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Claims for Patent: 5,433,959

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Claims for Patent: 5,433,959

Title: Stabilized pharmaceutical composition
Abstract:The pharmaceutical composition of the invention, which comprises a benzimidazole compound of the formula ##STR1## wherein R.sup.1 is 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:08/120,867
Patent Claims: 1. A stabilized pharmaceutical composition for the inhibition of gastric acid secretion, comprising:

an effective amount of a 2-[(2-pyridyl)methylsulphinyl]benzimidazole compound of a pharmaceutically acceptable salt thereof having a gastric acid secretion inhibitory property;

a basic inorganic salt stabilizing agent which is present in an amount effective to stabilize the composition, the benzimidazole compound or its salt 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 benzimidazole compound or its salt and the stabilizing agent.

7. A method of providing a gastric 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-[(2-pyridyl)methylsulphinyl]benzimidazole compound or a pharmaceutically acceptable salt thereof having a gastric acid secretion inhibitory property;

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

an enteric coating for the composition.

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

12. A stabilized pharmaceutical composition for the inhibition of gastric acid secretion, comprising:

an effective amount of a 2-[(2-pyridyl)methylsulphinyl]benzimidazole compound or a pharmaceutically acceptable salt thereof having a gastric acid secretion inhibitory property;

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

an enteric coating for the composition.

13. The composition of claim 12, wherein the stabilizing agent is selected from the group consisting of heavy magnesium carbonate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium metasilicate aluminate, magnesium silicate, magnesium aluminate, synthetic hydrotalcite, aluminum magnesium hydroxide, precipitated calcium carbonate and calcium hydroxide.

14. A method of providing a gastric 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-[(2-pyridyl)methylsulphinyl]benzimidazole compound or a pharmaceutically acceptable salt thereof having a gastric acid secretion inhibitory property;

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

an enteric coating for the composition.

15. The method of claim 14, wherein the stabilizing agent is selected from the group consisting of heavy magnesium carbonate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium metasilicate aluminate, magnesium silicate, magnesium aluminate, synthetic hydrotalcite, aluminum magnesium hydroxide, precipitated calcium carbonate and calcium hydroxide.
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