Montelukast oral disintegrating tablet formulation and its preparing method

A technology of orally disintegrating tablets and montelukast sodium, which is applied in the field of preparation of orally disintegrating tablet preparations of montelukast, can solve problems such as poor physical strength of orally disintegrating tablets, unsuitability for industrial production, and insoluble tablets , to achieve the effect of accelerating the dissolution of the main drug, the process is feasible, and the drug release is fast

Inactive Publication Date: 2008-06-11
SUZHOU DAWNRAYS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The freeze-drying method can uniformly disperse the drug in the porous structure composed of water-soluble support agents, and the disintegration speed is fast, but the physical strength of the orally disintegrating tablet is poor, the tablet is fragile, and the production process is complicated and the production cost is expensive , not suitable for industrial production
[0008] Compression molding method (non-vacuum freeze-drying method), wet tableting and wet granulation tableting methods overcome the characteristics of poor tablet strength, but the tablets made cannot be completely dissolved in the oral cavity, have a gritty feeling, and collapse. The dissolution time and drug onset time are not as fast as lyophilized orally disintegrating tablets
At the same time, these methods should not be used for drugs that are easy to decompose when exposed to water, and whose physical and chemical properties are changed when exposed to heat and humidity.

Method used

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  • Montelukast oral disintegrating tablet formulation and its preparing method
  • Montelukast oral disintegrating tablet formulation and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Preparation prescription of the present invention is made up of following components by weight

[0033] Montelukast Sodium (Containing Montelukast 40g) 41.6g

[0034] Mannitol (Pearlitol SD100) 1500g

[0035] Hydroxypropyl Methyl Cellulose E5 80g

[0036] Purified water 800g

[0037] Croscarmellose Sodium 100g

[0038] Micronized silica gel 10g

[0039] Solid lemon essence 4g

[0040] Magnesium Stearate 20g

[0041] A total of 10,000 pieces were made

[0042] Process: Feed the prescribed amount of mannitol into the fluidized bed equipped with bottom spray equipment as the base and in a fluidized state, dissolve the prescribed amount of montelukast, stabilizer, hydroxypropyl methylcellulose and micropowdered silica gel Or dispersed in purified water, sprayed on the mannitol on the base to form a particle package:

[0043] Air intake volume: about 13scfm

[0044] Inlet air temperature: about 65°C

[0045] Intake air dew point: about 15°C

[0046] Atomizing air ...

Embodiment 2

[0055] Preparation prescription of the present invention is made up of following components by weight

[0056] Montelukast Sodium (Containing Montelukast 50g) 52g

[0057] Mannitol 1700g

[0058] Microcrystalline Cellulose 300g

[0059] Polyvinylpyrrolidone 50g

[0060] Purified water 500g

[0061] Croscarmellose Sodium 100g

[0062] Orange Oil Flavor 3g

[0063] Micronized silica gel 10g

[0064] Magnesium Stearate 20g

[0065] A total of 10,000 pieces were made

[0066] Process: put montelukast sodium, mannitol pulverization and microcrystalline cellulose in a high-speed stirring granulator, mix evenly, dissolve polyvinylpyrrolidone in pure water, add a high-speed stirring granulator to granulate, dry, take out. Add orange oil essence, micronized silica gel and magnesium stearate, mix well, and press into tablets to obtain the product.

Embodiment 3

[0068] Preparation prescription of the present invention is made up of following components by weight

[0069] Montelukast Sodium (Containing Montelukast 100g) 104g

[0070] Mannitol (Pearlitol SD100) 2000g

[0071] Microcrystalline Cellulose 300g

[0072] Cross-linked polyvinylpyrrolidone 100g

[0073] Strawberry essence 5g

[0074] Micronized silica gel 20g

[0075] Magnesium Stearate 30g

[0076] A total of 10,000 pieces were made

[0077] Process: Mix montelukast sodium, mannitol, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, strawberry essence, micropowder silica gel, magnesium stearate, and press into tablets to obtain the product.

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Abstract

The present invention discloses a montelukast oral disintegrant tablet preparation and its preparation method. It is made up by using montelukast sodium as main medicine and adding other ingredient as auxiliary material through a certain preparation process. Said montelukast oral disintegrant tablet preparation can be used for curing asthma.

Description

technical field [0001] The invention relates to a drug montelukast orally disintegrating tablet for the prevention and long-term treatment of asthma in adults and children and a preparation method thereof. The product disintegrates rapidly in the mouth and can be directly ingested by the oral mucosa without water, and is suitable for use in Asthma patients who have an acute attack of the disease, have difficulty swallowing or chewing tablets, or go out without drinking water and must take temporary medication. Background technique [0002] Montelukast sodium, the chemical name is [R-(E)]-1-[[[1-[3-[2-[7-chloro-2-quinoline]vinyl]phenyl-3 -[2-(1-Hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid monosodium salt, a leukotriene used in the treatment of adults and children over 2 years of age with asthma Receptor antagonists can also be used to treat aspirin-sensitive asthmatics and prevent exercise-induced bronchoconstriction. [0003] Asthma, as a common ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/47A61P11/06
Inventor 初虹马成孝
Owner SUZHOU DAWNRAYS PHARM CO LTD
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