Controlled release preparation of clarithromycin or tinidazole

A technology for controlled release preparations and clarithromycin, which is applied in the directions of medical preparations containing active ingredients, pill delivery, organic active ingredients, etc., and can solve problems such as water-soluble low-dose high-dose drugs

Inactive Publication Date: 2005-02-02
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Therefore, so far, none of the oral control drug delivery systems can fully meet the needs of delivering high-dose drugs with low water solubility.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] This example involves the use of 2.37% of the total rate controlling cellulose ether polymer (hydroxypropyl methylcellulose mixtures of viscosities of 15000 and 4000 cps available under the trade names Methocel K15 MCR and Methocel K4 MCR, respectively). Tinidazole controlled-release tablet.

[0038] Element

mg / tablet

Composition % (wt / wt)

tinidazole

1000.0

87.1

Methocel K15 MCR®

17.5

1.5

Methocel K4 MCR®

10.0

0.87

lactose

50.0

4.36

Polyvinylpyrrolidone K30

25.0

2.18

Talc

10.0

0.87

Colloidal silica

5.0

0.44

Sodium Octadecyl Fumarate

31.5

2.74

Magnesium stearate

1.0

0.1

total

1148.0

[0039] The drug was blended with the two polymers and lactose and granulated with polyvinylpyrrolidone solution in water. The granules are drie...

Embodiment 2

[0044] This example describes clarithromycin controlled release tablets made using 3.23% total rate controlling cellulose ether polymer (a blend of 4000 and 15000 cps viscosity grades of hydroxypropyl methylcellulose).

[0045] Element

mg / tablet

Composition % (wt / wt)

clarithromycin

1000.0

86.1

Methocel K15 MCR®

25

2.15

Methocel K4 MCR®

12.5

1.08

lactose

50.0

4.3

Sodium Octadecyl Fumarate

20.0

1.72

Magnesium stearate

12.5

1.08

Talc

10.0

0.86

Colloidal silica

0.5

0.43

total

1161.5

[0046] Clarithromycin was blended with both polymers and lactose and wet granulated with water. The granules are dried, coated, lubricated and compressed into tablets.

[0047] The tablets thus obtained are optionally film-coated. Tablets were tested for drug release in USP Appa...

Embodiment 3

[0050] The Tinidazole controlled-release tablets prepared in this example used 1.2% of the total rate controlling cellulose ether polymer (mixture of 15000 and 4000 cps hydroxypropyl methylcellulose).

[0051] Element

mg / tablet

Composition % (wt / wt)

Tinidazole

1000.0

86.5

Methocel K15 MCR®

10.0

0.865

Methocel K4 MCR®

4.0

0.346

Starch 1500

75.0

6.5

Polyvinylpyrrolidone K30

15.0

1.3

Talc

10.0

0.865

Sodium Octadecyl Fumarate

31.5

2.73

Colloidal silica

5.0

0.43

Magnesium stearate

5.0

0.43

total

1155.5

[0052] The drug was blended with the two polymers and lactose and granulated with starch 1500 in water. The granules are dried, coated, lubricated and compressed into tablets.

[0053] The tablets thus obtained are optionally film-coate...

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PUM

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Abstract

The present invention relates to a controlled release pharmaceutical composition comprising amounts ranging from about 0.1 to about 4.5% w / w, of one or more of rate controlling cellulosic ether polymers.

Description

field of invention [0001] The present invention relates to controlled release pharmaceutical compositions comprising about 0.1-4.5% (w / w) of one or more rate controlling cellulose ether polymers. Background of the invention [0002] Those skilled in the art are familiar with the optimal therapeutic effect of such controlled release formulations, which are effective in maintaining therapeutic blood levels for prolonged periods of time. Not only do they reduce the frequency of dosing, facilitating patient compliance; they also reduce the severity and frequency of side effects because they maintain essentially constant blood levels, avoiding the need for conventional immediate-release formulations that are taken 3-4 times a day resulting fluctuations. However, it is difficult to develop controlled-release formulations of high-dose drugs due to unacceptable large-sized finished dosage forms. [0003] To overcome the size and compliance problems encountered by patients, Abbott ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/22
CPCA61K9/2054
Inventor A·兰珀尔R·S·拉格胡凡世M·库马
Owner RANBAXY LAB LTD
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