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Oral preparation of Tegaserod or its acid salt and its preparing process

An oral preparation, tegaserod technology, applied in the field of western medicine preparations, can solve the problems of unfavorable labor protection, high cost, and more dust, and achieves the effects of favorable labor protection, low cost, and no dust

Inactive Publication Date: 2005-10-26
孟凡清
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although the above mentioned disintegrant is added, the dissolution rate is improved, but its cost is relatively high, and there is more dust during production, which is not conducive to labor protection.

Method used

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  • Oral preparation of Tegaserod or its acid salt and its preparing process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Component Quantity (mg / grain)

[0029] Tegaserod Maleate 2.77 (Tegaserod 2mg)

[0030] Polyethylene glycol 6000 5.4

[0031] Polyethylene glycol 4000 16

[0032] Polyethylene glycol 400 5.4

[0033] Tween 80 0.3

[0034] Mint flavor 0.2

[0035] Total weight 30mg

Embodiment 2

[0037] Component Quantity (mg / grain)

[0038] Tegaserod maleate 4.16 (tegaserod 3mg)

[0039] Polyethylene glycol 4000 15.3

[0040] Tween 80 0.25

[0041] Mint flavor 0.1

[0042] Aspartame 0.2

[0043] Total weight 20mg

Embodiment 3

[0045] Component Quantity (mg / grain)

[0046] Tegaserod maleate 8.31 (tegaserod 6mg)

[0047] Polyethylene glycol 4000 16.5

[0048] Poloxamer 16.5

[0049] Mint flavor 0.2

[0050] Aspartame 0.4

[0051] Total weight 42mg

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PUM

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Abstract

The invention relates to an oral preparation containing tegaserod or its pharmaceutically acceptable salt and its preparation, wherein the oral preparation is a drop pill prepared by mixing add medicinal effective dose of tegaserod with salt and right amount of base material. The preparation method includes adding tegaserod or its acid into salt, melting it with its base material, instiling into cooling liquid, thus preparing drop pills.

Description

(1) Technical field [0001] The invention relates to an oral preparation containing tegaserod or a pharmaceutically acceptable salt thereof and a preparation method thereof, belonging to the technical field of western medicine preparations. (2) Background technology [0002] Tegaserod or 3-(5-methoxy-1H-indole-3-methylene)-N-pentyl-iminoguanidine is a 5-HT 4 Receptor partial agonists, disclosed in EP505322, it can activate 5-HT throughout the gastrointestinal tract 4 Receptors to speed up colonic transit, so it can be used to treat irritable bowel syndrome mainly manifested as constipation. Its acid addition salt is mainly used clinically, preferably maleate. [0003] It has been reported that tegaserod has a solubility in water at 25°C of about 0.02% and is acid sensitive. The prior art related to increasing the dissolution rate of oral preparations of tegaserod or pharmaceutically acceptable salts thereof is mainly achieved by adding disintegrants to the preparations, su...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/404A61P1/10
Inventor 孟凡清
Owner 孟凡清