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Claims for Patent: 5,093,132

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Claims for Patent: 5,093,132

Title: Stabilized pharmaceutical composition and its production
Abstract:The pharmaceutical composition of the invention, which comprises a benzimidazole compound of the formula ##STR1## wherein R.sup.1 hydrogen, alkyl, halogen, cyano, carboxy, carboalkoxy, carboalkoxyalkyl, carbamoyl, carbamoylalkyl, hydroxy, alkoxy, hydroxyalkyl, trifluoromethyl, acyl, carbamoyloxy, nitro, acyloxy, aryl, aryloxy, alkylthio or alkylsulfinyl, R.sup.2 is hydrogen, alkyl, acyl, carboalkoxy, carbamoyl, alkylcarbamoyl, dialkylcarbamoyl, alkylcarbonylmethyl, alkoxycarbonylmethyl or alkylsulfonyl, R.sup.3 and R.sup.5 are the same or different and each is hydrogen, alkyl, alkoxy or alkoxyalkoxy, R.sup.4 is hydrogen, alkyl, alkoxy which may optionally be fluorinated, or alkoxyalkoxy, and m is an integer of 0 through 4, and a basic inorganic salt stabilizing agent, is physically stable. Magnesium and calcium basic inorganic salt stabilizing agents are particularly useful.
Inventor(s): Makino; Tadashi (Osaka, JP), Tabata; Tetsuro (Osaka, JP), Hirai; Shin-ichiro (Kyoto, JP)
Assignee: Takeda Chemical Industries, Ltd. (Osaka, JP)
Application Number:07/575,897
Patent Claims: 1. A stabilized pharmaceutical composition for the inhibition of gastric acid secretion, comprising:

an effective amount of a 2-benzimidazole derivative selected from the group consisting of 2-benzimidazole and 5-methoxy-2-benzimidazole, or a pharmaceutically acceptable salt thereof;

a basic inorganic salt stabilizing agent which is present in an amount effective to stabilize the composition, the benzimidazole derivative being in contact with the basic inorganic salt evenly; and

an enteric coating for the composition.

2. The composition of claim 1, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of magnesium which is effective to stabilize the composition.

3. The composition of claim 1, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of calcium which is effective to stabilize the composition.

4. The composition of claim 1, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of potassium which is effective to stabilize the composition.

5. The composition of claim 1, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of sodium which is effective to stabilize the composition.

6. The composition of claim 1, wherein the composition comprises a plurality of enteric coated granules, each of the granules containing therein said active compound and said basic inorganic salt stabilizing agent.

7. A method for providing a gastic acid secretion inhibitory effect to a subject in need thereof, comprising:

orally administering to the subject a stabilized pharmaceutical composition comprising:

an effective amount of a 2-benzimidazole derivative selected from the group consisting of 2-benzimidazole and 5-methoxy-2-benzimidazole, or a pharmaceutically acceptable salt thereof;

a basic inorganic salt stabilizing agent which is present in an amount effective to stabilize the composition, the benzimidazole derivative being in contact with the basic inorganic salt evenly; and

an enteric coating for the composition.

8. The method of claim 7, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of magnesium which is effective to stabilize the composition.

9. The method of claim 7, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of calcium which is effective to stabilize the composition.

10. The method of claim 7, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of potassium which is effective to stabilize the composition.

11. The method of claim 7, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of sodium which is effective to stabilize the composition.
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