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Details for Patent: 6,548,513

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Details for Patent: 6,548,513

Title: Pharmaceutical compositions
Abstract:The present invention relates to pharmaceutical compositions and more particularly to a pharmaceutical composition containing (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl (methylsulfonyl)amino]pyrimidin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-enoic acid or a pharmaceutically-acceptable salt thereof as the active ingredient and an inorganic salt in which the cation is multivalent.
Inventor(s): Creekmore; Joseph R (Wilmington, DE), Wiggins; Norman A. (Wilmington, DE)
Assignee: AstraZeneca AB (Sodertalje, SE)
Filing Date:Aug 04, 2000
Application Number:09/633,114
Claims:1. A pharmaceutical composition comprising (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrim idin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-enoic acid or a pharmaceutically acceptable salt thereof as the active ingredient and an inorganic salt in which the cation is multivalent, provided that said multivalent cation is not synthetic hydrotalcite.

2. A pharmaceutical composition as claimed in claim 1 wherein the cation of the inorganic salt is selected from calcium, magnesium, zinc, aluminium and iron.

3. A pharmaceutical composition as claimed in claim 1 wherein the inorganic salt is selected from aluminium magnesium metasilicate, tribasic calcium phosphate, tribasic magnesium phosphate and tribasic aluminium phosphate.

4. A pharmaceutical composition as claimed in 3 wherein the inorganic salt is aluminium magnesium metasilicate.

5. A pharmaceutical composition as claimed in claim 1 or claim 2 which is a tablet or powder.

6. A pharmaceutical composition as claimed in claim 1 or claim 2 in which more than 5 mg of active ingredient is present.

7. A pharmaceutical composition as claimed in claim 6 in which more than 10 mg of active ingredient is present.

8. A pharmaceutical composition as claimed in claim 1 or claim 2 wherein the ratio of the inorganic salt to the active ingredient is in the range of 1:80 to 50:1 by weight.

9. A pharmaceutical composition as claimed in claim 1 or claim 2 additionally comprising one or more fillers, binders, disintegrants or lubricants.

10. A pharmaceutical composition as claimed in claim 1 or claim 2 wherein the active ingredient is present in an amount 1 to 50% by weight of the composition.

11. A pharmaceutical composition as claimed in claim 1 or claim 2 wherein the inorganic salt is present in an amount 1 to 50% by weight of the composition.

12. A pharmaceutical composition as claimed in claim 9 wherein the filler is present in an amount 30 to 90% by weight of the composition.

13. A pharmaceutical composition as claimed in claim 10 wherein the binder is present in an amount 2 to 90% by weight of the composition.

14. A pharmaceutical composition as claimed in claim 10 wherein the disintegrant is present in an amount 2 to 10% by weight of the composition.

15. A pharmaceutical composition as claimed in claim 10 wherein the lubricant is present in an amount 0.5 to 3% by weight.

16. A pharmaceutical composition as claimed in claim 1 or claim 2 wherein the active ingredient is the calcium salt of (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrim idin-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-enoic acid.

17. The method of claim 21 wherein the inorganic salt in which the cation is multivalent is selected from aluminium magnesium metasilicate, tribasic calcium phosphate, tribasic magnesium phosphate and tribasic aluminium phosphate.

18. A method of producing a stabilised pharmaceutical composition which comprises incorporating an inorganic salt in which the cation is multivalent in a pharmaceutical composition containing the compound (E)-7-[4-(4-fluorophenyl)-6-isopropyl2-[methyl(methylsulfonyl)amino]pyrimi din-5-yl]-(3R, 5S)-3,5-dihydroxyhept-6-enoic acid or a pharmaceutically acceptable salt thereof, provided that said multivalent cation is not synthetic hydrotalcite.

19. A method as claimed in claim 18 wherein the inorganic salt in which the cation is multivalent is aluminium magnesium metasilicate.
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