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Medical composition containing rebamipide

A technology of rebamipide and composition, applied in the direction of drug combination, medical preparations containing active ingredients, medical preparations without active ingredients, etc., can solve the problem of reducing the stability of drug ingredients and unsatisfactory suppression of bitter taste , increasing bitterness, spicy and other issues

Inactive Publication Date: 2010-07-14
OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some flavoring agents may reduce the stability of the drug ingredient over time
In the above cases, it is impossible to add a flavoring agent in an amount that can sufficiently suppress the bitterness of the preparation and improve its ingestibility
Furthermore, only increasing the amount of sweeteners cannot suppress bitterness satisfactorily, and some synthetic sweeteners will instead increase unpleasant tastes such as bitterness and pungentness
Furthermore, no flavoring or sweetening agent has been developed that satisfactorily suppresses the intense and persistent bitter taste of rebamipide

Method used

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  • Medical composition containing rebamipide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086]Utilize vertical granulator, the mixture of 1010g rebamipide, 1845g lactose, 510g cornstarch, 140g crystalline cellulose, 680g dextrin, 150g sodium carboxymethyl starch and 90g croscarmellose sodium and A mixed solution of 20 g of L-arginine, 838 g of purified water, and 140 g of polysorbate 80 was kneaded. The resulting mixture was granulated using an extrusion granulator (TDG-80, manufactured by Fuji Trading Co.) equipped with a screen with a pore size of 0.6 mm, and then prepared using a spherical granulator (QJ-400, manufactured by Fuji Trading Co.) spherical. The obtained particles were dried, and particles having a particle diameter of 0.355 to 1 mm were collected as core particles.

[0087] Separately, citrate fatty acid glyceride (SunSoft 621G, manufactured by Sun Chemical, 60 g) was added to a mixture of 144 g of ethanol and 36 g of water, and dissolved by heating. Add D-mannitol (60g), then stir to suspend it to obtain a coating solution.

[0088] Nuclei gra...

Embodiment 2

[0095] Using a vertical granulator, 60.6g rebamipide, 110.7g lactose, 30.6g corn starch, 8.4g crystalline cellulose, 36.0g dextrin, 9.0g sodium carboxymethyl starch and 5.4g cross-linked carboxymethyl The mixture of sodium cellulose and 6 g of L-arginine, 50.3 g of purified water and 8.4 g of polysorbate 80 were kneaded. The same operation was repeated 3 times, and the kneaded material obtained was granulated using an extrusion granulator (TDG-80, manufactured by Fuji Trading Co., Ltd.) equipped with a screen with an aperture of 0.6 mm, and then granulated using a spherical granulator (QJ -400, manufactured by Fuji Trading Co., Ltd.) into a spherical shape. The obtained particles were dried, and particles having a particle diameter of 0.355 to 1 mm were collected as core particles. Coated granules were produced in the same manner as in Example 1.

Embodiment 3～7

[0099] Produced in the same manner as in Example 2, except that rebamipide, L-arginine (or L-arginine hydrochloride), citric acid, and thaumatin were used in the amounts shown in Table 1 below. The coated granules of Examples 3-7. In addition, citric acid and L-arginine hydrochloride were added to the liquid mixture in the same manner as L-arginine. Thaumatin is not added to the mixture, but added to rebamipide, lactose, etc. By controlling the amount of dextrin, the weight changes caused by the changes in the amounts of L-arginine, L-arginine hydrochloride, citric acid, and thaumatin were adjusted so that the total weight of the pharmaceutical preparation was the same in each case.

[0100] [Table 1]

[0101]

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Abstract

The present invention provides a pharmaceutical preparation wherein the expression of bitterness is reduced. The medical composition of the present invention contains rebamipide or a salt thereof and L-arginine or a salt thereof. The preferable embodiment of the medical composition of the present invention contains rebamipide or a salt thereof and L-arginine or a salt thereof along with at least one sweetener selected from the group consisting of thaumatin, stevia and luohan fruit extracts. By adding such a sweetener, bitterness of medical composition attributable to rebamipide or a salt thereof can be remarkably reduced.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing rebamipide. Background technique [0002] Rebamipide or a salt thereof (hereinafter also simply referred to as "rebamipide") is known as a drug for alleviating subjective and other symptoms of diseases such as gastric ulcer and gastritis. [0003] Rebamipide itself is very bitter, so when it is used in pharmaceutical preparations for oral administration, a coating is formed around rebamipide in order to reduce the bitterness in the mouth. Therefore, rebamipide is generally made into film-coated tablets, film-coated granules, etc. (Japanese Patent No. 3466921). [0004] However, even with the coating, when the patient cannot swallow the tablet, the tablet is sometimes crushed and taken. In the case of granules, the development of a bitter taste is unavoidable when the granules left in the mouth are crushed between the patient's teeth. In consideration of the above-mentioned circumstance...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/18A61K47/42A61K31/4704
CPCA61K47/183A61K47/42A61K9/5015A61K31/4704A61P1/02A61P1/04
Inventor 原好男
Owner OTSUKA PHARM CO LTD
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