly, when it is locked, an enteric coating applied to the surface of the body where it overlaps with the cap prevents gastric juices from entering through the fitting part of the cap and body. They have discovered that the backing effect is sufficient to prevent this, and have completed this invention.

[Means for Solving the Problems] The present invention provides an intestine comprising a cap and a body in which a film of enteric agent is formed on the entire surface of the cap and at least on the body surface of the part overlapping with the cap when locked and the part exposed from the cap. Soluble hard capsules and enteric-coated hard capsules made in this way are filled with pharmaceuticals, etc.
This invention relates to an enteric-coated hard capsule formed by locking a cap and a body.

Therefore, specifically, the present invention provides enteric-coated hard capsules in which a film of an enteric agent is formed on the entire surface of the cap and the body, respectively, and then put into a pre-locked state, and These include enteric-coated hard capsules formed with a solvent film, and enteric-coated hard capsules obtained by filling the enteric-coated hard capsules obtained in this manner with pharmaceuticals, etc., and then locking the cap and body.

As the hard capsule itself in this invention, ordinary gelatin capsules can be used as they are, and these capsules may be of either the so-called lock type or snap-fit type.

Enteric-coated agents include hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose
Common enteric agents such as acetyl succinate, cellulose acetate phthalate, methacrylic acid/methyl methacrylate copolymers may be used.

Formation of the enteric agent film can be carried out by a conventional film coating method in which a solution containing the enteric agent is sprayed onto capsules in a rotating pan under heating.

The thickness of the film formed on the capsule surface is not particularly limited as long as it can prevent moisture from entering from the fitting portion between the cap and the body, but a thickness of about 80 μm is usually sufficient.

[Example] A case where a film of an enteric agent is formed on the surface of a capsule in a pre-locked state will be described below.

Example coating liquid formulation: HP-55* 8.1 parts by weight triacetin 0.9 parts by weight ethanol 45.5
Parts by weight Dichloromethane 45.5 Parts by weight Place 1 in a pre-locked state [see Figure 1 (A)] in a coating pan (Hi-Coat Mini, manufactured by Freund Sangyo Co., Ltd.).
Add 1,500 capsules and rotate the pan (20 rpm)
) The coating liquid having the above composition was continuously sprayed from a spray gun (caliber 1.5 mm) at a rate of 10 ml/min. The intake air temperature during spraying is 40℃, and the exhaust temperature is 25℃.
~30°C, the spray air pressure was 1.0 kg/am''.Thus, the enteric agent coating amounts were 10 mg, 14 mg, 18 mg and 38 m per capsule, respectively.
A capsule of g was obtained [see FIG. 1(B)].

Separate the cap and body of these capsules [Figure 1 (
C)], the pharmaceutical powder was filled and locked by a conventional method to obtain enteric-coated hard capsules [see FIG.

(*HP-55: Hydroxypropyl methylcellulose phthalate manufactured by Shin-Etsu Chemical Co., Ltd.) Test Example Using the enteric-coated hard capsules obtained in the above example and the untreated hard capsules (control) (Group 1, 6 capsule),
A disintegration test was conducted according to the disintegration test method for enteric-coated preparations stipulated in the 10th edition of the Japanese Pharmacopoeia. The temperature of both the first liquid and the second liquid was 37° C., and a disc was used in both the first liquid test and the second liquid test.

The test results (disintegration time) are shown in the table below.

As is clear from the above test results, those having an enteric coated coating amount of 14 mg or more per capsule met the standards for enteric coated preparations.

However, in capsules with a coating amount of 38 mg per capsule, the coating is a little too thick and may cause problems in locking the capsule after filling with the drug.

Therefore, it was determined that the amount of film per capsule was preferably around 18 mg. The thickness of the capsule film was approximately 80 μm.

[Effects of the Invention] The enteric-coated hard capsules of the present invention meet the test standards for enteric-coated preparations simply by applying an enteric coating to the capsule surface in a pre-locked state, reducing the production cost of enteric-coated hard capsules. It has an excellent effect.

[Brief explanation of the drawing]

FIG. 1 is a longitudinal cross-sectional view showing the manufacturing process of the enteric hard capsule of the present invention, in which (A) is a pre-locked state before film formation, (B) is a pre-locked state after film formation, and (C) is a capped state. (D) shows the state in which the body is released, and (D) shows the locked state after filling the medicine.

Claims (2)

[Claims] (1) An enteric-coated hard capsule consisting of a cap and a body in which a film of an enteric agent is formed on the entire surface of the cap and at least on the body surface of the portion overlapping with the cap and the portion exposed from the cap when locked. (2) Filling an enteric-coated hard capsule consisting of a cap and body with an enteric agent film formed on the entire surface of the cap, at least the part overlapping the cap when locked, and the body surface of the part exposed from the cap, with pharmaceuticals, etc.; Enteric-coated hard capsule with a locked cap and body.