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Pharmaceutical composition of rosuvastatin calcium

A technology of rosuvastatin calcium and polymer, which is applied in the field of pharmaceutical compositions and can solve the problems of unstable medicine and difficult realization, etc.

Inactive Publication Date: 2017-10-17
ASTRAZENECA UK LTD LONDON
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The instability of the aforementioned agents suggests that this will be very difficult to achieve

Method used

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  • Pharmaceutical composition of rosuvastatin calcium
  • Pharmaceutical composition of rosuvastatin calcium
  • Pharmaceutical composition of rosuvastatin calcium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0124] Table 1 Example 1 formula

[0125]

[0126] Chips were coated with a mixture comprising Opadry YS-1-10925A and water. The spray was carried out at a rate of 70 g / min for 184 minutes with an inlet temperature of 70-72°C.

Embodiment 2

[0128] Table 2

[0129]

[0130] Chips were coated with a mixture comprising Opadry II 85F19250 and water. The spray was carried out at a rate of 70 g / min for 160 minutes with an inlet temperature of 70-73°C.

Embodiment 3

[0132] table 3

[0133] sub-coating

per tablet (mg)

as example 1

Drug coating

per tablet (mg)

sub-coated tablet

1293

potion

20.8

Opadry YS-1-10925A

166.4

water

3972.8

surface coating

per tablet (mg)

pharmaceutical coated tablet

1484

Opadry 03B94523

72.3

water

891.7

[0134] The coated chips were coated with a mixture of medicament, Opadry YS-1-10925A and water. The spray was carried out at a rate of 15 g / min for 330 minutes with an inlet temperature of 56.0-61.9°C.

[0135] After the drug coating was completed, the tablets were coated with a surface coating system consisting of Opadry 03B94523 and water. The spray was carried out at a rate of 15 g / min for 70 minutes with an inlet temperature of 60.8-62.5°C.

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Abstract

The invention relates to pharmaceutical composition of rosuvastatin calcium, specifically to pharmaceutical compositions containing rosuvastatin calcium of formula (I) and processes for their manufacture. Formula I is described in the description.

Description

[0001] This application is a divisional application of the invention patent application with the application number 201280024199.0, the application date is May 17, 2012, and the invention name is "the pharmaceutical composition of rosuvastatin calcium". technical field [0002] The present invention relates to a pharmaceutical composition, more specifically to a compound containing bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl) Amino]pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt (hereinafter the compound of formula I, also known as rosuvastatin calcium (rosuvastatin calcium) and hereinafter referred to as "agents") and methods for their manufacture. [0003] [0004] Formula I. Background technique [0005] This agent is disclosed as 3-hydroxy-3-methylglutaryl-CoA reductase (HMG- CoA reductase), and can be used for the treatment of hypercholesterolemia, hyperlipidproteinemia (hyperlipidproteinemia) and atherosclerosis. [0...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/32A61K9/50A61K9/16A61K47/02A61K47/38A61K47/12A61K31/505A61K31/616A61K31/155A61K31/455A61P3/06A61P9/10
CPCA61K9/167A61K9/1694A61K9/209A61K9/2813A61K9/282A61K9/2866A61K9/2886A61K9/2893A61K9/501A61K9/5015A61K9/5042A61K9/5073A61K31/155A61K31/455A61K31/505A61K31/616A61K2300/00A61K9/1676A61K9/2086A61K9/5078A61P3/06A61P43/00A61P9/10A61K9/2853A61K45/06A61K9/0053A61K9/2095A61K9/28A61K47/34A61K47/38A61K2121/00
Inventor J.R.克里克莫雷S.H.科塔里B.J.米勒Y.彭
Owner ASTRAZENECA UK LTD LONDON
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