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Rosiglitazone maleate dispersible tablet and preparation method thereof

A technology of rosiglitazone maleate and dispersible tablets, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problem of no rosiglitazone maleate dispersible tablets and other problems, to achieve the effect of long-term storage quality stability, novel dosage form, and good absorption

Inactive Publication Date: 2008-04-30
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no rosiglitazone maleate dispersible tablet on the market

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Rosiglitazone Maleate 5%

[0022] Sodium Carboxymethyl Starch 5%

[0023] Lactose 69.5%

[0024] Microcrystalline Cellulose 20%

[0025] Magnesium Stearate 0.5%

[0026] 50% ethanol appropriate amount

[0027] The above raw materials are passed through a 200-mesh sieve, and the auxiliary materials are passed through a 100-mesh sieve, granulated by a wet method, and pressed into dispersible tablets.

[0028] The specific preparation method is:

[0029] Add the above-mentioned rosiglitazone maleate, filler lactose, and microcrystalline cellulose in equal amounts, and add the disintegrant sodium carboxymethyl starch to mix the raw and auxiliary materials evenly;

[0030] (2) Use 50% ethanol to make soft materials, granulate with a 16-24 mesh sieve, and dry the wet granules at 50-80°C;

[0031] (3) 16-24 mesh sieve, granulate, add lubricant magnesium stearate, press, obtain rosiglitazone maleate dispersible tablet.

Embodiment 2

[0033] Rosiglitazone Maleate 10%

[0034] Crospovidone 10%

[0035] Lactose 50%

[0036] Starch 29.5%

[0037] Talc 0.5%

[0038] 50% ethanol appropriate amount

[0039] The above raw materials are passed through a 200-mesh sieve, and the auxiliary materials are passed through a 100-mesh sieve, granulated by a wet method, and pressed into dispersible tablets. The specific preparation process is the same as in Example 1.

Embodiment 3

[0041] Rosiglitazone Maleate 5%

[0042] Low-substituted hydroxypropyl cellulose 20%

[0043] Lactose 40%

[0044] Dextrin 34.5%

[0045] Magnesium Lauryl Sulfate 0.5%

[0046] 50% ethanol appropriate amount

[0047] The above raw materials are passed through a 200-mesh sieve, and the auxiliary materials are passed through a 100-mesh sieve, granulated by a wet method, and pressed into dispersible tablets. The specific preparation process is the same as in Example 1.

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PUM

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Abstract

The invention discloses a new preparation of rosiglitazone maleate: rosiglitazone maleate tablets and a process for preparation, which is made of rosiglitazone maleate 1-20%, disintegration agent 1-70%, bulking agent 10-90%, and lubricating agent 0.1-2%. The invention of rosiglitazone maleate tablets have the advantages of novel preparation, convenient intaking, excellent absorbability, less stimulation on the gastrointestinal tract, stable quality for long-term storage, and especially adapt to the old and the patient with deglutition difficulties. The preparation technique is simple and has no particular requirement on equipment, which adapts to large-scale production. The invention can be used to prepare the medicament for the treatment of II-type diabetes mellitus.

Description

technical field [0001] The invention relates to the technical field of medicine and pharmacy, in particular to a rosiglitazone maleate dispersible tablet and a preparation method thereof. Background technique [0002] Rosiglitazone maleate is a thiazolidinedione insulin sensitizer approved by the U.S. FDA in May 1999, and its chemical name is (±)-5-[[4-[2-(methyl-2- Pyridylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione-maleate for the treatment of non-insulin-dependent (type II) diabetic patients. As a highly selective PPARγ agonist, rosiglitazone maleate controls blood glucose levels by improving insulin sensitivity. Its main mechanism of action is to activate the PPARγ nuclear receptors in insulin-acting tissues such as fat, skeletal muscle, and liver, thereby regulating the transcription of insulin-responsive genes and controlling the production, transport, and utilization of blood sugar. The results of clinical trials show that in addition to reducing insulin resist...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/20A61K47/38A61P3/10
Inventor 杨亚军冯海俊张志华
Owner KANGYA OF NINGXIA PHARMA
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