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Claims for Patent: 9,066,936

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Claims for Patent: 9,066,936

Title:Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Abstract: The present invention provides a solid pharmaceutical composition containing compound (I) having an angiotensin II receptor antagonistic action and defined in the specification and a pH control agent, which composition is superior in the stability and dissolution property of compound (I).
Inventor(s): Yoneyama; Shuji (Osaka, JP), Tanoue; Yutaka (Osaka, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:12/450,403
Patent Claims: 1. A solid pharmaceutical composition comprising a compound which is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]met- hyl}-1H-benzimidazole-7-carboxylate potassium salt and a solid pH control agent which provides a pH of 3 to 5 when dissolved or suspended in water at a concentration of 1% w/v at 25.degree. C.

2. The pharmaceutical composition of claim 1, wherein the pH control agent is monosodium fumarate or a combination of fumaric acid and sodium hydroxide.

3. A method of stabilizing a compound which is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]met- hyl}-1H-benzimidazole-7-carboxylate potassium salt in a solid pharmaceutical composition or improving dissolution of a compound which is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]met- hyl}-1H-benzimidazole-7-carboxylate potassium salt from a solid pharmaceutical composition, which comprises adding a pH control agent having a pH of 3 to 5 when dissolved or suspended in water at a concentration of 1% w/v at 25.degree. C. to the solid pharmaceutical composition comprising the compound.
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