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Stable montelukast sodium chewable-tablets and preparation method thereof

A technology of montelukast sodium and chewable tablets, which is applied in the field of leukotriene receptor antagonist montelukast sodium chewable tablets and its preparation, which can solve the problem that the SDS dissolution medium does not have the ability to distinguish, and the research has no guiding significance, etc. problems, to achieve the effects of easy control of process parameters, short production time, and good process reproducibility

Inactive Publication Date: 2019-06-04
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

From the above data, it can be seen that the dissolution medium of high concentration SDS has no distinguishing power, and has no guiding significance for the development of product formulation and process research.

Method used

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  • Stable montelukast sodium chewable-tablets and preparation method thereof
  • Stable montelukast sodium chewable-tablets and preparation method thereof
  • Stable montelukast sodium chewable-tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1 montelukast sodium chewable tablet

[0044]

[0045] Take montelukast sodium, add 46.8g of purified water to prepare a 10% by weight aqueous solution, take hydroxypropyl cellulose, add 171g of purified water to prepare a 3.41% by weight aqueous solution, and mix the two. Take microcrystalline cellulose, mannitol, croscarmellose sodium, red iron oxide, aspartame, and cherry essence and add them to the mixer, mix well and transfer to the fluidized bed, spray montelukast sodium and The aqueous solution of hydroxypropyl cellulose is granulated, dried until the water content is less than 1.5% by weight, granulated with a 30-mesh sieve, added with magnesium stearate and mixed for 8 minutes, and compressed into tablets with a rotary tablet press. Dissolution test results are shown in Table 1-3 below:

[0046] Table 1 Cumulative dissolution % of each point of 0.01% Tween pH1.0

[0047] t / min

[0048] Table 2 Cumulative dissolution % of each point of ...

Embodiment 2

[0054] Example 2 Montelukast Sodium Chewable Tablets

[0055]

[0056] Take montelukast sodium, add 46.8g of purified water to prepare a 10% by weight aqueous solution, take hydroxypropyl cellulose, add 171g of purified water to prepare a 5% by weight aqueous solution, and mix the two. Take microcrystalline cellulose, mannitol, croscarmellose sodium, red iron oxide, aspartame, and cherry essence and add them to the mixer, mix well and transfer to the fluidized bed, spray montelukast sodium and The aqueous solution of hydroxypropyl cellulose is granulated, dried until the water content is less than 1.5% by weight, granulated with a 30-mesh sieve, added with magnesium stearate and mixed for 8 minutes, and compressed into tablets with a rotary tablet press. The dissolution test results are shown in Table 4-6 below:

[0057] Table 4 Cumulative dissolution % of each point of 0.01% Tween pH1.0

[0058] t / min

[0059] Table 5 Cumulative dissolution % of each point of 0...

Embodiment 3

[0064] Example 3 Montelukast Sodium Chewable Tablets

[0065]

[0066] Take montelukast sodium, add 46.8g of purified water to prepare a 10% by weight aqueous solution, take hydroxypropyl cellulose, add 171g of purified water to prepare a 6.56% by weight aqueous solution, and mix the two. Add microcrystalline cellulose, mannitol, croscarmellose sodium, red iron oxide, aspartame, and cherry essence into a mixer, mix well and transfer to a fluidized bed, spray montelukast sodium hydroxyl The propyl cellulose aqueous solution is granulated, dried until the water content is less than 1.5% by weight, sized with a 30-mesh sieve, added with magnesium stearate and mixed for 8 minutes, and compressed into tablets with a rotary tablet press. The dissolution test results are as follows in Table 7-9:

[0067] Table 7 Cumulative dissolution % of each point of 0.01% Tween pH1.0

[0068] t / min

[0069] Table 8 Cumulative dissolution % of each point of 0.01% Tween pH4.0

[007...

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Abstract

The invention discloses stable montelukast sodium chewable-tablets. The stable montelukast sodium chewable-tablets are composed of montelukast sodium and an adhesive. A preparation method of the stable montelukast sodium chewable-tablets comprises the following steps: blending the montelukast sodium and the adhesive so as to obtain a mixed solution; and then, carrying out granulation by adopting awet method. In addition, the invention further provides a preparation method of the stable montelukast sodium chewable-tablets. The preparation method provided by the invention is simple, controllable, easy to amplify, and good in reproducibility; moreover, the prepared montelukast sodium chewable-tablets are uniform in appearance, color and luster, small in inter-batch differences, and stable inin-vitro dissolution and release.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a leukotriene receptor antagonist montelukast sodium chewable tablet and a preparation method thereof. Background technique [0002] Montelukast sodium was first developed by Merck, and the currently marketed preparations include Montelukast Sodium Tablets, Montelukast Sodium Chewable Tablets and Montelukast Sodium Granules. (Singulair). [0003] Chinese patent CN101365450A discloses a chewable tablet of montelukast sodium, which is composed of montelukast sodium, hydroxypropyl cellulose, sodium starch glycolate, mannitol, colored iron oxide, aspartame, lauryl Sodium sulfate, flavoring agent and magnesium stearate are compression molded after wet granulation process. [0004] Chinese patent CN101773481A discloses a kind of montelukast sodium chewable tablet, and it is made of montelukast sodium, microcrystalline cellulose, mannitol, povidone K30...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K31/47A61P11/06
Inventor 王磊徐浩宇蔡伟崔佳音李丹丹
Owner YANGTZE RIVER PHARM GRP CO LTD
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