.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 6,316,460

« Back to Dashboard

Claims for Patent: 6,316,460

Title: Pharmaceutical compositions
Abstract:The invention concerns a pharmaceutical composition comprising the HMG CoA reductase inhibitor (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, which remains stable over a prolonged period.
Inventor(s): Creekmore; Joseph R (Wilmington, DE), Wiggins; Norman A. (Wilmington, DE)
Assignee: Astrazeneca AB (Sodertalje, SE)
Application Number:09/633,064
Patent 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 a tribasic phosphate salt in which the cation is multivalent.

2. The pharmaceutical composition as claimed in claim 1 wherein the tribasic phosphate salt in which the cation is multivalent is selected from the group consisting of tribasic calcium phosphate, tribasic magnesium phosphate and tribasic aluminum phosphate.

3. The pharmaceutical composition as claimed in claim 1 or 2 wherein the tribasic phosphate salt in which the cation is multivalent is tribasic calcium phosphate.

4. The pharmaceutical composition as claimed in claim 1 or 2 wherein the ratio of the tribasic phosphate salt to the active ingredient is in the range of 1:80 to 50:1 by weight.

5. The pharmaceutical composition as claimed in claim 1 or 2 additionally comprising one or more fillers, binders, disintegrates or lubricants.

6. A pharmaceutical composition for oral administration 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, one or more fillers, one or more binders, one or more disintegrants, one or more lubricants and a tribasic phosphate salt in which the cation is multivalent.

7. The pharmaceutical composition as claimed in claim 6 wherein the active ingredient is present in an amount 1 to 80% by weight of the composition.

8. The pharmaceutical composition as claimed in claim 6 or 7 wherein the tribasic phosphate salt is present in an amount 1 to 50% by weight of the composition.

9. The pharmaceutical composition as claimed in claim 6 or 7 wherein the filler is present in an amount 30 to 90% by weight of the composition.

10. The pharmaceutical composition as claimed in claim 6 or 7 wherein the binder is present in an amount 2 to 90% by weight of the composition.

11. The pharmaceutical composition as claimed in claim 6 or 7 wherein the disintegrant is present in an amount 2 to 10% by weight of the composition.

12. The pharmaceutical composition as claimed in claim 6 or 7 wherein the lubricant is present in an amount 0.5 to 3% by weight.

13. 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, tribasic calcium phosphate, microcrystalline cellulose, lactose, sodium starch glycollate, butylated hydroxytoluene and magnesium stearate.

14. 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, tribasic calcium phosphate, povidone, microcrystalline cellulose, mannitol, sodium starch glycollate, butylated hydroxytoluene and magnesium stearate.

15. 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, tribasic calcium phosphate, crospovidone, microcrystalline cellulose, lactose and magnesium stearate.

16. 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, tribasic calcium phosphate, povidone, microcrystalline cellulose, lactose, sodium starch glycollate, butylated hydroxytoluene and magnesium stearate.

17. The pharmaceutical composition as claimed in claim 1, 2, 6, 13, 14, 15 or 16 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.

18. A method of producing a stabilised pharmaceutical composition, said method comprising the step of incorporating a tribasic phosphate salt in which the cation is multivalent in a pharmaceutical composition containing the compound (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.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc