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Indacaterol tablet and preparation method thereof

A technology of indacaterol tablets and indacaterol, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of slow disintegration of tablets and slow drug speed , to achieve high dissolution rate, reduce equipment and operation costs, and excellent appearance

Inactive Publication Date: 2014-06-04
熊妲妮
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets prepared by wet granulation were slower to disintegrate and release drug into the dissolution medium at a slower rate

Method used

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  • Indacaterol tablet and preparation method thereof
  • Indacaterol tablet and preparation method thereof
  • Indacaterol tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048]

[0049] A total of 70.18g 100% made into 1000 pieces

[0050] Preparation method: pulverize the indacaterol raw material with an airflow mill, weigh 1000 pieces of indacaterol raw material of the prescription amount, and set aside; The croscarmellose sodium and carboxymethyl starch sodium are fully mixed, and then fully mixed with the prescribed amount of microcrystalline cellulose, direct-pressed lactose, and magnesium stearate in turn; the mixed powder is tested for bulk density, angle of repose , according to the content conversion, the weight of the tablet should be compressed, and the tablet should be pressed to adjust the hardness of the tablet The loading difference is ±5.0%.

Embodiment 2

[0052]

[0053] A total of 70.18g 100% made into 1000 pieces

[0054] Preparation method: pulverize the indacaterol raw material with an airflow mill, weigh 1000 pieces of indacaterol raw material of the prescription amount, and set aside; The croscarmellose sodium is fully mixed, and then fully mixed with the prescribed amount of pregelatinized starch, sodium hydroxymethyl starch, microcrystalline cellulose, direct-pressed lactose, and magnesium stearate; the mixed material is tested After the content is determined, the weight of the tablet should be converted according to the content, and the tablet should be pressed to adjust the hardness of the tablet The loading difference is ±5.0%.

Embodiment 3

[0056]

[0057] A total of 70.18g 100% made into 1000 pieces

[0058] Preparation method: pulverize the raw material of indacaterol with a jet mill, weigh 1000 tablets of the raw material of indacaterol in the prescribed amount, and set aside; adopt the method of increasing the amount of indacaterol, first mix the raw material of indacaterol and the raw material of the prescribed amount Sodium carboxymethyl starch is fully mixed, and then fully mixed with pregelatinized starch, microcrystalline cellulose, direct-pressed lactose, and magnesium stearate in sequence; after the mixed powder detects the angle of repose and bulk density content, according to The content conversion should be based on the weight of the tablet, and the tablet should be pressed to adjust the hardness of the tablet The loading difference is ±5.0%.

[0059] The dissolution curves of the above-mentioned examples were measured respectively, and the results are shown in Table 1.

[0060] Table 1 each e...

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Abstract

The invention provides an indacaterol tablet and a preparation method thereof. According to the method, the indacaterol tablet is prepared in a manner that the powder is directly pressed to form the tablet. Thus, the production process is simple; the production cycle is shortened; and the equipment cost and the operating cost are lowered. The prepared indacaterol tablet is good in appearance, smooth in technological process, good in operability as well as high in dissolubility and has the qualified content uniformity; and the good bioavailability of the indacaterol tablet in a human body is realized. Thus, a good treatment effect is obtained.

Description

field of invention [0001] The invention belongs to the field of medicines, and in particular relates to tablets containing indacaterol and a preparation method thereof. Background of the invention [0002] Indacaterol is a bronchodilator that belongs to the long-acting inhaled β2-adrenergic receptor agonist (LABA) class and is suitable for the maintenance treatment of adult patients with chronic obstructive pulmonary disease (COPD). It takes effect in 5 minutes and lasts for 24 hours. Indacaterol is produced by Swiss Novartis Pharmaceuticals and has been listed in more than 70 countries and regions around the world since 2009; it was approved by the State Food and Drug Administration in June 2012 to be listed in China. It is the first LABA approved for the treatment of COPD in my country class of single preparations. Clinical trials have shown that taking indacaterol once a day can cause bronchodilation for more than 24 hours, and its bronchodilation time is longer than tha...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4704A61K47/38A61K47/26A61K47/36A61P11/08A61P11/06
Inventor 熊妲妮王爱华孙文娟程志娟薛红
Owner 熊妲妮
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