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A Montelukast sodium and pulse technology, applied in respiratory diseases, pharmaceutical formulations, block delivery, etc.
Active Publication Date: 2014-01-22
TIANYAO PHARMA TECH DEV SHANGHAI
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[0009] The above patents at home and abroad have not yet seen reports on Montelukast sodium pulse pellets
Method used
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Embodiment 1
[0024] Take 33g of montelukast sodium and 220g of lactose, place in a wet method, mix for 180 seconds, then add 550g of microcrystalline cellulose, and mix for 180 seconds; take 587g of ethyl cellulose aqueous dispersion (ECD30), add sebacic acid di 44g of butyl ester, stirred for 120 minutes and then added to the wet granulator under stirring to produce soft material; then the soft material was extruded through a 0.6mm screen, and then rounded. Transfer the wet pellets to a fluidized bed for drying, set the inlet air temperature at 60°C, dry until LOD<3.0%, discharge, and sieve to remove sticky and fine particles.
[0025] Take 930g of the aforementioned finished pellets and transfer them to a fluidized bed; take 70g of Opadry Clear, add water to prepare a 15% coating solution, spray it into the fluidized bed, and keep the temperature of the material at 38°C to 45°C; after coating, continue to dry until LOD<3.0%.
[0026] Take 20g of Montelukast Sodium and 20g of HPC EF, add...
Embodiment 2
[0028] Take 800g blank pellet core and put it in the fluidized bed; take 30g of montelukast sodium raw material and HPMC E530g, add 540g of water, stir well and spray into the fluidized bed, keep the temperature of the material at 38°C-45°C, and finish spraying After that, continue to dry until LOD SR30D170g, NE30D267g, GMS6g, Tween803g, add appropriate amount of water, make a coating solution with a solid content of 15%, continue to spray into the fluidized bed, control the temperature of the material at 25 ° C ~ 28 ° C, after spraying, add 1% hard pellets Calcium fatty acid, continue to dry, make the material temperature reach 38 ℃ ~ 42 ℃, keep for 30 minutes.
[0029] Take 20g of Montelukast Sodium and 20g of HPC EF, add 360g of water, stir to fully dissolve; put the above-mentioned pellets in a fluidized bed, spray the above-mentioned Montelukast Sodium and HPC EF suspension, and keep the material temperature at 35°C ~45°C; after spraying, take 60g of Opadry White, add w...
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Abstract
The invention relates to an oral solid drug dosage form containing montelukast sodium as a single active drug. The dosage form is prepared from a slow-release kernel and a quick-release outer layer, wherein the slow-release kernel can be prepared from blank-pellets coated by slow-release garments after loading a drug, also can be prepared from a main drug and other proper slow-release macromolecule after extrusion and spheronization, and then the quick-release outer layer is prepared on the slow-release kernel in a manner of loading the drug; the pellets can be filled into the capsules or tabletted. Compared with a common preparation, the novel pulsed release capsules disclosed by the invention achieve the peak plasma concentration at the moment that asthma easily breaks out before dawn; the target of enough time to treat can be met; the medication availability and security of an asthma patient are improved.
Description
technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a time-selective pulse-release pellet of montelukast sodium, which mixes pellets with different drug release speeds to form tablets or capsules for oral administration. Background technique [0002] Asthma is an allergic disease that occurs on the basis of airway hyperresponsiveness, and its essence is chronic non-specific airway inflammation. Clinically, the leukotriene receptor antagonist montelukast sodium For the treatment of asthma in adults 15 years of age and older. Leukotrienes are an important inflammatory mediator of asthma, and blocking leukotrienes can reduce the acute attack of asthma. The pharmacological effect of montelukast sodium is to selectively inhibit the activity of leukotriene polypeptides in airway smooth muscle, reduce the expression of vascular endothelial growth factor to adjust vascular permeability, improve airway edema, and effectively pr...
Claims
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Application Information
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