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Claims for Patent: 6,465,477

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Claims for Patent: 6,465,477

Title: Stable pharmaceutical composition
Abstract:Disclosed is a pharmaceutical composition comprising (E)-3,5-dihydroxy-7-[4'-4"-fluorophenyl-2'-cyclopropyl-quinolin-3'-yl]-6-h eptenoic acid, or its salt or ester, of which the aqueous solution or dispersion has pH of from 6.8 to 8. The composition has good time-dependent stability and has no change in its outward appearance even after having been stored long.
Inventor(s): Muramatsu; Toyojiro (Shizuoka, JP), Mashita; Katsumi (Fuji, JP), Shinoda; Yasuo (Shizuoka, JP), Sassa; Hironori (Numazu, JP), Kawashima; Hiroyuki (Fuji, JP), Tanizawa; Yoshio (Okayama, JP), Takeuchi; Hideatsu (Fuji, JP)
Assignee: Kowa Company, Ltd. (Aichi-Ken, JP) Nissan Chemical Industries, Ltd. (Tokyo, JP)
Application Number:09/436,789
Patent Claims: 1. A pharmaceutical composition comprising (E)-3,5-dihydroxy-7-[4'-4"-flurophenyl-2'-cyclopropyl-quinolin-3'-yl]-6-he ptenoic acid, or its salt or ester, and a pharmaceutically acceptable carrier, of which an aqueous solution or dispersion of the pharmaceutical composition has pH of from 6.8 to 7.8.

2. The pharmaceutical composition as claimed in claim 1, wherein the salt of (E)-3,5-dihydroxy-7-[4'-4"-fluorophenyl-2'-cyclopropyl-quinolin-3'-yl]-6-h eptenoic acid is a calcium salt of the acid.

3. The pharmaceutical composition of claim 1 wherein the composition further comprises a basic substance.

4. The pharmaceutical composition of claim 3 wherein the basic substance is an organic base compound.

5. The pharmaceutical composition of claim 3 wherein the basic substance is an alkaline earth metal silicate.

6. The pharmaceutical composition of claim 5 wherein the basic substance is an aluminum compound.

7. The pharmaceutical composition of claim 5 wherein the alkaline earth metal silicate is a magnesium salt.

8. The pharmaceutical composition of claim 3 wherein the basic substance is one or more selected from magnesium aluminometasilicate, magnesium aluminosilicate and magnesium aluminum silicate.

9. The pharmaceutical composition of claim 3 wherein the basic substance is L-arginie.

10. The pharmaceutical composition of claim 3 wherein the composition further comprises at least one material selected from the group consisting of vehicles, disintegrators, binders and lubricants.

11. The pharmaceutical composition of claim 3 wherein the composition further comprises a peroral solid preparation.

12. The pharmaceutical composition of claim 3 wherein the composition further comprises a lactose vehicle.

13. The pharmaceutical composition of claim 3 wherein the composition further comprises hydroxypropyl cellulose with a low degree of substitution.

14. The pharmaceutical composition of claim 3 wherein the composition further comprises a binder of hydroxy propylmethyl cellulose.

15. The pharmaceutical composition of claim 1 wherein the composition further comprises at least one material selected from the group consisting of vehicles, disintegrators, binders and lubricants.
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