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Montelukast sodium orally disintegrating tablet and preparation method thereof

A technology for disintegrating tablets and prescriptions, applied in the field of Montelustena orally disintegrating tablets and their preparation, can solve problems such as poor control of drying temperature, migration of soluble components, easy discoloration and decomposition when exposed to light, and achieves improved bioavailability, The effect of accelerated drug dissolution and more absorption points

Inactive Publication Date: 2017-03-08
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Wet granulation is often used in the process, the drying time is long, the drying temperature is not easy to control, and the soluble components are easy to migrate during the drying process, resulting in a decrease in content and an increase in related substances. The resulting tablet has poor stability and is prone to discoloration and decomposition when exposed to light.
[0006] Patent CN1962467A discloses a granule of Montelus Turner, patent CN1287792C discloses a kind of Montelus Turner dispersible tablet, patent CN101773481A discloses a kind of chewable tablet containing Montelus Turner, the preparation of above-mentioned patents all It is prepared by the general process, and the prepared preparation is also poor in stability, and it is easy to change color and decompose when exposed to light

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1: Preparation of orally disintegrating Montelustena tablets

[0034] The prescription is:

[0035] Montelus Turner 4%

[0036] Mannitol 48.8%

[0037] Lactose monohydrate 39.5%

[0038] Cross-linked polyvinylpyrrolidone (PVPP) 5%

[0039] Red Iron Oxide 0.2%

[0040] Aspartan 0.5%

[0041] Orange flavor 0.5%

[0042] Magnesium Stearate 1.5%.

[0043] Preparation: This dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct tableting process. The specific preparation method is as follows: grind the essence, aspartame, red iron oxide, and the main drug separately and pass through an 80-mesh sieve. Spartan, red iron oxide and the main drug are mixed evenly; cross-linked polyvinylpyrrolidone is passed through a 100-mesh sieve, mannitol and lactose are respectively passed through a 40-mesh sieve, weighed according to the amount and added to the main drug mixed with essence and aspartame in sequence Mix evenly, then ...

Embodiment 2

[0045] The prescription is:

[0046] Montelus Turner 6%

[0047] Mannitol 38%

[0048] Lactose 38.3%

[0049] Microcrystalline Cellulose 10%

[0050] Red Iron Oxide 0.2%

[0051] Cross-linked polyvinylpyrrolidone (PVPP) 5%

[0052] Aspartan 0.5%

[0053] Orange flavor 0.5%

[0054] Magnesium Stearate 1.5%.

[0055]Preparation: This dosage form can be produced by using conventional tablet pharmaceutical equipment and prepared by direct tableting process. The specific preparation method is as follows: grind red iron oxide, essence, aspartame and main drug separately and pass through 80 mesh sieve, red iron oxide , essence, aspartame and the main ingredient are mixed evenly; the cross-linked polyvinylpyrrolidone is passed through a 100-mesh sieve, and the mannitol, lactose and microcrystalline cellulose are respectively passed through a 40-mesh sieve; Iron oxide and aspartame are mixed evenly in the main ingredients, then the prescribed amount of magnesium stearate is add...

Embodiment 3

[0057] The prescription is:

[0058] Montelus Turner 8%

[0059] Mannitol 42.6%

[0060] Lactose monohydrate 28.7%

[0061] Microcrystalline Cellulose (MCC PH101) 8%

[0062] Red Iron Oxide 0.2%

[0063] Low-substituted hydroxypropyl cellulose (L-HPC) 8%

[0064] Cross-linked polyvinylpyrrolidone (PVPP) 2%

[0065] Aspartan 0.5%

[0066] Orange flavor 0.5%

[0067] Magnesium Stearate 1.5%.

[0068] Preparation: The dosage form can be produced by using conventional tablet pharmaceutical equipment and prepared by dry granulation and tableting process. The specific preparation method is as follows: the main drug, red iron oxide, orange essence, aspartame, mannitol, lactose, micro Crystalline cellulose, low-substituted hydroxypropyl cellulose and cross-linked polyvinylpyrrolidone were passed through a 100-mesh sieve, weighed and added in sequence, sieved and mixed, pressed into tablets, and passed through a 24-mesh sieve for dry granulation. Then add the magnesium stearat...

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Abstract

The invention provides a montelukast sodium orally disintegrating tablet. The montelukast sodium orally disintegrating tablet is prepared by adopting a direct tabletting method and a dry granulating method, the process is simple and reproducible, the influences of the drying process as well as dampness and heat to the quality of the product are avoided, and thus the stability of the preparation is improved. The montelukast sodium orally disintegrating tablet provided by the invention rapidly disintegrates when meeting saliva so as to be dispersed into fine particles, the medicine dissolving is rapid, the distribution area in the gastrointestinal tract is large, many absorption points are available, and the bioavailability can be improved. For the patients such as infants, old people and the bedridden people having difficulty in changing body posture, the orally disintegrating tablet is convenient to take, no water is needed, no chewing is needed, so that the compliance of the patients is improved, and the clinical treatment effectiveness and emergency are improved.

Description

technical field [0001] The present invention relates to Montelus Turner, in particular to a Montelus Turner orally disintegrating tablet with improved stability and a preparation method thereof. Background technique [0002] Asthma is a chronic inflammatory disease characterized by tracheal hyperresponsiveness and reversible airway obstruction. Leukotrienes are one of the important mediators of bronchial asthma. They play a key role in the occurrence and development of asthma. Some studies have shown that the reaction caused by it is similar to the pathological changes of asthma in vivo or in vitro. Its level is higher than that of normal people during the action period or stable period. Leukotriene receptor antagonists have become a new approach in the treatment of asthma. [0003] Montelukast is a highly specific cysteine ​​leukotriene receptor antagonist, which blocks the interaction between the half peptide aminophthalein leukotriene and the receptor, thereby blocking ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/47A61K47/26A61P11/06
CPCA61K9/0056A61K9/2018A61K31/47
Inventor 冷志爽马莉
Owner AVENTIS PHARMA HAINAN
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