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Claims for Patent: 6,123,962

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Claims for Patent: 6,123,962

Title: Process for producing 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, Inc. (Osaka, JP)
Application Number:09/429,957
Patent Claims: 1. A granule which comprises nonpareils coated with a mixture of a benzimidazole compound, a basic inorganic salt stabilizing agent and an additive.

2. A granule of claim 1, wherein the basic inorganic salt stabilizing agent has a pH of not less than 7 when it is in the form of a 1% aqueous solution or suspension.

3. A granule of claim 1, wherein the amount of the basic inorganic salt stabilizing agent relative to parts by weight of the benzimidazole compound is about 0.3 to 20 parts by weight.

4. A granule of claim 1, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of magnesium.

5. A granule of claim 1, wherein the basic inorganic salt stabilizing agent is a basic inorganic salt of calcium.

6. A granule of claim 1, wherein the benzimidazole compound is a compound of the formula: ##STR8## 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 from 0 to 4.

7. A granule of claim 1, wherein the benzimidazole compound is 2-[3-methyl-4-(2, 2,2-trifluoroethoxy-2-pyridyl)methylsulfinyl]benzimidazole.
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